December 14, 2023
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Key takeaways:
- Therapy courses in RA did not appear to impact risk for infections in patients.
- Tuberculosis diagnoses were more common before 2009.
Among patients with rheumatoid arthritis, the chosen course of therapy does not have an impact on the risk for developing a serious infection, according to data published in Rheumatology.
“When evaluating adverse effects of RA treatments, including serious infections, conclusions from randomized controlled trials may be limited because they are generally underpowered for such outcomes with small sample sizes and short study duration,” Kim Lauper, MD, of Geneva University Hospitals, in Switzerland, and colleagues wrote. “Additionally, the population is very selected and often does not represent the patients treated in routine clinical care.
“We did not find major differences in the risk of serious infection among [biologic DMARDs] after taking into account potential confounding factors, including line of therapy,” Kim Lauper, MD, and colleagues wrote: Image: Adobe Stock
Kim Lauper
“Most information about the risk of serious infections therefore comes from observational studies,” they added. “This is also not without limitations, as in observational studies, patients are not randomized and baseline characteristics of patients usually differ between treatment groups.”
To investigate the impact of various RA therapy courses on the risk for serious infections and tuberculosis, Lauper and colleagues analyzed patient data from the British Society for Rheumatology Biologics Register-RA cohort. The researchers included patients who started therapy with etanercept (Enbrel, Amgen), certolizumab pegol (Cimzia, UCB), infliximab (Remicade, Janssen), adalimumab (Humira, AbbVie), abatacept (Orencia, Bristol Myers Squibb), rituximab (Rituxan, Genentech) or tocilizumab (Actemra, Genentech) as the first through fifth line of therapy between October 2001 and March 2019. Patients treated with Janus kinase inhibitors were excluded from the analysis.
Follow-up lasted up to 3 years. The primary exposure variable was treatment, based on the time from initiation to three half-lives after the final dose. Patients were followed until the end of the study period, death, or until they were lost to follow-up. For patients receiving rituximab, the exposure period extended to 360 days past the last infusion date. The primary outcome was the development of a serious infection, with the secondary being the development of TB.
The analysis included a total of 33,897 treatment courses, representing 62,513 patient-years. Among these were 10,643 courses with etanercept, 7,835 with adalimumab, 4,430 with infliximab, 1,614 with certolizumab, 5,556 with rituximab, 2,633 with tocilizumab and 1,186 with abatacept. The overall incidence rate for the development of serious infections was 4.4 per 100 patient-years (5% CI, 4.2-4.5). According to the researchers, there was no discernible pattern regarding infection manifestation — in terms of incidence rate or HR — when stratified by therapy. Sensitivity analyses similarly revealed no differences in HR between the drugs.
There were a total of 49 cases of TB, all occurring in the first three lines of therapy. Cases of TB after 2009 were rare, according to the researchers.
“We did not find major differences in the risk of serious infection among [biologic DMARDs] after taking into account potential confounding factors, including line of therapy,” Lauper and colleagues wrote. “We did not find patterns by line of therapy for overall serious infections. However, we found that the incidence of TB was higher in the first lines of therapy and that some cases happened even after the widespread use of screening with IFN- assay.”
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Sources/Disclosures
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Disclosures:
Lauper reports honoraria from Celltrion, Pfizer and Viatris. Please see the full study for a comprehensive list of financial disclosures from all authors.
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