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Altered skin biomarker levels predict atopic dermatitis risk in infants
Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.
Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P = .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P = .02) and 18 (P = .000001) were different in children who developed vs did not develop AD.
Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.
Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.
Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518
Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.
Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P = .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P = .02) and 18 (P = .000001) were different in children who developed vs did not develop AD.
Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.
Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.
Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518
Key clinical point: Certain cutaneous biomarkers isolated from the clinically healthy skin of 2-month-old infants were able to predict the onset of atopic dermatitis (AD) in the first year of life.
Major finding: Skin thymus- and activation-regulated chemokine levels were slightly but significantly higher (0.02 vs 0.01 pg/μg, P = .01), phytosphingosine levels were significantly lower (238 vs 535 pmol/mg, P < .001), and sphingoid bases of chain lengths 17 (P = .02) and 18 (P = .000001) were different in children who developed vs did not develop AD.
Study details: Findings are from a prospective birth cohort study that analyzed tape strips collected at 2 months of age before AD onset in 44 children who developed AD in the first year of life and 44 matched controls who did not develop AD.
Disclosures: This study was supported by the LEO Foundation and other sources. Four authors declared serving as advisors, speakers, or consultants, or receiving research grants or support from several sources, including LEO Pharma. The other authors reported no conflicts of interest.
Source: Rinnov MR et al. Skin biomarkers predict development of atopic dermatitis in infancy. Allergy. 2022 (Sep 16). Doi: 10.1111/all.15518
Moderate-to-severe atopic dermatitis: Abrocitinib shows rapid itch relief
Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.
Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).
Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.
Disclosures: This study was funded by Pfizer, Inc. Five authors declared being current or former employees and stockholders of Pfizer. The other authors reported ties with several sources.
Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042
Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.
Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).
Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.
Disclosures: This study was funded by Pfizer, Inc. Five authors declared being current or former employees and stockholders of Pfizer. The other authors reported ties with several sources.
Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042
Key clinical point: Abrocitinib demonstrated a rapid improvement in the signs and symptoms of atopic dermatitis (AD) in patients with moderate-to-severe AD.
Major finding: At week 12, a higher proportion of patients receiving 200/100 mg abrocitinib (70.3%/58.7%) vs placebo (27.1%) achieved ≥75% improvement in the Eczema Area and Severity Index (EASI-75). The time to achieve EASI-75 was significantly lower in the 200/100 mg abrocitinib vs placebo group (29/57 days vs 114 days; 2-sided P < .0001).
Study details: Findings are from the phase 3 JADE COMPARE study including adults with moderate-to-severe AD who were randomly assigned to receive 200/100 mg oral abrocitinib once daily+placebo, dupilumab+placebo, or placebo for 16 weeks.
Disclosures: This study was funded by Pfizer, Inc. Five authors declared being current or former employees and stockholders of Pfizer. The other authors reported ties with several sources.
Source: Reich K et al. Magnitude and time course of response to abrocitinib for moderate-to-severe atopic dermatitis. J Allergy Clin Immunol Pract. 2022 (Sep 12). Doi: 10.1016/j.jaip.2022.08.042
Atopic dermatitis: Rapid and sustained “itch-free” state with ruxolitinib
Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.
Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.
Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.
Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.
Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010
Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.
Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.
Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.
Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.
Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010
Key clinical point: Patients with atopic dermatitis (AD) who received ruxolitinib achieved an itch-free state within 2 days, which was maintained throughout the 8-week treatment period.
Major finding: A significantly higher proportion of patients receiving ruxolitinib (1.5%/0.75%) vs vehicle achieved itch numerical rating scale (NRS) score of 0/1 as early as within 2 days (19.0%/15.4% vs 4.6%), with improvements sustained till week 8 (49.5%/43.9% vs 18.3%; all P < .05). The median time to achieve itch NRS 0/1 was <15 days with ruxolitinib cream and not estimable with the vehicle.
Study details: Findings are from a pooled analysis of two phase 3 studies, TRuE-AD1 and TruE-AD2, including 1208 patients with AD and itch NRS score of >1 who were randomly assigned to receive ruxolitinib cream or vehicle.
Disclosures: This study was funded by Incyte Corporation. Three authors declared being employees and shareholders of Incyte Corporation. The other authors declared serving as scientific advisors, investigators, or consultants, or receiving research grants or honoraria from several sources, including Incyte.
Source: Blauvelt A et al. Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: Pooled analysis from two randomized phase 3 studies. J Am Acad Dermatol. 2022 (Sep 13). Doi: 10.1016/j.jaad.2022.09.010
Moderate-to-severe atopic dermatitis: Children younger than 6 years can now receive dupilumab
Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.
Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.
Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.
Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2
Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.
Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.
Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.
Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2
Key clinical point: Dupilumab reduced disease severity and showed a tolerable safety profile in children with moderate-to-severe atopic dermatitis (AD) as young as 6 months.
Major finding: At week 16, a significantly higher proportion of children receiving dupilumab vs placebo achieved the Investigator’s Global Assessment score of 0/1 (28% vs 4%; P < .0001). Both groups had a similar prevalence of adverse events (AE; 64% vs 74%), and no dupilumab-related serious AE were reported.
Study details: Findings are from the phase 3 LIBERTY AD PRESCHOOL study including 162 children between the ages of 6 months and 6 years with moderate-to-severe AD who were randomly assigned to receive subcutaneous dupilumab or placebo, both with low-potency topical corticosteroids.
Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals. Ten authors declared being current or former employees and shareholders of Regeneron Pharmaceuticals, and 5 authors declared being employees or shareholders of Sanofi. The other authors reported ties with several sources.
Source: Paller AS et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10356):908-919 (Sep 17). Doi: 10.1016/S0140-6736(22)01539-2
FDA approves upadacitinib (Rinvoq) for sixth indication
The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.
The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.
Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.
“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”
Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.
Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.
Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.
A version of this article first appeared on Medscape.com.
The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.
The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.
Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.
“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”
Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.
Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.
Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.
A version of this article first appeared on Medscape.com.
The United States Food and Drug Administration has approved the Janus kinase (JAK) inhibitor upadacitinib (Rinvoq) for adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation and who have had an inadequate response to or are intolerant of one or more tumor necrosis factor (TNF) inhibitors, according to an announcement from the manufacturer, AbbVie.
The indication is the sixth in the United States for the JAK inhibitor. Upadacitinib 15 mg once daily is already approved in the United States for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS). All these indications are for patients who have had an inadequate response to or are intolerant of one or more TNF inhibitors.
Upadacitinib is now the only JAK inhibitor that has been approved for both nr-axSpA and AS.
“Many patients living with nr-axSpA continue to experience symptoms and are unable to control disease with current treatments. In the SELECT-AXIS 2 trials, Rinvoq demonstrated efficacy in both nr-axSpA and AS with safety that was consistent across indications,” Atul Deodhar, MD, lead investigator of the trial, said in the announcement. “Today’s FDA approval offers an important new therapeutic option for patients and their caregivers to help take control of their symptoms and disease.”
Upadacitinib is also approved at a dose of 15 mg once daily for adults and children 12 years of age and older who weigh at least 40 kg and who have refractory, moderate to severe atopic dermatitis that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
It is approved as well at 45 mg once daily for 8 weeks as an induction therapy for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or are intolerant of one or more TNF blockers. Following induction therapy for patients with ulcerative colitis, the recommended dose for maintenance treatment is 15 mg once daily, but a dose of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
The FDA’s decision is supported by data from the phase 3 SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety, and tolerability of upadacitinib in adults with active nr-axSpA.
Nearly half of patients treated with upadacitinib had achieved 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), the primary endpoint, at week 14, compared with placebo (44.9% vs. 22.3%). These responses were observed as early as 2 weeks after initiation of therapy. The safety profile was consistent with what’s known in patients with RA, PsA, and AS.
Upadacitinib can lower the ability to fight infections. Serious infections, some fatal, have occurred, including tuberculosis and infections caused by bacteria, fungi, or viruses. It is associated with an increased risk of death and major cardiovascular events in people aged 50 and older who have at least one heart disease risk factor, and it is associated with an increased risk of some cancers, including lymphoma and skin cancers.
A version of this article first appeared on Medscape.com.
Evidence mounting that full-body emollients don’t prevent AD in at-risk babies
MONTREAL – , according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.
“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).
The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.
At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.
“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”
The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.
“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.
“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.
“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”
Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”
He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.
Dr. Williams and Dr. Drucker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
MONTREAL – , according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.
“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).
The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.
At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.
“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”
The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.
“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.
“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.
“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”
Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”
He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.
Dr. Williams and Dr. Drucker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
MONTREAL – , according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.
“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).
The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.
At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.
“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”
The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.
“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.
“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.
“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”
Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”
He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.
Dr. Williams and Dr. Drucker report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ISAD 2022
Florida sees spike in deadly bacterial infections after Hurricane Ian
At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release.
Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said.
“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”
Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.
“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement. “Individuals with wound infections should also seek care promptly.”
A version of this article first appeared on WebMD.com.
At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release.
Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said.
“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”
Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.
“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement. “Individuals with wound infections should also seek care promptly.”
A version of this article first appeared on WebMD.com.
At least 4 people have died and 29 have been infected in Lee County after the hurricane, Florida health officials said in a news release.
Vibrio vulnificus bacteria is found in warm, brackish seawater, according to the Florida Department of Health. Anyone with open wounds or cuts should avoid standing water, floodwater, or seawater in the area, health officials said.
“Sewage spills in coastal waters, like those caused by Hurricane Ian, may increase bacteria levels,” the department advised in a news release. “People with open wounds, cuts, or scratches can be exposed to Vibrio vulnificus through direct contact with sea water or brackish water … Vibrio vulnificus can also cause disease in those who eat raw or undercooked oysters and shellfish.”
Infection can cause severe illness or death. Symptoms include fever, chills, decreased blood pressure, and blistering skin lesions. The bacteria does not spread person to person.
“If someone is concerned that they may have been exposed to Vibrio vulnificus and are experiencing the above symptoms, they should seek medical attention immediately,” officials said in the statement. “Individuals with wound infections should also seek care promptly.”
A version of this article first appeared on WebMD.com.
Psoriatic arthritis has greater impact on women than men
Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.
Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.
In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.
The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).
Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).
Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).
Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).
More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.
However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).
“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.
The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
Mechanisms driving sex differences remain unclear
“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.
The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.
Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.
The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.
Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.
Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.
In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.
The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).
Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).
Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).
Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).
More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.
However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).
“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.
The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
Mechanisms driving sex differences remain unclear
“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.
The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.
Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.
The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.
Women with psoriatic arthritis (PsA) experience a higher disease burden than that of men with regard to pain, disability, and quality of life, based on data from a cross-sectional survey of more than 2,000 individuals and their rheumatologists and dermatologists.
Although PsA affects men and women in equal numbers, previous research suggests differences in clinical manifestations based on gender that may manifest in many ways, including quality of life, but data on sex differences in PsA are limited, wrote Laure Gossec, MD, of the Pitié-Salpêtrière Hospital and Sorbonne University, Paris, and colleagues.
In a study published in The Journal of Rheumatology, the researchers conducted a cross-sectional survey of rheumatologists and dermatologists and their patients with PsA during June-August 2018. The study population included 2,270 adults from France, Germany, Italy, Spain, the United Kingdom, and the United States. The mean age of the patients was 48.6 years, the mean duration of disease was 4.9 years, and 46% (1,047 patients) were women.
The survey data included information on demographics, treatment, and clinical characteristics, such as tender and swollen joint counts and body surface area affected by psoriasis. The researchers assessed quality of life on the survey using the EuroQoL 5-Dimension questionnaire (EQ-5D) and the impact of disease using the 12-item Psoriatic Arthritis Impact of Disease (PsAID12). They assessed patients’ disability and work productivity using the Health Assessment Questionnaire–Disability Index (HAQ-DI) and Work Productivity and Impairment questionnaire (WPAI).
Overall disease presentation, duration, and use of biologics were similar between men and women. However, women reported significantly worse quality of life compared with men, with a mean EQ-5D score of 0.80 vs. 0.82 (P = .02).
Women also scored higher than men on measures of disability and work impairment, with mean HAQ-DI scores of 0.56 vs. 0.41 and mean WPAI scores of 27.9% vs. 24.6%, respectively (P < .01).
Disease burden was significantly higher in women vs. men based on PsAID12 scores (2.66 vs. 2.27, respectively) and women reported significantly higher levels of fatigue and pain (P < .01 for all).
More men than women reported working full-time (68.6% vs. 49.4%) but no gender differences emerged for work time missed because of PsA, the researchers noted.
However, women had significantly fewer comorbidities compared with men, based on the Charlson Comorbidity Index (1.10 vs. 1.15, P < .01).
“Other factors not assessed in the study are likely to be contributing to disease burden, and these unmeasured factors may affect men and women differently,” the researchers wrote in their discussion. These factors may include hormone levels and treatment outcomes, as well as sleep disturbance, anxiety, and joint erosion, they said.
The study findings were limited by several factors, including the possible overrepresentation of patients who visited physicians more often, the use of self-reports, and potential recall bias, as well as the lack of data on fibromyalgia prevalence using a validated score, the researchers noted. However, the results were strengthened by the large and geographically diverse study population and highlight the need for more research to examine the additional disease burden of PsA in women, and the potential of alternative treatment regimens to improve management of PsA in women, they concluded.
