More than half of patients sustain RA remission after tapering, ceasing DMARDs
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Approximately half of patients who reduced their disease-modifying antirheumatic drugs while in stable rheumatoid arthritis remission maintained their remission status, according to data published in The Lancet Rheumatology.
However, the researchers cautioned that relapse rates were significantly higher in patients who tapered or ceased their DMARDs, compared with those who continued their full doses, suggesting that such strategies require close monitoring.
“The management of patients with rheumatoid arthritis in stable remission needs to be better explored,” Georg Schett, MD, of Friedrich-Alexander University Erlangen-Nürnberg, in Germany, and colleagues wrote. “From the patient’s perspective in particular, alternatives are welcome to life-long continuation of DMARD therapy despite the absence of symptoms.”
“Several observational studies (mostly on tapering biological DMARDs) have investigated the effect of tapering or withdrawal of treatment in patients with rheumatoid arthritis in stable remission,” they added. “However, there are few randomized controlled trials (RCTs) addressing this topic that exclusively targeted and recruited patients with rheumatoid arthritis in stable remission; to our knowledge, none of these RCTs compared the outcomes of different management strategies in a real-life setting.”
To determine whether remission could be maintained while tapering or ceasing DMARDs in patients in stable RA remission, Schett and colleagues conducted the Rheumatoid Arthritis in Ongoing Remission (RETRO) study, a multicenter, prospective, randomized, controlled, open-label, parallel-group phase 3 trial. Participants included 303 adults from 14 German centers who had RA for at least 1 year prior to randomization, and who were in sustained remission based on DAS28 with erythrocyte sedimentation rate (DAS28-ESR).
The included patients were randomized 1:1:1 to either continue with their full dose, taper to 50% of their regular dose, or taper to 50% for 6 months before withdrawing completely. Participants were assessed every 3 months and screened for disease activity and relapse. The primary endpoint was the proportion of participants who maintained DAS28-ESR remission at 1 year. The analysis included a log-rank test of trend and Cox regression and focused on a modified intention-to-treat population of 282 participants without any missing baseline data.
According to the researchers, 81.2% (95% CI, 73.3-90) of the full-dose group sustained remission at 1 year, compared with 58.6% (95% CI, 49.2-70) of the taper group, and 43.3% (95% CI, 34.6-55.5) of the withdrawal group. Hazard ratios for relapse were 3.02 (95% C, 1.69-5.4) for the taper group and 4.34 (95% CI, 2.48-7.6) for the withdrawal group, compared with the full-dose group. Most participants who relapsed regained remission status after returning to their full DMARD dose.
Serious adverse events occurred in 11% of patients in the full-dose group, 8% of those in the taper group, and in 14% of those who withdrew. None of the serious adverse events were reported to be related to the intervention. The most common type of serious adverse event was injury or procedural complication, with a total of nine cases.
“The key takeaway is that a considerable number of patients — about 50% — stay in remission despite tapering or stopping DMARDs,” Schett told Healio Rheumatology. “These patients profited from a treatment flexibilization. On the other hand, patients who relapsed were re-treated and the vast majority of them regained remission very fast. These data indicate that tapering treatment and stopping treatment after successful tapering is a feasible approach in patients in stable remission.”
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