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Table 1 Time to initial response for outcomes in OPAL Broaden and Beyond (FAS)

From: Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo

 

OPAL Broaden

OPAL Beyond

Responders

Days to response

Responders

Days to response

Response

 Treatment sequence

N at baseline

Responders (up to month 12)

25th percentile (95% CI)

Median (95% CI)

N at baseline

Responders (up to month 6)

25th percentile (95% CI)

Median (95% CI)

HAQ-DI score responsea

 Tofacitinib 5 mg BID

96

84

15.0 (15.0–16.0)

30.0 (27.0–57.0)

116

88

16.0 (15.0–20.0)

37.0 (29.0–61.0)

 Tofacitinib 10 mg BID

92

71

16.0 (15.0–27.0)

53.5 (29.0–90.0)

123

80

16.0 (15.0–29.0)

64.0 (57.0–113.0)

 ADA 40 mg SC Q2W

96

73

15.0 (15.0–27.0)

29.0 (29.0–57.0)

–

–

–

–

 PBO → tofacitinib 5 mg BID

48

30

55.0 (28.0–113.0)

162.0 (85.0–NE)

57

40

16.0 (15.0–57.0)

85.0 (57.0–169.0)

 PBO → tofacitinib 10 mg BID

46

36

29.0 (16.0–60.0)

112.0 (57.0–169.0)

59

38

30.0 (17.0–84.0)

113.0 (84.0–169.0)

p value

   

0.0031**

   

0.1458

FACIT-F total score responseb

 Tofacitinib 5 mg BID

107

87

29.0 (NE–NE)

31.0 (29.0–43.0)

130

98

29.0 (NE–NE)

31.0 (30.0–84.0)

 Tofacitinib 10 mg BID

104

84

29.0 (29.0–30.0)

85.0 (34.0–92.0)

132

91

29.0 (NE–NE)

84.0 (32.0–91.0)

 ADA 40 mg SC Q2W

106

83

29.0 (29.0–30.0)

85.0 (61.0–92.0)

–

–

–

–

 PBO → tofacitinib 5 mg BID

52

42

30.5 (29.0–85.0)

86.0 (85.0–169.0)

66

49

29.0 (29.0–34.0)

85.0 (35.0–164.0)

 PBO → tofacitinib 10 mg BID

53

41

29.5 (29.0–33.0)

85.0 (31.0–170.0)

65

41

29.0 (29.0–44.0)

92.0 (81.0–175.0)

p value

   

0.4136

   

0.1164

MDA responsec

 Tofacitinib 5 mg BID

107

55

85.0 (85.0–253.0)

337.0 (256.0–NE)

131

46

92.0 (85.0–169.0)

NE (NE–NE)

 Tofacitinib 10 mg BID

104

54

86.0 (85.0–168.0)

337.0 (171.0–NE)

132

39

96.0 (85.0–NE)

NE (NE–NE)

 ADA 40 mg SC Q2W

106

53

86.0 (83.0–169.0)

339.0 (171.0–NE)

–

–

–

–

 PBO → tofacitinib 5 mg BID

52

21

251.0 (169.0–339.0)

342.0 (337.0–NE)

66

17

167.0 (86.0–189.0)

189.0 (NE–NE)

 PBO → tofacitinib 10 mg BID

53

25

169.0 (168.0–241.0)

338.0 (176.0–NE)

65

21

169.0 (162.0–176.0)

176.0 (174.0–NE)

p value

   

0.5962

   

0.6995

PASDAS score responsed

 Tofacitinib  5 mg BID

107

67

90.0 (84.0–170.0)

253.0 (174.0–335.0)

123

49

85.0 (83.0–167.0)

NE (NE–NE)

 Tofacitinib 10 mg BID

103

67

85.0 (83.0–88.0)

176.0 (166.0–258.0)

129

51

86.0 (85.0–168.0)

182.0 (169.0–NE)

 ADA 40 mg SC Q2W

104

59

87.0 (85.0–169.0)

253.0 (169.0–NE)

–

–

–

–

 PBO → tofacitinib 5 mg BID

52

24

170.0 (166.0–253.0)

344.0 (251.0–NE)

63

22

168.0 (85.0–173.0)

189.0 (169.0–189.0)

 PBO → tofacitinib 10 mg BID

52

31

169.0 (169.0–175.0)

241.0 (170.0–323.0)

65

28

169.0 (163.0–169.0)

173.0 (169.0–190.0)

p value

   

0.2118

   

0.9613

  1. Log-rank (Mantel–Haenszel) tests comparing Kaplan–Meier curves across treatments; p value based on chi-square test with degrees of freedom = number of treatments – 1; **p ≤ 0.01
  2. PBO → tofacitinib 5 or 10 mg BID groups refers to blinded placebo treatment to month 3 followed by blinded switching to tofacitinib 5 or 10 mg BID
  3. aHAQ-DI ≥ 0.35-point improvement from baseline (analyzed for patients with baseline HAQ-DI ≥ 0.35)
  4. bFACIT-F total score ≥ 4-point improvement from baseline
  5. cMDA yes/no composite response (meeting at least 5 of 7 criteria)
  6. dPASDAS post-baseline score of ≤ 3.2 and > 1.6-point improvement from baseline (analyzed for patients with baseline PASDAS > 3.2)
  7. Abbreviations: ADA adalimumab, BID twice daily, CI confidence interval, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, FAS full analysis set, HAQ-DI Health Assessment Questionnaire-Disability Index, MDA minimal disease activity, NE not estimable, PASDAS Psoriatic Arthritis Disease Activity Score, PBO placebo, Q2W once every 2 weeks, SC subcutaneous
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Arthritis Research & Therapy

ISSN: 1478-6362

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