Pediatrics

This lesion was diagnosed as an accessory tragus. Although sometimes called a preauricular skin tag, it is more aptly named accessory tragus since it arises embryonically along with the tragus from the first branchial arch. It usually is slightly anterior to the ear and can be seen unilaterally or bilaterally. The lesions usually feel firm to palpation due to an underlying cartilaginous component.

While this finding can be seen in congenital syndromes—most commonly oculoauriculovertebral syndrome (also known as Goldenhar syndrome)—it usually occurs in isolation. If there are no other abnormalities on exam to suggest a congenital syndrome, no additional work-up is necessary.

Concerns have been raised about a possible association with decreased hearing. Routine hearing screens are performed in the United States and this child’s screen was normal, so no further investigation for inner ear abnormalities was warranted.

These lesions usually are asymptomatic (unless traumatized). If removal is desired, it is important to remove the cartilaginous component, which can be deep and require additional dissection rather than simple transection at the base. Incomplete removal of the cartilage can cause chondritis, impede skin healing, and lead to infection.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This lesion was diagnosed as an accessory tragus. Although sometimes called a preauricular skin tag, it is more aptly named accessory tragus since it arises embryonically along with the tragus from the first branchial arch. It usually is slightly anterior to the ear and can be seen unilaterally or bilaterally. The lesions usually feel firm to palpation due to an underlying cartilaginous component.

While this finding can be seen in congenital syndromes—most commonly oculoauriculovertebral syndrome (also known as Goldenhar syndrome)—it usually occurs in isolation. If there are no other abnormalities on exam to suggest a congenital syndrome, no additional work-up is necessary.

Concerns have been raised about a possible association with decreased hearing. Routine hearing screens are performed in the United States and this child’s screen was normal, so no further investigation for inner ear abnormalities was warranted.

These lesions usually are asymptomatic (unless traumatized). If removal is desired, it is important to remove the cartilaginous component, which can be deep and require additional dissection rather than simple transection at the base. Incomplete removal of the cartilage can cause chondritis, impede skin healing, and lead to infection.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This lesion was diagnosed as an accessory tragus. Although sometimes called a preauricular skin tag, it is more aptly named accessory tragus since it arises embryonically along with the tragus from the first branchial arch. It usually is slightly anterior to the ear and can be seen unilaterally or bilaterally. The lesions usually feel firm to palpation due to an underlying cartilaginous component.

While this finding can be seen in congenital syndromes—most commonly oculoauriculovertebral syndrome (also known as Goldenhar syndrome)—it usually occurs in isolation. If there are no other abnormalities on exam to suggest a congenital syndrome, no additional work-up is necessary.

Concerns have been raised about a possible association with decreased hearing. Routine hearing screens are performed in the United States and this child’s screen was normal, so no further investigation for inner ear abnormalities was warranted.

These lesions usually are asymptomatic (unless traumatized). If removal is desired, it is important to remove the cartilaginous component, which can be deep and require additional dissection rather than simple transection at the base. Incomplete removal of the cartilage can cause chondritis, impede skin healing, and lead to infection.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

Two new clinical guidance documents from the American College of Rheumatology provide evidence-based recommendations for managing pediatric rheumatic disease during the COVID-19 pandemic as well as diagnostic and treatment recommendations for multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 infection.

Although several children’s hospitals have published their treatment protocols for MIS-C since the condition’s initial discovery, the ACR appears to be the first medical organization to review all the most current evidence to issue interim guidance with the expectations that it will change as more data become available.

“It is challenging having to make recommendations not having a lot of scientific evidence, but we still felt we had to use whatever’s out there to the best of our ability and use our experience to put together these recommendations,” Dawn M. Wahezi, MD, chief of pediatric rheumatology at Children’s Hospital at Montefiore and an associate professor of pediatrics at Albert Einstein College of Medicine, New York, said in an interview.

“We wanted to be mindful of the fact that there are things we know and things we don’t know, and we have to be careful about what we’re recommending,” said Dr. Wahezi, a member of the ACR working group that assembled the recommendations for pediatric rheumatic disease management during the pandemic. “We’re recommending the best we can at this moment, but if there are new studies that come out and suggest otherwise, we will definitely have to go back and amend the document.”

The foremost priority of the pediatric rheumatic disease guidance focuses on maintaining control of the disease and avoiding flares that may put children at greater risk of infection. Dr. Wahezi said the ACR has received many calls from patients and clinicians asking whether patients should continue their immunosuppressant medications. Fear of the coronavirus infection, medication shortages, difficulty getting to the pharmacy, uneasiness about going to the clinic or hospital for infusions, and other barriers may have led to gaps in medication.

“We didn’t want people to be too quick to hold patients’ medications just because they were scared of COVID,” Dr. Wahezi said. “If they did have medication stopped for one reason or another and their disease flared, having active disease, regardless of which disease it is, actually puts you at higher risk for infection. By controlling their disease, that would be the way to protect them the most.”

A key takeaway in the guidance on MIS-C, meanwhile, is an emphasis on its rarity lest physicians be too quick to diagnose it and miss another serious condition with overlapping symptoms, explained Lauren Henderson, MD, an attending rheumatologist at Boston Children’s Hospital and assistant professor of pediatrics at Harvard Medical School, Boston. Dr. Henderson participated in the ACR group that wrote the MIS-C guidance.

“The first thing we want to be thoughtful about clinically is to recognize that children in general with the acute infectious phase of SARS-CoV-2 have mild symptoms and generally do well,” Dr. Henderson said. “From what we can tell from all the data, MIS-C is rare. That really needs to be considered when clinicians on the ground are doing the diagnostic evaluation” because of concerns that clinicians “could rush to diagnose and treat patients with MIS-C and miss important diagnoses like malignancies and infections.”

Management of pediatric rheumatic disease during the pandemic

The COVID-19 clinical guidance for managing pediatric rheumatic disease grew from the work of the North American Pediatric Rheumatology Clinical Guidance Task Force, which included seven pediatric rheumatologists, two pediatric infectious disease physicians, one adult rheumatologist, and one pediatric nurse practitioner. The general guidance covers usual preventive measures for reducing risk for COVID-19 infection, the recommendation that children continue to receive recommended vaccines unless contraindicated by medication, and routine in-person visits for ophthalmologic surveillance of those with a history of uveitis or at high risk for chronic uveitis. The guidance also notes the risk of mental health concerns, such as depression and anxiety, related to quarantine and the pandemic.

The top recommendation is initiation or continuation of all medications necessary to control underlying disease, including NSAIDs, hydroxychloroquine, ACE inhibitors/angiotensin II receptor blockers, colchicine, conventional disease-modifying antirheumatic drugs (cDMARDs), biologic DMARDs, and targeted synthetic DMARDs. Even patients who may have had exposure to COVID-19 or who have an asymptomatic COVID-19 infection should continue to take these medications with the exception of ACEi/ARBs.

In those with pediatric rheumatic disease who have a symptomatic COVID-19 infection, “NSAIDs, HCQ, and colchicine may be continued, if necessary, to control underlying disease,” as can interleukin (IL)-1 and IL-6 inhibitors, but “cDMARDs, bDMARDs [except IL-1 and IL-6 inhibitors] and tsDMARDs should be temporarily delayed or withheld,” according to the guidance. Glucocorticoids can be continued at the lowest possible dose to control disease.

“There’s nothing in the literature that suggests people who have rheumatic disease, especially children, and people who are on these medications, really are at increased risk for COVID-19,” Dr. Wahezi said. “That’s why we didn’t want people to be overcautious in stopping medications when the main priority is to control their disease.”

She noted some experts’ speculations that these medications may actually benefit patients with rheumatic disease who develop a COVID-19 infection because the medications keep the immune response in check. “If you allow them to have this dysregulated immune response and have active disease, you’re potentially putting them at greater risk,” Dr. Wahezi said, although she stressed that inadequate evidence exists to support these speculations right now.

Lack of evidence has been the biggest challenge all around with developing this guidance, she said.

“Because this is such an unprecedented situation and because people are so desperate to find treatments both for the illness and to protect those at risk for it, there are lots of people trying to put evidence out there, but it may not be the best-quality evidence,” Dr. Wahezi said.

Insufficient evidence also drove the group’s determination that “SARS-CoV-2 antibody testing is not useful in informing on the history of infection or risk of reinfection,” as the guidance states. Too much variability in the assays exist, Dr. Wahezi said, and, further, it’s unclear what the clinical significance of a positive test would be.

“We didn’t want anyone to feel they had to make clinical decisions based on the results of that antibody testing,” she said. “Even if the test is accurate, we don’t know how to interpret it because it’s so new.”

The guidance also notes that patients with stable disease and previously stable lab markers on stable doses of their medication may be able to extend the interval for medication toxicity lab testing a few months if there is concern about exposure to COVID-19 to get the blood work.

“If you’re just starting a medicine or there’s someone who’s had abnormalities with the medicine in the past or you’re making medication adjustments, you wouldn’t do it in those scenarios, but if there’s someone who’s been on the drug for a long time and are nervous to get [blood] drawn, it’s probably okay to delay it,” Dr. Wahezi said. Lab work for disease activity measures, on the other hand, remain particularly important, especially since telemedicine visits may require clinicians to rely on lab results more than previously.

Management of MIS-C associated with COVID-19

The task force that developed guidance for the new inflammatory condition recently linked to SARS-CoV-2 infections in children included nine pediatric rheumatologists, two adult rheumatologists, two pediatric cardiologists, two pediatric infectious disease specialists, and one pediatric critical care physician.

The guidance includes a figure for the diagnostic pathway in evaluating children suspected of having MIS-C and extensive detail on diagnostic work-up, but the task force intentionally avoided providing a case definition for the condition. Existing case definitions from the Centers for Disease Control and Prevention, World Health Organization, and the United Kingdom’s Royal College of Paediatrics and Child Health differ from one another and are based on unclear evidence, Dr. Henderson noted. “We really don’t have enough data to know the sensitivity and specificity of each parameter, and until that’s available, we didn’t want to add to the confusion,” she said.

The guidance also stresses that MIS-C is a rare complication, so patients suspected of having the condition who do not have “life-threatening manifestations should undergo diagnostic evaluation for MIS-C as well as other possible infectious and noninfectious etiologies before immunomodulatory treatment is initiated,” the guidance states.

