Biologic Use for Psoriasis May Increase Serious Infection Risk


Gastrointestinal infections were the most common serious infections associated with biologics, according to a cohort analysis.


Findings from a cohort study of psoriasis patients suggest that new users of adalimumab or infliximab may be at increased risk for serious infection compared to users of etanercept.

Data also showed that infection risk was lower for ustekinumab while remaining comparable for secukinumab, ixekizumab, brodalumab, guselkumab, or apremilast versus etanercept.

A team of investigators from France, led by Laetitia Penso, MSc, evaluated patient data from the National Health Data System in order to comprehensively capture real-world risk for serious infection associated with biologics use.

“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,” Penso and colleagues indicated.

They included those who had not had or used prescriptions of a biologic or apremilast within the previous year.

The Study

The investigators defined serious infection as infection leading to hospitalization.

As such, the primary endpoint they sought was the occurrence of a serious infection as well as time to first occurrence. They further assessed serious infection outcomes, such as gastrointestinal, cutaneous, eyes, ear-nose-throat, musculo-skeletal, pulmonary, and nervous system, among others.

They also took note of patient sociodemographic characteristics as well as any previous or current use of nonbiologic antipsoriatic agents, nonsteroidal anti-inflammatory drugs (NSAIDs), and systemic corticosteroids.


A total of 44,239 patients were new users of a biologic/biosimilar or a targeted synthetic antipsoriatic agent. 

Of this population, 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.

Penso’s team thus reported that 1656 serious infections occurred across the entire evaluated population, with gastrointestinal (38.9%) being the most frequently observed type of infection—followed by skin (19.6%) and pulmonary infections (14.8%).

The overall crude incidence rate was 25.0 (95% CI, 23.8-26.2) per 1000 person-years, and the median time to event was 9 months.

“After adjusting for time-dependent covariables, risk of serious infections was higher for new users of adalimumab ([hazard ratio] HR, 1.22; 95% CI, 1.07-1.38) or infliximab (HR, 1.79; 95% CI 1.49-2.16) vs etanercept, whereas ustekinumab was associated with a lower risk of having a serious infection (HR, 0.79; 95% CI, 0.67-0.94),” Penso and team wrote.

Patients who used guselkumab or apremilast did not demonstrate any increased risk for serious infection versus new users of etancercept. However, risk was higher among those with concomitant use of NSAIDs (HR, 1.47; 95% CI, 1.25-1.73) or systemic corticosteroids (HR, 2.32; 95% CI, 1.95-2.76).


“The findings of this study are important because recent biologic agents, including secukizumab, ixekizumab, brodalumab, and guselkumab, were compared with one another,” Penso and colleagues wrote.

They noted that observational studies have produced conflicting results in regard to biologic use and risk of infections. One potential explanation offered by the investigators was the differences between study populations, namely the condition treated by the biologic and inclusion/exclusion criteria.

Nevertheless, they acknowledged that additional observational studies to confirm these findings among psoriasis patients are warranted.

The study, “Association Between Biologics Use and Risk of Serious Infection in Patients With Psoriasis,” was published online in JAMA Dermatology.

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