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Study finds most adverse events from microneedling are minimal
according to the results of a systematic review of nearly 3,000 patients.
Microneedling involves the use of instruments including dermarollers and microneedling pens to cause controlled microtraumas at various skin depths and induce a wounding cascade that ultimately improves the visual appearance of the skin, Sherman Chu, DO, of the department of dermatology at the University of California, Irvine, and colleagues wrote.
Microneedling has increased in popularity because of its relatively low cost, effectiveness, and ease of use, and is often promoted as “a safe alternative treatment, particularly in skin of color, but the safety of microneedling and its complications are not often discussed,” the researchers noted.
In the study, published in Dermatologic Surgery, Dr. Chu and coauthors identified 85 articles for the systematic review of safety data on microneedling. The studies included 30 randomized, controlled trials; 24 prospective studies; 16 case series; 12 case reports; and 3 retrospective cohort studies, with a total of 2,805 patients treated with microneedling.
The devices used in the studies were primarily dermarollers (1,758 procedures), but 425 procedures involved dermapens, and 176 involved unidentified microneedling devices.
The most common adverse effect after microneedling with any device was any of anticipated transient procedural side effects including transient erythema or edema, pain, burning, bruising, pruritus, stinging, bleeding, crusting, and desquamation. Overall, these effects resolved within a week with little or no treatment, the researchers said.
The most commonly reported postprocedure side effects of microneedling were postinflammatory hyperpigmentation (46 incidents), followed by dry skin and exfoliation (41 incidents). Fewer than 15 incidents were reported of each the following: acne flare, pruritus, persistent erythema, herpetic infection, flushing, seborrheic dermatitis, burning, headache, stinging, milia, tram-track scarring, facial allergic granulomatous reaction and systematic hypersensitivity, and tender cervical lymphadenopathy. In addition, one incident each was reported of periorbital dermatitis, phototoxic reaction, pressure urticaria, irritant contact dermatitis, widespread facial inoculation of varicella, pustular folliculitis, and tinea corporis.
The studies suggest that microneedling is generally well tolerated, the researchers wrote. Factors that increased the risk of adverse events included the presence of active infections, darker skin types, metal allergies, and the use of combination therapies. For example, they noted, one randomized, controlled trial showed greater skin irritation in patients treated with both microneedling and tranexamic acid compared with those treated with tranexamic acid alone.
Other studies described increased risk of postinflammatory hyperpigmentation in patients treated with both microneedling and platelet-rich plasma, and with microneedling and topical 5-FU or tacrolimus. Also, in one of the studies in the review, “the development of a delayed granulomatous hypersensitivity reaction in 2 patients was attributed to a reaction to vitamin C serum, whereas another study attributes vitamin A and vitamin C oil to be the cause of a patient’s prolonged erythema and pruritus,” the researchers said.
The study findings were limited to adverse events reported by clinicians in published literature, and did not account for adverse events that occur when microneedling is performed at home or in medical spas. Although the results suggest that microneedling is relatively safe for patients of most skin types, “great caution should be taken when performing microneedling with products not approved to be used intradermally,” they emphasized.
“Further studies are needed to determine which patients are at a higher chance of developing scarring because depth of the needle and skin type do not directly correlate as initially believed,” they concluded.
Microneedling offers safe alternative to lasers
“Microneedling is a popular procedure that can be used as an alternative to laser treatments to provide low down time, and lower-cost treatments for similar indications in which lasers are used, such as rhytides and scars,” Catherine M. DiGiorgio, MD, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, said in an interview.
“Many clinicians and/or providers utilize microneedling in their practice also because they may not have the ability to perform laser and energy-based device treatments,” noted Dr. DiGiorgio, who was asked to comment on the study findings. “Microneedling is safer than energy-based devices in darker skin types due to the lack of energy or heat being delivered to the epidermis. However, as shown in this study, darker skin types remain at risk for [postinflammatory hyperpigmentation], particularly in the hands of an unskilled, inexperienced operator.”
Dr. DiGiorgio said she was not surprised by the study findings. “Microneedling creates microwounds in the skin, which contributes to the risk of all of the side effects listed in the study. Further, the proper use of microneedling devices by the providers performing the procedure is variable and depths of penetration can vary based on which device or roller pen is used and the experience of the person performing the procedures. Depth, after a certain point, can be inaccurate and can superficially abrade the epidermis rather than the intended individual microneedle punctures.”
Laser and energy-based device treatments can be performed safely in patients with darker skin types in the hands of skilled and experienced laser surgeons, said Dr. DiGiorgio. However, “more studies are needed to determine the effectiveness of microneedling alone compared to other treatment modalities. Patients tend to select microneedling due to affordability and less down time; however, sometimes it may not be the best treatment option for their skin condition.
“Patient education is an important factor because one treatment that worked for one of their friends, for example, may not be the best treatment option for their skin complaints.”
Dr. DiGiorgio added that there are few randomized, controlled trials comparing microneedling to laser treatment. “More studies of this nature would benefit the scientific literature and the addition of histological analysis would help us better understand how these treatments compare on a microscopic level.”
The study received no outside funding and the author has no disclosures. Dr. DiGiorgio has served as a consultant for Allergan Aesthetics.
according to the results of a systematic review of nearly 3,000 patients.
Microneedling involves the use of instruments including dermarollers and microneedling pens to cause controlled microtraumas at various skin depths and induce a wounding cascade that ultimately improves the visual appearance of the skin, Sherman Chu, DO, of the department of dermatology at the University of California, Irvine, and colleagues wrote.
Microneedling has increased in popularity because of its relatively low cost, effectiveness, and ease of use, and is often promoted as “a safe alternative treatment, particularly in skin of color, but the safety of microneedling and its complications are not often discussed,” the researchers noted.
In the study, published in Dermatologic Surgery, Dr. Chu and coauthors identified 85 articles for the systematic review of safety data on microneedling. The studies included 30 randomized, controlled trials; 24 prospective studies; 16 case series; 12 case reports; and 3 retrospective cohort studies, with a total of 2,805 patients treated with microneedling.
The devices used in the studies were primarily dermarollers (1,758 procedures), but 425 procedures involved dermapens, and 176 involved unidentified microneedling devices.
The most common adverse effect after microneedling with any device was any of anticipated transient procedural side effects including transient erythema or edema, pain, burning, bruising, pruritus, stinging, bleeding, crusting, and desquamation. Overall, these effects resolved within a week with little or no treatment, the researchers said.
The most commonly reported postprocedure side effects of microneedling were postinflammatory hyperpigmentation (46 incidents), followed by dry skin and exfoliation (41 incidents). Fewer than 15 incidents were reported of each the following: acne flare, pruritus, persistent erythema, herpetic infection, flushing, seborrheic dermatitis, burning, headache, stinging, milia, tram-track scarring, facial allergic granulomatous reaction and systematic hypersensitivity, and tender cervical lymphadenopathy. In addition, one incident each was reported of periorbital dermatitis, phototoxic reaction, pressure urticaria, irritant contact dermatitis, widespread facial inoculation of varicella, pustular folliculitis, and tinea corporis.
The studies suggest that microneedling is generally well tolerated, the researchers wrote. Factors that increased the risk of adverse events included the presence of active infections, darker skin types, metal allergies, and the use of combination therapies. For example, they noted, one randomized, controlled trial showed greater skin irritation in patients treated with both microneedling and tranexamic acid compared with those treated with tranexamic acid alone.
Other studies described increased risk of postinflammatory hyperpigmentation in patients treated with both microneedling and platelet-rich plasma, and with microneedling and topical 5-FU or tacrolimus. Also, in one of the studies in the review, “the development of a delayed granulomatous hypersensitivity reaction in 2 patients was attributed to a reaction to vitamin C serum, whereas another study attributes vitamin A and vitamin C oil to be the cause of a patient’s prolonged erythema and pruritus,” the researchers said.
The study findings were limited to adverse events reported by clinicians in published literature, and did not account for adverse events that occur when microneedling is performed at home or in medical spas. Although the results suggest that microneedling is relatively safe for patients of most skin types, “great caution should be taken when performing microneedling with products not approved to be used intradermally,” they emphasized.
“Further studies are needed to determine which patients are at a higher chance of developing scarring because depth of the needle and skin type do not directly correlate as initially believed,” they concluded.
Microneedling offers safe alternative to lasers
“Microneedling is a popular procedure that can be used as an alternative to laser treatments to provide low down time, and lower-cost treatments for similar indications in which lasers are used, such as rhytides and scars,” Catherine M. DiGiorgio, MD, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, said in an interview.
“Many clinicians and/or providers utilize microneedling in their practice also because they may not have the ability to perform laser and energy-based device treatments,” noted Dr. DiGiorgio, who was asked to comment on the study findings. “Microneedling is safer than energy-based devices in darker skin types due to the lack of energy or heat being delivered to the epidermis. However, as shown in this study, darker skin types remain at risk for [postinflammatory hyperpigmentation], particularly in the hands of an unskilled, inexperienced operator.”
Dr. DiGiorgio said she was not surprised by the study findings. “Microneedling creates microwounds in the skin, which contributes to the risk of all of the side effects listed in the study. Further, the proper use of microneedling devices by the providers performing the procedure is variable and depths of penetration can vary based on which device or roller pen is used and the experience of the person performing the procedures. Depth, after a certain point, can be inaccurate and can superficially abrade the epidermis rather than the intended individual microneedle punctures.”
Laser and energy-based device treatments can be performed safely in patients with darker skin types in the hands of skilled and experienced laser surgeons, said Dr. DiGiorgio. However, “more studies are needed to determine the effectiveness of microneedling alone compared to other treatment modalities. Patients tend to select microneedling due to affordability and less down time; however, sometimes it may not be the best treatment option for their skin condition.
“Patient education is an important factor because one treatment that worked for one of their friends, for example, may not be the best treatment option for their skin complaints.”
Dr. DiGiorgio added that there are few randomized, controlled trials comparing microneedling to laser treatment. “More studies of this nature would benefit the scientific literature and the addition of histological analysis would help us better understand how these treatments compare on a microscopic level.”
The study received no outside funding and the author has no disclosures. Dr. DiGiorgio has served as a consultant for Allergan Aesthetics.
according to the results of a systematic review of nearly 3,000 patients.
Microneedling involves the use of instruments including dermarollers and microneedling pens to cause controlled microtraumas at various skin depths and induce a wounding cascade that ultimately improves the visual appearance of the skin, Sherman Chu, DO, of the department of dermatology at the University of California, Irvine, and colleagues wrote.
Microneedling has increased in popularity because of its relatively low cost, effectiveness, and ease of use, and is often promoted as “a safe alternative treatment, particularly in skin of color, but the safety of microneedling and its complications are not often discussed,” the researchers noted.
In the study, published in Dermatologic Surgery, Dr. Chu and coauthors identified 85 articles for the systematic review of safety data on microneedling. The studies included 30 randomized, controlled trials; 24 prospective studies; 16 case series; 12 case reports; and 3 retrospective cohort studies, with a total of 2,805 patients treated with microneedling.
The devices used in the studies were primarily dermarollers (1,758 procedures), but 425 procedures involved dermapens, and 176 involved unidentified microneedling devices.
The most common adverse effect after microneedling with any device was any of anticipated transient procedural side effects including transient erythema or edema, pain, burning, bruising, pruritus, stinging, bleeding, crusting, and desquamation. Overall, these effects resolved within a week with little or no treatment, the researchers said.
