Abstract
Objective Evaluate the impact of tofacitinib on American College of Rheumatology (ACR) response criteria components in patients with rheumatoid arthritis (RA).
Methods This posthoc analysis pooled data from RA phase III randomized controlled trials (RCTs) assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab, or placebo, with conventional synthetic disease-modifying antirheumatic drugs, and a phase IIIb/IV RCT assessing tofacitinib 5 mg BID monotherapy, tofacitinib 5 mg BID with methotrexate, or adalimumab with methotrexate. Outcomes included: proportions of patients achieving ACR20/50/70 responses and ≥20/50/70% improvement rates in ACR components at Week 2 and Months 1, 3, and 6; mean percent improvement in ACR components and Clinical or Simplified Disease Activity Index (CDAI or SDAI) low disease activity or remission rates, at Month 3, for ACR20/50/70 responders.
Results Across treatment groups, ≥20/50/70% improvement rates were numerically higher for most physician- versus patient-reported measures. In phase III RCTs, at earlier timepoints, ≥50/70% improvements in Patient Global Assessment of Disease Activity, Pain and Clinician Global Assessment were similar. Among ACR20 responders receiving tofacitinib, mean percent improvements for tender and swollen joint counts were >70% at Month 3. CDAI/SDAI remission was achieved by 27.8–45.0% of ACR70 responders receiving tofacitinib at Month 3.
Conclusion Among ACR20 responders treated with tofacitinib, physician-reported components particularly exceeded 20% response improvement. At Month 3, disease state generally did not corroborate ACR70 response criteria. Divergences between physician- and patient-reported measures highlight the importance of identifying appropriate patient-reported outcome targets to manage RA symptoms in clinical practice.