Unless a child is in shock or otherwise requires urgent care, physicians should take the time to complete the diagnostic work-up while monitoring the child, Dr. Henderson said. If the child does have MIS-C, the guidance currently recommends intravenous immunoglobulin (IVIG) and/or glucocorticoids to prevent coronary artery aneurysms, the same treatment other institutions have been recommending.

“We don’t have rigorous comparative studies looking at different types of treatments,” Dr. Henderson said, noting that the vast majority of children in the literature received IVIG and/or glucocorticoid treatment. “Often children really responded quite forcefully to those treatments, but we don’t have high-quality data yet to know that this treatment is better than supportive care or another medication.”

Dr. Henderson also stressed the importance of children receiving care at a facility with the necessary expertise to manage MIS-C and receiving long-term follow-up care from a multidisciplinary clinical team that includes a rheumatologist, an infectious disease doctor, a cardiologist, and possibly a hematologist.

“Making sure children are admitted to a hospital that has the resources and are followed by physicians with expertise or understanding of the intricacies of MIS-C is really important,” she said, particularly for children with cardiac involvement. “We don’t know if all the kids presenting with left ventricular dysfunction and shock are at risk for having myocardial fibrosis down the line,” she noted. “There is so much we do not understand and very little data to guide us on what to do, so these children really need to be under the care of a cardiologist and rheumatologist to make sure that their care is tailored to them.”

Although MIS-C shares overlapping symptoms with Kawasaki disease, it’s still unclear how similar or different the two conditions are, Dr. Henderson said.

“We can definitely say that when we look at MIS-C and compare it to historical groups of Kawasaki disease before the pandemic, there are definitely different features in the MIS-C group,” she said. Kawasaki disease generally only affects children under age 5, whereas MIS-C patients run the gamut from age 1-17. Racial demographics are also different, with a higher proportion of black children affected by MIS-C.

It’s possible that the pathophysiology of both conditions will turn out to be similar, particularly given the hypothesis that Kawasaki disease is triggered by infections in genetically predisposed people. However, the severity of symptoms and risk of aneurysms appear greater with MIS-C so far.

“The degree to which these patients are presenting with left ventricular dysfunction and shock is much higher than what we’ve seen previously,” Dr. Henderson said. “Children can have aneurysms even if they don’t meet all the Kawasaki disease features, which makes it feel that this is somehow clinically different from what we’ve seen before. It’s not just the kids who have the rash and the conjunctivitis and the extremity changes and oral changes who have the aneurysms.”

The reason for including both IVIG and glucocorticoids as possible first-line drugs to prevent aneurysms is that some evidence suggests children with MIS-C may have higher levels of IVIG resistance, she said.

Like Dr. Wahezi, Dr. Henderson emphasized the necessarily transient nature of these recommendations.

“These recommendations will almost certainly change based on evolving understanding of MIS-C and the data,” Dr. Henderson said, adding that this new, unique condition highlights the importance of including children in allocating funding for research and in clinical trials.

“Children are not always identical to adults, and it’s really important that we have high-quality data to inform our decisions about how to care for them,” she said.

Dr. Wahezi had no disclosures. Dr. Henderson has consulted for Sobi and Adaptive Technologies. The guidelines did not note other disclosures for members of the ACR groups.

SOURCES: COVID-19 Clinical Guidance for Pediatric Patients with Rheumatic Disease and Clinical Guidance for Pediatric Patients with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with SARS-CoV-2 and Hyperinflammation in COVID-19

Two new clinical guidance documents from the American College of Rheumatology provide evidence-based recommendations for managing pediatric rheumatic disease during the COVID-19 pandemic as well as diagnostic and treatment recommendations for multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 infection.

Although several children’s hospitals have published their treatment protocols for MIS-C since the condition’s initial discovery, the ACR appears to be the first medical organization to review all the most current evidence to issue interim guidance with the expectations that it will change as more data become available.

“It is challenging having to make recommendations not having a lot of scientific evidence, but we still felt we had to use whatever’s out there to the best of our ability and use our experience to put together these recommendations,” Dawn M. Wahezi, MD, chief of pediatric rheumatology at Children’s Hospital at Montefiore and an associate professor of pediatrics at Albert Einstein College of Medicine, New York, said in an interview.

“We wanted to be mindful of the fact that there are things we know and things we don’t know, and we have to be careful about what we’re recommending,” said Dr. Wahezi, a member of the ACR working group that assembled the recommendations for pediatric rheumatic disease management during the pandemic. “We’re recommending the best we can at this moment, but if there are new studies that come out and suggest otherwise, we will definitely have to go back and amend the document.”

The foremost priority of the pediatric rheumatic disease guidance focuses on maintaining control of the disease and avoiding flares that may put children at greater risk of infection. Dr. Wahezi said the ACR has received many calls from patients and clinicians asking whether patients should continue their immunosuppressant medications. Fear of the coronavirus infection, medication shortages, difficulty getting to the pharmacy, uneasiness about going to the clinic or hospital for infusions, and other barriers may have led to gaps in medication.

“We didn’t want people to be too quick to hold patients’ medications just because they were scared of COVID,” Dr. Wahezi said. “If they did have medication stopped for one reason or another and their disease flared, having active disease, regardless of which disease it is, actually puts you at higher risk for infection. By controlling their disease, that would be the way to protect them the most.”

A key takeaway in the guidance on MIS-C, meanwhile, is an emphasis on its rarity lest physicians be too quick to diagnose it and miss another serious condition with overlapping symptoms, explained Lauren Henderson, MD, an attending rheumatologist at Boston Children’s Hospital and assistant professor of pediatrics at Harvard Medical School, Boston. Dr. Henderson participated in the ACR group that wrote the MIS-C guidance.

“The first thing we want to be thoughtful about clinically is to recognize that children in general with the acute infectious phase of SARS-CoV-2 have mild symptoms and generally do well,” Dr. Henderson said. “From what we can tell from all the data, MIS-C is rare. That really needs to be considered when clinicians on the ground are doing the diagnostic evaluation” because of concerns that clinicians “could rush to diagnose and treat patients with MIS-C and miss important diagnoses like malignancies and infections.”

Management of pediatric rheumatic disease during the pandemic

The COVID-19 clinical guidance for managing pediatric rheumatic disease grew from the work of the North American Pediatric Rheumatology Clinical Guidance Task Force, which included seven pediatric rheumatologists, two pediatric infectious disease physicians, one adult rheumatologist, and one pediatric nurse practitioner. The general guidance covers usual preventive measures for reducing risk for COVID-19 infection, the recommendation that children continue to receive recommended vaccines unless contraindicated by medication, and routine in-person visits for ophthalmologic surveillance of those with a history of uveitis or at high risk for chronic uveitis. The guidance also notes the risk of mental health concerns, such as depression and anxiety, related to quarantine and the pandemic.

The top recommendation is initiation or continuation of all medications necessary to control underlying disease, including NSAIDs, hydroxychloroquine, ACE inhibitors/angiotensin II receptor blockers, colchicine, conventional disease-modifying antirheumatic drugs (cDMARDs), biologic DMARDs, and targeted synthetic DMARDs. Even patients who may have had exposure to COVID-19 or who have an asymptomatic COVID-19 infection should continue to take these medications with the exception of ACEi/ARBs.

In those with pediatric rheumatic disease who have a symptomatic COVID-19 infection, “NSAIDs, HCQ, and colchicine may be continued, if necessary, to control underlying disease,” as can interleukin (IL)-1 and IL-6 inhibitors, but “cDMARDs, bDMARDs [except IL-1 and IL-6 inhibitors] and tsDMARDs should be temporarily delayed or withheld,” according to the guidance. Glucocorticoids can be continued at the lowest possible dose to control disease.

“There’s nothing in the literature that suggests people who have rheumatic disease, especially children, and people who are on these medications, really are at increased risk for COVID-19,” Dr. Wahezi said. “That’s why we didn’t want people to be overcautious in stopping medications when the main priority is to control their disease.”

She noted some experts’ speculations that these medications may actually benefit patients with rheumatic disease who develop a COVID-19 infection because the medications keep the immune response in check. “If you allow them to have this dysregulated immune response and have active disease, you’re potentially putting them at greater risk,” Dr. Wahezi said, although she stressed that inadequate evidence exists to support these speculations right now.

Lack of evidence has been the biggest challenge all around with developing this guidance, she said.

“Because this is such an unprecedented situation and because people are so desperate to find treatments both for the illness and to protect those at risk for it, there are lots of people trying to put evidence out there, but it may not be the best-quality evidence,” Dr. Wahezi said.

Insufficient evidence also drove the group’s determination that “SARS-CoV-2 antibody testing is not useful in informing on the history of infection or risk of reinfection,” as the guidance states. Too much variability in the assays exist, Dr. Wahezi said, and, further, it’s unclear what the clinical significance of a positive test would be.

“We didn’t want anyone to feel they had to make clinical decisions based on the results of that antibody testing,” she said. “Even if the test is accurate, we don’t know how to interpret it because it’s so new.”

The guidance also notes that patients with stable disease and previously stable lab markers on stable doses of their medication may be able to extend the interval for medication toxicity lab testing a few months if there is concern about exposure to COVID-19 to get the blood work.

“If you’re just starting a medicine or there’s someone who’s had abnormalities with the medicine in the past or you’re making medication adjustments, you wouldn’t do it in those scenarios, but if there’s someone who’s been on the drug for a long time and are nervous to get [blood] drawn, it’s probably okay to delay it,” Dr. Wahezi said. Lab work for disease activity measures, on the other hand, remain particularly important, especially since telemedicine visits may require clinicians to rely on lab results more than previously.

Management of MIS-C associated with COVID-19

The task force that developed guidance for the new inflammatory condition recently linked to SARS-CoV-2 infections in children included nine pediatric rheumatologists, two adult rheumatologists, two pediatric cardiologists, two pediatric infectious disease specialists, and one pediatric critical care physician.

The guidance includes a figure for the diagnostic pathway in evaluating children suspected of having MIS-C and extensive detail on diagnostic work-up, but the task force intentionally avoided providing a case definition for the condition. Existing case definitions from the Centers for Disease Control and Prevention, World Health Organization, and the United Kingdom’s Royal College of Paediatrics and Child Health differ from one another and are based on unclear evidence, Dr. Henderson noted. “We really don’t have enough data to know the sensitivity and specificity of each parameter, and until that’s available, we didn’t want to add to the confusion,” she said.

The guidance also stresses that MIS-C is a rare complication, so patients suspected of having the condition who do not have “life-threatening manifestations should undergo diagnostic evaluation for MIS-C as well as other possible infectious and noninfectious etiologies before immunomodulatory treatment is initiated,” the guidance states.

