medwireNews: Adding sarilumab to methotrexate significantly improves the signs and symptoms of rheumatoid arthritis (RA) relative to placebo in Japanese patients with an inadequate response to methotrexate monotherapy, study findings indicate.
Yoshiya Tanaka (University of Occupational and Environmental Health, Kitakyushu, Japan) and colleagues say that the results from the phase III KAKEHASI study are in line with those of the MOBILITY trial, which was conducted among non-Japanese patients, and therefore “permit bridging” between the two populations.
The KAKEHASI trial included 243 patients aged 20–75 years with moderately to severely active RA who were randomly assigned to receive methotrexate plus subcutaneous sarilumab 150 mg or 200 mg, or placebo every 2 weeks for 24 weeks. At 24 weeks, patients in the placebo group switched, on a random basis, to sarilumab 150 mg or 200 mg, and all patients continued treatment for a further 28 weeks.
At 24 weeks significantly more patients receiving the human anti-interleukin (IL)-6 receptor monoclonal antibody achieved the primary study endpoint of an ACR20 response than did those receiving placebo.
Specifically, the ACR20 response rates were 67.9% and 57.5% with sarilumab 150 mg and 200 mg, respectively, versus 14.8% with placebo.
The researchers note that the ACR20 response was sustained throughout the study, with rates of 71.6% and 60.0% observed at week 52 among patients receiving sarilumab 150 mg and 200 mg, respectively. The patients who switched from placebo to sarilumab 150 mg or 200 mg at week 24 also achieved an ACR20 response at week 52, with respective rates of 64.3% and 66.7%.
Tanaka and team additionally explored a number of secondary efficacy endpoints including ACR50, ACR70, disease activity score based on C-reactive protein, Simplified Disease Activity Index, Clinical Disease Activity Index, and physical function as assessed by the Health Assessment Questionnaire-Disability Index, all of which showed significant improvements in both sarilumab groups versus placebo at week 24.
Moreover, the investigators observed no unexpected safety signals and described the adverse event profile as “consistent with the anticipated effects of IL-6 inhibition and the known safety profile of sarilumab.”
Writing in Arthritis Research & Therapy, Tanaka and co-authors conclude: “Despite the availability of a wide range of treatment options for RA, there remains an unmet need globally for the treatment of patients who are intolerant or refractory to current therapies.
“These important findings show that a new treatment option that has been assessed globally is also effective for Japanese patients with RA.”
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
Arthritis Res Ther 2019; 21: 79
See also: