medwireNews: Sarilumab has consistent safety and efficacy profiles over 2 years among patients with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to methotrexate, results of an open-label extension study suggest.
The previously published MOBILITY trial demonstrated that patients who were treated with subcutaneous sarilumab 150 mg or 200 mg every 2 weeks plus weekly methotrexate had significantly greater improvements in disease activity and physical function, and better radiographic outcomes, at 1 year compared with participants given placebo plus methotrexate, say Mark Genovese (Stanford University Medical Center, Palo Alto, USA) and co-investigators.
After completion of the MOBILITY trial, 776 patients received open-label treatment with the interleukin (IL)-6 receptor inhibitor at a dose of 200 mg every 2 weeks plus methotrexate for an additional year, they explain.
As reported in Rheumatology, rates of treatment-emergent adverse events (TEAEs) and serious TEAEs at the 2-year follow-up were 279.6 and 16.6 per 100 person–years, respectively, and the most common TEAEs were neutropenia, injection site erythema, and increased alanine aminotransferase (ALT) levels.
A total of 14.4% of patients had their sarilumab dose reduced to 150 mg, mainly due to laboratory abnormalities including reduced absolute neutrophil counts and elevated ALT levels. The investigators note that most (89.4%) of these patients were able to complete the 2-year study following dose reduction, without an apparent impact on treatment efficacy.
“Sarilumab safety through year 2 was consistent with IL-6 receptor blockade,” and no new safety concerns were identified in the extension study, write Genovese and colleagues.
In the efficacy analysis, disease activity remained consistent or improved from the 1- to the 2-year follow-up, and was similar at 2 years regardless of patients’ initial treatment allocation in the MOBILITY trial. Mean Disease Activity Scores at 28 joints based on C-reactive protein (DAS28-CRP) at 1 year were 2.8 points for patients originally allocated to sarilumab 200 mg, 2.9 points for those given sarilumab 150 mg, and 3.6 points for those initially given placebo. The corresponding DAS28-CRP scores at the 2-year follow-up were 2.4, 2.5, and 2.5 points.
The researchers point out that patients initially treated with sarilumab 200 mg experienced the most favorable radiographic outcomes, but even those assigned to placebo in MOBILITY experienced “markedly reduced” radiographic progression following the switch to sarilumab.
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See also:
- Sarilumab given FDA approval for RA
- Sarilumab approved for RA treatment in Europe
- Sarilumab recommended for severe RA in the UK