Unless a child is in shock or otherwise requires urgent care, physicians should take the time to complete the diagnostic work-up while monitoring the child, Dr. Henderson said. If the child does have MIS-C, the guidance currently recommends intravenous immunoglobulin (IVIG) and/or glucocorticoids to prevent coronary artery aneurysms, the same treatment other institutions have been recommending.

“We don’t have rigorous comparative studies looking at different types of treatments,” Dr. Henderson said, noting that the vast majority of children in the literature received IVIG and/or glucocorticoid treatment. “Often children really responded quite forcefully to those treatments, but we don’t have high-quality data yet to know that this treatment is better than supportive care or another medication.”

Dr. Henderson also stressed the importance of children receiving care at a facility with the necessary expertise to manage MIS-C and receiving long-term follow-up care from a multidisciplinary clinical team that includes a rheumatologist, an infectious disease doctor, a cardiologist, and possibly a hematologist.

“Making sure children are admitted to a hospital that has the resources and are followed by physicians with expertise or understanding of the intricacies of MIS-C is really important,” she said, particularly for children with cardiac involvement. “We don’t know if all the kids presenting with left ventricular dysfunction and shock are at risk for having myocardial fibrosis down the line,” she noted. “There is so much we do not understand and very little data to guide us on what to do, so these children really need to be under the care of a cardiologist and rheumatologist to make sure that their care is tailored to them.”

Although MIS-C shares overlapping symptoms with Kawasaki disease, it’s still unclear how similar or different the two conditions are, Dr. Henderson said.

“We can definitely say that when we look at MIS-C and compare it to historical groups of Kawasaki disease before the pandemic, there are definitely different features in the MIS-C group,” she said. Kawasaki disease generally only affects children under age 5, whereas MIS-C patients run the gamut from age 1-17. Racial demographics are also different, with a higher proportion of black children affected by MIS-C.

It’s possible that the pathophysiology of both conditions will turn out to be similar, particularly given the hypothesis that Kawasaki disease is triggered by infections in genetically predisposed people. However, the severity of symptoms and risk of aneurysms appear greater with MIS-C so far.

“The degree to which these patients are presenting with left ventricular dysfunction and shock is much higher than what we’ve seen previously,” Dr. Henderson said. “Children can have aneurysms even if they don’t meet all the Kawasaki disease features, which makes it feel that this is somehow clinically different from what we’ve seen before. It’s not just the kids who have the rash and the conjunctivitis and the extremity changes and oral changes who have the aneurysms.”

The reason for including both IVIG and glucocorticoids as possible first-line drugs to prevent aneurysms is that some evidence suggests children with MIS-C may have higher levels of IVIG resistance, she said.

Like Dr. Wahezi, Dr. Henderson emphasized the necessarily transient nature of these recommendations.

“These recommendations will almost certainly change based on evolving understanding of MIS-C and the data,” Dr. Henderson said, adding that this new, unique condition highlights the importance of including children in allocating funding for research and in clinical trials.

“Children are not always identical to adults, and it’s really important that we have high-quality data to inform our decisions about how to care for them,” she said.

Dr. Wahezi had no disclosures. Dr. Henderson has consulted for Sobi and Adaptive Technologies. The guidelines did not note other disclosures for members of the ACR groups.

SOURCES: COVID-19 Clinical Guidance for Pediatric Patients with Rheumatic Disease and Clinical Guidance for Pediatric Patients with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with SARS-CoV-2 and Hyperinflammation in COVID-19

Two new clinical guidance documents from the American College of Rheumatology provide evidence-based recommendations for managing pediatric rheumatic disease during the COVID-19 pandemic as well as diagnostic and treatment recommendations for multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 infection.

Although several children’s hospitals have published their treatment protocols for MIS-C since the condition’s initial discovery, the ACR appears to be the first medical organization to review all the most current evidence to issue interim guidance with the expectations that it will change as more data become available.

“It is challenging having to make recommendations not having a lot of scientific evidence, but we still felt we had to use whatever’s out there to the best of our ability and use our experience to put together these recommendations,” Dawn M. Wahezi, MD, chief of pediatric rheumatology at Children’s Hospital at Montefiore and an associate professor of pediatrics at Albert Einstein College of Medicine, New York, said in an interview.

“We wanted to be mindful of the fact that there are things we know and things we don’t know, and we have to be careful about what we’re recommending,” said Dr. Wahezi, a member of the ACR working group that assembled the recommendations for pediatric rheumatic disease management during the pandemic. “We’re recommending the best we can at this moment, but if there are new studies that come out and suggest otherwise, we will definitely have to go back and amend the document.”

The foremost priority of the pediatric rheumatic disease guidance focuses on maintaining control of the disease and avoiding flares that may put children at greater risk of infection. Dr. Wahezi said the ACR has received many calls from patients and clinicians asking whether patients should continue their immunosuppressant medications. Fear of the coronavirus infection, medication shortages, difficulty getting to the pharmacy, uneasiness about going to the clinic or hospital for infusions, and other barriers may have led to gaps in medication.

“We didn’t want people to be too quick to hold patients’ medications just because they were scared of COVID,” Dr. Wahezi said. “If they did have medication stopped for one reason or another and their disease flared, having active disease, regardless of which disease it is, actually puts you at higher risk for infection. By controlling their disease, that would be the way to protect them the most.”

A key takeaway in the guidance on MIS-C, meanwhile, is an emphasis on its rarity lest physicians be too quick to diagnose it and miss another serious condition with overlapping symptoms, explained Lauren Henderson, MD, an attending rheumatologist at Boston Children’s Hospital and assistant professor of pediatrics at Harvard Medical School, Boston. Dr. Henderson participated in the ACR group that wrote the MIS-C guidance.

“The first thing we want to be thoughtful about clinically is to recognize that children in general with the acute infectious phase of SARS-CoV-2 have mild symptoms and generally do well,” Dr. Henderson said. “From what we can tell from all the data, MIS-C is rare. That really needs to be considered when clinicians on the ground are doing the diagnostic evaluation” because of concerns that clinicians “could rush to diagnose and treat patients with MIS-C and miss important diagnoses like malignancies and infections.”

Management of pediatric rheumatic disease during the pandemic

The COVID-19 clinical guidance for managing pediatric rheumatic disease grew from the work of the North American Pediatric Rheumatology Clinical Guidance Task Force, which included seven pediatric rheumatologists, two pediatric infectious disease physicians, one adult rheumatologist, and one pediatric nurse practitioner. The general guidance covers usual preventive measures for reducing risk for COVID-19 infection, the recommendation that children continue to receive recommended vaccines unless contraindicated by medication, and routine in-person visits for ophthalmologic surveillance of those with a history of uveitis or at high risk for chronic uveitis. The guidance also notes the risk of mental health concerns, such as depression and anxiety, related to quarantine and the pandemic.

The top recommendation is initiation or continuation of all medications necessary to control underlying disease, including NSAIDs, hydroxychloroquine, ACE inhibitors/angiotensin II receptor blockers, colchicine, conventional disease-modifying antirheumatic drugs (cDMARDs), biologic DMARDs, and targeted synthetic DMARDs. Even patients who may have had exposure to COVID-19 or who have an asymptomatic COVID-19 infection should continue to take these medications with the exception of ACEi/ARBs.

In those with pediatric rheumatic disease who have a symptomatic COVID-19 infection, “NSAIDs, HCQ, and colchicine may be continued, if necessary, to control underlying disease,” as can interleukin (IL)-1 and IL-6 inhibitors, but “cDMARDs, bDMARDs [except IL-1 and IL-6 inhibitors] and tsDMARDs should be temporarily delayed or withheld,” according to the guidance. Glucocorticoids can be continued at the lowest possible dose to control disease.

“There’s nothing in the literature that suggests people who have rheumatic disease, especially children, and people who are on these medications, really are at increased risk for COVID-19,” Dr. Wahezi said. “That’s why we didn’t want people to be overcautious in stopping medications when the main priority is to control their disease.”

She noted some experts’ speculations that these medications may actually benefit patients with rheumatic disease who develop a COVID-19 infection because the medications keep the immune response in check. “If you allow them to have this dysregulated immune response and have active disease, you’re potentially putting them at greater risk,” Dr. Wahezi said, although she stressed that inadequate evidence exists to support these speculations right now.

Lack of evidence has been the biggest challenge all around with developing this guidance, she said.

“Because this is such an unprecedented situation and because people are so desperate to find treatments both for the illness and to protect those at risk for it, there are lots of people trying to put evidence out there, but it may not be the best-quality evidence,” Dr. Wahezi said.

Insufficient evidence also drove the group’s determination that “SARS-CoV-2 antibody testing is not useful in informing on the history of infection or risk of reinfection,” as the guidance states. Too much variability in the assays exist, Dr. Wahezi said, and, further, it’s unclear what the clinical significance of a positive test would be.

“We didn’t want anyone to feel they had to make clinical decisions based on the results of that antibody testing,” she said. “Even if the test is accurate, we don’t know how to interpret it because it’s so new.”

The guidance also notes that patients with stable disease and previously stable lab markers on stable doses of their medication may be able to extend the interval for medication toxicity lab testing a few months if there is concern about exposure to COVID-19 to get the blood work.

“If you’re just starting a medicine or there’s someone who’s had abnormalities with the medicine in the past or you’re making medication adjustments, you wouldn’t do it in those scenarios, but if there’s someone who’s been on the drug for a long time and are nervous to get [blood] drawn, it’s probably okay to delay it,” Dr. Wahezi said. Lab work for disease activity measures, on the other hand, remain particularly important, especially since telemedicine visits may require clinicians to rely on lab results more than previously.

Management of MIS-C associated with COVID-19

The task force that developed guidance for the new inflammatory condition recently linked to SARS-CoV-2 infections in children included nine pediatric rheumatologists, two adult rheumatologists, two pediatric cardiologists, two pediatric infectious disease specialists, and one pediatric critical care physician.

The guidance includes a figure for the diagnostic pathway in evaluating children suspected of having MIS-C and extensive detail on diagnostic work-up, but the task force intentionally avoided providing a case definition for the condition. Existing case definitions from the Centers for Disease Control and Prevention, World Health Organization, and the United Kingdom’s Royal College of Paediatrics and Child Health differ from one another and are based on unclear evidence, Dr. Henderson noted. “We really don’t have enough data to know the sensitivity and specificity of each parameter, and until that’s available, we didn’t want to add to the confusion,” she said.

