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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