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Original Investigation
July 21, 2021

Association Between Biologics Use and Risk of Serious Infection in Patients With Psoriasis

Author Affiliations
  • 1Groupement d’intérêt scientifique Epidémiologie des produits de santé, L’Agence Nationale de Sécurité du Médicament et des Produits de Santé–Caisse Nationale de l'Assurance Maladie, Paris, France
  • 2Epidémiologie en Dermatologie et Evaluation des Thérapeutiques, Université Paris–Est Creteil, Créteil, France
  • 3Caisse Nationale d’Assurance Maladie des Travailleurs Salariés, Paris, France
  • 4Département de Rhumatologie, Assistance Publique–Hôpitaux de Paris, Hôpitaux universitaires Henri Mondor, Créteil, France
  • 5INSERM, Echappement aux anti-infectieux et Pharmacoépidémiologie, Centre de recherche en épidémiologie et santé des populations, Université de Versailles Saint-Quentin-en-Yvelines, Montigny le Bretonneux, France
  • 6Département de Dermatologie, Assistance Publique–Hôpitaux de Paris, Hôpitaux universitaires Henri Mondor, Université Paris–Est Creteil, Créteil, France
  • 7INSERM, Centre d’Investigation Clinique 1430, Créteil, France
JAMA Dermatol. 2021;157(9):1056-1065. doi:10.1001/jamadermatol.2021.2599
Key Points

Question  Is the risk of serious infections different between biologic or targeted exposures in patients with psoriasis?

Findings  In this cohort study of 44 239 new users of biologics, the risk of serious infections was higher for new users of adalimumab or infliximab vs etanercept, whereas ustekinumab was associated with a lower risk of a serious infection. Risk of serious infections was not increased for new users of secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast vs etanercept, but the risk of serious infections was increased with the use of concomitant nonsteroidal anti-inflammatory drugs or systemic corticosteroids.

Meaning  These results could help physicians choose a biologic for patients with psoriasis who are at risk of serious infections.

Abstract

Importance  Biologics and targeted therapies, such as apremilast, are efficient treatments to manage moderate to severe psoriasis. More information about the risk of serious infection is needed for the newest treatment options in a real-world setting.

Objective  To assess the risk of serious infection among biologics and apremilast used to treat psoriasis, with etanercept as the comparator.

Design, Setting, and Participants  This nationwide cohort study from France involved data from the National Health Data System covering approximately 99% of the French population. All adults with psoriasis, defined as receiving at least 2 prescriptions of a topical vitamin D derivative within a 2-year period, registered in the database between January 1, 2008, and May 31, 2019, were eligible. The study population included those who were new users of biologic agents or apremilast (ie, without any prescriptions of a biologic or apremilast during the previous year). Patients with HIV infection or a history of cancer, transplant, or serious infection were excluded. End of follow-up was January 31, 2020.

Main Outcome Measures  The primary end point was a serious infection in a time-to-event analysis using propensity score–weighted Cox proportional hazards regression models, estimating weighted hazard ratios (wHRs) and 95% CIs.

Results  A total of 44 239 new users of biologic treatment were identified (mean [SD] age, 48.4 [13.8] years; 22 866 [51.7%] men; median follow-up, 12 months [interquartile range, 7-24 months]). A total of 29 618 (66.9%) were prescribed a tumor necrosis factor inhibitor first, 6658 (15.0%) an interleukin (IL) 12/23 inhibitor, 4093 (9.3%) an IL-17 inhibitor, 526 (1.2%) an IL-23 inhibitor, and 3344 (7.6%) apremilast. The total number of serious infections was 1656, and the overall crude incidence rate was 25.0 (95% CI, 23.8-26.2) per 1000 person-years. The most frequent serious infections were gastrointestinal infections (645 patients [38.9%]). After adjusting for time-dependent covariables, risk of serious infections was higher for new users of adalimumab (wHR, 1.22; 95% CI, 1.07-1.38) or infliximab (wHR, 1.79; 95% CI 1.49-2.16) vs etanercept, whereas ustekinumab was associated with a lower risk of having a serious infection (wHR, 0.79; 95% CI, 0.67-0.94). Risk of serious infections was not increased for new users of IL-17 and the IL-23 inhibitor guselkumab or apremilast vs etanercept. Risk of serious infections was increased with concomitant nonsteroidal anti-inflammatory drugs or systemic corticosteroids.

Conclusions and Relevance  In this cohort study of individuals with moderate to severe psoriasis, risk of serious infections was increased in new users of infliximab and adalimumab vs etanercept, whereas ustekinumab users had lower risk of having a serious infection but not new users of IL-17 and IL-23 inhibitors or apremilast. Other observational studies are needed to confirm results for the most recent drugs.

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