The guidance also stresses that MIS-C is a rare complication, so patients suspected of having the condition who do not have “life-threatening manifestations should undergo diagnostic evaluation for MIS-C as well as other possible infectious and noninfectious etiologies before immunomodulatory treatment is initiated,” the guidance states.

Unless a child is in shock or otherwise requires urgent care, physicians should take the time to complete the diagnostic work-up while monitoring the child, Dr. Henderson said. If the child does have MIS-C, the guidance currently recommends intravenous immunoglobulin (IVIG) and/or glucocorticoids to prevent coronary artery aneurysms, the same treatment other institutions have been recommending.

“We don’t have rigorous comparative studies looking at different types of treatments,” Dr. Henderson said, noting that the vast majority of children in the literature received IVIG and/or glucocorticoid treatment. “Often children really responded quite forcefully to those treatments, but we don’t have high-quality data yet to know that this treatment is better than supportive care or another medication.”

Dr. Henderson also stressed the importance of children receiving care at a facility with the necessary expertise to manage MIS-C and receiving long-term follow-up care from a multidisciplinary clinical team that includes a rheumatologist, an infectious disease doctor, a cardiologist, and possibly a hematologist.

“Making sure children are admitted to a hospital that has the resources and are followed by physicians with expertise or understanding of the intricacies of MIS-C is really important,” she said, particularly for children with cardiac involvement. “We don’t know if all the kids presenting with left ventricular dysfunction and shock are at risk for having myocardial fibrosis down the line,” she noted. “There is so much we do not understand and very little data to guide us on what to do, so these children really need to be under the care of a cardiologist and rheumatologist to make sure that their care is tailored to them.”

Although MIS-C shares overlapping symptoms with Kawasaki disease, it’s still unclear how similar or different the two conditions are, Dr. Henderson said.

“We can definitely say that when we look at MIS-C and compare it to historical groups of Kawasaki disease before the pandemic, there are definitely different features in the MIS-C group,” she said. Kawasaki disease generally only affects children under age 5, whereas MIS-C patients run the gamut from age 1-17. Racial demographics are also different, with a higher proportion of black children affected by MIS-C.

It’s possible that the pathophysiology of both conditions will turn out to be similar, particularly given the hypothesis that Kawasaki disease is triggered by infections in genetically predisposed people. However, the severity of symptoms and risk of aneurysms appear greater with MIS-C so far.

“The degree to which these patients are presenting with left ventricular dysfunction and shock is much higher than what we’ve seen previously,” Dr. Henderson said. “Children can have aneurysms even if they don’t meet all the Kawasaki disease features, which makes it feel that this is somehow clinically different from what we’ve seen before. It’s not just the kids who have the rash and the conjunctivitis and the extremity changes and oral changes who have the aneurysms.”

The reason for including both IVIG and glucocorticoids as possible first-line drugs to prevent aneurysms is that some evidence suggests children with MIS-C may have higher levels of IVIG resistance, she said.

Like Dr. Wahezi, Dr. Henderson emphasized the necessarily transient nature of these recommendations.

“These recommendations will almost certainly change based on evolving understanding of MIS-C and the data,” Dr. Henderson said, adding that this new, unique condition highlights the importance of including children in allocating funding for research and in clinical trials.

“Children are not always identical to adults, and it’s really important that we have high-quality data to inform our decisions about how to care for them,” she said.

Dr. Wahezi had no disclosures. Dr. Henderson has consulted for Sobi and Adaptive Technologies. The guidelines did not note other disclosures for members of the ACR groups.

SOURCES: COVID-19 Clinical Guidance for Pediatric Patients with Rheumatic Disease and Clinical Guidance for Pediatric Patients with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with SARS-CoV-2 and Hyperinflammation in COVID-19

A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has devised recommendations for ordering imaging studies in suspected cases of the infection.

The review also included useful radiographic findings to help in the differential diagnosis of COVID-19 pneumonia from other respiratory infections. Alexandra M. Foust, DO, of Boston Children’s Hospital, and colleagues reported the summary of findings and recommendations in Pediatric Pulmonology.

“Pediatricians face numerous challenges created by increasing reports of severe COVID-19 related findings in affected children,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. “[The current review] represents a multinational collaboration to provide up to date information and key imaging findings to guide chest physicians caring for children with pneumonia symptoms during the COVID-19 pandemic.”
 

Clinical presentation in children

In general, pediatric patients infected with the virus show milder symptoms compared with adults, and based on the limited evidence reported to date, the most common clinical symptoms of COVID-19 in children are rhinorrhea and/or nasal congestion, fever and cough with sore throat, fatigue or dyspnea, and diarrhea.

As with other viral pneumonias in children, the laboratory parameters are usually nonspecific; however, while the complete blood count (CBC) is often normal, lymphopenia, thrombocytopenia, and neutropenia have been reported in some cases of pediatric COVID-19, the authors noted.

The current Centers for Disease Control and Prevention (CDC) recommendation for initial diagnosis of SARS-CoV-2 is obtaining a nasopharyngeal swab, followed by reverse transcription polymerase chain reaction (RT-PCR) testing, they explained.
 

Role of imaging in diagnosis

The researchers reported that current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as a upfront test to diagnose pediatric COVID-19, but they may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course.

The potential benefits of utilizing radiologic evaluation, such as establishing a baseline for monitoring disease progression, must be balanced with potential drawbacks, which include radiation exposure, and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
 

Recommendations for ordering imaging studies

Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia.

The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia.

“The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Dr. Cataletto. “By synthesizing the available imaging case series and guidelines, this primer provides a useful tool for the practicing pulmonologist,” she explained.
 

Key recommendations: CXR

“For pediatric patients with suspected or known COVID-19 infection with moderate to severe clinical symptoms requiring hospitalization (i.e., hypoxia, moderate or severe dyspnea, signs of sepsis, shock, cardiovascular compromise, altered mentation), CXR is usually indicated to establish an imaging baseline and to assess for an alternative diagnosis,” they recommended.

“Sequential CXRs may be helpful to assess pediatric patients with COVID-19 who demonstrate worsening clinical symptoms or to assess response to supportive therapy,” they wrote.
 

Key recommendations: CT

“Due to the increased radiation sensitivity of pediatric patients, chest CT is not recommended as an initial diagnostic test for pediatric patients with known or suspected COVID-19 pneumonia,” they explained.

The guide also included several considerations around the differential diagnosis of COVID-19 pneumonia from other pediatric lung disorders, including immune-related conditions, infectious etiologies, hematological dyscrasias, and inhalation-related lung injury.

As best practice recommendations for COVID-19 continue to evolve, the availability of practical clinical decision-making tools becomes essential to ensure optimal patient care.

No funding sources or financial disclosures were reported in the manuscript.

SOURCE: Foust AM et al. Pediatr Pulmonol. 2020 May 28. doi: 10.1002/ppul.24870.

A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has devised recommendations for ordering imaging studies in suspected cases of the infection.

The review also included useful radiographic findings to help in the differential diagnosis of COVID-19 pneumonia from other respiratory infections. Alexandra M. Foust, DO, of Boston Children’s Hospital, and colleagues reported the summary of findings and recommendations in Pediatric Pulmonology.

“Pediatricians face numerous challenges created by increasing reports of severe COVID-19 related findings in affected children,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. “[The current review] represents a multinational collaboration to provide up to date information and key imaging findings to guide chest physicians caring for children with pneumonia symptoms during the COVID-19 pandemic.”
 

Clinical presentation in children

In general, pediatric patients infected with the virus show milder symptoms compared with adults, and based on the limited evidence reported to date, the most common clinical symptoms of COVID-19 in children are rhinorrhea and/or nasal congestion, fever and cough with sore throat, fatigue or dyspnea, and diarrhea.

As with other viral pneumonias in children, the laboratory parameters are usually nonspecific; however, while the complete blood count (CBC) is often normal, lymphopenia, thrombocytopenia, and neutropenia have been reported in some cases of pediatric COVID-19, the authors noted.

The current Centers for Disease Control and Prevention (CDC) recommendation for initial diagnosis of SARS-CoV-2 is obtaining a nasopharyngeal swab, followed by reverse transcription polymerase chain reaction (RT-PCR) testing, they explained.
 

Role of imaging in diagnosis

The researchers reported that current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as a upfront test to diagnose pediatric COVID-19, but they may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course.

The potential benefits of utilizing radiologic evaluation, such as establishing a baseline for monitoring disease progression, must be balanced with potential drawbacks, which include radiation exposure, and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
 

Recommendations for ordering imaging studies

Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia.

The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia.

“The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Dr. Cataletto. “By synthesizing the available imaging case series and guidelines, this primer provides a useful tool for the practicing pulmonologist,” she explained.
 

Key recommendations: CXR

“For pediatric patients with suspected or known COVID-19 infection with moderate to severe clinical symptoms requiring hospitalization (i.e., hypoxia, moderate or severe dyspnea, signs of sepsis, shock, cardiovascular compromise, altered mentation), CXR is usually indicated to establish an imaging baseline and to assess for an alternative diagnosis,” they recommended.

“Sequential CXRs may be helpful to assess pediatric patients with COVID-19 who demonstrate worsening clinical symptoms or to assess response to supportive therapy,” they wrote.
 

Key recommendations: CT

“Due to the increased radiation sensitivity of pediatric patients, chest CT is not recommended as an initial diagnostic test for pediatric patients with known or suspected COVID-19 pneumonia,” they explained.

The guide also included several considerations around the differential diagnosis of COVID-19 pneumonia from other pediatric lung disorders, including immune-related conditions, infectious etiologies, hematological dyscrasias, and inhalation-related lung injury.

As best practice recommendations for COVID-19 continue to evolve, the availability of practical clinical decision-making tools becomes essential to ensure optimal patient care.

No funding sources or financial disclosures were reported in the manuscript.

SOURCE: Foust AM et al. Pediatr Pulmonol. 2020 May 28. doi: 10.1002/ppul.24870.

A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has devised recommendations for ordering imaging studies in suspected cases of the infection.

The review also included useful radiographic findings to help in the differential diagnosis of COVID-19 pneumonia from other respiratory infections. Alexandra M. Foust, DO, of Boston Children’s Hospital, and colleagues reported the summary of findings and recommendations in Pediatric Pulmonology.

