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Table 2 Proportion of csDMARD-IR patients reporting each clinically meaningful PRO improvement at month 3

From: Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib

PRO, n (%) Tofacitinib 5 mg BID + csDMARDs (N = 695) Placebo + csDMARDs (N = 366)
PtGA
 LDA (PtGA VAS score ≤ 20 mm) 216 (31.1) 62 (16.9)
 Moderate PtGA improvement (≥ 30% decrease from baseline)a 421 (60.8) 119 (32.6)
 Substantial PtGA improvement (≥ 50% decrease from baseline)a 301 (43.5) 73 (20.0)
Pain
 Mild Pain (VAS score ≤ 20 mm) 246 (35.4) 62 (16.9)
 Moderate Pain improvement (≥ 30% decrease from baseline)a 419 (60.5) 124 (34.0)
 Substantial Pain improvement (≥ 50% decrease from baseline)a 310 (44.8) 70 (19.2)
HAQ-DI
 HAQ-DI score ≥ normative value (≤ 0.25) 142 (20.4) 44 (12.0)
 HAQ-DI change ≥ MCID (≥ 0.22 improvement from baseline)b 463 (66.8) 166 (45.6)
FACIT-F
 FACIT-F score ≥ normative value (≥ 43.5)c 138 (19.9) 46 (12.6)
 FACIT-F change ≥ MCID (≥ 4.0 improvement from baseline)d 381 (55.0) 131 (36.1)
  1. Abbreviations: BID twice daily, csDMARD conventional synthetic disease-modifying antirheumatic drug, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, IR inadequate responder, LDA low disease activity, MCID minimum clinically important difference, PRO patient-reported outcome, PtGA Patient Global Assessment of Disease Activity, VAS Visual Analog Scale
  2. aTofacitinib 5 mg BID + csDMARDs, N = 692; placebo + csDMARDs, N = 365
  3. bTofacitinib 5 mg BID + csDMARDs, N = 693; placebo + csDMARDs, N = 364
  4. cTofacitinib 5 mg BID + csDMARDs, N = 694; placebo + csDMARDs, N = 365
  5. dTofacitinib 5 mg BID + csDMARDs, N = 693; placebo + csDMARDs, N = 363