Efficacy of Withdrawal or Tapering of bDMARDs Versus Standard Regimen in Axial Spondyloarthritis Patients: Systematic Review and Meta-Analysis informing the Update of the Spanish Society of Rheumatology Guideline

Hye-Sang Park¹Petra Díaz del Campo^2*Maria Nieves Planas^3*Jessica Polo y La Borda⁴Mercedes Guerra-Rodriguez²Mireia Moreno⁵Juan D Cañete⁶

• ¹Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
• ²Spanish Society of Rheumatology, Madrid, Spain
• ³Hospital Universitario Ramón y Cajal, Madrid, Spain
• ⁴Hospital Central de la Defensa Gómez Ulla, Madrid, Spain
• ⁵Hospital Parc Taulí, Sabadell, Spain
• ⁶Hospital Clinic de Barcelona, Universitat de Barcelona, Barcelona, Spain

Objectives: To assess efficacy of withdrawal or tapering biologic disease-modifying antirheumatic drugs (bDMARDs) versus maintaining a standard regimen in patients with axial spondyloarthritis (axSpA) to sustain remission.We conducted a systematic review of randomized controlled trials (RCTs) through July 2025, comparing treatment discontinuation or tapering against standard bDMARDs regimens in axSpA. We included RCTs of axSpA patients randomised to treatment interruption or tapering compared with standard treatment regimens. Outcomes measures included remission or flare measured by ASDAS, BASDAI, and acute phase reactants. We rated the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. We presented dichotomous outcomes as risk ratios (RR) with their 95% confidence intervals (CI). We used a random-effect model to perform a pooled analysis.Results: Eight RCTs involving 1,384 participants were analysed. For those in sustained remission >6 months, withdrawal led to a significantly lower rate of inactive disease state (RR 0.58, CI 0.45-0.76; high certainty) and increased risks of flare (RR 1.79, CI 1.34-2.38; high certainty) and partial flares (RR 1.57, CI 1.25-1.97; high certainty) compared to the standard regimen. Patients with short-term remission <6 months and treatment withdrawal experienced significantly higher rates of flares (RR 0.41 CI 0.23-0.72, low certainty) and increased disease activity (RR 0.36 CI 0.15-0.86, low certainty). Tapering in 211 patients showed non-significant risk reductions in maintaining remission or low disease activity (RR 0.89, CI 0.66-1.18; moderate certainty).Treatment withdrawal reduces the likelihood of maintaining inactive or low disease activity. Tapering does not significantly compromise the maintenance of remission or low disease activity offering a safer alternative to complete treatment withdrawal.