“Pediatricians face numerous challenges created by increasing reports of severe COVID-19 related findings in affected children,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. “[The current review] represents a multinational collaboration to provide up to date information and key imaging findings to guide chest physicians caring for children with pneumonia symptoms during the COVID-19 pandemic.”
 

Clinical presentation in children

In general, pediatric patients infected with the virus show milder symptoms compared with adults, and based on the limited evidence reported to date, the most common clinical symptoms of COVID-19 in children are rhinorrhea and/or nasal congestion, fever and cough with sore throat, fatigue or dyspnea, and diarrhea.

As with other viral pneumonias in children, the laboratory parameters are usually nonspecific; however, while the complete blood count (CBC) is often normal, lymphopenia, thrombocytopenia, and neutropenia have been reported in some cases of pediatric COVID-19, the authors noted.

The current Centers for Disease Control and Prevention (CDC) recommendation for initial diagnosis of SARS-CoV-2 is obtaining a nasopharyngeal swab, followed by reverse transcription polymerase chain reaction (RT-PCR) testing, they explained.
 

Role of imaging in diagnosis

The researchers reported that current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as a upfront test to diagnose pediatric COVID-19, but they may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course.

The potential benefits of utilizing radiologic evaluation, such as establishing a baseline for monitoring disease progression, must be balanced with potential drawbacks, which include radiation exposure, and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
 

Recommendations for ordering imaging studies

Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia.

The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia.

“The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Dr. Cataletto. “By synthesizing the available imaging case series and guidelines, this primer provides a useful tool for the practicing pulmonologist,” she explained.
 

Key recommendations: CXR

“For pediatric patients with suspected or known COVID-19 infection with moderate to severe clinical symptoms requiring hospitalization (i.e., hypoxia, moderate or severe dyspnea, signs of sepsis, shock, cardiovascular compromise, altered mentation), CXR is usually indicated to establish an imaging baseline and to assess for an alternative diagnosis,” they recommended.

“Sequential CXRs may be helpful to assess pediatric patients with COVID-19 who demonstrate worsening clinical symptoms or to assess response to supportive therapy,” they wrote.
 

Key recommendations: CT

“Due to the increased radiation sensitivity of pediatric patients, chest CT is not recommended as an initial diagnostic test for pediatric patients with known or suspected COVID-19 pneumonia,” they explained.

The guide also included several considerations around the differential diagnosis of COVID-19 pneumonia from other pediatric lung disorders, including immune-related conditions, infectious etiologies, hematological dyscrasias, and inhalation-related lung injury.

As best practice recommendations for COVID-19 continue to evolve, the availability of practical clinical decision-making tools becomes essential to ensure optimal patient care.

No funding sources or financial disclosures were reported in the manuscript.

SOURCE: Foust AM et al. Pediatr Pulmonol. 2020 May 28. doi: 10.1002/ppul.24870.

The desire to feel better is a major driver for patients with first-episode psychosis (FEP) to turn to cannabis, new research shows.

An analysis of more than 1,300 individuals from six European countries showed patients with FEP were four times more likely than their healthy peers to start smoking cannabis in order to make themselves feel better.

The results also revealed that initiating cannabis use to feel better was associated with a more than tripled risk of being a daily user.

These findings could be used to help tailor treatment interventions, as well as offer an opportunity for psychoeducation – particularly as the reasons for starting cannabis appear to influence frequency of use, study investigator Edoardo Spinazzola, MD, Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, said in an interview.

Patients who start smoking cannabis because their friends or family partakes may benefit from therapies that encourage more “assertiveness” and being “socially comfortable without the substance,” Dr. Spinazzola said, noting that it might also be beneficial to identify the specific cause of the psychological discomfort driving cannabis use, such as depression, and specifically treat that issue.

The results were scheduled to be presented at the Congress of the Schizophrenia International Research Society 2020, but the meeting was canceled because of the coronavirus pandemic.
 

Answering the skeptics

Previous studies suggest that cannabis use can increase risk for psychosis up to 290%, with both frequency of use and potency playing a role, the researchers noted.

However, they added that “skeptics” argue the association could be caused by individuals with psychosis using cannabis as a form of self-medication, the comorbid effect of other psychogenic drugs, or a common genetic vulnerability between cannabis use and psychosis.

The reasons for starting cannabis use remain “largely unexplored,” so the researchers examined records from the European network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) database, which includes patients with FEP and healthy individuals acting as controls from France, Italy, the Netherlands, Spain, United Kingdom, and Brazil.

The analysis included 1,347 individuals, of whom 446 had a diagnosis of nonaffective psychosis, 89 had bipolar disorder, and 58 had psychotic depression.

Reasons to start smoking cannabis and patterns of use were determined using the modified version of the Cannabis Experiences Questionnaire.

Results showed that participants who started cannabis to feel better were significantly more likely to be younger, have fewer years of education, to be black or of mixed ethnicity, to be single, or to not be living independently than those who started it because their friends or family were using it (P < .001 for all comparisons).

In addition, 68% of the patients with FEP and 85% of the healthy controls started using cannabis because friends or family were using it. In contrast, 18% of those with FEP versus 5% of controls starting using cannabis to feel better; 13% versus 10%, respectively, started using for “other reasons.”

After taking into account gender, age, ethnicity, and study site, the patients with FEP were significantly more likely than their healthy peers to have started using cannabis to feel better (relative risk ratio, 4.67; P < .001).

Starting to smoke cannabis to feel better versus any other reason was associated with an increased frequency of use in both those with and without FEP, with an RRR of 2.9 for using the drug more than once a week (P = .001) and an RRR of 3.13 for daily use (P < .001). However, the association was stronger in the healthy controls than in those with FEP, with an RRR for daily use of 4.45 versus 3.11, respectively.

The investigators also examined whether there was a link between reasons to start smoking and an individual’s polygenic risk score (PRS) for developing schizophrenia.

Multinomial regression indicated that PRS was not associated with starting cannabis to feel better or because friends were using it. However, there was an association between PRS score and starting the drug because family members were using it (RRR, 0.68; P < .05).
 

Complex association

Gabriella Gobbi, MD, PhD, professor in the neurobiological psychiatry unit, department of psychiatry, at McGill University, Montreal, said the data confirm “what we already know about cannabis.”

She noted that one of the “major causes” of young people starting cannabis is the social environment, while the desire to use the drug to feel better is linked to “the fact that cannabis, in a lot of cases, is used as a self-medication” in order to be calmer and as a relief from anxiety.

There is a “very complex” association between using cannabis to feel better and the self-medication seen with cigarette smoking and alcohol in patients with schizophrenia, said Dr. Gobbi, who was not involved with the research.

“When we talk about [patients using] cannabis, alcohol, and cigarettes, actually we’re talking about the same group of people,” she said.

Although “it is true they say that people look to cigarettes, tobacco, and alcohol to feel happier because they are depressed, the risk of psychosis is only for cannabis,” she added. “It is very low for alcohol and tobacco.”

As a result, Dr. Gobbi said she and her colleagues are “very worried” about the consequences for mental health of the legalization of cannabis consumption in Canada in October 2018 with the passing of the Cannabis Act.

Although there are no firm statistics yet, she has observed that since the law was passed, cannabis use has stabilized at a lower level among adolescents. “But now we have another population of people aged 34 and older that consume cannabis,” she said.

Particularly when considering the impact of higher strength cannabis on psychosis risk, Dr. Gobbi believes the increase in consumption in this age group will result in a “more elevated” risk for mental health issues.

Dr. Spinazzola and Dr. Gobbi have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

The desire to feel better is a major driver for patients with first-episode psychosis (FEP) to turn to cannabis, new research shows.

An analysis of more than 1,300 individuals from six European countries showed patients with FEP were four times more likely than their healthy peers to start smoking cannabis in order to make themselves feel better.

The results also revealed that initiating cannabis use to feel better was associated with a more than tripled risk of being a daily user.

These findings could be used to help tailor treatment interventions, as well as offer an opportunity for psychoeducation – particularly as the reasons for starting cannabis appear to influence frequency of use, study investigator Edoardo Spinazzola, MD, Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, said in an interview.

Patients who start smoking cannabis because their friends or family partakes may benefit from therapies that encourage more “assertiveness” and being “socially comfortable without the substance,” Dr. Spinazzola said, noting that it might also be beneficial to identify the specific cause of the psychological discomfort driving cannabis use, such as depression, and specifically treat that issue.

The results were scheduled to be presented at the Congress of the Schizophrenia International Research Society 2020, but the meeting was canceled because of the coronavirus pandemic.
 

Answering the skeptics

Previous studies suggest that cannabis use can increase risk for psychosis up to 290%, with both frequency of use and potency playing a role, the researchers noted.

However, they added that “skeptics” argue the association could be caused by individuals with psychosis using cannabis as a form of self-medication, the comorbid effect of other psychogenic drugs, or a common genetic vulnerability between cannabis use and psychosis.

The reasons for starting cannabis use remain “largely unexplored,” so the researchers examined records from the European network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) database, which includes patients with FEP and healthy individuals acting as controls from France, Italy, the Netherlands, Spain, United Kingdom, and Brazil.

The analysis included 1,347 individuals, of whom 446 had a diagnosis of nonaffective psychosis, 89 had bipolar disorder, and 58 had psychotic depression.

Reasons to start smoking cannabis and patterns of use were determined using the modified version of the Cannabis Experiences Questionnaire.

Results showed that participants who started cannabis to feel better were significantly more likely to be younger, have fewer years of education, to be black or of mixed ethnicity, to be single, or to not be living independently than those who started it because their friends or family were using it (P < .001 for all comparisons).

In addition, 68% of the patients with FEP and 85% of the healthy controls started using cannabis because friends or family were using it. In contrast, 18% of those with FEP versus 5% of controls starting using cannabis to feel better; 13% versus 10%, respectively, started using for “other reasons.”

After taking into account gender, age, ethnicity, and study site, the patients with FEP were significantly more likely than their healthy peers to have started using cannabis to feel better (relative risk ratio, 4.67; P < .001).

Starting to smoke cannabis to feel better versus any other reason was associated with an increased frequency of use in both those with and without FEP, with an RRR of 2.9 for using the drug more than once a week (P = .001) and an RRR of 3.13 for daily use (P < .001). However, the association was stronger in the healthy controls than in those with FEP, with an RRR for daily use of 4.45 versus 3.11, respectively.

The investigators also examined whether there was a link between reasons to start smoking and an individual’s polygenic risk score (PRS) for developing schizophrenia.

