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Table 3 Patients achieving MCIDs for each PRO at week 12

From: Effect of filgotinib, a selective JAK 1 inhibitor, with and without methotrexate in patients with rheumatoid arthritis: patient-reported outcomes

  Methotrexate add-on study Monotherapy study (all q.d. doses)
  Placebo (N = 86) 50 mg q.d. (N = 82) 100 mg q.d. (N = 85) 200 mg q.d. (N = 86) 25 mg b.i.d. (N = 86) 50 mg b.i.d. (N = 85) 100 mg b.i.d. (N = 84) Placebo (N = 72) 50 mg (N = 72) 100 mg (N = 70) 200 mg (N = 69)
HAQ-DI, n (%) 49 (57) 60 (73) 64 (75) 74 (86) 61 (71) 57 (67) 70 (83) 37 (52) 51 (73) 55 (79) 55 (80)
Patient Global, n (%) 52 (61) 56 (68) 60 (71) 67 (78) 58 (67) 62 (73) 65 (77) 35 (49) 56 (78) 50 (71) 52 (75)
Patient Pain, n (%) 50 (58) 54 (66) 55 (66) 66 (77) 59 (69) 58 (68) 67 (80) 39 (55) 54 (77) 51 (73) 56 (81)
FACIT-Fatigue scale, n (%) 51 (59) 47 (57) 60 (71) 64 (74) 54 (63) 55 (65) 59 (71) 32 (45) 48 (69) 52 (74) 51 (74)
SF-36 PCS, n (%) 43 (50) 55 (67) 60 (71) 68 (79) 58 (67) 62 (73) 66 (80) 30 (42) 48 (69) 49 (70) 54 (78)
SF-36 MCS, n (%) 49 (57) 44 (54) 48 (57) 64 (74) 43 (50) 38 (45) 53 (64) 34 (48) 39 (56) 52 (74) 46 (67)
  1. Minimal clinically important differences (MCIDs) were defined as follows: 0.22-point decrease from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI); 10% (10 mm) decrease from baseline in the 'Patient' Global Assessment of Disease Activity and Patient Pain visual analog scale (VAS) scores; 4-point increase in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score; 2.5-point increase from baseline in the 36-Item Short Form Health Survey (SF-36) physical component score (PCS) and mental component score (MCS)
  2. b.i.d. twice daily, PRO patient-reported outcome, q.d. once daily