Switching to monotherapy for rheumatoid arthritis more effective for patients in LDA
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Key takeaways:
- Rheumatoid factor negativity and low C-reactive protein levels are linked to sustained remission.
- A shorter duration on etanercept therapy was also linked to sustained remission in patients with rheumatoid arthritis.
Patients with rheumatoid arthritis who have lower disease activity are more likely to remain in 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 Curtis, MD, MS, MPH, of 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 factors that may be linked to maintaining remission among patients with RA who switch from combination therapy to monotherapy, Curtis and colleagues conducted SEAM-RA, a phase 3, multicenter, randomized withdrawal, double-blind, controlled study. The analysis included a 30-day screening period, a 24-week open-label run-in period, a double-blind treatment period lasting 48 weeks and 30 days of safety follow-up.
Patients were included if they were aged 18 years and older, had RA and were taking both etanercept (Enbrel, Amgen) and methotrexate for 6 or more months before enrollment. Patients were excluded if they experienced disease worsening during the run-in period.
During the run-in period, patients received etanercept and methotrexate at levels consistent with what they were receiving prior to enrollment. Following the run-in period, patients who maintained remission — defined as Simplified Disease Activity Index (SDAI) scores of 3.3 or less — were randomized 2:2:1 to begin receiving either etanercept 50 mg plus placebo, methotrexate 10 mg to 25 mg plus placebo, or etanercept 50 mg plus methotrexate 10 mg to 25 mg. Patients who demonstrated disease worsening during this period received rescue therapy.
In all, 253 patients entered randomization. Factors linked to treatment success or initial remission included younger age, longer methotrexate therapy duration and lower severity of disease overall. Meanwhile, factors linked to maintaining remission or low disease activity included reduced patient global assessment of disease activity scores, lower levels of C-reactive protein, rheumatoid factor negativity, longer duration of RA during treatment with methotrexate and shorter reception of etanercept therapy, according to the researchers.
“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. “[Rheumatoid factor]-negative status and lower PtGA scores in particular were associated with likelihood of remaining in remission/LDA with methotrexate or etanercept monotherapy.”
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