Multinomial regression indicated that PRS was not associated with starting cannabis to feel better or because friends were using it. However, there was an association between PRS score and starting the drug because family members were using it (RRR, 0.68; P < .05).
 

Complex association

Gabriella Gobbi, MD, PhD, professor in the neurobiological psychiatry unit, department of psychiatry, at McGill University, Montreal, said the data confirm “what we already know about cannabis.”

She noted that one of the “major causes” of young people starting cannabis is the social environment, while the desire to use the drug to feel better is linked to “the fact that cannabis, in a lot of cases, is used as a self-medication” in order to be calmer and as a relief from anxiety.

There is a “very complex” association between using cannabis to feel better and the self-medication seen with cigarette smoking and alcohol in patients with schizophrenia, said Dr. Gobbi, who was not involved with the research.

“When we talk about [patients using] cannabis, alcohol, and cigarettes, actually we’re talking about the same group of people,” she said.

Although “it is true they say that people look to cigarettes, tobacco, and alcohol to feel happier because they are depressed, the risk of psychosis is only for cannabis,” she added. “It is very low for alcohol and tobacco.”

As a result, Dr. Gobbi said she and her colleagues are “very worried” about the consequences for mental health of the legalization of cannabis consumption in Canada in October 2018 with the passing of the Cannabis Act.

Although there are no firm statistics yet, she has observed that since the law was passed, cannabis use has stabilized at a lower level among adolescents. “But now we have another population of people aged 34 and older that consume cannabis,” she said.

Particularly when considering the impact of higher strength cannabis on psychosis risk, Dr. Gobbi believes the increase in consumption in this age group will result in a “more elevated” risk for mental health issues.

Dr. Spinazzola and Dr. Gobbi have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

The desire to feel better is a major driver for patients with first-episode psychosis (FEP) to turn to cannabis, new research shows.

An analysis of more than 1,300 individuals from six European countries showed patients with FEP were four times more likely than their healthy peers to start smoking cannabis in order to make themselves feel better.

The results also revealed that initiating cannabis use to feel better was associated with a more than tripled risk of being a daily user.

These findings could be used to help tailor treatment interventions, as well as offer an opportunity for psychoeducation – particularly as the reasons for starting cannabis appear to influence frequency of use, study investigator Edoardo Spinazzola, MD, Institute of Psychiatry, Psychology, and Neuroscience at King’s College London, said in an interview.

Patients who start smoking cannabis because their friends or family partakes may benefit from therapies that encourage more “assertiveness” and being “socially comfortable without the substance,” Dr. Spinazzola said, noting that it might also be beneficial to identify the specific cause of the psychological discomfort driving cannabis use, such as depression, and specifically treat that issue.

The results were scheduled to be presented at the Congress of the Schizophrenia International Research Society 2020, but the meeting was canceled because of the coronavirus pandemic.
 

Answering the skeptics

Previous studies suggest that cannabis use can increase risk for psychosis up to 290%, with both frequency of use and potency playing a role, the researchers noted.

However, they added that “skeptics” argue the association could be caused by individuals with psychosis using cannabis as a form of self-medication, the comorbid effect of other psychogenic drugs, or a common genetic vulnerability between cannabis use and psychosis.

The reasons for starting cannabis use remain “largely unexplored,” so the researchers examined records from the European network of national schizophrenia networks studying Gene-Environment Interactions (EU-GEI) database, which includes patients with FEP and healthy individuals acting as controls from France, Italy, the Netherlands, Spain, United Kingdom, and Brazil.

The analysis included 1,347 individuals, of whom 446 had a diagnosis of nonaffective psychosis, 89 had bipolar disorder, and 58 had psychotic depression.

Reasons to start smoking cannabis and patterns of use were determined using the modified version of the Cannabis Experiences Questionnaire.

Results showed that participants who started cannabis to feel better were significantly more likely to be younger, have fewer years of education, to be black or of mixed ethnicity, to be single, or to not be living independently than those who started it because their friends or family were using it (P < .001 for all comparisons).

In addition, 68% of the patients with FEP and 85% of the healthy controls started using cannabis because friends or family were using it. In contrast, 18% of those with FEP versus 5% of controls starting using cannabis to feel better; 13% versus 10%, respectively, started using for “other reasons.”

After taking into account gender, age, ethnicity, and study site, the patients with FEP were significantly more likely than their healthy peers to have started using cannabis to feel better (relative risk ratio, 4.67; P < .001).

Starting to smoke cannabis to feel better versus any other reason was associated with an increased frequency of use in both those with and without FEP, with an RRR of 2.9 for using the drug more than once a week (P = .001) and an RRR of 3.13 for daily use (P < .001). However, the association was stronger in the healthy controls than in those with FEP, with an RRR for daily use of 4.45 versus 3.11, respectively.

The investigators also examined whether there was a link between reasons to start smoking and an individual’s polygenic risk score (PRS) for developing schizophrenia.

Multinomial regression indicated that PRS was not associated with starting cannabis to feel better or because friends were using it. However, there was an association between PRS score and starting the drug because family members were using it (RRR, 0.68; P < .05).
 

Complex association

Gabriella Gobbi, MD, PhD, professor in the neurobiological psychiatry unit, department of psychiatry, at McGill University, Montreal, said the data confirm “what we already know about cannabis.”

She noted that one of the “major causes” of young people starting cannabis is the social environment, while the desire to use the drug to feel better is linked to “the fact that cannabis, in a lot of cases, is used as a self-medication” in order to be calmer and as a relief from anxiety.

There is a “very complex” association between using cannabis to feel better and the self-medication seen with cigarette smoking and alcohol in patients with schizophrenia, said Dr. Gobbi, who was not involved with the research.

“When we talk about [patients using] cannabis, alcohol, and cigarettes, actually we’re talking about the same group of people,” she said.

Although “it is true they say that people look to cigarettes, tobacco, and alcohol to feel happier because they are depressed, the risk of psychosis is only for cannabis,” she added. “It is very low for alcohol and tobacco.”

As a result, Dr. Gobbi said she and her colleagues are “very worried” about the consequences for mental health of the legalization of cannabis consumption in Canada in October 2018 with the passing of the Cannabis Act.

Although there are no firm statistics yet, she has observed that since the law was passed, cannabis use has stabilized at a lower level among adolescents. “But now we have another population of people aged 34 and older that consume cannabis,” she said.

Particularly when considering the impact of higher strength cannabis on psychosis risk, Dr. Gobbi believes the increase in consumption in this age group will result in a “more elevated” risk for mental health issues.

Dr. Spinazzola and Dr. Gobbi have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Hospital charges for the treatment of children with asthma made up nearly half of all potentially avoidable pediatric inpatient costs in 2017, according to the Agency for Healthcare Research and Quality.

The cost of potentially avoidable visits for asthma that year was $278 million, versus $284 million combined for the other three conditions “that evidence suggests may be avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in an AHRQ statistical brief.

Those three other conditions are diabetes short-term complications, gastroenteritis, and urinary tract infections (UTIs). Neonatal stays were excluded from the analysis, Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ noted.

The state inpatient databases of the AHRQ’s Healthcare Cost and Utilization Project included 1.4 million inpatient stays among children aged 3 months to 17 years in 2017, of which 8% (108,300) were deemed potentially preventable. Hospital charges for the preventable stays came to $561.6 million, or 3% of the $20 billion in total costs for all nonneonatal stays, they said.

Rates of potentially avoidable stays for asthma (159 per 100,000 population), gastroenteritis (90 per 100,000), and UTIs (41 per 100,000) were highest for children aged 0-4 years and generally decreased with age, but diabetes stays increased with age, rising from 12 per 100,000 in children aged 5-9 years to 38 per 100,000 for those 15-17 years old, the researchers said.

Black children had a much higher rate of potentially avoidable stays for asthma (218 per 100,000) than did Hispanic children (74), Asian/Pacific Islander children (46), or white children (43), but children classified as other race/ethnicity were higher still: 380 per 100,000. Rates for children classified as other race/ethnicity were highest for the other three conditions as well, they reported.

Comparisons by sex for the four conditions ended up in a 2-2 tie: Girls had higher rates for diabetes (28 vs. 23) and UTIs (35 vs. 8), and boys had higher rates for asthma (96 vs. 67) and gastroenteritis (38 vs. 35), Dr. McDermott and Dr. Jiang reported.

[email protected]

SOURCE: McDermott KW, Jiang HJ. HCUP Statistical Brief #259. June 2020.

Hospital charges for the treatment of children with asthma made up nearly half of all potentially avoidable pediatric inpatient costs in 2017, according to the Agency for Healthcare Research and Quality.

The cost of potentially avoidable visits for asthma that year was $278 million, versus $284 million combined for the other three conditions “that evidence suggests may be avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in an AHRQ statistical brief.

Those three other conditions are diabetes short-term complications, gastroenteritis, and urinary tract infections (UTIs). Neonatal stays were excluded from the analysis, Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ noted.

The state inpatient databases of the AHRQ’s Healthcare Cost and Utilization Project included 1.4 million inpatient stays among children aged 3 months to 17 years in 2017, of which 8% (108,300) were deemed potentially preventable. Hospital charges for the preventable stays came to $561.6 million, or 3% of the $20 billion in total costs for all nonneonatal stays, they said.

Rates of potentially avoidable stays for asthma (159 per 100,000 population), gastroenteritis (90 per 100,000), and UTIs (41 per 100,000) were highest for children aged 0-4 years and generally decreased with age, but diabetes stays increased with age, rising from 12 per 100,000 in children aged 5-9 years to 38 per 100,000 for those 15-17 years old, the researchers said.

Black children had a much higher rate of potentially avoidable stays for asthma (218 per 100,000) than did Hispanic children (74), Asian/Pacific Islander children (46), or white children (43), but children classified as other race/ethnicity were higher still: 380 per 100,000. Rates for children classified as other race/ethnicity were highest for the other three conditions as well, they reported.

Comparisons by sex for the four conditions ended up in a 2-2 tie: Girls had higher rates for diabetes (28 vs. 23) and UTIs (35 vs. 8), and boys had higher rates for asthma (96 vs. 67) and gastroenteritis (38 vs. 35), Dr. McDermott and Dr. Jiang reported.

[email protected]

SOURCE: McDermott KW, Jiang HJ. HCUP Statistical Brief #259. June 2020.

Hospital charges for the treatment of children with asthma made up nearly half of all potentially avoidable pediatric inpatient costs in 2017, according to the Agency for Healthcare Research and Quality.

