Patients with low RA activity more likely to stay in remission after switch to monotherapy
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Key takeaway:
- Patients with lower rheumatoid arthritis disease activity were more likely to maintain remission.
- Younger age and lower C-reactive protein also were associated with sustained remission.
Patients with rheumatoid arthritis who demonstrate lower disease activity are more likely to remain in LDA or remission after switching from combination therapy to monotherapy, according to data published in the Journal of Rheumatology.
“We have previously conducted a univariate logistic regression analysis to identify baseline factors associated with persisting in remission following medication withdrawal in SEAM-RA,” Jeffrey R. Curtis, MD, MS, MPH, a professor of medicine at the University of Alabama at Birmingham, and colleagues wrote. “Here we conducted a more rigorous assessment using multivariate logistic regression analysis to identify factors associated with maintaining remission both on combination therapy and after switching to monotherapy.”
To investigate the feasibility of switching from combination therapies to monotherapy in patients with RA, Curtis and colleagues conducted an analysis of the SEAM-RA trial, a phase 3, multicenter, randomized withdrawal, double-blind, controlled study. The trial included a 30-day screening period, a 24-week open-label run-in period, 48 weeks of double-blind therapy and 30 days of follow-up for safety signals.
Patients were eligible for the study if they were aged 18 years or older, had RA, and had been taking etanercept and methotrexate for 6 or more months prior to the beginning of the study. Patients were disqualified if they demonstrated clinically significant changes to eligibility criteria during the run-in period. These criteria included worsening disease while taking both etanercept and methotrexate.
During the run-in period, patients received etanercept (Enbrel, Amgen) and methotrexate at the doses they were accustomed to. Patients who achieved remission during the run-in period were randomized 2:2:1 to receive etanercept 50 mg and an oral placebo, methotrexate 10 mg to 25 mg plus a subcutaneous placebo weekly, or etanercept 50 mg and oral methotrexate on a weekly basis.
A total of 253 patients entered the double-blind period of the study. According to the researchers, variables associated with achieving LDA or remission following the run-in period included younger age, longer therapy duration with methotrexate and less severe disease activity. Following the 48-week therapy period, variables associated with sustained remission or LDA included lower patient-reported outcomes, lower C-reactive protein levels and rheumatoid factor negativity.
“Even within the significant constraints that patients had to meet to qualify for SEAM-RA, patients with overall lower disease activity are more likely to achieve and remain in SDAI remission/LDA,” Curtis and colleagues wrote. “RF-negative status and lower PtGA scores in particular were associated with increased likelihood of remaining in remission/LDA with MTX or ETN monotherapy.”
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