The most commonly reported postprocedure side effects of microneedling were postinflammatory hyperpigmentation (46 incidents), followed by dry skin and exfoliation (41 incidents). Fewer than 15 incidents were reported of each the following: acne flare, pruritus, persistent erythema, herpetic infection, flushing, seborrheic dermatitis, burning, headache, stinging, milia, tram-track scarring, facial allergic granulomatous reaction and systematic hypersensitivity, and tender cervical lymphadenopathy. In addition, one incident each was reported of periorbital dermatitis, phototoxic reaction, pressure urticaria, irritant contact dermatitis, widespread facial inoculation of varicella, pustular folliculitis, and tinea corporis.
The studies suggest that microneedling is generally well tolerated, the researchers wrote. Factors that increased the risk of adverse events included the presence of active infections, darker skin types, metal allergies, and the use of combination therapies. For example, they noted, one randomized, controlled trial showed greater skin irritation in patients treated with both microneedling and tranexamic acid compared with those treated with tranexamic acid alone.
Other studies described increased risk of postinflammatory hyperpigmentation in patients treated with both microneedling and platelet-rich plasma, and with microneedling and topical 5-FU or tacrolimus. Also, in one of the studies in the review, “the development of a delayed granulomatous hypersensitivity reaction in 2 patients was attributed to a reaction to vitamin C serum, whereas another study attributes vitamin A and vitamin C oil to be the cause of a patient’s prolonged erythema and pruritus,” the researchers said.
The study findings were limited to adverse events reported by clinicians in published literature, and did not account for adverse events that occur when microneedling is performed at home or in medical spas. Although the results suggest that microneedling is relatively safe for patients of most skin types, “great caution should be taken when performing microneedling with products not approved to be used intradermally,” they emphasized.
“Further studies are needed to determine which patients are at a higher chance of developing scarring because depth of the needle and skin type do not directly correlate as initially believed,” they concluded.
Microneedling offers safe alternative to lasers
“Microneedling is a popular procedure that can be used as an alternative to laser treatments to provide low down time, and lower-cost treatments for similar indications in which lasers are used, such as rhytides and scars,” Catherine M. DiGiorgio, MD, a laser and cosmetic dermatologist at the Boston Center for Facial Rejuvenation, said in an interview.
“Many clinicians and/or providers utilize microneedling in their practice also because they may not have the ability to perform laser and energy-based device treatments,” noted Dr. DiGiorgio, who was asked to comment on the study findings. “Microneedling is safer than energy-based devices in darker skin types due to the lack of energy or heat being delivered to the epidermis. However, as shown in this study, darker skin types remain at risk for [postinflammatory hyperpigmentation], particularly in the hands of an unskilled, inexperienced operator.”
Dr. DiGiorgio said she was not surprised by the study findings. “Microneedling creates microwounds in the skin, which contributes to the risk of all of the side effects listed in the study. Further, the proper use of microneedling devices by the providers performing the procedure is variable and depths of penetration can vary based on which device or roller pen is used and the experience of the person performing the procedures. Depth, after a certain point, can be inaccurate and can superficially abrade the epidermis rather than the intended individual microneedle punctures.”
Laser and energy-based device treatments can be performed safely in patients with darker skin types in the hands of skilled and experienced laser surgeons, said Dr. DiGiorgio. However, “more studies are needed to determine the effectiveness of microneedling alone compared to other treatment modalities. Patients tend to select microneedling due to affordability and less down time; however, sometimes it may not be the best treatment option for their skin condition.
“Patient education is an important factor because one treatment that worked for one of their friends, for example, may not be the best treatment option for their skin complaints.”
Dr. DiGiorgio added that there are few randomized, controlled trials comparing microneedling to laser treatment. “More studies of this nature would benefit the scientific literature and the addition of histological analysis would help us better understand how these treatments compare on a microscopic level.”
The study received no outside funding and the author has no disclosures. Dr. DiGiorgio has served as a consultant for Allergan Aesthetics.
FROM DERMATOLOGIC SURGERY
Choosing Wisely campaign targets waste and overuse in hospital pediatrics
“Health care spending and health care waste is a huge problem in the U.S., including for children,” Vivian Lee, MD, of Children’s Hospital, Los Angeles, said in a presentation at the 2021 virtual Pediatric Hospital Medicine conference.
Data from a 2019 study suggested that approximately 25% of health care spending in the United States qualifies as “wasteful spending,” in categories such as overtesting, and unnecessary hospitalization, Dr. Lee said. “It is essential for physicians in hospitals to be stewards of high-value care,” she emphasized.
To combat wasteful spending and control health care costs, the Choosing Wisely campaign was created in 2012 as an initiative from the American Board of Internal Medicine Foundation. An ongoing goal of the campaign is to raise awareness among physicians and patients about potential areas of low-value services and overuse. The overall campaign includes clinician-driven recommendations from multiple medical organizations.
The PHM produced its first set of five recommendations in 2012, Dr. Lee said. These recommendations, titled “Five Things Physicians and Patients Should Question,” have been updated for 2021. The updated recommendations were created as a partnership among the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine. A joint committee reviewed the latest evidence, and the updates were approved by the societies and published by the ABIM in January 2021.
“We think these recommendations truly reflect an exciting and evolving landscape for pediatric hospitalists,” Dr. Lee said. “There is a greater focus on opportunities to transition out of the hospital sooner, or avoid hospitalization altogether. There is an emphasis on antibiotic stewardship and a growing recognition of the impact that overuse may have on our vulnerable neonatal population,” she said. Several members of the Choosing Wisely panel presented the recommendations during the virtual presentation.
Revised recommendations
The new “Five Things Physicians and Patients Should Question” are as follows:
1. Do not prescribe IV antibiotics for predetermined durations for patients hospitalized with infections such as pyelonephritis, osteomyelitis, and complicated pneumonia. Consider early transition to oral antibiotics.
Many antibiotic doses used in clinical practice are preset durations that are not based on high-quality evidence, said Mike Tchou, MD, of Children’s Hospital of Colorado in Aurora. However, studies now show that earlier transition to enteral antibiotics can improve a range of outcomes including neonatal UTIs, osteomyelitis, and complicated pneumonia, he said. Considering early transition based on a patient’s response can decrease adverse events, pain, length of stay, and health care costs, he explained.
2. Do not continue hospitalization in well-appearing febrile infants once bacterial cultures (i.e., blood, cerebrospinal, and/or urine) have been confirmed negative for 24-36 hours, if adequate outpatient follow-up can be assured.
Recent data indicate that continuing hospitalization beyond 24-36 hours of confirmed negative bacterial cultures does not improve clinical outcomes for well-appearing infants admitted for concern of serious bacterial infection, said Paula Soung, MD, of Children’s Wisconsin in Milwaukee. In fact, “blood culture yield is highest in the first 12-36 hours after incubation with multiple studies demonstrating > 90% of pathogen cultures being positive by 24 hours,” Dr. Soung said. “If adequate outpatient follow-up can be assured, discharging well-appearing febrile infants at 24-36 hours after confirming cultures are negative has many positive outcomes,” she said.
3. Do not initiate phototherapy in term or late preterm well-appearing infants with neonatal hyperbilirubinemia if their bilirubin is below levels at which the AAP guidelines recommend treatment.
In making this recommendation, “we considered that the risk of kernicterus and cerebral palsy is extremely low in otherwise healthy term and late preterm newborns,” said Allison Holmes, MD, of Children’s Hospital at Dartmouth-Hitchcock, Manchester, N.H. “Subthreshold phototherapy leads to unnecessary hospitalization and its associated costs and harms,” and data show that kernicterus generally occurs close to 40 mg/dL and occurs most often in infants with hemolysis, she added.
The evidence for the recommendations included data showing that, among other factors, 8.6 of 100,000 babies have a bilirubin greater than 30 mg/dL, said Dr. Holmes. Risks of using subthreshold phototherapy include increased length of stay, increased readmissions, and increased costs, as well as decreased breastfeeding, bonding with parents, and increased parental anxiety. “Adding prolonged hospitalization for an intervention that might not be necessary can be stressful for parents,” she said.
4. Do not use broad-spectrum antibiotics such as ceftriaxone for children hospitalized with uncomplicated community-acquired pneumonia. Use narrow-spectrum antibiotics such as penicillin, ampicillin, or amoxicillin.
Michelle Lossius, MD, of the Shands Hospital for Children at the University of Florida, Gainesville, noted that the recommendations reflect IDSA guidelines from 2011 advising the use of ampicillin or penicillin for this population of children. More recent studies with large populations support the ability of narrow-spectrum antibiotics to limit the development of resistant organisms while achieving the same or better outcomes for children hospitalized with CAP, she said.
5. Do not start IV antibiotic therapy on well-appearing newborn infants with isolated risk factors for sepsis such as maternal chorioamnionitis, prolonged rupture of membranes, or untreated group-B streptococcal colonization. Use clinical tools such as an evidence-based sepsis risk calculator to guide management.
“This recommendation combines other recommendations,” said Prabi Rajbhandari, MD, of Akron (Ohio) Children’s Hospital. The evidence is ample, as the Centers for Disease Control and Prevention recommends the use of sepsis calculators to guide clinical management in sepsis patients, she said.
Data comparing periods before and after the adoption of a sepsis risk calculator showed a significant reduction in the use of blood cultures and antibiotics, she noted. Other risks of jumping to IV antibiotics include increased hospital stay, increased parental anxiety, and decreased parental bonding, Dr. Rajbhandari added.
Next steps include how to prioritize implementation, as well as deimplementation of outdated practices, said Francisco Alvarez, MD, of Lucile Packard Children’s Hospital, Palo Alto, Calif. “A lot of our practices were started without good evidence for why they should be done,” he said. Other steps include value improvement research; use of dashboards and benchmarking; involving other stakeholders including patients, families, and other health care providers; and addressing racial disparities, he concluded.
The presenters had no financial conflicts to disclose. The conference was sponsored by the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine.
“Health care spending and health care waste is a huge problem in the U.S., including for children,” Vivian Lee, MD, of Children’s Hospital, Los Angeles, said in a presentation at the 2021 virtual Pediatric Hospital Medicine conference.
Data from a 2019 study suggested that approximately 25% of health care spending in the United States qualifies as “wasteful spending,” in categories such as overtesting, and unnecessary hospitalization, Dr. Lee said. “It is essential for physicians in hospitals to be stewards of high-value care,” she emphasized.
To combat wasteful spending and control health care costs, the Choosing Wisely campaign was created in 2012 as an initiative from the American Board of Internal Medicine Foundation. An ongoing goal of the campaign is to raise awareness among physicians and patients about potential areas of low-value services and overuse. The overall campaign includes clinician-driven recommendations from multiple medical organizations.
The PHM produced its first set of five recommendations in 2012, Dr. Lee said. These recommendations, titled “Five Things Physicians and Patients Should Question,” have been updated for 2021. The updated recommendations were created as a partnership among the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine. A joint committee reviewed the latest evidence, and the updates were approved by the societies and published by the ABIM in January 2021.
“We think these recommendations truly reflect an exciting and evolving landscape for pediatric hospitalists,” Dr. Lee said. “There is a greater focus on opportunities to transition out of the hospital sooner, or avoid hospitalization altogether. There is an emphasis on antibiotic stewardship and a growing recognition of the impact that overuse may have on our vulnerable neonatal population,” she said. Several members of the Choosing Wisely panel presented the recommendations during the virtual presentation.