The cost of potentially avoidable visits for asthma that year was $278 million, versus $284 million combined for the other three conditions “that evidence suggests may be avoidable, in part, through timely and quality primary and preventive care,” Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in an AHRQ statistical brief.

Those three other conditions are diabetes short-term complications, gastroenteritis, and urinary tract infections (UTIs). Neonatal stays were excluded from the analysis, Dr. McDermott of IBM Watson Health and Dr. Jiang of the AHRQ noted.

The state inpatient databases of the AHRQ’s Healthcare Cost and Utilization Project included 1.4 million inpatient stays among children aged 3 months to 17 years in 2017, of which 8% (108,300) were deemed potentially preventable. Hospital charges for the preventable stays came to $561.6 million, or 3% of the $20 billion in total costs for all nonneonatal stays, they said.

Rates of potentially avoidable stays for asthma (159 per 100,000 population), gastroenteritis (90 per 100,000), and UTIs (41 per 100,000) were highest for children aged 0-4 years and generally decreased with age, but diabetes stays increased with age, rising from 12 per 100,000 in children aged 5-9 years to 38 per 100,000 for those 15-17 years old, the researchers said.

Black children had a much higher rate of potentially avoidable stays for asthma (218 per 100,000) than did Hispanic children (74), Asian/Pacific Islander children (46), or white children (43), but children classified as other race/ethnicity were higher still: 380 per 100,000. Rates for children classified as other race/ethnicity were highest for the other three conditions as well, they reported.

Comparisons by sex for the four conditions ended up in a 2-2 tie: Girls had higher rates for diabetes (28 vs. 23) and UTIs (35 vs. 8), and boys had higher rates for asthma (96 vs. 67) and gastroenteritis (38 vs. 35), Dr. McDermott and Dr. Jiang reported.

[email protected]

SOURCE: McDermott KW, Jiang HJ. HCUP Statistical Brief #259. June 2020.

In response to COVID-19, we have seen a rapid transformation to virtually delivered mental health care, essential for the prevention and treatment of various mental health conditions during an isolating and stress-inducing pandemic. Yet teletherapy and virtual medication management alone may not adequately address the needs of some of the populations we serve.

Take Jackson, whose name and details have been changed for privacy. A year ago, Jackson, in his last year of high school, began hearing voices that others could not hear. After becoming increasingly withdrawn, his father sought out treatment for him and learned that Jackson was experiencing his first episode of psychosis.

Psychosis involves disruptions in the way one processes thoughts and feelings or behaves, and includes delusions – or unusual beliefs – and hallucinations, meaning seeing and hearing things that others cannot. “First-episode psychosis” (FEP) simply refers to the first time an individual experiences this. It typically occurs between one’s teenage years and their 20s. Whereas some individuals recover from their first episode and may not experience another, others go on to experience recurrence, and sometimes a waxing and waning illness course.

Jackson enrolled in a comprehensive mental health program that not only includes a psychiatrist, but also therapists who provide case management services, as well as a peer specialist; this is someone with lived experience navigating mental illness. The program also includes an employment and education specialist and family and group therapy sessions. His team helped him identify and work toward his personal recovery goals: graduating from high school, obtaining a job, and maintaining a strong relationship with his father.

One hundred thousand adolescents and young adults like Jackson experience FEP each year, and now, in the wake of COVID-19, they probably have more limited access to the kind of support that can be vital to recovery.

Studies have shown that untreated psychosis can detrimentally affect quality of life in several ways, including by negatively affecting interpersonal relationships, interfering with obtaining or maintaining employment, and increasing the risk for problematic substance use. The psychosocial effects of COVID-19 could compound problems that individuals navigating psychosis already face, such as stigmatization, social isolation, and unemployment. On top of this, individuals who experience additional marginalization and downstream effects of systematic discriminatory practices by virtue of their race or ethnicity, immigration status, or language bear the brunt of some of this pandemic’s worst health inequities.

Early and efficacious treatment is critically important for individuals experiencing psychosis. Evidence shows that engagement in coordinated specialty care (CSC) specifically can improve outcomes, including the likelihood of being engaged in school or work and lower rates of hospitalization. CSC is a team-based approach that utilizes the unique skills of every team member to support an individual in reaching their recovery goals, whether it’s starting or finishing college or building a new relationship.

Unlike traditional treatment goals, which often focus on “symptom reduction,” recovery-oriented care is about supporting an individual in obtaining a sense of satisfaction, meaning, and purpose in life. CSC involves not only individual sessions with one’s psychiatrist or therapist, but collaboration with a patient’s peers, groups, family, and work. It also supports navigating such experiences as a job interview or a date. These key, multifaceted components must be made accessible and adapted during these times.

For individuals like Jackson, it is crucial to be able to continue accessing quality CSC, even during our current pandemic. Lisa Dixon, MD, a professor of psychiatry at Columbia University, leads ONTrackNY, a statewide FEP program. She states that “effective, recovery-oriented treatment can make such a huge difference in the lives of these young people who are at a potential inflection point in their lives. Creative, collaborative clinicians can maintain connection and support.”

So how can we adapt CSC during this time? In addition to virtualized medication management and individual therapy, other components of CSC can be creatively adapted for online platforms. Group sessions can be completed virtually, from family to peer-led. Though the unemployment rate continues to rise, we can still help participants with a desire to work find employers that are offering remote work or navigate the risks of potential COVID-19 work exposures if remote options aren’t available. We can also support their developing skills to be used once other employers that pose less risk reopen.

For those in school, virtual education support can provide study skills, ways to cope with transition to an online classroom, or help with obtaining tutoring. Nutritionists can work remotely to provide support and creatively use online platforms for real-time feedback in a participant’s kitchen. Virtual case management is even more essential in the wake of COVID-19, from assistance with applying for unemployment insurance and financial aid to obtaining health insurance or determining eligibility.

For those without access to virtual platforms, individual and group telephone sessions and text check-ins can provide meaningful opportunities for continued engagement. For those who are unstably housed or have limited privacy in housing, teams must generate ideas of where to have remote sessions, such as a nearby park.

In a world now dominated by virtual care, it is critically important that individuals needing to see a clinician in person still be able to do so. Whether it is due to an acute crisis or to administer a long-acting injection medication, it is our responsibility to thoughtfully and judiciously remain available to patients, using appropriate personal protective equipment and precautions.

Jackson is one of many young people in recovery from psychosis. He is not defined by or limited by his experiences, but rather is navigating the possibilities that lie ahead of him, defining for himself who he wants to be in this world as it evolves. In the midst of COVID-19, as we seek to innovate – from how we exercise to how we throw birthday parties – let’s also be innovative in how we provide care and support for individuals experiencing psychosis.

This article first appeared on Medscape.com.

In response to COVID-19, we have seen a rapid transformation to virtually delivered mental health care, essential for the prevention and treatment of various mental health conditions during an isolating and stress-inducing pandemic. Yet teletherapy and virtual medication management alone may not adequately address the needs of some of the populations we serve.

Take Jackson, whose name and details have been changed for privacy. A year ago, Jackson, in his last year of high school, began hearing voices that others could not hear. After becoming increasingly withdrawn, his father sought out treatment for him and learned that Jackson was experiencing his first episode of psychosis.

Psychosis involves disruptions in the way one processes thoughts and feelings or behaves, and includes delusions – or unusual beliefs – and hallucinations, meaning seeing and hearing things that others cannot. “First-episode psychosis” (FEP) simply refers to the first time an individual experiences this. It typically occurs between one’s teenage years and their 20s. Whereas some individuals recover from their first episode and may not experience another, others go on to experience recurrence, and sometimes a waxing and waning illness course.

Jackson enrolled in a comprehensive mental health program that not only includes a psychiatrist, but also therapists who provide case management services, as well as a peer specialist; this is someone with lived experience navigating mental illness. The program also includes an employment and education specialist and family and group therapy sessions. His team helped him identify and work toward his personal recovery goals: graduating from high school, obtaining a job, and maintaining a strong relationship with his father.

One hundred thousand adolescents and young adults like Jackson experience FEP each year, and now, in the wake of COVID-19, they probably have more limited access to the kind of support that can be vital to recovery.

Studies have shown that untreated psychosis can detrimentally affect quality of life in several ways, including by negatively affecting interpersonal relationships, interfering with obtaining or maintaining employment, and increasing the risk for problematic substance use. The psychosocial effects of COVID-19 could compound problems that individuals navigating psychosis already face, such as stigmatization, social isolation, and unemployment. On top of this, individuals who experience additional marginalization and downstream effects of systematic discriminatory practices by virtue of their race or ethnicity, immigration status, or language bear the brunt of some of this pandemic’s worst health inequities.

Early and efficacious treatment is critically important for individuals experiencing psychosis. Evidence shows that engagement in coordinated specialty care (CSC) specifically can improve outcomes, including the likelihood of being engaged in school or work and lower rates of hospitalization. CSC is a team-based approach that utilizes the unique skills of every team member to support an individual in reaching their recovery goals, whether it’s starting or finishing college or building a new relationship.

Unlike traditional treatment goals, which often focus on “symptom reduction,” recovery-oriented care is about supporting an individual in obtaining a sense of satisfaction, meaning, and purpose in life. CSC involves not only individual sessions with one’s psychiatrist or therapist, but collaboration with a patient’s peers, groups, family, and work. It also supports navigating such experiences as a job interview or a date. These key, multifaceted components must be made accessible and adapted during these times.

For individuals like Jackson, it is crucial to be able to continue accessing quality CSC, even during our current pandemic. Lisa Dixon, MD, a professor of psychiatry at Columbia University, leads ONTrackNY, a statewide FEP program. She states that “effective, recovery-oriented treatment can make such a huge difference in the lives of these young people who are at a potential inflection point in their lives. Creative, collaborative clinicians can maintain connection and support.”

So how can we adapt CSC during this time? In addition to virtualized medication management and individual therapy, other components of CSC can be creatively adapted for online platforms. Group sessions can be completed virtually, from family to peer-led. Though the unemployment rate continues to rise, we can still help participants with a desire to work find employers that are offering remote work or navigate the risks of potential COVID-19 work exposures if remote options aren’t available. We can also support their developing skills to be used once other employers that pose less risk reopen.

For those in school, virtual education support can provide study skills, ways to cope with transition to an online classroom, or help with obtaining tutoring. Nutritionists can work remotely to provide support and creatively use online platforms for real-time feedback in a participant’s kitchen. Virtual case management is even more essential in the wake of COVID-19, from assistance with applying for unemployment insurance and financial aid to obtaining health insurance or determining eligibility.

