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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