Revised recommendations
The new “Five Things Physicians and Patients Should Question” are as follows:
1. Do not prescribe IV antibiotics for predetermined durations for patients hospitalized with infections such as pyelonephritis, osteomyelitis, and complicated pneumonia. Consider early transition to oral antibiotics.
Many antibiotic doses used in clinical practice are preset durations that are not based on high-quality evidence, said Mike Tchou, MD, of Children’s Hospital of Colorado in Aurora. However, studies now show that earlier transition to enteral antibiotics can improve a range of outcomes including neonatal UTIs, osteomyelitis, and complicated pneumonia, he said. Considering early transition based on a patient’s response can decrease adverse events, pain, length of stay, and health care costs, he explained.
2. Do not continue hospitalization in well-appearing febrile infants once bacterial cultures (i.e., blood, cerebrospinal, and/or urine) have been confirmed negative for 24-36 hours, if adequate outpatient follow-up can be assured.
Recent data indicate that continuing hospitalization beyond 24-36 hours of confirmed negative bacterial cultures does not improve clinical outcomes for well-appearing infants admitted for concern of serious bacterial infection, said Paula Soung, MD, of Children’s Wisconsin in Milwaukee. In fact, “blood culture yield is highest in the first 12-36 hours after incubation with multiple studies demonstrating > 90% of pathogen cultures being positive by 24 hours,” Dr. Soung said. “If adequate outpatient follow-up can be assured, discharging well-appearing febrile infants at 24-36 hours after confirming cultures are negative has many positive outcomes,” she said.
3. Do not initiate phototherapy in term or late preterm well-appearing infants with neonatal hyperbilirubinemia if their bilirubin is below levels at which the AAP guidelines recommend treatment.
In making this recommendation, “we considered that the risk of kernicterus and cerebral palsy is extremely low in otherwise healthy term and late preterm newborns,” said Allison Holmes, MD, of Children’s Hospital at Dartmouth-Hitchcock, Manchester, N.H. “Subthreshold phototherapy leads to unnecessary hospitalization and its associated costs and harms,” and data show that kernicterus generally occurs close to 40 mg/dL and occurs most often in infants with hemolysis, she added.
The evidence for the recommendations included data showing that, among other factors, 8.6 of 100,000 babies have a bilirubin greater than 30 mg/dL, said Dr. Holmes. Risks of using subthreshold phototherapy include increased length of stay, increased readmissions, and increased costs, as well as decreased breastfeeding, bonding with parents, and increased parental anxiety. “Adding prolonged hospitalization for an intervention that might not be necessary can be stressful for parents,” she said.
4. Do not use broad-spectrum antibiotics such as ceftriaxone for children hospitalized with uncomplicated community-acquired pneumonia. Use narrow-spectrum antibiotics such as penicillin, ampicillin, or amoxicillin.
Michelle Lossius, MD, of the Shands Hospital for Children at the University of Florida, Gainesville, noted that the recommendations reflect IDSA guidelines from 2011 advising the use of ampicillin or penicillin for this population of children. More recent studies with large populations support the ability of narrow-spectrum antibiotics to limit the development of resistant organisms while achieving the same or better outcomes for children hospitalized with CAP, she said.
5. Do not start IV antibiotic therapy on well-appearing newborn infants with isolated risk factors for sepsis such as maternal chorioamnionitis, prolonged rupture of membranes, or untreated group-B streptococcal colonization. Use clinical tools such as an evidence-based sepsis risk calculator to guide management.
“This recommendation combines other recommendations,” said Prabi Rajbhandari, MD, of Akron (Ohio) Children’s Hospital. The evidence is ample, as the Centers for Disease Control and Prevention recommends the use of sepsis calculators to guide clinical management in sepsis patients, she said.
Data comparing periods before and after the adoption of a sepsis risk calculator showed a significant reduction in the use of blood cultures and antibiotics, she noted. Other risks of jumping to IV antibiotics include increased hospital stay, increased parental anxiety, and decreased parental bonding, Dr. Rajbhandari added.
Next steps include how to prioritize implementation, as well as deimplementation of outdated practices, said Francisco Alvarez, MD, of Lucile Packard Children’s Hospital, Palo Alto, Calif. “A lot of our practices were started without good evidence for why they should be done,” he said. Other steps include value improvement research; use of dashboards and benchmarking; involving other stakeholders including patients, families, and other health care providers; and addressing racial disparities, he concluded.
The presenters had no financial conflicts to disclose. The conference was sponsored by the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine.
“Health care spending and health care waste is a huge problem in the U.S., including for children,” Vivian Lee, MD, of Children’s Hospital, Los Angeles, said in a presentation at the 2021 virtual Pediatric Hospital Medicine conference.
Data from a 2019 study suggested that approximately 25% of health care spending in the United States qualifies as “wasteful spending,” in categories such as overtesting, and unnecessary hospitalization, Dr. Lee said. “It is essential for physicians in hospitals to be stewards of high-value care,” she emphasized.
To combat wasteful spending and control health care costs, the Choosing Wisely campaign was created in 2012 as an initiative from the American Board of Internal Medicine Foundation. An ongoing goal of the campaign is to raise awareness among physicians and patients about potential areas of low-value services and overuse. The overall campaign includes clinician-driven recommendations from multiple medical organizations.
The PHM produced its first set of five recommendations in 2012, Dr. Lee said. These recommendations, titled “Five Things Physicians and Patients Should Question,” have been updated for 2021. The updated recommendations were created as a partnership among the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine. A joint committee reviewed the latest evidence, and the updates were approved by the societies and published by the ABIM in January 2021.
“We think these recommendations truly reflect an exciting and evolving landscape for pediatric hospitalists,” Dr. Lee said. “There is a greater focus on opportunities to transition out of the hospital sooner, or avoid hospitalization altogether. There is an emphasis on antibiotic stewardship and a growing recognition of the impact that overuse may have on our vulnerable neonatal population,” she said. Several members of the Choosing Wisely panel presented the recommendations during the virtual presentation.
Revised recommendations
The new “Five Things Physicians and Patients Should Question” are as follows:
1. Do not prescribe IV antibiotics for predetermined durations for patients hospitalized with infections such as pyelonephritis, osteomyelitis, and complicated pneumonia. Consider early transition to oral antibiotics.
Many antibiotic doses used in clinical practice are preset durations that are not based on high-quality evidence, said Mike Tchou, MD, of Children’s Hospital of Colorado in Aurora. However, studies now show that earlier transition to enteral antibiotics can improve a range of outcomes including neonatal UTIs, osteomyelitis, and complicated pneumonia, he said. Considering early transition based on a patient’s response can decrease adverse events, pain, length of stay, and health care costs, he explained.
2. Do not continue hospitalization in well-appearing febrile infants once bacterial cultures (i.e., blood, cerebrospinal, and/or urine) have been confirmed negative for 24-36 hours, if adequate outpatient follow-up can be assured.
Recent data indicate that continuing hospitalization beyond 24-36 hours of confirmed negative bacterial cultures does not improve clinical outcomes for well-appearing infants admitted for concern of serious bacterial infection, said Paula Soung, MD, of Children’s Wisconsin in Milwaukee. In fact, “blood culture yield is highest in the first 12-36 hours after incubation with multiple studies demonstrating > 90% of pathogen cultures being positive by 24 hours,” Dr. Soung said. “If adequate outpatient follow-up can be assured, discharging well-appearing febrile infants at 24-36 hours after confirming cultures are negative has many positive outcomes,” she said.
3. Do not initiate phototherapy in term or late preterm well-appearing infants with neonatal hyperbilirubinemia if their bilirubin is below levels at which the AAP guidelines recommend treatment.
In making this recommendation, “we considered that the risk of kernicterus and cerebral palsy is extremely low in otherwise healthy term and late preterm newborns,” said Allison Holmes, MD, of Children’s Hospital at Dartmouth-Hitchcock, Manchester, N.H. “Subthreshold phototherapy leads to unnecessary hospitalization and its associated costs and harms,” and data show that kernicterus generally occurs close to 40 mg/dL and occurs most often in infants with hemolysis, she added.
The evidence for the recommendations included data showing that, among other factors, 8.6 of 100,000 babies have a bilirubin greater than 30 mg/dL, said Dr. Holmes. Risks of using subthreshold phototherapy include increased length of stay, increased readmissions, and increased costs, as well as decreased breastfeeding, bonding with parents, and increased parental anxiety. “Adding prolonged hospitalization for an intervention that might not be necessary can be stressful for parents,” she said.
4. Do not use broad-spectrum antibiotics such as ceftriaxone for children hospitalized with uncomplicated community-acquired pneumonia. Use narrow-spectrum antibiotics such as penicillin, ampicillin, or amoxicillin.
Michelle Lossius, MD, of the Shands Hospital for Children at the University of Florida, Gainesville, noted that the recommendations reflect IDSA guidelines from 2011 advising the use of ampicillin or penicillin for this population of children. More recent studies with large populations support the ability of narrow-spectrum antibiotics to limit the development of resistant organisms while achieving the same or better outcomes for children hospitalized with CAP, she said.
5. Do not start IV antibiotic therapy on well-appearing newborn infants with isolated risk factors for sepsis such as maternal chorioamnionitis, prolonged rupture of membranes, or untreated group-B streptococcal colonization. Use clinical tools such as an evidence-based sepsis risk calculator to guide management.
“This recommendation combines other recommendations,” said Prabi Rajbhandari, MD, of Akron (Ohio) Children’s Hospital. The evidence is ample, as the Centers for Disease Control and Prevention recommends the use of sepsis calculators to guide clinical management in sepsis patients, she said.
Data comparing periods before and after the adoption of a sepsis risk calculator showed a significant reduction in the use of blood cultures and antibiotics, she noted. Other risks of jumping to IV antibiotics include increased hospital stay, increased parental anxiety, and decreased parental bonding, Dr. Rajbhandari added.
Next steps include how to prioritize implementation, as well as deimplementation of outdated practices, said Francisco Alvarez, MD, of Lucile Packard Children’s Hospital, Palo Alto, Calif. “A lot of our practices were started without good evidence for why they should be done,” he said. Other steps include value improvement research; use of dashboards and benchmarking; involving other stakeholders including patients, families, and other health care providers; and addressing racial disparities, he concluded.
The presenters had no financial conflicts to disclose. The conference was sponsored by the Academic Pediatric Association, the American Academy of Pediatrics, and the Society of Hospital Medicine.
FROM PHM 2021
COVID-19 continues to complicate children’s mental health care
The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.
In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.
Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.
He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.
Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.
The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.
This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.
Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.
Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.
Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.
Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.
“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.
Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.
Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.
Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.
Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.
Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.
More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.
Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.
In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.
Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.
He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.
Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.
The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.
This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.
Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.
Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.
Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.
Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.
“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.
Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.
Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.
Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.
Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.
Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.
More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.
Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The COVID-19 pandemic continues to impact child and adolescent mental health, and clinicians are learning as they go to develop strategies that address the challenges of providing both medical and mental health care to young patients, including those who test positive for COVID-19, according to Hani Talebi, PhD, director of pediatric psychology, and Jorge Ganem, MD, FAAP, director of pediatric hospital medicine, both of the University of Texas at Austin and Dell Children’s Medical Center.
In a presentation at the 2021 virtual Pediatric Hospital Medicine conference, Dr. Talebi and Dr. Ganem shared their experiences in identifying the impact of the pandemic on mental health services in a freestanding hospital, and synthesizing inpatient mental health care and medical care outside of a dedicated mental health unit.
Mental health is a significant pediatric issue; approximately one in five children have a diagnosable mental or behavioral health problem, but nearly two-thirds get little or no help, Dr. Talebi said. “COVID-19 has only exacerbated these mental health challenges,” he said.
