First-Time Biologic Therapy for Psoriasis and Risk for Serious Infection

IBS stomachache stomach
Woman has stomach ache
The risk for serious infection in patients with psoriasis treated with biologic agents and apremilast, using etanercept as a comparator, is examined.

Patients with moderate to severe psoriasis as new users of biologic agents infliximab and adalimumab rather than etanercept had an increased risk for developing a serious infection, according to findings from a nationwide cohort study published in JAMA Dermatology.

Investigators extracted data from France’s National Health Data System which covers about 99% of the population. They included data from adult patients with moderate to severe psoriasis who were new users of biologic agents or apremilast from 2008 to 2019. The follow-up period ended January 31, 2020. The primary endpoint was serious infection in a time-to-event analysis that used propensity score-weighted Cox proportional hazards regression models, estimated weighted hazard ratios (wHRs), and 95% CIs.

Of 44,239 new biologic agents users included, 51.7% were men and the mean age was 48.4 (SD, 13.8) years. The total number of serious infections was 1,656, and the overall crude incidence rate was 25.0 (95% CI, 23.8-26.2) per 1,000 person-years. Gastrointestinal infections were the most frequent, occurring in 38.9% of patients.

After adjusting for time-dependent covariables, serious infection risk 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.

Ustekinumab was associated with a lower risk for serious infection (wHR, 0.79; 95% CI, 0.67-0.94). There was no increased infection risk for patients who used IL-17 and IL-23 inhibitors apremilast and guselkumab vs etanercept. Concomitant use of NSAIDs (wHR, 1.47; 95% CI, 1.25-1.73) or systemic corticosteroids (wHR, 2.32; 95% CI, 1.95-2.76) increased the risk for serious infection.

  However, adalimumab was not associated with a higher risk for serious infection compared with etanercept in a subgroup analysis that excluded patients with concomitant psoriatic arthritis or IBD.

Limitations of the study included investigators’ definition of psoriasis which had 85% sensitivity and likely underestimated the number of patients with psoriasis.

The investigators believe the study findings are particularly relevant as newer biologic agents were compared with each other, rather than the “conventional systemic immunosuppressive treatment as a comparator” often seen in other studies. “These results could help physicians choose a biologic [agent] for patients with psoriasis who are at risk of serious infection,” the study authors wrote.


Penso L, Dray-Spira R, Weill A, Pina Vegas L, Zureik M, Sbidian E. Association between biologics use and risk of serious infection in patients with psoriasis. JAMA Dermatol. Published online July 21, 2021. doi:10.1001/jamadermatol.2021.2599