Patient-Reported Outcomes Following Discontinuation Of Tumor Necrosis Factor Inhibitors In Rheumatoid Arthritis Remission/Low Disease Activity: A Randomized Placebo-Controlled Trial
In brief
Stopping TNF blockers raises pain and disability at 12 weeks, then normalizes after restart
In a 48-week double-blind trial, RA patients who discontinued TNF inhibitors reported higher pain, worse global assessment and higher HAQ scores by week 12 compared with those who continued therapy; the differences were modest. After most relapses were retreated, patient-reported outcomes returned to baseline by week 48, suggesting short-term worsening but reversible effects.
- Journal
- The Journal of rheumatology (Q1)
- Published
- 15 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Michael M Ward, Arthur Weinstein, Paloma Alejandro-Silva, Alan K Matsumoto, Rukmini M Konatalapalli, Neil Stahl, et al.
- PMID
- 42744394
- DOI
- 10.3899/jrheum.2026-0356
Why clinicians should know about it
- Picked for Rheumatology (top studies of the week, 20 September 2026): TNF inhibitor discontinuation impacts PROs in RA remission
Abstract
OBJECTIVE: To compare changes in patient-reported outcomes (PROs) over 48 weeks between patients with rheumatoid arthritis (RA) in remission/low disease activity who discontinued treatment with tumor necrosis factor inhibitors (TNFi) and those who continued TNFi treatment. METHODS: In this double-blind placebo-controlled randomized trial, patients with RA in sustained remission/low disease activity treated with TNFi were randomly assigned to placebo (i.e discontinuation of TNFi) or continuation of TNFi. Patients completed PROs, including the patient global assessment (PGA), pain scale, Health Assessment Questionnaire (HAQ), Fatigue Severity Scale, and Short Form-36 (SF36), at randomization and every 12 weeks for 48 weeks. We compared PROs over time between treatment groups using generalized estimating equations. We also compared mean changes from baseline at each time point, and separately among patients who relapsed. RESULTS: Sixty-nine patients were randomized to placebo and 33 patients were randomized to the TNFi group. Over the trial, group mean scores on the PGA, pain score, and HAQ were significantly higher in the placebo group than in the TNFi group. Effect sizes were small or moderate for all PROs. Compared to Week 0, all measures were significantly higher in the placebo group at Week 12, but not at later times, in paired analyses, corresponding to the timing of most relapses. Pain and social function were the domains most affected. PROs returned to baseline values by trial end, after resumption of TNFi treatment. CONCLUSION: PROs generally worsened shortly after TNFi discontinuation in patients with RA, but recovered promptly when reinstituted. Trial registration NCT01793519.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.