He noted that beginning in April 2020, the proportion of children’s mental health-related emergency department visits increased and remained elevated through the spring, summer, and fall of 2020, as families fearful of COVID-19 avoided regular hospital visits.
Data suggest that up to 50% of all adolescent psychiatric crises that led to inpatient admissions were related in some way to COVID-19, Dr. Talebi said. In addition, “individuals with a recent diagnosis of a mental health disorder are at increased risk for COVID-19 infection,” and the risk is even higher among women and African Americans, he said.
The past year significantly impacted the mental wellbeing of parents and children, Dr. Talebi said. He cited a June 2020 study in Pediatrics in which 27% of parents reported worsening mental health for themselves, and 14% reported worsening behavioral health for their children. Ongoing issues including food insecurity, loss of regular child care, and an overall “very disorienting experience in the day-to-day” compromised the mental health of families, Dr. Talebi emphasized. Children isolated at home were not meeting developmental milestones that organically occur when socializing with peers, parents didn’t know how to handle some of their children’s issues without support from schools, and many people were struggling with other preexisting health conditions, he said.
This confluence of factors helped drive a surge in emergency department visits, meaning longer wait times and concerns about meeting urgent medical and mental health needs while maintaining safety, he added.
Parents and children waited longer to seek care, and community hospitals such as Dell Children’s Medical Center were faced with children in the emergency department with crisis-level mental health issues, along with children already waiting in the ED to address medical emergencies. All these patients had to be tested for COVID-19 and managed accordingly, Dr. Talebi noted.
Dr. Talebi emphasized the need for clinically robust care of the children who were in isolation for 10 days on the medical unit, waiting to test negative. New protocols were created for social workers to conduct daily safety checks, and to develop regular schedules for screening, “so they are having an experience on the medical floors similar to what they would have in a mental health unit,” he said.
Dr. Ganem reflected on the logistical challenges of managing mental health care while observing COVID-19 safety protocols. “COVID-19 added a new wrinkle of isolation,” he said. As institutional guidelines on testing and isolation evolved, negative COVID-19 tests were required for admission to the mental health units both in the hospital and throughout the region. Patients who tested positive had to be quarantined for 10 days, at which time they could be admitted to a mental health unit if necessary, he said.
Dr. Ganem shared details of some strategies adopted by Dell Children’s. He explained that the COVID-19 psychiatry patient workflow started with an ED evaluation, followed by medical clearance and consideration for admission.
“There was significant coordination between the social worker in the emergency department and the psychiatry social worker,” he said.
Key elements of the treatment plan for children with positive COVID-19 tests included an “interprofessional huddle” to coordinate the plan of care, goals for admission, and goals for safety, Dr. Ganem said.
Patients who required admission were expected to have an initial length of stay of 72 hours, and those who tested positive for COVID-19 were admitted to a medical unit with COVID-19 isolation, he said.
Once a patient is admitted, an RN activates a suicide prevention pathway, and an interprofessional team meets to determine what patients need for safe and effective discharge, said Dr. Ganem. He cited the SAFE-T protocol (Suicide Assessment Five-step Evaluation and Triage) as one of the tools used to determine safe discharge criteria. Considerations on the SAFE-T list include family support, an established outpatient therapist and psychiatrist, no suicide attempts prior to the current admission, or a low lethality attempt, and access to partial hospitalization or intensive outpatient programs.
Patients who could not be discharged because of suicidality or inadequate support or concerns about safety at home were considered for inpatient admission. Patients with COVID-19–positive tests who had continued need for inpatient mental health services could be transferred to an inpatient mental health unit after a 10-day quarantine.
Overall, “this has been a continuum of lessons learned, with some things we know now that we didn’t know in April or May of 2020,” Dr. Ganem said. Early in the pandemic, the focus was on minimizing risk, securing personal protective equipment, and determining who provided services in a patient’s room. “We developed new paradigms on the fly,” he said, including the use of virtual visits, which included securing and cleaning devices, as well as learning how to use them in this setting,” he said.
More recently, the emphasis has been on providing services to patients before they need to visit the hospital, rather than automatically admitting any patients with suicidal ideation and a positive COVID-19 test, Dr. Ganem said.
Dr. Talebi and Dr. Ganem had no financial conflicts to disclose. The conference was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
FROM PHM 2021
Anakinra improved survival in hospitalized COVID-19 patients
Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.
Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.
Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.
Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.
In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.
The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m2.
At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).
The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).
“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.
All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.
Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.
Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).
The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
Cytokine storm syndrome remains a treatment challenge
“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.
“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.
Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.
“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
Predicting risk for severe disease
“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.
“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.
The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.
However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.
The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.
Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.
Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.
Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.
Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.
Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.
In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.
The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m2.
At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).
The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).
“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.
All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.
Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.
Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).
The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
Cytokine storm syndrome remains a treatment challenge
“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.
“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.
Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.
“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
Predicting risk for severe disease
“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.
“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.
The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.
However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.
The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.
Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.
Hospitalized COVID-19 patients at increased risk for respiratory failure showed significant improvement after treatment with anakinra, compared with placebo, based on data from a phase 3, randomized trial of nearly 600 patients who also received standard of care treatment.
Anakinra, a recombinant interleukin (IL)-1 receptor antagonist that blocks activity for both IL-1 alpha and beta, showed a 70% decrease in the risk of progression to severe respiratory failure in a prior open-label, phase 2, proof-of-concept study, wrote Evdoxia Kyriazopoulou, MD, PhD, of National and Kapodistrian University of Athens, and colleagues.
Previous research has shown that soluble urokinase plasminogen activator receptor (suPAR) serum levels can signal increased risk of progression to severe disease and respiratory failure in COVID-19 patients, they noted.
Supported by these early findings, “the SAVE-MORE study (suPAR-guided anakinra treatment for validation of the risk and early management of severe respiratory failure by COVID-19) is a pivotal, confirmatory, phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of early initiation of anakinra treatment in hospitalized patients with moderate or severe COVID-19,” the researchers said.
In the SAVE-MORE study published Sept. 3 in Nature Medicine, the researchers identified 594 adults with COVID-19 who were hospitalized at 37 centers in Greece and Italy and at risk of progressing to respiratory failure based on plasma suPAR levels of at least 6 ng/mL.
The primary objective was to assess the impact of early anakinra treatment on the clinical status of COVID-19 patients at risk for severe disease according to the 11-point, ordinal World Health Organization Clinical Progression Scale (WHO-CPS) at 28 days after starting treatment. All patients received standard of care, which consisted of regular monitoring of physical signs, oximetry, and anticoagulation. Patients with severe disease by the WHO definition were also received 6 mg of dexamethasone intravenously daily for 10 days. A total of 405 were randomized to anakinra and 189 to placebo. Approximately 92% of the study participants had severe pneumonia according to the WHO classification for COVID-19. The average age of the patients was 62 years, 58% were male, and the average body mass index was 29.5 kg/m2.
At 28 days, 204 (50.4%) of the anakinra-treated patients had fully recovered, with no detectable viral RNA, compared with 50 (26.5%) of the placebo-treated patients (P < .0001). In addition, significantly fewer patients in the anakinra group had died by 28 days (13 patients, 3.2%), compared with patients in the placebo group (13 patients, 6.9%).
The median decrease in WHO-CPS scores from baseline to 28 days was 4 points in the anakinra group and 3 points in the placebo group, a statistically significant difference (P < .0001).
“Overall, the unadjusted proportional odds of having a worse score on the 11-point WHO-CPS at day 28 with anakinra was 0.36 versus placebo,” and this number remained the same in adjusted analysis, the researchers wrote.
All five secondary endpoints on the WHO-CPS showed significant benefits of anakinra, compared with placebo. These included an absolute decrease of WHO-CPS at day 28 and day 14 from baseline; an absolute decrease of Sequential Organ Failure Assessment scores at day 7 from baseline; and a significantly shorter mean time to both hospital and ICU discharge (1 day and 4 days, respectively) with anakinra versus placebo.
Follow-up laboratory data showed a significant increase in absolute lymphocyte count at 7 days, a significant decrease in circulating IL-6 levels at 4 and 7 days, and significantly decreased plasma C-reactive protein (CRP) levels at 7 days.
Serious treatment-emergent adverse events were reported in 16% with anakinra and in 21.7% with placebo; the most common of these events were infections (8.4% with anakinra and 15.9% with placebo). The next most common serious treatment-emergent adverse events were ventilator-associated pneumonia, septic shock and multiple organ dysfunction, bloodstream infections, and pulmonary embolism. The most common nonserious treatment-emergent adverse events were an increase of liver function tests and hyperglycemia (similar in anakinra and placebo groups) and nonserious anemia (lower in the anakinra group).
The study findings were limited by several factors, including the lack of patients with critical COVID-19 disease and the challenge of application of suPAR in all hospital settings, the researchers noted. However, “the results validate the findings of the previous SAVE open-label phase 2 trial,” they said. The results suggest “that suPAR should be measured upon admission of all patients with COVID-19 who do not need oxygen or who need nasal or mask oxygen, and that, if suPAR levels are 6 ng/mL or higher, anakinra treatment might be a suitable therapy,” they concluded.
Cytokine storm syndrome remains a treatment challenge
“Many who die from COVID-19 suffer hyperinflammation with features of cytokine storm syndrome (CSS) and associated acute respiratory distress syndrome,” wrote Randy Q. Cron, MD, and W. Winn Chatham, MD, of the University of Alabama at Birmingham, and Roberto Caricchio, MD, of Temple University, Philadelphia, in an accompanying editorial. They noted that the SAVE-MORE trial results contrast with another recent randomized trial of canakinumab, which failed to show notable benefits, compared with placebo, in treating hospitalized patients with COVID-19 pneumonia.
“There are some key differences between these trials, one being that anakinra blocks signaling of both IL-1 alpha and IL-1 beta, whereas canakinumab binds only IL-1 beta,” the editorialists explained. “SARS-CoV-2–infected endothelium may be a particularly important source of IL-1 alpha that is not targeted by canakinumab,” they noted.
Additional studies have examined IL-6 inhibition to treat COVID-19 patients, but data have been inconsistent, the editorialists said.
“One thing that is clearly emerging from this pandemic is that the CSS associated with COVID-19 is relatively unique, with only modestly elevated levels of IL-6, CRP, and ferritin, for example,” they noted. However, the SAVE-MORE study suggests that more targeted approaches, such as anakinra, “may allow earlier introduction of anticytokine treatment” and support the use of IL-1 blockade with anakinra for cases of severe COVID-19 pneumonia.
Predicting risk for severe disease
“One of the major challenges in the management of patients with COVID-19 is identifying patients at risk of severe disease who would warrant early intervention with anti-inflammatory therapy,” said Salim Hayek, MD, medical director of the University of Michigan’s Frankel Cardiovascular Center Clinics, in an interview. “We and others had found that soluble urokinase plasminogen activator receptor (suPAR) levels are the strongest predictor of severe disease amongst biomarkers of inflammation,” he said. “In this study, patients with high suPAR levels derived benefit from anakinra, compared to those with placebo. This study is a great example of how suPAR levels could be used to identify high-risk patients that would benefit from therapies targeting inflammation,” Dr. Hayek emphasized.
“The findings are in line with the hypothesis that patients with the highest degrees of inflammation would benefit the best from targeting the hyperinflammatory cascade using anakinra or other interleukin antagonists,” Dr. Hayek said. “Given suPAR levels are the best predictors of high-risk disease, it is not surprising to see that patients with high levels benefit from targeting inflammation,” he noted.
