Dupilumab and the risk of conjunctivitis and serious infection in patients with atopic dermatitis: A propensity score–matched cohort study - 11/01/21
, Seoyoung C. Kim, MD, ScD a, c, d, Richard Wyss, PhD a, Sebastian Schneeweiss, MD, ScD a, Joseph F. Merola, MD, MMSc b, c, dAbstract |
Background |
Dupilumab is an effective treatment for moderate to severe atopic dermatitis (AD) with limited safety data in clinical practice.
Objective |
To assess the 6-month risk of conjunctivitis and serious infections in patients with AD who initiated dupilumab.
Methods |
In a cohort study using US claims data, we compared the risk of conjunctivitis and serious infections in patients with AD who initiated either dupilumab, methotrexate (MTX), cyclosporine, or mycophenolate. Relative risks (RRs) were computed after 1:1 propensity score matching.
Results |
We identified 1775 dupilumab, 1034 MTX, 186 cyclosporine, and 257 mycophenolate users. The 6-month risk for any conjunctivitis was 6.5% for dupilumab, 3.3% for MTX, 4.8% for cyclosporine, and 1.2% for mycophenolate initiators. After PS matching, the RR of any conjunctivitis was increased in dupilumab users versus MTX (RR, 2.45; 95% confidence interval [CI], 1.47-4.08), versus cyclosporine (RR, 1.56; 95% CI, 0.69-3.50), and versus mycophenolate (RR, 7.00; 95% CI, 2.12-23.2). The risk of serious infection was 0.6% in dupilumab and 1.0% in MTX initiators (RR, 0.90; 95% CI, 0.37-2.20).
Limitations |
Analyses were based on few events, and differential surveillance is a concern.
Conclusions |
Although dupilumab shows a low risk of serious infections, it is associated with a clinically meaningful increase in conjunctivitis that needs to be managed in practice.
Le texte complet de cet article est disponible en PDF.Key words : atopic dermatitis, conjunctivitis, dupilumab, epidemiology, immunomodulating drugs, methotrexate, opportunistic infections, real-world evidence, safety, serious bacterial infections
Abbreviations used : AD, CI, ICD-9, ICD-10, MTX, NNH, PS, RCT, RR
Plan
| Funding sources: Supported by the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital. No further funding was received for this study. |
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| Disclosure: Dr Kim has received research grants to the Brigham and Women's Hospital from Pfizer, AbbVie, Roche, and Bristol Myers Squibb for unrelated studies. Dr S. Schneeweiss is the principal investigator of investigator-initiated grants to the Brigham and Women's Hospital from the US Food and Drug Adminstration, National Institutes of Health, Patient-Centered Outcomes Research Institute, Bayer, Vertex, and Boehringer Ingelheim unrelated to the topic of this study; is a consultant to Aetion, a software manufacturer in which he owns equity; his interests were declared, reviewed, and approved by the Brigham and Women's Hospital and Partners HealthCare System in accordance with their institutional compliance policies. Dr Merola is a consultant and/or investigator for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and Leo Pharma. Drs Wyss and M. Schneeweiss have no conflicts of interest to declare. |
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| IRB approval status: The Brigham and Women's Hospital ethics board approved this study (#2011P002580) with a signed data use agreement in place. |
Vol 84 - N° 2
P. 300-311 - février 2021 Retour au numéro
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