Background/Purpose: Targeted therapies have demonstrated their efficacy in the treatment of psoriatic arthritis (PsA), with an increased risk of serious infections. However, a comparison of this risk according to the different classes of drugs, in real world settings, remains an unmet need. This study aimed to assess and compare the risk of serious infections associated with different targeted therapies used in PsA from a national healthcare database.

Methods: This nationwide cohort study used data from the French National Health Insurance Database (SNDS), which covers over 98.8% of the French population.

All adults aged over 18 years with PsA registered in the SNDS were eligible for inclusion between January 1, 2015 and June 30, 2021. New users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab, infliximab [TNF_i], secukinumab and ixekizumab [IL17_i], ustekinumab [IL12/23_i], and tofacitinib [JAK_i]) were included, defined as patients who had no previous prescriptions of targeted therapies in the year prior the index date. Patients with HIV infection, a history of cancer, transplant or serious infection were excluded. The follow-up period extended to December 31, 2021. The primary end point was the occurrence of a serious infection in a time-to-event analysis using propensity score-weighted Cox proportional hazards regression models, with adalimumab as comparator, estimating weighted hazard ratios (_wHR) with their corresponding 95% confidence intervals (CIs). Other drugs used as add-on therapies (csDMARDs, NSAIDs and prednisone) were considered as time-dependant covariables.

Results: Between 2015 and 2021, 12,071 new users of targeted therapies were included (mean age 48.7 ± 12.7 years; 6,909 [57.8%] women; median follow-up 13.2 [interquartile range: 6.4-31.5] months).

Among new users, 8,946 (74.1%) were treated with a TNF_i, 1,796 (14.9%) with an IL17_i, 1,177 (9.8%) with an IL12/23_i, and 152 (1.3%) with a JAK_i.

The total number of serious infections was 367, with an overall crude incidence rate of 17.0 (95%CI, 15.2-18.7) per 1,000 person-years. The most frequent serious infections were pulmonary infections (94 [0.8%] patients) (Table 1).

After inverse propensity weighting and adjustment for time-dependent covariables, risk of serious infection appeared significantly lower for patients receiving etanercept (_wHR, 0.70; 95%CI, 0.54-0.93) or ustekinumab (_wHR, 0.56; 95%CI, 0.36-0.89) than for those receiving adalimumab. No significant difference in the risk of serious infection was detected for the other targeted therapies (Figure 1). Concomitant use of systemic corticosteroids was associated with an increased risk of serious infection (_wHR, 1.85; 95%CI, 1.48-2.31).

Conclusion: Overall, the incidence of serious infections associated with targeted therapies used in PsA patients in real world settings is low. Compared with new users of adalimumab, this risk was lower among new users of etanercept and ustekinumab, with no difference among new users of the other TNF_i, IL17_i or JAK_i. Given the numerous therapeutic options available for PsA treatment, these findings could assist physicians in optimizing their therapeutic strategies based on individual patients’ characteristics.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparisons-of-the-risk-of-serious-infections-associated-with-the-different-classes-of-targeted-therapies-used-in-psoriatic-arthritis-patients-a-nationwide-cohort-study-from-the-french-health-insuran/