The take-home message for clinicians at this time is that anakinra effectively improves outcomes in COVID-19 patients with high suPAR levels, Dr. Hayek said. “SuPAR can be measured easily at the point of care. Thus, a targeted strategy using suPAR to identify patients who would benefit from anakinra appears to be viable,” he explained.
However, “Whether anakinra is effective in patients with lower suPAR levels (<6 ng/mL) is unclear and was not answered by this study,” he said. “We eagerly await results of other trials to make that determination. Whether suPAR levels can also help guide the use of other therapies for COVID-19 should be explored and would enhance the personalization of treatment for COVID-19 according to the underlying inflammatory state,” he added.
The SAVE-MORE study was funded by the Hellenic Institute for the Study of Sepsis and Sobi, which manufactures anakinra. Some of the study authors reported financial relationships with Sobi and other pharmaceutical companies.
Dr. Cron disclosed serving as a consultant to Sobi, Novartis, Pfizer, and Sironax. Dr. Cron and Dr. Chatham disclosed having received grant support from Sobi for investigator-initiated clinical trials, and Dr. Caricchio disclosed serving as a consultant to GlaxoSmithKline, Johnson & Johnson, Aurinia, and Bristol-Myers Squibb. Dr. Hayek had no relevant financial conflicts to disclose.
FROM NATURE MEDICINE
Alcohol use by young adolescents drops during pandemic
The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.
Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”
In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.
Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.
The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.
Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.
In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.
Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.
“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.
The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.
Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
Predicting use and identifying risk factors
“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.
“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.
The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.
Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”
In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.
Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.
The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.
Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.
In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.
Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.
“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.
The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.
Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
Predicting use and identifying risk factors
“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.
“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.
The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
The restrictions resulting from the COVID-19 pandemic altered patterns of substance use by early adolescents to less alcohol use and greater use and misuse of nicotine and prescription drugs, based on data from more than 7,000 youth aged 10-14 years.
Substance use in early adolescence is a function of many environmental factors including substance availability, parent and peer use, and family function, as well as macroeconomic factors, William E. Pelham III, PhD, of the University of California, San Diego, and colleagues wrote. “Thus, it is critical to evaluate how substance use during early adolescence has been impacted by the coronavirus disease 2019 (COVID-19) pandemic, a source of large and sustained disruptions to adolescents’ daily lives in terms of education, contact with family/friends, and health behaviors.”
In a prospective, community-based cohort study, published in the Journal of Adolescent Health, the researchers conducted a three-wave assessment of substance use between May 2020 and August 2020, and reviewed prepandemic assessments from 2018 to 2019. The participants included 7,842 adolescents with an average age of 12 years who were initially enrolled in the Adolescent Brain Cognitive Development (ABCD) study at age 9-10 years. At the start of the study, 48% of the participants were female, 20% were Hispanic, 15% were Black, and 2% were Asian. Participants completed three online surveys between May 2020 and August 2020.
Each survey included the number of days in the past 30 days in which the adolescents drank alcohol; smoked cigarettes; used electronic nicotine delivery systems; smoked a cigar, hookah, or pipe; used smokeless tobacco products; used a cannabis product; abused prescription drugs; used inhalants; or used any other drugs. The response scale was 0 days to 10-plus days.
The overall prevalence of substance use among young adolescents was similar between prepandemic and pandemic periods; however fewer respondents reported using alcohol, but more reported using nicotine or misusing prescription medications.
Across all three survey periods, 7.4% of youth reported any substance use, 3.4% reported ever using alcohol, and 3.2% reported ever using nicotine. Of those who reported substance use, 79% reported 1-2 days of use in the past month, and 87% reported using a single substance.
In comparing prepandemic and pandemic substance use, the prevalence of alcohol use in the past 30 days decreased significantly, from 2.1% to 0.8%. However, use of nicotine increased significantly from 0% to 1.3%, and misuse of prescription drugs increased significantly from 0% to 0.6%. “Changes in the rates of use of any substance, cannabis, or inhalants were not statistically significant,” the researchers wrote.
Sex and ethnicity were not associated with substance use during the pandemic, but rates of substance use were higher among youth whose parents were unmarried or had lower levels of education, and among those with preexisting externalizing and internalizing behaviors. Youth who reported higher levels of uncertainty related to COVID-19 were significantly more likely to report substance use; additionally, stress, anxiety, and depressive symptoms were positively association with any substance use during the pandemic survey periods. Youth whose parents experienced hardship or whose parents used alcohol or drugs also were more likely to report substance use.
“Stability in the overall rate of substance use in this cohort is reassuring given that the pandemic has brought increases in teens’ unoccupied time, stress, and loneliness, reduced access to support services, and disruptions to routines and family/parenting practices, all of which might be expected to have increased youth substance use,” the researchers noted. The findings do not explain the decreased alcohol use, but the researchers cited possible reasons for reduced alcohol use including lack of contact with friends and social activities, and greater supervision by parents.
The study findings were limited by several factors including the comparison of prepandemic and pandemic substance use in younger adolescents, which may not reflect changes in substance use in older adolescents. The study also could not establish causality, and did not account for the intensity of substance use, such as number of drinks, the researchers wrote. However, the results were strengthened by the longitudinal design and large, diverse study population, and the use of prepandemic assessments that allowed evaluation of changes over time.
Overall, the results highlight the importance of preexisting and acute risk protective factors in mitigating substance use in young adolescents, and suggest the potential of economic support for families and emotional support for youth as ways to reduce risk, the researchers concluded.
Predicting use and identifying risk factors
“It was important to conduct research at this time so we know how trends have changed during the pandemic,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. The research helps clinicians “so we can better predict which substances our patients may be using, especially those with preexisting psychological conditions and those at socioeconomic disadvantage.
“I was surprised by the increased prescription drug use, but it make sense, as adolescents are at home more and may be illicitly using their parents medications,” Dr. Kinsella noted. “I think as they go back to school, trends will shift back to where they were as they will be spending more time with friends.” The take-home message to clinicians is the increased use of nicotine and prescription drugs during the pandemic, and future research should focus on substance use trends in 14- to 20-year-olds.
The ABCD study was supported by the National Institutes of Health, and the current study also received support from the National Science Foundation and Children and Screens: Institute of Digital Media and Child Development. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
FROM THE JOURNAL OF ADOLESCENT HEALTH
ACR updates COVID vaccine guidance with booster schedule
Patients on immunosuppressive or immunomodulatory therapy should receive a third dose of either the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine at least 28 days after the second dose of either of these two mRNA vaccines, according to updated recommendations from the American College of Rheumatology.
The update follows the Centers for Disease Control and Prevention’s recommendation that certain immunocompromised patients receive a third dose of an mRNA vaccine to reduce their risk of contracting COVID-19.
Individuals receiving the Pfizer vaccine must be aged 12 years and older, while those receiving the Moderna vaccine must be 18 years and older, the ACR emphasized.
“These statements were based upon a dearth of high-quality data and are not intended to replace clinical judgment,” the authors wrote. “Modifications made to treatment plans, particularly in complex rheumatic disease patients, are highly disease, patient, geography, and time specific and, therefore, must be individualized as part of a shared decision-making process.”
The task force recommended using the same mRNA vaccine booster as the patient received for their initial two-dose series when possible, but notes that either mRNA vaccine is acceptable, and recommends the mRNA vaccine for patients who have yet to receive any vaccine because of the availability of the booster. The task force emphasized that they achieved no consensus on recommending a booster mRNA vaccine to patients who received a single dose of Johnson & Johnson vaccine because the safety data are uncertain.
The updated guidance also identifies the Food and Drug Administration’s emergency use authorization in August for the use of REGEN-COV monoclonal antibody treatment for emergency postexposure prophylaxis for COVID-19 in adults and adolescents aged 12 years and older who weigh at least 40 kg and are at increased risk for severe COVID-19, which includes patients receiving immunosuppressive or immunomodulatory therapies other than hydroxychloroquine. Patients who have been exposed to an individual with COVID-19 should discuss this treatment with their health care provider as an added precaution; however, the guidance emphasized that the prophylactic treatment is not a substitute for COVID-19 vaccination.
The recommendations advise clinicians to counsel their patients to refrain from taking certain immunomodulatory or immunosuppressive medications for 1-2 weeks after booster vaccination if disease activity allows, with the exception of glucocorticoids and anticytokines such as tumor necrosis factor inhibitors and others including interleukin-17, IL-12/23, IL-23, IL-1R, IL-6R antagonists, for which the task force did not achieve a consensus recommendation.
The guidance notes that patients on rituximab or other anti-CD20 medications “should discuss the optimal timing [of the booster] with their rheumatology provider” and that some practitioners measure CD19 B cells as a tool with which to time the booster and subsequent rituximab dosing. For those who elect to dose without such information, or for whom such measurement is not available or feasible, provide the booster 2-4 weeks before next anticipated rituximab dose (e.g., at month 5.0 or 5.5 for patients on an every-6-month rituximab dosing schedule).”
There was strong consensus from the task force that health care providers “should not routinely order any lab testing (e.g., antibody tests for IgM and/or IgG to spike or nucleocapsid proteins) to assess immunity to COVID-19 post vaccination, nor to assess the need for vaccination in a yet-unvaccinated person.”
“The updated information from the ACR addresses not only booster vaccination but also other important and practical issues facing rheumatology providers and their patients related to the pandemic,” said task force chair Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, in an ACR statement announcing the updates.
“Although the guidance is issued in light of the best evidence available, the science regarding COVID-19 vaccination as it affects the practice of rheumatology is undergoing rapid evolution,” he noted. “We need direct evidence such as that from randomized trials to inform the best practices of what we can do to protect our patients from SARS-CoV-2.”
The update retains the current recommendations that rheumatology patients follow all public health guidelines regarding physical distancing and other preventive measures following vaccination, but the task force did not recommend exceeding current public health guidance. “The appropriateness for continued preventive measures (e.g., masking, physical distancing) should be discussed with patients as their rheumatology providers deem appropriate,” they wrote.
The full updated version of the ACR’s COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases will be published in Arthritis & Rheumatology. The summary was developed by the ACR COVID-19 Vaccine Clinical Guidance Task Force, which included 9 rheumatologists, 2 infectious disease specialists, and 2 public health experts with current or past employment history with the CDC.
The ACR encourages clinicians with questions or concerns to email [email protected] for support.
Patients on immunosuppressive or immunomodulatory therapy should receive a third dose of either the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine at least 28 days after the second dose of either of these two mRNA vaccines, according to updated recommendations from the American College of Rheumatology.
The update follows the Centers for Disease Control and Prevention’s recommendation that certain immunocompromised patients receive a third dose of an mRNA vaccine to reduce their risk of contracting COVID-19.
Individuals receiving the Pfizer vaccine must be aged 12 years and older, while those receiving the Moderna vaccine must be 18 years and older, the ACR emphasized.
“These statements were based upon a dearth of high-quality data and are not intended to replace clinical judgment,” the authors wrote. “Modifications made to treatment plans, particularly in complex rheumatic disease patients, are highly disease, patient, geography, and time specific and, therefore, must be individualized as part of a shared decision-making process.”
The task force recommended using the same mRNA vaccine booster as the patient received for their initial two-dose series when possible, but notes that either mRNA vaccine is acceptable, and recommends the mRNA vaccine for patients who have yet to receive any vaccine because of the availability of the booster. The task force emphasized that they achieved no consensus on recommending a booster mRNA vaccine to patients who received a single dose of Johnson & Johnson vaccine because the safety data are uncertain.
