TNFi-induced sustained clinical remission in peripheral spondyloarthritis patients cannot be maintained with a step-down strategy based on methotrexate.
Treatment with golimumab monotherapy in early peripheral Spondyloarthritis (pSpA) results in higher rates of clinical remission compared to treatment in more longstanding disease. When reaching remission, treat-to-target recommendations suggest tapering of treatment. We therefore explored whether addition of methotrexate would permit discontinuation of golimumab in patients with pSpA in sustained clinical remission.After a 2-year extension phase with golimumab treatment, patients with pSpA reaching clinical remission in the CRESPA-trial were offered a tapering strategy leading to discontinuation of golimumab and replacement by methotrexate monotherapy. Patients were prospectively followed to assess the rate of sustained biological-free clinical remission. In case of relapse of arthritis, enthesitis or dactylitis under methotrexate monotherapy, golimumab was restarted.Twenty-five of the original 60 pSpA patients, entered the step-down strategy. Currently, only 4 patients (16%) are still in sustained remission under methotrexate monotherapy. In 21 patients (84%), golimumab was re-installed because of relapse of disease activity (n = 19) or development of adverse events related to methotrexate (n = 2). Restarting golimumab treatment promptly restored clinical remission in all patients within 12 weeks.In patients with early pSpA achieving clinical remission after 2 years of golimumab treatment, stepdown therapy to monotherapy with MTX led to high rates of clinical relapse. This underscores the overall weak efficacy of methotrexate in maintaining clinical remission in pSpA.ClinicalTrials.gov, https://clinicaltrials.gov, NCT01426815.