Targeted psoriatic arthritis therapies demonstrate low risk for serious infection
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Key takeaways:
- Risk for serious infection was lower in new users of etanercept and ustekinumab vs. with adalimumab.
- Concomitant prednisone use significantly increased infection risk.
Serious infections were uncommon among patients with psoriatic arthritis exposed to targeted therapies for the first time in “a large and exhaustive” French cohort, according to data published in RMD Open.
Compared with new users of adalimumab (Humira, Abbvie), risk for serious infection was significantly lower among new users of etanercept (Enbrel, Immunex) and ustekinumab (Stelara, Janssen), the researchers wrote. Other drugs had similar levels of risk.
“Current [PsA] treatment guidelines recommend targeted therapies when standard treatments (including non-steroidal anti-inflammatory drugs [NSAIDs] and conventional synthetic disease-modifying antirheumatic drugs [csDMARDs]) fail to control the disease or are not tolerated,” Léa Bastard, of the University Paris-Est Créteil Val de Mame, and colleagues wrote. “The efficacy of these treatments has been clearly proven, but some concerns remain regarding their potential infectious risk.”
To examine the comparative risks for serious infection among targeted therapies for PsA, Bastard and colleagues conducted a nationwide cohort study using data from the French national health insurance database. The study included 12,071 adults who initiated adalimumab, etanercept, golimumab (Simponi Aria, Janssen Biotech), certolizumab pegol (Cimzia, UCB), infliximab (Remicade, Janssen), secukinumab (Cosentyx, Novartis), ixekizumab (Taltz, Eli Lilly & Co.), ustekinumab and tofacitinib (Xeljanz, Pfizer) for the first time from January 2015 through June 2021.
The primary outcome was serious infection, defined as hospitalization with a main discharge diagnosis of infection. The researchers performed a time-to-event analysis using propensity score-weighted Cox proportional hazards regression models. The comparators were new users of adalimumab, which is the “most widely prescribed molecule for PsA in France,” they wrote.
A total of 367 serious infections occurred during follow-up at a crude incidence rate of 17 (95% CI, 15.2-18.7) per 1,000 person-years, according to the researchers. Serious infection risk was significantly lower for new users of etanercept (weighted HR = 0.72; 95% CI, 0.53-0.97) and ustekinumab (weighted HR = 0.57; 95% CI, 0.35-0.93), compared with adalimumab, after inverse propensity score weighting and adjustment for time-dependent covariates and calendar year.
Other drugs did not yield a statistically modified risk vs adalimumab, the researchers wrote. However, the risk for serious infection increased significantly with concomitant prednisone use (weighted HR = 1.9; 95% CI, 1.47-2.46).
“The overall risk of serious infection was low, which confirms the good safety of the studied treatments,” Bastard and colleagues wrote. “Considering the number of current treatment options for PsA, further studies, especially of other large-scale cohorts in real-world settings, are needed to confirm these results and evaluate the most recent treatments to help physicians optimize their therapeutic choice for each patient.”
Perspective
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Daniel J. Wallace, MD, FACP, MACR
France has a national health data system that allows researchers to glean more information on patients started on specific interventions. In the case of psoriatic arthritis, more than 12,000 patients were treated with biologics and only a 3% serious infection rate was found. This is very encouraging!
There was further evidence that etanercept and ustekinumab were safer than adalimumab. Many patients with psoriatic arthritis are given disease modifying agents such as methotrexate, leflunomide or cyclosporin, which also suppress the immune system. These data suggest that biologics should perhaps be considered in more individuals with psoriatic arthritis.
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Bastard L, et al. RMD Open. 2024;doi:10.1136/rmdopen-2023-003865.
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