The updated guidance also identifies the Food and Drug Administration’s emergency use authorization in August for the use of REGEN-COV monoclonal antibody treatment for emergency postexposure prophylaxis for COVID-19 in adults and adolescents aged 12 years and older who weigh at least 40 kg and are at increased risk for severe COVID-19, which includes patients receiving immunosuppressive or immunomodulatory therapies other than hydroxychloroquine. Patients who have been exposed to an individual with COVID-19 should discuss this treatment with their health care provider as an added precaution; however, the guidance emphasized that the prophylactic treatment is not a substitute for COVID-19 vaccination.
The recommendations advise clinicians to counsel their patients to refrain from taking certain immunomodulatory or immunosuppressive medications for 1-2 weeks after booster vaccination if disease activity allows, with the exception of glucocorticoids and anticytokines such as tumor necrosis factor inhibitors and others including interleukin-17, IL-12/23, IL-23, IL-1R, IL-6R antagonists, for which the task force did not achieve a consensus recommendation.
The guidance notes that patients on rituximab or other anti-CD20 medications “should discuss the optimal timing [of the booster] with their rheumatology provider” and that some practitioners measure CD19 B cells as a tool with which to time the booster and subsequent rituximab dosing. For those who elect to dose without such information, or for whom such measurement is not available or feasible, provide the booster 2-4 weeks before next anticipated rituximab dose (e.g., at month 5.0 or 5.5 for patients on an every-6-month rituximab dosing schedule).”
There was strong consensus from the task force that health care providers “should not routinely order any lab testing (e.g., antibody tests for IgM and/or IgG to spike or nucleocapsid proteins) to assess immunity to COVID-19 post vaccination, nor to assess the need for vaccination in a yet-unvaccinated person.”
“The updated information from the ACR addresses not only booster vaccination but also other important and practical issues facing rheumatology providers and their patients related to the pandemic,” said task force chair Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, in an ACR statement announcing the updates.
“Although the guidance is issued in light of the best evidence available, the science regarding COVID-19 vaccination as it affects the practice of rheumatology is undergoing rapid evolution,” he noted. “We need direct evidence such as that from randomized trials to inform the best practices of what we can do to protect our patients from SARS-CoV-2.”
The update retains the current recommendations that rheumatology patients follow all public health guidelines regarding physical distancing and other preventive measures following vaccination, but the task force did not recommend exceeding current public health guidance. “The appropriateness for continued preventive measures (e.g., masking, physical distancing) should be discussed with patients as their rheumatology providers deem appropriate,” they wrote.
The full updated version of the ACR’s COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases will be published in Arthritis & Rheumatology. The summary was developed by the ACR COVID-19 Vaccine Clinical Guidance Task Force, which included 9 rheumatologists, 2 infectious disease specialists, and 2 public health experts with current or past employment history with the CDC.
The ACR encourages clinicians with questions or concerns to email [email protected] for support.
Patients on immunosuppressive or immunomodulatory therapy should receive a third dose of either the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine at least 28 days after the second dose of either of these two mRNA vaccines, according to updated recommendations from the American College of Rheumatology.
The update follows the Centers for Disease Control and Prevention’s recommendation that certain immunocompromised patients receive a third dose of an mRNA vaccine to reduce their risk of contracting COVID-19.
Individuals receiving the Pfizer vaccine must be aged 12 years and older, while those receiving the Moderna vaccine must be 18 years and older, the ACR emphasized.
“These statements were based upon a dearth of high-quality data and are not intended to replace clinical judgment,” the authors wrote. “Modifications made to treatment plans, particularly in complex rheumatic disease patients, are highly disease, patient, geography, and time specific and, therefore, must be individualized as part of a shared decision-making process.”
The task force recommended using the same mRNA vaccine booster as the patient received for their initial two-dose series when possible, but notes that either mRNA vaccine is acceptable, and recommends the mRNA vaccine for patients who have yet to receive any vaccine because of the availability of the booster. The task force emphasized that they achieved no consensus on recommending a booster mRNA vaccine to patients who received a single dose of Johnson & Johnson vaccine because the safety data are uncertain.
The updated guidance also identifies the Food and Drug Administration’s emergency use authorization in August for the use of REGEN-COV monoclonal antibody treatment for emergency postexposure prophylaxis for COVID-19 in adults and adolescents aged 12 years and older who weigh at least 40 kg and are at increased risk for severe COVID-19, which includes patients receiving immunosuppressive or immunomodulatory therapies other than hydroxychloroquine. Patients who have been exposed to an individual with COVID-19 should discuss this treatment with their health care provider as an added precaution; however, the guidance emphasized that the prophylactic treatment is not a substitute for COVID-19 vaccination.
The recommendations advise clinicians to counsel their patients to refrain from taking certain immunomodulatory or immunosuppressive medications for 1-2 weeks after booster vaccination if disease activity allows, with the exception of glucocorticoids and anticytokines such as tumor necrosis factor inhibitors and others including interleukin-17, IL-12/23, IL-23, IL-1R, IL-6R antagonists, for which the task force did not achieve a consensus recommendation.
The guidance notes that patients on rituximab or other anti-CD20 medications “should discuss the optimal timing [of the booster] with their rheumatology provider” and that some practitioners measure CD19 B cells as a tool with which to time the booster and subsequent rituximab dosing. For those who elect to dose without such information, or for whom such measurement is not available or feasible, provide the booster 2-4 weeks before next anticipated rituximab dose (e.g., at month 5.0 or 5.5 for patients on an every-6-month rituximab dosing schedule).”
There was strong consensus from the task force that health care providers “should not routinely order any lab testing (e.g., antibody tests for IgM and/or IgG to spike or nucleocapsid proteins) to assess immunity to COVID-19 post vaccination, nor to assess the need for vaccination in a yet-unvaccinated person.”
“The updated information from the ACR addresses not only booster vaccination but also other important and practical issues facing rheumatology providers and their patients related to the pandemic,” said task force chair Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, in an ACR statement announcing the updates.
“Although the guidance is issued in light of the best evidence available, the science regarding COVID-19 vaccination as it affects the practice of rheumatology is undergoing rapid evolution,” he noted. “We need direct evidence such as that from randomized trials to inform the best practices of what we can do to protect our patients from SARS-CoV-2.”
The update retains the current recommendations that rheumatology patients follow all public health guidelines regarding physical distancing and other preventive measures following vaccination, but the task force did not recommend exceeding current public health guidance. “The appropriateness for continued preventive measures (e.g., masking, physical distancing) should be discussed with patients as their rheumatology providers deem appropriate,” they wrote.
The full updated version of the ACR’s COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases will be published in Arthritis & Rheumatology. The summary was developed by the ACR COVID-19 Vaccine Clinical Guidance Task Force, which included 9 rheumatologists, 2 infectious disease specialists, and 2 public health experts with current or past employment history with the CDC.
The ACR encourages clinicians with questions or concerns to email [email protected] for support.
COVID-19: New GI symptoms don’t raise death risk in IBD
Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.
Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.
In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.
The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.
The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.
IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.
The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.
Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).
The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.
The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.
“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
Data to guide clinical care
“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”
Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19,” she added.
“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”
“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.
“This approach – considering the possibility of COVID-19 in the context of new GI symptoms – is consistent with the AGA’s published guidelines and best practices,” said David Leiman, MD, MSHP, of Duke University, Durham, N.C., and Chair of the AGA’s Quality Committee. “Clinicians should also be aware of the possibility for variation in implementation of this approach, with some patients potentially at risk for disparate testing practices.” As outlined by the AGA’s Quality Committee, tracking adherence to this clinical approach through ongoing quality improvement may limit the development of such gaps in care.
The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg and Dr. Leiman had no financial conflicts to disclose.
Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.
Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.
In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.
The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.
The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.
IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.
The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.
Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).
The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.
The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.
“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
Data to guide clinical care
“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”
Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19,” she added.
“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”
“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.
“This approach – considering the possibility of COVID-19 in the context of new GI symptoms – is consistent with the AGA’s published guidelines and best practices,” said David Leiman, MD, MSHP, of Duke University, Durham, N.C., and Chair of the AGA’s Quality Committee. “Clinicians should also be aware of the possibility for variation in implementation of this approach, with some patients potentially at risk for disparate testing practices.” As outlined by the AGA’s Quality Committee, tracking adherence to this clinical approach through ongoing quality improvement may limit the development of such gaps in care.
The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg and Dr. Leiman had no financial conflicts to disclose.
Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.
Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.
In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.
The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.
The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.
IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.
The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.
Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).
The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.
The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.
“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
Data to guide clinical care
“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”
Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19,” she added.
“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”
“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.
“This approach – considering the possibility of COVID-19 in the context of new GI symptoms – is consistent with the AGA’s published guidelines and best practices,” said David Leiman, MD, MSHP, of Duke University, Durham, N.C., and Chair of the AGA’s Quality Committee. “Clinicians should also be aware of the possibility for variation in implementation of this approach, with some patients potentially at risk for disparate testing practices.” As outlined by the AGA’s Quality Committee, tracking adherence to this clinical approach through ongoing quality improvement may limit the development of such gaps in care.
The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg and Dr. Leiman had no financial conflicts to disclose.
FROM INFLAMMATORY BOWEL DISEASES
COVID-19: New GI symptoms don’t raise death risk in IBD
Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.
Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.
In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.
The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.
The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.
IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.
The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.
Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).
The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.
The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.
“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
Data to guide clinical care
“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”
Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19.
“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.
“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”
The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg had no financial conflicts to disclose.
Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.
Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.
In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.
The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.
The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.
IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.
The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.
Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).
The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.
The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.
“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
Data to guide clinical care
“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”
Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19.
“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.
“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”
The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg had no financial conflicts to disclose.
Death from COVID-19 was not more likely among patients with inflammatory bowel disease (IBD) who had COVID-19 who developed new GI symptoms after becoming infected, according to international registry data from nearly 3,000 adults.
Although GI symptoms may arise in the general population of COVID-19 patients, data on the association between GI symptoms and COVID-19 in patients with IBD are limited, as are data on the association of GI symptoms and COVID-19 outcomes in this population, Ryan C. Ungaro, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote.
In a study published in Inflammatory Bowel Diseases, the researchers identified 2,917 adults with IBD who developed COVID-19 using the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database, a global registry created to understand COVID-19 outcomes in IBD patients.
The researchers recorded all new GI symptoms experienced by the patients while they were infected with COVID-19. Overall, 764 (26.2%) experienced new GI symptoms and 2,153 did not. The most common symptom was diarrhea, reported by 80% of the patients, followed by abdominal pain in 34%. Nausea and vomiting were reported by 24% and 12%, respectively, of all patients.
The average age of the patients was 43 years for those with no new GI symptoms and 40 for those without new GI symptoms; overall, approximately half were women and approximately three-quarters were White. Overall, 50% of those with new GI symptoms were in remission, as was the case for 58.4% of those without.
IBD patients who developed new GI symptoms were significantly more likely to be women, of Asian race, older, or have at least one comorbidity.
The researchers found no difference in new GI symptoms in patients with Crohn’s disease and ulcerative colitis. “Patients on any medication – but in particular [tumor necrosis factor] antagonist monotherapy – were less likely to report new GI symptoms.” they wrote.
