Support for abatacept–methotrexate combination therapy in RA patients
medwireNews: Adding abatacept to methotrexate improves disease activity and reduces structural progression among anticitrullinated protein antibody (ACPA)-positive rheumatoid arthritis (RA) patients with early erosion, Japanese researchers report.
In their phase IV study, Tsukasa Matsubara (Matsubara Mayflower Hospital, Hyogo) and co-investigators randomly assigned 405 biologic-naïve patients with active RA despite methotrexate treatment for at least 3 months to receive intravenous abatacept at a dose of 500–1000 mg (depending on bodyweight) on day 1, week 2, week 4, and every 4 weeks thereafter, or to receive placebo. All participants continued to receive methotrexate throughout the study, at an average dose of 9.6 mg/week.
The team found that ACR20 response rates at the 16-week follow-up were 75.4% for the 203 patients treated with abatacept and 27.7% for the 202 treated with placebo, a significant difference. These responses were maintained or further improved at the 1-year follow-up.
Moreover, radiographic progression from baseline to week 16 was significantly lower among participants given abatacept versus placebo, with average increases in mTSS score of 0.84 and 1.26 points, respectively.
“Importantly, these positive clinical and radiographic outcomes with abatacept in combination with [methotrexate] were also consistently associated with improved patient-reported HAQ-DI response rates,” write Matsubara and team in RMD Open.
Indeed, the proportion of patients who experienced at least a 0.3-point reduction in HAQ-DI score from baseline to week 16 was 57.1% in the abatacept group compared with just 22.4% for those given placebo.
The investigators report that the incidence of adverse events (AEs) and serious AEs was “similar in both treatment arms,” and that the safety profile of abatacept “was consistent with that observed in previous Japanese and international clinical trials.”
Incidence rates of treatment-related AEs at week 16 were 137.1 and 94.2 per 100 patient–years in the abatacept and placebo groups, respectively, and the corresponding rates at 1 year were 90.2 and 70.8 per 100 patient–years.
Together, these findings suggest “that abatacept with [methotrexate] could be considered a suitable treatment option for biologic-naive Japanese patients with RA,” conclude Matsubara et al.
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