For those without access to virtual platforms, individual and group telephone sessions and text check-ins can provide meaningful opportunities for continued engagement. For those who are unstably housed or have limited privacy in housing, teams must generate ideas of where to have remote sessions, such as a nearby park.

In a world now dominated by virtual care, it is critically important that individuals needing to see a clinician in person still be able to do so. Whether it is due to an acute crisis or to administer a long-acting injection medication, it is our responsibility to thoughtfully and judiciously remain available to patients, using appropriate personal protective equipment and precautions.

Jackson is one of many young people in recovery from psychosis. He is not defined by or limited by his experiences, but rather is navigating the possibilities that lie ahead of him, defining for himself who he wants to be in this world as it evolves. In the midst of COVID-19, as we seek to innovate – from how we exercise to how we throw birthday parties – let’s also be innovative in how we provide care and support for individuals experiencing psychosis.

This article first appeared on Medscape.com.

In response to COVID-19, we have seen a rapid transformation to virtually delivered mental health care, essential for the prevention and treatment of various mental health conditions during an isolating and stress-inducing pandemic. Yet teletherapy and virtual medication management alone may not adequately address the needs of some of the populations we serve.

Take Jackson, whose name and details have been changed for privacy. A year ago, Jackson, in his last year of high school, began hearing voices that others could not hear. After becoming increasingly withdrawn, his father sought out treatment for him and learned that Jackson was experiencing his first episode of psychosis.

Psychosis involves disruptions in the way one processes thoughts and feelings or behaves, and includes delusions – or unusual beliefs – and hallucinations, meaning seeing and hearing things that others cannot. “First-episode psychosis” (FEP) simply refers to the first time an individual experiences this. It typically occurs between one’s teenage years and their 20s. Whereas some individuals recover from their first episode and may not experience another, others go on to experience recurrence, and sometimes a waxing and waning illness course.

Jackson enrolled in a comprehensive mental health program that not only includes a psychiatrist, but also therapists who provide case management services, as well as a peer specialist; this is someone with lived experience navigating mental illness. The program also includes an employment and education specialist and family and group therapy sessions. His team helped him identify and work toward his personal recovery goals: graduating from high school, obtaining a job, and maintaining a strong relationship with his father.

One hundred thousand adolescents and young adults like Jackson experience FEP each year, and now, in the wake of COVID-19, they probably have more limited access to the kind of support that can be vital to recovery.

Studies have shown that untreated psychosis can detrimentally affect quality of life in several ways, including by negatively affecting interpersonal relationships, interfering with obtaining or maintaining employment, and increasing the risk for problematic substance use. The psychosocial effects of COVID-19 could compound problems that individuals navigating psychosis already face, such as stigmatization, social isolation, and unemployment. On top of this, individuals who experience additional marginalization and downstream effects of systematic discriminatory practices by virtue of their race or ethnicity, immigration status, or language bear the brunt of some of this pandemic’s worst health inequities.

Early and efficacious treatment is critically important for individuals experiencing psychosis. Evidence shows that engagement in coordinated specialty care (CSC) specifically can improve outcomes, including the likelihood of being engaged in school or work and lower rates of hospitalization. CSC is a team-based approach that utilizes the unique skills of every team member to support an individual in reaching their recovery goals, whether it’s starting or finishing college or building a new relationship.

Unlike traditional treatment goals, which often focus on “symptom reduction,” recovery-oriented care is about supporting an individual in obtaining a sense of satisfaction, meaning, and purpose in life. CSC involves not only individual sessions with one’s psychiatrist or therapist, but collaboration with a patient’s peers, groups, family, and work. It also supports navigating such experiences as a job interview or a date. These key, multifaceted components must be made accessible and adapted during these times.

For individuals like Jackson, it is crucial to be able to continue accessing quality CSC, even during our current pandemic. Lisa Dixon, MD, a professor of psychiatry at Columbia University, leads ONTrackNY, a statewide FEP program. She states that “effective, recovery-oriented treatment can make such a huge difference in the lives of these young people who are at a potential inflection point in their lives. Creative, collaborative clinicians can maintain connection and support.”

So how can we adapt CSC during this time? In addition to virtualized medication management and individual therapy, other components of CSC can be creatively adapted for online platforms. Group sessions can be completed virtually, from family to peer-led. Though the unemployment rate continues to rise, we can still help participants with a desire to work find employers that are offering remote work or navigate the risks of potential COVID-19 work exposures if remote options aren’t available. We can also support their developing skills to be used once other employers that pose less risk reopen.

For those in school, virtual education support can provide study skills, ways to cope with transition to an online classroom, or help with obtaining tutoring. Nutritionists can work remotely to provide support and creatively use online platforms for real-time feedback in a participant’s kitchen. Virtual case management is even more essential in the wake of COVID-19, from assistance with applying for unemployment insurance and financial aid to obtaining health insurance or determining eligibility.

For those without access to virtual platforms, individual and group telephone sessions and text check-ins can provide meaningful opportunities for continued engagement. For those who are unstably housed or have limited privacy in housing, teams must generate ideas of where to have remote sessions, such as a nearby park.

In a world now dominated by virtual care, it is critically important that individuals needing to see a clinician in person still be able to do so. Whether it is due to an acute crisis or to administer a long-acting injection medication, it is our responsibility to thoughtfully and judiciously remain available to patients, using appropriate personal protective equipment and precautions.

Jackson is one of many young people in recovery from psychosis. He is not defined by or limited by his experiences, but rather is navigating the possibilities that lie ahead of him, defining for himself who he wants to be in this world as it evolves. In the midst of COVID-19, as we seek to innovate – from how we exercise to how we throw birthday parties – let’s also be innovative in how we provide care and support for individuals experiencing psychosis.

This article first appeared on Medscape.com.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

[email protected]

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

[email protected]

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

[email protected]

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

Scrapings of the child’s rash were analyzed with potassium hydroxide (KOH) under microscopy which revealed multiple septate hyphae.

She was diagnosed with Majocchi’s granuloma. The fungal culture was positive for Trichophyton rubrum.

The differential diagnosis for these lesions in children includes other granulomatous conditions such as granulomatous rosacea, sarcoidosis, and granuloma faciale, as well as bacterial or atypical mycobacterial infections, cutaneous leishmaniasis, and eosinophilic pustular folliculitis.

Treatment of MG requires systemic treatment with griseofulvin, itraconazole, or terbinafine for at least 4-8 weeks or until all the lesions have resolved. Our patient was treated with 6 weeks of high-dose griseofulvin with resolution of her lesions.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Dermatol Online J. 2018 Dec 15;24(12):13030/qt89k4t6wj.

2. Med Mycol. 2012 Jul;50(5):449-57.

3. Clin Microbiol Rev. 2011 Apr;24(2):247-80.

Scrapings of the child’s rash were analyzed with potassium hydroxide (KOH) under microscopy which revealed multiple septate hyphae.

She was diagnosed with Majocchi’s granuloma. The fungal culture was positive for Trichophyton rubrum.

The differential diagnosis for these lesions in children includes other granulomatous conditions such as granulomatous rosacea, sarcoidosis, and granuloma faciale, as well as bacterial or atypical mycobacterial infections, cutaneous leishmaniasis, and eosinophilic pustular folliculitis.

Treatment of MG requires systemic treatment with griseofulvin, itraconazole, or terbinafine for at least 4-8 weeks or until all the lesions have resolved. Our patient was treated with 6 weeks of high-dose griseofulvin with resolution of her lesions.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Dermatol Online J. 2018 Dec 15;24(12):13030/qt89k4t6wj.

2. Med Mycol. 2012 Jul;50(5):449-57.

3. Clin Microbiol Rev. 2011 Apr;24(2):247-80.

Scrapings of the child’s rash were analyzed with potassium hydroxide (KOH) under microscopy which revealed multiple septate hyphae.

She was diagnosed with Majocchi’s granuloma. The fungal culture was positive for Trichophyton rubrum.

The differential diagnosis for these lesions in children includes other granulomatous conditions such as granulomatous rosacea, sarcoidosis, and granuloma faciale, as well as bacterial or atypical mycobacterial infections, cutaneous leishmaniasis, and eosinophilic pustular folliculitis.

Treatment of MG requires systemic treatment with griseofulvin, itraconazole, or terbinafine for at least 4-8 weeks or until all the lesions have resolved. Our patient was treated with 6 weeks of high-dose griseofulvin with resolution of her lesions.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. Dermatol Online J. 2018 Dec 15;24(12):13030/qt89k4t6wj.

2. Med Mycol. 2012 Jul;50(5):449-57.

3. Clin Microbiol Rev. 2011 Apr;24(2):247-80.

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.

The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.

The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.

AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.

The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.

Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.

[email protected]

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.

The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.

The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.

AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.

The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.

Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.

[email protected]

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset Still’s disease (AOSD) to a previous approval for juvenile-onset Still’s disease, also known as systemic juvenile idiopathic arthritis (sJIA), making it the first approved treatment for AOSD, according to an FDA announcement.

The approval comes under a Priority Review designation that used “comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with sJIA, as well as the safety of canakinumab in patients with AOSD and other diseases,” the FDA said.

The results from a randomized, double-blind, placebo-controlled study of 36 patients with AOSD aged 22-70 years showed that the efficacy and safety data in AOSD were generally consistent with the results of a pooled analysis of sJIA patients, according to Novartis, which markets canakinumab.

AOSD and sJIA share certain similarities, such as fever, arthritis, rash, and elevated markers of inflammation, which has led to suspicion that they are part of a continuum rather than wholly distinct, according to the agency. In addition, the role of interleukin-1 is well established in both diseases and is blocked by canakinumab.

The most common side effects (occurring in greater than 10% of patients) in sJIA studies included infections, abdominal pain, and injection-site reactions. Serious infections (e.g., pneumonia, varicella, gastroenteritis, measles, sepsis, otitis media, sinusitis, adenovirus, lymph node abscess, pharyngitis) were observed in approximately 4%-5%, according to the full prescribing information.

Canakinumab is also approved for the periodic fever syndromes of cryopyrin-associated periodic syndromes in adults and children aged 4 years and older (including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome), tumor necrosis factor receptor associated periodic syndrome in adult and pediatric patients, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency in adult and pediatric patients, and familial Mediterranean fever in adult and pediatric patients.

[email protected]