For a study, researchers sought to assess how tofacitinib (TOF) affects rheumatoid arthritis (RA) patients’ responses to the American College of Rheumatology’s (ACR) response criteria.
RA phase III randomized controlled trials (RCTs) evaluating TOF 5 or 10 mg BID, adalimumab (ADA), or placebo, with traditional synthetic disease-modifying antirheumatic drugs, as well as a phase IIIb/IV RCT evaluating TOF 5 mg BID monotherapy, TOF 5 mg BID with methotrexate (MTX), or ADA with MTX, were combined for this post hoc analysis. Results included percentages of patients achieving ACR20/50/70 responses and more than or around 20/50/70% improvement rates in ACR components at weeks 2 and 1, 3, and 6; mean percent improvement in ACR components; and percentages of ACR20/50/70 responders with low disease activity or remission rates on the Clinical or Simplified Disease Activity Index (CDAI or SDAI) at month 3.
Most physician-reported metrics improved by ≥20/50/70% more than patient-reported measures across treatment groups. At early time points in phase III RCTs, 50/70% gains in the global patient evaluation of disease activity, pain, and global physician assessment were comparable. At month 3, the mean percent improvement for sore and swollen joint counts among ACR20 responders receiving TOF was greater than 70%. At month three, 27.8-45.0% of ACR70 responders who received TOF achieved CDAI/SDAI remission.
Physician-reported components, in an instance, exceeded 20% response improvement among ACR20 responders treated with TOF. At month 3, the illness status did not typically match the ACR70 response criteria. Divergences between physician- and patient-reported measures emphasize the significance of developing suitable patient-reported outcome objectives in clinical practice to treat RA symptoms.