medwireNews: Patients with rheumatoid arthritis (RA) who are treated with the interleukin (IL)-6 inhibitor sirukumab experience comparable benefits to those given adalimumab, results of the phase III SIRROUND-H trial suggest.
As described in the Annals of the Rheumatic Diseases, the investigators randomly assigned biologic-naïve patients with RA and an inadequate response or intolerance to methotrexate to receive monotherapy with subcutaneous sirukumab at a dose of 100 mg every 2 weeks or 50 mg every 4 weeks, or to receive the active comparator adalimumab 40 mg every 2 weeks.
Adalimumab, a tumor necrosis factor (TNF) inhibitor, is “the most commonly used [biologic] DMARD for the treatment of RA,” say Benjamin Hsu (Janssen Research & Development, Spring House, Pennsylvania, USA) and study co-authors.
The 185 patients given sirukumab 100 mg and the 185 given the 50 mg dose experienced a significantly greater improvement in disease activity – as measured by the Disease Activity Score at 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) – from baseline to week 24 than the 186 in the adalimumab group, with corresponding decreases of 2.96 and 2.58 versus 2.19 points.
However, the proportion of patients achieving at least a 50% improvement in ACR criteria (ACR50) was not significantly different in the sirukumab 100 mg and 50 mg versus adalimumab groups, at 35.3% and 26.9% versus 31.7%, respectively.
Improvements in physical function and patient-reported outcomes were also “generally similar” among patients in the three groups, and the benefits of treatment with both drugs were seen as early as week 2 and maintained at week 52, report the researchers.
“The safety profile of sirukumab was generally consistent with the known safety profile of anti–IL-6R antibody treatment and previous sirukumab RA studies,” they summarize.
In all, 71.7% of patients given sirukumab 100 mg, 74.7% of patients given sirukumab 50 mg, and 69.9% of those in the adalimumab group experienced treatment-emergent adverse events (TEAEs). The most frequently reported TEAE among sirukumab-treated patients was injection site erythema, affecting 17.6% and 9.1% of patients in the 100 mg and 50 mg groups, respectively, and 7.0% of those given adalimumab. Rates of infection were comparable across the three groups, at 31.6%, 33.9%, and 31.2%, respectively.
Taken together, the results of the SIRROUND-H trial suggest that treatment with sirukumab monotherapy resulted in “rapid and sustained” benefits that were “comparable to those achieved with adalimumab monotherapy,” write Hsu and colleagues.
However, they say that because regulatory agencies requested additional clinical data on sirukumab, the sponsor has made the decision to “prioritise other therapies in development and to terminate the sirukumab RA programme.”
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