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OBJECTIVE TNF-inhibiting biologicals (TNFi) are effective treatments for rheumatoid arthritis (RA). It is unclear if patients in remission or in stable low disease activity need to continue TNFi or can stop this treatment. This study was undertaken to assess whether RA patients in remission or stable low disease activity can effectively and safely stop their TNFi therapy. METHODS Pragmatic multicenter open-label randomized controlled trial. Inclusion criteria: patients diagnosed with RA according to the ACR 1987 criteria, using a TNFi for at least 1 year with stable dose DMARDs over the last 6 months, DAS28 <3.2 over the last 6 months. Patients were randomized to either stop or continue their current TNFi in a 2:1 ratio. Flare was defined as DAS28 ≥3.2 with an increase ≥0.6 compared to the previous DAS28. RESULTS 531 patients were allocated to the stop-group and 286 to the TNFi continuation-group. At 12 months, more patients in the stop-group (267/531 [50.3%]) had experienced a flare than in the continuation-group (52/286 [18.2%]; p<0.001). The hazard ratio for flare after stopping TNFi was 3.41 (95% CI: 2.53-4.59). Mean DAS28 scores in the stop-group were significantly higher during the follow-up period compared with the continuation-group (p<0.001). Of the 195 patients that restarted TNFi after a flare within 26 weeks, 165 (84.6%) had regained DAS28 <3.2 six months later and median time to regained DAS28 <3.2 was 12 weeks (95% Cl: 10.8-13.2). CONCLUSION Stopping TNFi treatment in RA patients in remission or stable low disease activity results in substantially more flares than continuing.

Stopping tumor necrosis factor inhibitors in well controlled rheumatoid arthritis patients: the poet study