Study evaluates infection risk in new users of biologics for psoriasis

Patients with psoriasis initially treated with infliximab or adalimumab had an increased risk for serious infection; however, those treated with IL-12/23, IL-17 or IL-23 inhibitors had a lower infection risk, according to a study.

“Systemic nonbiologic therapies, targeted therapies or biologics are commonly used to manage moderate to severe psoriasis, with higher efficacy for biologic than nonbiologic agents,” Laetitia Penso, MSc, and colleagues wrote. “With the fast emergence of these new therapeutic agents, evaluating long-term comparative safety in a real-world setting is needed because patients with moderate to severe psoriasis may be at an increased risk of serious infection, depending on the biologic agent used.”

A nationwide cohort study identified 44,239 new biologic users in France between 2008 and 2019.

TNF inhibitors were prescribed to 29,618 patients (66.9%): adalimumab to 15,925 (36%), etanercept to 9,661 (21.8%), infliximab to 3,002 (6.8%) and certolizumab to 1,030 (2.3%). The IL-12/23 inhibitor ustekinumab was prescribed to 6,658 patients (15.1%). Of the 4,093 patients who were assigned IL-17 inhibitors, 3,145 (7.5%) were prescribed secukinumab, 768 (1.7%) were prescribed ixekizumab and 180 (0.4%) were prescribed brodalumab. IL-23 inhibitors guselkumab and apremilast were prescribed to 526 patients (1.2%) and 3,344 patients (7.6%), respectively.

Follow-up evaluations identified serious infections in 1,656 individuals, which included 645 gastrointestinal infections, 324 skin infections and 245 pulmonary infections. “The overall crude incidence rate was 25.0 (95% CI, 23.8-26.2) per 1,000 person-years,” the study said.

Risk for infection was higher for new users of adalimumab (weighted HR, 1.22; 95% CI, 1.07-1.38) or infliximab (wHR, 1.79; 95% CI, 1.49-2.16) compared with etanercept. Users of ustekinumab had a reduced risk (wHR, 0.79; 95% CI, 0.67-0.94). There was no increased risk with secukinumab, ixekizumab, brodalumab, guselkumab and apremilast compared with etanercept.

Concomitant use of NSAIDS showed an increased risk for serious infection (wHR, 1.47; 95% CU, 1.25-1.73), as well as with systemic corticosteroids (wHR, 2.32; 95% CI, 1.95-2.76).

“The findings of this study are important because recent biologic agents, including secukinumab, ixekizumab, brodalumab and guselkumab, were compared with one another,” the authors wrote. “Prior observational studies have provided conflicting results on the risk of infection related to use of biologics and mostly used conventional systemic immunosuppressive treatment as a comparator.”

The authors recommended additional observational studies to confirm the results.