Although IBD patients with new GI symptoms were significantly more likely than were those without new GI symptoms to be hospitalized for COVID-19 in bivariate analyses (31.4% vs. 19.2%; P < .001), they were not more likely to need a ventilator or intensive care (5.8% vs. 4.6%; P < .18). In a multivariate analysis, IBD patients with new GI symptoms had no greater risk of death from COVID-19 than did those without new GI symptoms (adjusted odds ratio, 0.72; 95% confidence interval, 0.38-1.36).
The new-onset GI symptoms common to IBD patients with COVID-19 are not likely caused by underlying disease activity, given the number of patients in remission who reported new GI symptoms, the researchers wrote.
The study findings were limited by several factors including the retrospective design, potential reporting bias, and reliance on physician global assessment for disease assessment, the researchers noted. However, the results were strengthened by the large sample size, by the ability to assess GI symptoms before and after COVID-19, and by the evaluation of GI symptoms and COVID-19 outcomes.
“In summary, new GI symptoms are common in IBD patients with COVID-19 and are not associated with an increased risk of death due to COVID-19,” the researchers concluded. “Our findings suggest that an increase in GI symptoms in IBD patients should prompt consideration of a COVID-19 diagnosis.”
Data to guide clinical care
“There are several potential causes for common GI symptoms, such as diarrhea and abdominal pain, among patients with IBD,” Shirley Cohen-Mekelburg, MD, of the University of Michigan, Ann Arbor, said in an interview. “These can be the initial presentation of an IBD flare, a noninflammatory cause such as irritable bowel syndrome, small intestinal bacterial overgrowth, or an infection such as Clostridioides difficile or SARS-CoV-2. Each of these diagnoses require different treatments. An IBD flare may require escalation of immunosuppressive medications such as biologics or corticosteroids, which can cause harm in the context of an untreated infection. Therefore, any guidance that will increase health care providers’ awareness of the possible causes of similar GI symptoms is important in caring for our patients with IBD. This is especially true in context of a newer entity such as COVID-19 with which we are overall less familiar.”
Dr. Cohen-Meckelburg said the lack of association between GI symptoms and death in IBD is reassuring. “It is interesting to note that GI symptoms, and particularly new diarrhea, were very common among patients with IBD and COVID-19.
“Health care providers who treat patients with IBD should have a high-index of suspicion for SARS-CoV-2 infections when patients with IBD present with GI symptoms,” said Dr. Cohen-Meckelburg. “The data from the current study may help us to consider standard testing to rule out COVID-19 as an alternative diagnosis when considering whether to treat patients with IBD who develop new GI symptoms for an IBD flare. This would be similar to how we currently test for C. difficile and other enteric infections before treating IBD flares.
“Every study has its limitations, which need to be considered in interpreting findings,” Dr. Cohen-Meckelburg noted . “SECURE-IBD has provided great insight into COVID-19 infections among patients with IBD. However, the registry relies on individuals reporting cases, so there is the potential for underreporting, particularly with less symptomatic or subclinical cases.”
The study was supported in part by the Helmsley Charitable Trust with additional funding provided by Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arenapharm. Lead author Dr. Ungaro disclosed serving as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Pfizer, and Takeda and research support from AbbVie, Boehringer Ingelheim, and Pfizer. Other coauthors disclosed similar relationships with other pharmaceutical companies. Dr. Cohen-Mekelburg had no financial conflicts to disclose.
FROM INFLAMMATORY BOWEL DISEASES
Most stent misdeployments in EUS-GE are manageable
Most instances of stent misdeployment in cases of endoscopic ultrasound–guided gastroenterostomy (EUS-GE) can be managed endoscopically, based on data from 16 tertiary care centers in the United States and Europe.
EUS-GE provides a viable alternative to traditional surgical gastroenterostomy and stent placement for patients with gastric outlet obstruction (GOO), but the potential for stent misdeployment has limited adoption of the procedure because it remains the most common cause of technical failures and adverse events, Bachir Ghandour, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
However, data on outcomes and management of stent misdeployment during EUS-GE are limited, and the researchers hypothesized that most stent misdeployments could be managed endoscopically.
In a retrospective study published in Gastrointestinal Endoscopy, the researchers reviewed data from 467 EUS-GE procedures performed for gastric outlet obstruction between March 2015 and December 2020 at eight centers in the United States and eight in Europe. The primary outcome was the rate and severity of stent misdeployment.
Stent misdeployment occurred in 46 patients (9.9%). Of these, 73.2% occurred during the operators’ first 13 cases.
The researchers created a classification system of stent misdeployment according to type, depending on which flange was misdeployed.
Type I was the most common, and occurred in 29 patients; this type was defined as “the deployment of the distal flange in the peritoneum and proximal flange in the stomach without evidence of a resulting enterotomy”; type II (14 patients) was defined as “the deployment of the distal flange in the peritoneum and proximal flange in the stomach despite an enterotomy (i.e., visual confirmation of stent having penetrated targeted small bowel, under EUS or fluoroscopy, but migrated out on deployment)”; type III (1 patient) was defined as “the deployment of the distal flange in the small bowel and proximal flange in the peritoneum”; and type IV (2 patients) was defined as “the deployment of the distal flange in the colon and proximal flange in the stomach resulting in a gastrocolic anastomosis,” the researchers wrote.
The researchers also classified the stent misdeployment in terms of severity as mild (28 patients), moderate (11 patients), severe (6 cases) or fatal (1 case) based on the American Society for Gastrointestinal Endoscopy lexicon.
Overall, type I was significantly more likely to be mild in severity, compared with type II (75.9% vs. 42.9%; P = .04), although the rate of surgical repair was similar between these two types (10.3% vs. 7.1%). Rates of ICU admission were approximately 7% in patients with type I and type II stent misdeployments, and the median postprocedural stay was 4 days for these two groups.
Same-session salvage management of GOO was achieved by EUS/endoscopic-GE in 24 patients, duodenal stent placement in 6 patients, duodenal dilation in 1 patient, and gastroenterostomy with natural orifice transluminal endoscopic surgery in 3 patients. Of the remaining 12 patients, GOO was managed with subsequent EUS-GE in 6 patients and surgical GI in 6 patients.
The study findings were limited by several factors including the retrospective design and inclusion of a time period that encompassed changes and improvements in the EUS-GE, the researchers noted. The small sample size of type III and IV stent misdeployments prohibited comparison with other types.
However, the cohort size was relatively large, compared with previous studies, and included a range of centers and countries with different strategies for managing stent misdeployments. Given the steep learning curve for EUS-GE, the study findings may help endoscopists better understand the implications and potential consequences of stent misdeployment by classifying the misdeployments into types. “We believe that such a classification or categorization of the different types is important because patient outcomes vary depending on the specific [stent misdeployment] subtype and site of injury. Such a classification will also be very helpful for future research by standardizing the terminology,” the researchers said.
“Although [stent misdeployment] is not infrequent during EUS-GE, with a rate of approximately 10%, the majority of cases are mild in severity and can be managed or repaired endoscopically without ill consequences,” they concluded. “Surgical intervention is required in less than 11% of the cases.”
Data support safe stent use in GI disease
“The lines continue to be blurred between surgical and endoscopic management of gastrointestinal disease, especially with a rise in therapeutic EUS,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Stent misdeployment has been commonly reported during EUS-GE and may limit uptake of this more technically challenging procedure,” Dr. Ketwaroo said. “A comprehensive assessment of stent misdeployment, with suggestions for management and a classification system that predicts outcomes, can help practitioners to more confidently perform this procedure.”
Risks associated with misdeployed stents include “inability to perform the endoscopic management of gastric outlet obstruction, as well as adverse events such as peritonitis,” said Dr. Ketwaroo. He noted that, in most cases, the defect was closed and same-session salvage was performed, primarily by repeat EUS-GE.
Dr. Ketwaroo highlighted one challenge to endoscopic management of stent misdeployment. “If the proximal flange is deployed/slips into peritoneum (type III by currently proposed classification system), it can be more difficult to retrieve the stent,” but “this complication was treated with surgery, and it was very rare – only one case of this in the study,” he explained. “This is a large retrospective multicenter study, which adds validity to the generalizability of the study.” However, prospective studies will be needed as EUS-GE is more widely adopted, he added.
The study received no outside funding. Lead author Dr. Ghandour had no financial conflicts to disclose. Other authors disclosed industry relationships, such as consulting for Boston Scientific, Apollo, Olympus America, Medtronic, and GI Supply. Dr. Ketwaroo had no financial conflicts to disclose, but serves as a member of the GI & Hepatology News editorial advisory board.
Most instances of stent misdeployment in cases of endoscopic ultrasound–guided gastroenterostomy (EUS-GE) can be managed endoscopically, based on data from 16 tertiary care centers in the United States and Europe.
EUS-GE provides a viable alternative to traditional surgical gastroenterostomy and stent placement for patients with gastric outlet obstruction (GOO), but the potential for stent misdeployment has limited adoption of the procedure because it remains the most common cause of technical failures and adverse events, Bachir Ghandour, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
However, data on outcomes and management of stent misdeployment during EUS-GE are limited, and the researchers hypothesized that most stent misdeployments could be managed endoscopically.
In a retrospective study published in Gastrointestinal Endoscopy, the researchers reviewed data from 467 EUS-GE procedures performed for gastric outlet obstruction between March 2015 and December 2020 at eight centers in the United States and eight in Europe. The primary outcome was the rate and severity of stent misdeployment.
Stent misdeployment occurred in 46 patients (9.9%). Of these, 73.2% occurred during the operators’ first 13 cases.
The researchers created a classification system of stent misdeployment according to type, depending on which flange was misdeployed.
Type I was the most common, and occurred in 29 patients; this type was defined as “the deployment of the distal flange in the peritoneum and proximal flange in the stomach without evidence of a resulting enterotomy”; type II (14 patients) was defined as “the deployment of the distal flange in the peritoneum and proximal flange in the stomach despite an enterotomy (i.e., visual confirmation of stent having penetrated targeted small bowel, under EUS or fluoroscopy, but migrated out on deployment)”; type III (1 patient) was defined as “the deployment of the distal flange in the small bowel and proximal flange in the peritoneum”; and type IV (2 patients) was defined as “the deployment of the distal flange in the colon and proximal flange in the stomach resulting in a gastrocolic anastomosis,” the researchers wrote.
The researchers also classified the stent misdeployment in terms of severity as mild (28 patients), moderate (11 patients), severe (6 cases) or fatal (1 case) based on the American Society for Gastrointestinal Endoscopy lexicon.
Overall, type I was significantly more likely to be mild in severity, compared with type II (75.9% vs. 42.9%; P = .04), although the rate of surgical repair was similar between these two types (10.3% vs. 7.1%). Rates of ICU admission were approximately 7% in patients with type I and type II stent misdeployments, and the median postprocedural stay was 4 days for these two groups.
Same-session salvage management of GOO was achieved by EUS/endoscopic-GE in 24 patients, duodenal stent placement in 6 patients, duodenal dilation in 1 patient, and gastroenterostomy with natural orifice transluminal endoscopic surgery in 3 patients. Of the remaining 12 patients, GOO was managed with subsequent EUS-GE in 6 patients and surgical GI in 6 patients.
The study findings were limited by several factors including the retrospective design and inclusion of a time period that encompassed changes and improvements in the EUS-GE, the researchers noted. The small sample size of type III and IV stent misdeployments prohibited comparison with other types.