Mechanisms driving sex differences remain unclear
“In the past few decades, there has been increasing interest in the effect of sex on the manifestations and impact of PsA as well as on the response to therapy,” Dafna D. Gladman, MD, of the University of Toronto and the Krembil Research Institute at Toronto Western Hospital, wrote in an accompanying editorial.
The current study findings support previous research showing differences in disease expression in PsA between men and women, Dr. Gladman said. Several studies have shown more axial disease and joint damage in men than in women, while women reported greater functional disability and worse quality of life than men. The reasons for gender differences remain unclear, and genetics may play a role as well, she said.
Dr. Gladman emphasized the need for more research on the impact of fibromyalgia (FM) in particular. “As was shown in a previous study, the presence of FM affects the clinical assessment of patients with PsA,” she wrote. Fibromyalgia and pain reporting also may affect clinical trials of patients with PsA; however, the effect of fibromyalgia on sex differences is uncertain, she said. “In a disease that affects men and women equally, recognizing sex effect is important,” and more research is needed to explore the mechanisms behind this effect, she concluded.
The study was supported by Janssen Research & Development. Dr. Gossec disclosed receiving research grants and/or consulting fees from Janssen and 13 other pharmaceutical companies. Several study coauthors disclosed relationships with multiple companies, and several coauthors are employees and stockholders of Janssen. Dr. Gladman had no financial conflicts to disclose.
FROM THE JOURNAL OF RHEUMATOLOGY
25 years of chickenpox vaccine: 91 million cases prevented
WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.
Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
Deaths in under-20 group all but eliminated
Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.
Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.
Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.
However, chickenpox is still widespread in most of the world.
U.S. first with universal program
The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.
The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.
“It was a burden the United States considered unacceptable,” Dr. Marin said.
The leaders had seen the control of measles and polio and wanted the same for chickenpox.
Two-dose vaccines started in 2007
In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.
Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.
By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.
The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.
Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).
“The second dose adds 10% or more improved protection against all varicella,” she said.
But there have been gains beyond medical advances.
Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
Jaw-dropping results
Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”
She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.
Dr. Marrazzo also noted the economic savings calculations.
“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.
There are also messages for the current debates over COVID-19 vaccinations.
“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.
The authors and Dr. Marrazzo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.
Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
Deaths in under-20 group all but eliminated
Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.
Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.
Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.
However, chickenpox is still widespread in most of the world.
U.S. first with universal program
The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.
The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.
“It was a burden the United States considered unacceptable,” Dr. Marin said.
The leaders had seen the control of measles and polio and wanted the same for chickenpox.
Two-dose vaccines started in 2007
In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.
Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.
By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.
The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.
Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).
“The second dose adds 10% or more improved protection against all varicella,” she said.
But there have been gains beyond medical advances.
Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
Jaw-dropping results
Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”
She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.
Dr. Marrazzo also noted the economic savings calculations.
“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.
There are also messages for the current debates over COVID-19 vaccinations.
“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.
The authors and Dr. Marrazzo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.
Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
Deaths in under-20 group all but eliminated
Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.
Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.
Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.
However, chickenpox is still widespread in most of the world.
U.S. first with universal program
The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.
The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.
“It was a burden the United States considered unacceptable,” Dr. Marin said.
The leaders had seen the control of measles and polio and wanted the same for chickenpox.
Two-dose vaccines started in 2007
In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.
Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.
By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.
The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.
Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).
“The second dose adds 10% or more improved protection against all varicella,” she said.
But there have been gains beyond medical advances.
Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
Jaw-dropping results
Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”
She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.
Dr. Marrazzo also noted the economic savings calculations.
“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.
There are also messages for the current debates over COVID-19 vaccinations.
“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.
The authors and Dr. Marrazzo report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT IDWEEK 2022
Monkeypox presentations, prevention strategies shifting
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New areas of concern include transmissions among people experiencing homelessness and severe cases in immunocompromised persons.
Agam K. Rao, MD, with the Poxvirus and Rabies Branch of the Centers for Disease Control and Prevention, updated the global picture during an annual scientific meeting on infectious diseases: As of Oct. 14, the confirmed worldwide cases number 73,288, with more than one-third of them (27,317) in the United States. Case counts in the United States, however, have been decreasing since early August.
