Large French Cohort Finds Low Overall Infection Risk With Psoriasis Biologics

Among 39,669 new biologic users with psoriasis tracked across France's national health data system, infections requiring hospitalization were uncommon overall, but which biologic a patient started mattered, according to a cohort study published in the Journal of the American Academy of Dermatology.¹

A Safety Question Lagging Behind New Approvals

Biologic therapies have transformed psoriasis treatment, but newer agents (including interleukin-17 and interleukin-23 inhibitors) have reached the market faster than long-term, real-world infection-risk data can accumulate for them. Joint guidelines from the American Academy of Dermatology and National Psoriasis Foundation already call for infection screening before starting biologics, but comparative infection risk across the full modern biologic landscape has remained incompletely characterized.²

Researchers in France turned to the French National Health Data System (SNDS) to simultaneously assess inpatient- and outpatient-managed infection risks across biologics used for psoriasis, a scale of real-world data uncommon in dermatologic pharmacoepidemiology.¹

Using SNDS claims data from 2013 through 2022, the investigators conducted a cohort study of 39,669 adults with psoriasis who were new users of biologic therapy. Three outcomes were compared across biologics: time to hospitalization for infection, time to first outpatient anti-infective dispensation, and the proportion of days covered by anti-infectives over 2 years of follow-up, with adalimumab (the most frequently prescribed biologic in the cohort) serving as the reference comparator.

Ustekinumab and IL-23 Inhibitors Stood Out as Lower Risk

During biologic exposure, inpatient-managed infections occurred at a rate of 27.1 per 1000 person-years, and median systemic anti-infective coverage across the cohort was low, at 5.5% (95% CI, 2.6-11.5). Compared with adalimumab, inpatient-managed infection risk was lower with ustekinumab (weighted hazard ratio [wHR], 0.75), secukinumab (wHR, 0.72), and risankizumab (wHR, 0.57).

Time to first outpatient antibacterial use was higher with certolizumab (wHR, 1.19) and lower with ustekinumab (wHR, 0.92), guselkumab (wHR, 0.85), and risankizumab (wHR, 0.81), while antibacterial coverage over 2 years was lower with ustekinumab, secukinumab, ixekizumab, risankizumab, and tildrakizumab. Interleukin-17 inhibitors, by contrast, were associated with higher antimycotic coverage than other biologic classes: secukinumab (wHR, 1.88), brodalumab (wHR, 1.88), and ixekizumab (wHR, 1.60) all carried increased risk. Ustekinumab carried lower risk (wHR, 0.77), a pattern consistent with this class's known mechanistic link to mucocutaneous candidiasis.

“Biologics were associated with low infection risks among patients with psoriasis,” the researchers wrote. Among the biologics compared, ustekinumab and interleukin-23 inhibitors showed the lowest overall risk based on time to the first inpatient or outpatient infection event.

Claims Data Without Clinical Detail

Because the analysis relied on claims data, it lacked granular clinical information, such as disease severity, prior treatment history, or the specific organism responsible for each infection, that might have explained some of the observed differences between biologics. The authors noted this limitation constrained their assessment specifically to systemic anti-infectives, potentially missing infections managed without a dispensed prescription.

As an observational cohort rather than a randomized comparison, the findings also remain subject to confounding by indication, since clinicians may have preferentially prescribed certain biologics to patients perceived as lower infection risk to begin with.

For payers and dermatologists weighing biologic selection in patients with psoriasis who have elevated infection risk (whether from age, comorbidities, or prior infection history), the findings offer real-world reassurance that overall infection risk with modern biologics is low, while suggesting that ustekinumab and interleukin-23 inhibitors may warrant particular consideration in that higher-risk subgroup, pending confirmation in populations outside France.

References

1. Le TTK, Vo TT, Sbidian E. Infection risk among psoriasis biologic-new users: A cohort study on the French National Health Data System. J Am Acad Dermatol. 2026;95(1):78-86. doi:10.1016/j.jaad.2026.01.024
2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057