However, the cohort size was relatively large, compared with previous studies, and included a range of centers and countries with different strategies for managing stent misdeployments. Given the steep learning curve for EUS-GE, the study findings may help endoscopists better understand the implications and potential consequences of stent misdeployment by classifying the misdeployments into types. “We believe that such a classification or categorization of the different types is important because patient outcomes vary depending on the specific [stent misdeployment] subtype and site of injury. Such a classification will also be very helpful for future research by standardizing the terminology,” the researchers said.
“Although [stent misdeployment] is not infrequent during EUS-GE, with a rate of approximately 10%, the majority of cases are mild in severity and can be managed or repaired endoscopically without ill consequences,” they concluded. “Surgical intervention is required in less than 11% of the cases.”
Data support safe stent use in GI disease
“The lines continue to be blurred between surgical and endoscopic management of gastrointestinal disease, especially with a rise in therapeutic EUS,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Stent misdeployment has been commonly reported during EUS-GE and may limit uptake of this more technically challenging procedure,” Dr. Ketwaroo said. “A comprehensive assessment of stent misdeployment, with suggestions for management and a classification system that predicts outcomes, can help practitioners to more confidently perform this procedure.”
Risks associated with misdeployed stents include “inability to perform the endoscopic management of gastric outlet obstruction, as well as adverse events such as peritonitis,” said Dr. Ketwaroo. He noted that, in most cases, the defect was closed and same-session salvage was performed, primarily by repeat EUS-GE.
Dr. Ketwaroo highlighted one challenge to endoscopic management of stent misdeployment. “If the proximal flange is deployed/slips into peritoneum (type III by currently proposed classification system), it can be more difficult to retrieve the stent,” but “this complication was treated with surgery, and it was very rare – only one case of this in the study,” he explained. “This is a large retrospective multicenter study, which adds validity to the generalizability of the study.” However, prospective studies will be needed as EUS-GE is more widely adopted, he added.
The study received no outside funding. Lead author Dr. Ghandour had no financial conflicts to disclose. Other authors disclosed industry relationships, such as consulting for Boston Scientific, Apollo, Olympus America, Medtronic, and GI Supply. Dr. Ketwaroo had no financial conflicts to disclose, but serves as a member of the GI & Hepatology News editorial advisory board.
Most instances of stent misdeployment in cases of endoscopic ultrasound–guided gastroenterostomy (EUS-GE) can be managed endoscopically, based on data from 16 tertiary care centers in the United States and Europe.
EUS-GE provides a viable alternative to traditional surgical gastroenterostomy and stent placement for patients with gastric outlet obstruction (GOO), but the potential for stent misdeployment has limited adoption of the procedure because it remains the most common cause of technical failures and adverse events, Bachir Ghandour, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
However, data on outcomes and management of stent misdeployment during EUS-GE are limited, and the researchers hypothesized that most stent misdeployments could be managed endoscopically.
In a retrospective study published in Gastrointestinal Endoscopy, the researchers reviewed data from 467 EUS-GE procedures performed for gastric outlet obstruction between March 2015 and December 2020 at eight centers in the United States and eight in Europe. The primary outcome was the rate and severity of stent misdeployment.
Stent misdeployment occurred in 46 patients (9.9%). Of these, 73.2% occurred during the operators’ first 13 cases.
The researchers created a classification system of stent misdeployment according to type, depending on which flange was misdeployed.
Type I was the most common, and occurred in 29 patients; this type was defined as “the deployment of the distal flange in the peritoneum and proximal flange in the stomach without evidence of a resulting enterotomy”; type II (14 patients) was defined as “the deployment of the distal flange in the peritoneum and proximal flange in the stomach despite an enterotomy (i.e., visual confirmation of stent having penetrated targeted small bowel, under EUS or fluoroscopy, but migrated out on deployment)”; type III (1 patient) was defined as “the deployment of the distal flange in the small bowel and proximal flange in the peritoneum”; and type IV (2 patients) was defined as “the deployment of the distal flange in the colon and proximal flange in the stomach resulting in a gastrocolic anastomosis,” the researchers wrote.
The researchers also classified the stent misdeployment in terms of severity as mild (28 patients), moderate (11 patients), severe (6 cases) or fatal (1 case) based on the American Society for Gastrointestinal Endoscopy lexicon.
Overall, type I was significantly more likely to be mild in severity, compared with type II (75.9% vs. 42.9%; P = .04), although the rate of surgical repair was similar between these two types (10.3% vs. 7.1%). Rates of ICU admission were approximately 7% in patients with type I and type II stent misdeployments, and the median postprocedural stay was 4 days for these two groups.
Same-session salvage management of GOO was achieved by EUS/endoscopic-GE in 24 patients, duodenal stent placement in 6 patients, duodenal dilation in 1 patient, and gastroenterostomy with natural orifice transluminal endoscopic surgery in 3 patients. Of the remaining 12 patients, GOO was managed with subsequent EUS-GE in 6 patients and surgical GI in 6 patients.
The study findings were limited by several factors including the retrospective design and inclusion of a time period that encompassed changes and improvements in the EUS-GE, the researchers noted. The small sample size of type III and IV stent misdeployments prohibited comparison with other types.
However, the cohort size was relatively large, compared with previous studies, and included a range of centers and countries with different strategies for managing stent misdeployments. Given the steep learning curve for EUS-GE, the study findings may help endoscopists better understand the implications and potential consequences of stent misdeployment by classifying the misdeployments into types. “We believe that such a classification or categorization of the different types is important because patient outcomes vary depending on the specific [stent misdeployment] subtype and site of injury. Such a classification will also be very helpful for future research by standardizing the terminology,” the researchers said.
“Although [stent misdeployment] is not infrequent during EUS-GE, with a rate of approximately 10%, the majority of cases are mild in severity and can be managed or repaired endoscopically without ill consequences,” they concluded. “Surgical intervention is required in less than 11% of the cases.”
Data support safe stent use in GI disease
“The lines continue to be blurred between surgical and endoscopic management of gastrointestinal disease, especially with a rise in therapeutic EUS,” Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.
“Stent misdeployment has been commonly reported during EUS-GE and may limit uptake of this more technically challenging procedure,” Dr. Ketwaroo said. “A comprehensive assessment of stent misdeployment, with suggestions for management and a classification system that predicts outcomes, can help practitioners to more confidently perform this procedure.”
Risks associated with misdeployed stents include “inability to perform the endoscopic management of gastric outlet obstruction, as well as adverse events such as peritonitis,” said Dr. Ketwaroo. He noted that, in most cases, the defect was closed and same-session salvage was performed, primarily by repeat EUS-GE.
Dr. Ketwaroo highlighted one challenge to endoscopic management of stent misdeployment. “If the proximal flange is deployed/slips into peritoneum (type III by currently proposed classification system), it can be more difficult to retrieve the stent,” but “this complication was treated with surgery, and it was very rare – only one case of this in the study,” he explained. “This is a large retrospective multicenter study, which adds validity to the generalizability of the study.” However, prospective studies will be needed as EUS-GE is more widely adopted, he added.
The study received no outside funding. Lead author Dr. Ghandour had no financial conflicts to disclose. Other authors disclosed industry relationships, such as consulting for Boston Scientific, Apollo, Olympus America, Medtronic, and GI Supply. Dr. Ketwaroo had no financial conflicts to disclose, but serves as a member of the GI & Hepatology News editorial advisory board.
FROM GASTROINTESTINAL ENDOSCOPY
Bimekizumab approved in Europe for psoriasis treatment
, according to a statement from the manufacturer.
Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F, the statement from UCB said.
In the United States, the Food and Drug Administration is expected to make a decision on approval of bimekizumab for treating psoriasis on Oct. 15.
Approval in the EU was based on data from three phase 3 trials including a total of 1,480 adult patients with moderate to severe psoriasis, which found that those treated with bimekizumab experienced significantly greater skin clearance, compared with placebo, ustekinumab, and adalimumab, with a favorable safety profile, according to the company.
In all three studies (BE VIVID, BE READY, and BE SURE), more than 80% of patients treated with bimekizumab showed improved skin clearance after 16 weeks, significantly more than those treated with ustekinumab, placebo, or adalimumab, based on an improvement of at least 90% in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). In all three studies, these clinical responses persisted after 1 year.
The recommended dose of bimekizumab is 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks. However, for “some patients” weighing 120 kg or more who have not achieved complete skin clearance at 16 weeks, 320 mg every 4 weeks after that time may improve response to treatment, according to the company statement.
The most common treatment-related adverse events in the studies were upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.
Results of BE READY and BE VIVID were published in The Lancet. Results of the BE SURE study were published in The New England Journal of Medicine.
Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance. More details on bimekizumab are available on the website of the European Medicines Agency.
, according to a statement from the manufacturer.
Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F, the statement from UCB said.
In the United States, the Food and Drug Administration is expected to make a decision on approval of bimekizumab for treating psoriasis on Oct. 15.
Approval in the EU was based on data from three phase 3 trials including a total of 1,480 adult patients with moderate to severe psoriasis, which found that those treated with bimekizumab experienced significantly greater skin clearance, compared with placebo, ustekinumab, and adalimumab, with a favorable safety profile, according to the company.
In all three studies (BE VIVID, BE READY, and BE SURE), more than 80% of patients treated with bimekizumab showed improved skin clearance after 16 weeks, significantly more than those treated with ustekinumab, placebo, or adalimumab, based on an improvement of at least 90% in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). In all three studies, these clinical responses persisted after 1 year.
The recommended dose of bimekizumab is 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks. However, for “some patients” weighing 120 kg or more who have not achieved complete skin clearance at 16 weeks, 320 mg every 4 weeks after that time may improve response to treatment, according to the company statement.
The most common treatment-related adverse events in the studies were upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.
Results of BE READY and BE VIVID were published in The Lancet. Results of the BE SURE study were published in The New England Journal of Medicine.
Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance. More details on bimekizumab are available on the website of the European Medicines Agency.
, according to a statement from the manufacturer.
Bimekizumab (Bimzelx), a humanized IgG1 monoclonal antibody, is the first approved treatment for moderate to severe plaque psoriasis that selectively inhibits interleukin (IL)–17A and IL-17F, the statement from UCB said.
In the United States, the Food and Drug Administration is expected to make a decision on approval of bimekizumab for treating psoriasis on Oct. 15.
Approval in the EU was based on data from three phase 3 trials including a total of 1,480 adult patients with moderate to severe psoriasis, which found that those treated with bimekizumab experienced significantly greater skin clearance, compared with placebo, ustekinumab, and adalimumab, with a favorable safety profile, according to the company.
In all three studies (BE VIVID, BE READY, and BE SURE), more than 80% of patients treated with bimekizumab showed improved skin clearance after 16 weeks, significantly more than those treated with ustekinumab, placebo, or adalimumab, based on an improvement of at least 90% in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1). In all three studies, these clinical responses persisted after 1 year.
The recommended dose of bimekizumab is 320 mg, given in two subcutaneous injections every 4 weeks to week 16, then every 8 weeks. However, for “some patients” weighing 120 kg or more who have not achieved complete skin clearance at 16 weeks, 320 mg every 4 weeks after that time may improve response to treatment, according to the company statement.
The most common treatment-related adverse events in the studies were upper respiratory tract infections (a majority of which were nasopharyngitis), reported by 14.5% of patients, followed by oral candidiasis, reported by 7.3%.
Results of BE READY and BE VIVID were published in The Lancet. Results of the BE SURE study were published in The New England Journal of Medicine.
Bimekizumab is contraindicated for individuals with clinically important active infections such as tuberculosis, and for individuals with any hypersensitivity to the active substance. More details on bimekizumab are available on the website of the European Medicines Agency.