Cases have been most commonly found in men who have sex with men (MSM), though monkeypox has also been diagnosed in cisgender and transgender women, children, and men who do not report recent sex with other men.
Shift away from White men
Dr. Rao described a demographic shift in infections from White, non-Hispanic men early on to non-Hispanic Black and Hispanic men.
“There’s a lot of emphasis right now at CDC to try to understand these spreads, whether they are household [transmission] or another contact. We know that some of the women have had sexual contact with men who were diagnosed with monkeypox,” Dr. Rao said.
In children under age 12, direct skin-to-skin contact with household members seems to be the source, she said. In adolescents, as in adults, the main source seems to be male-male consensual sex.
“And just as in adults, Black and Hispanic children have been disproportionately affected,” she said.
No sustained spread outside MSM
Dr. Rao said that so far there has been no sustained spread detected beyond the MSM community. A CDC study of inmates in Cook County Jail in Chicago at the end of September, she noted, found no secondary cases.
However, health care workers are another group that was suspected to be at higher risk given close contact with patients, although there have been only three confirmed exposures. Sharps injuries from unroofed lesions are tied to some of those confirmed or suspected cases.
“We do not recommend unroofing lesions,” she said. “We’re getting very good samples from just rigorous swabbing of the lesions.”
She said that the CDC is also monitoring “a few hundred” cases, some of them severe, among people experiencing homelessness.
“We are working to try to understand the exposures that have occurred to those individuals and whether transmission has occurred person-to-person,” Dr. Rao said.
Severe cases among immunocompromised
Also of concern are people with compromised immune systems owing to advanced HIV or organ or stem cell transplants.
Among immunocompromised persons, Dr. Rao said, “we’re seeing large necrotic lesions affecting a large percentage of body surface, lesions that continue to develop over weeks.”
Boghuma Titanji, MD, PhD, MSc, a physician-scientist at Emory University in Atlanta, and an emerging-disease specialist, addressed the difference in presentations between immunocompromised and immunocompetent patients.
She said the main distinction is the extent of the lesions. Patients with AIDS and very low CD4 counts, for instance, are presenting with more lesions and have a longer course of illness.
Dr. Rao said in an interview, “It’s really important to understand someone’s immune status and understand whether they are severely immunocompromised. If there is a concern that a person has monkeypox, also testing for HIV concurrently may be important. It could be a missed opportunity to evaluate for it, especially given the fact that these can occur together.”
Assessing the size and appearance of the lesions is important to understanding whether patients could develop severe infection, she said.
Differences from past epidemics
Dr. Titanji said the current outbreak has some differences from historic outbreaks.
The incubation period, for instance, has tended to be shorter than in previous outbreaks – now 7-10 days, with a range of 5-14 days instead of a range of up to 21 days in previous outbreaks.
There are also more cases of presentations with only single lesions, which were infrequent in past epidemics, she said.
The scope of suspected cases has also broadened, with changing clinical features.
“We have expanded the clinical descriptions to include presentations that involve isolated rectal presentation – individuals presenting solely with rectal pain as the primary manifestation of monkeypox – or presenting with a sore throat as the only manifestation,” she said.
Expanding the case definition will help identify who should be tested.
“Monkeypox is an incredible clinical mimic,” Dr. Titanji said. “The rash can really take the form of a lot of the things we encounter on a regular basis in ID. It’s important to always have a low index of suspicion to test patients when they fit the right epidemiological profile.”
Vaccine strategy has evolved
Brett Petersen, MD, MPH, captain of the U.S. Public Health Service with the CDC, said that Jynneos, licensed by the U.S. Food and Drug Administration, continues to be the primary vaccine for monkeypox. However, the strategy has changed.
Whereas the initial vaccine strategy was to administer the vaccine after known exposure, the guidance now includes vaccinating after “both known and presumed exposures, as described in the eligible populations.”
It’s now been expanded even further to include preexposure inoculations for a wide group of people at greater risk, he explained.
Early data from the CDC indicate that the Jynneos vaccine is effective.
In a report updated in September, the CDC found that among 32 U.S. jurisdictions, monkeypox incidence was much higher among at-risk, unvaccinated people for whom vaccination is recommended than among those who got the Jynneos vaccine.
“Unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated,” the CDC reported.
Asked about the end goal for monkeypox, Dr. Petersen said, “Our goal should be elimination. I think that is an achievable goal, but it will depend on a lot of factors and a lot of continued public health efforts.”
Dr. Rao, Dr. Titanji, and Dr. Petersen declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM IDWEEK 2022