Ultrasound-based withdrawal of biologics in rheumatoid arthritis (RA-BioStop).

OBJECTIVE: To test whether ultrasonography of patients with rheumatoid arthritis (RA) in the American College of Rheumatology/the European Alliance of Associations for Rheumatology (ACR/EULAR) remission is useful for prediction of relapse after discontinuation of a biological disease-modifying antirheumatic drug (bDMARD). METHODS: Prospective trial including patients with RA in persistent ACR/EULAR remission treated with conventional synthetic DMARDs plus bDMARDs. After stopping the bDMARD, nine study visits including clinical examination and ultrasound of 14 joints (blinded to clinical data) were conducted within 52 weeks. The primary hypothesis was that a Power Doppler (PD) score≥1 predicted relapse occurring within week 16 after bDMARD cessation. Relapse was defined as a change from remission to moderate/high disease activity according to the Simplified Disease Activity Score. RESULTS: Inclusion of 110 patients was originally planned; however, the study was terminated after reaching 38 (34.5%) patients due to insufficient recruitment. Relapses till week 16 were numerically more common in patients with PD score≥1 at baseline than in those with PD=0 (9/30 (30.0%) vs 0/7 (0%), p=0.160). Similar observations were made for weeks 24 and 52. PD scores were higher at the time of relapse than at preceding visits (mean PD score difference: 3.2 (±4.5) points, p=0.034). There were trends towards a higher baseline PD score in patients who had a relapse until week 16 as compared with those who remained in remission (5.2±5.8 vs 2.3±3.0, p=0.079). CONCLUSION: The primary endpoint was not reached. The presented data should be interpreted as hypothesis-generating, serving to stimulate future research on the value of ultrasound in assessing remission and predicting relapse in RA. TRIAL REGISTRATION NUMBER: NCT01602302.