medwireNews: Findings from the MIRACLE study indicate that patients with rheumatoid arthritis (RA) and inadequate response to methotrexate who receive a reduced dose of methotrexate at adalimumab initiation have comparable remission outcomes to those given the maximum tolerable dose, and may have fewer adverse events.
The phase 4 study included 134 participants who, despite starting treatment with methotrexate at 6–8 mg per week and increasing to the maximum tolerated dose by week 12 (average dose 12.6 mg/week), had not achieved remission (SDAI ≤3.3 points). at week 24. The average dose of methotrexate at week 24 was 12.6 mg/week.
They were randomly assigned to continue methotrexate at either a reduced dose (6–8 mg per week; n=66) or at the maximum tolerable dose (10–25 mg per week; n=68), alongside subcutaneous adalimumab 40 mg every other week for 24 weeks in all participants.
Speaking at the EULAR 2022 Congress in Copenhagen, Denmark, Hiroya Tamai (Keio University School of Medicine, Tokyo, Japan) said that noninferiority of reduced-dose methotrexate to continuing the maximum dose at adalimumab initiation was demonstrated at week 48.
Specifically, the rates of remission at week 48 were 44.8 % in the reduced-dose group and 38.4% in the maximum dose group, corresponding to a difference of 6.4 percentage points, which fell below the predefined threshold for noninferiority.
Tamari also reported no significant differences in the health assessment questionnaire disability index nor in radiographic remission rates.
In addition, the presenter said that treatment with the reduced dose of methotrexate was associated with “numerically fewer adverse events” than treatment with the maximum dose after 24 weeks, at 19.7% versus 35.3%, respectively. Anti-adalimumab positivity rates were comparable in the two groups.
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