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Table 2 Secondary efficacy endpoints

From: Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial

Endpoint

Week

2 % tofacitinib BID

1 % tofacitinib BID

Vehicle BID

2 % tofacitinib QD

1 % tofacitinib QD

Vehicle QD

PGA-C, clear (0) or almost clear (1)

Responders, % (n/N)

Odds ratios (80 % CI)

8

41.8 (26/61)

2.13b (1.29, 3.54)

20.9 (14/64)

0.79 (0.45, 1.36)

25.2 (16/55)

35.9 (23/60)

3.52b (1.97, 6.28)

23.4 (16/67)

1.92b (1.06, 3.48)

13.8 (9/58)

12

39.7 (24/58)

1.75b (1.06, 2.90)

28.4 (18/57)

1.06 (0.62, 1.78)

27.3 (17/55)

36.1 (19/53)

1.36 (0.81, 2.28)

32.9 (22/62)

1.18 (0.71, 1.97)

29.3 (17/52)

PASI75

Responders, % (n/N)

Odds ratios (80 % CI)

8

15.2 (10/61)

2.06 (0.96, 4.45)

9.1 (6/64)

1.15 (0.50, 2.66)

8.0 (5/55)

17.9 (11/60)

2.40b (1.14, 5.05)

7.2 (5/67)

0.85 (0.36, 2.01)

8.3 (5/58)

12

20.3 (12/58)

1.42 (0.76, 2.64)

14.4 (9/57)

0.94 (0.48, 1.83)

15.2 (9/55)

23.0 (11/53)

3.11b (1.47, 6.55)

12.1 (8/62)

1.44 (0.65, 3.19)

8.8 (5/52)

PASI, % change from baseline

LSM, % (N)

Differencea (80 % CI)

8

−31.8 (61)

−8.3 (−17.3, 0.6)

−26.7 (64)

−3.2 (−12.1, 5.7)

−23.5 (55)

−28.3 (60)

−9.2b (−17.1, −1.4)

−25.5 (67)

−6.4 (−14.1, 1.3)

−19.1 (58)

12

−33.9 (58)

−6.5 (−17.1, 4.1)

−32.6 (57)

−5.2 (−15.7, 5.3)

−27.4 (55)

−33.4 (53)

−12.3b (−21.8, −2.8)

−27.0 (62)

−5.9 (−15.2, 3.3)

−21.1 (52)

BSA, % change from baseline

LSM, % (N)

Differencea (80 % CI)

8

−22.1 (61)

−4.2 (−13.1, 4.7)

−20.9 (64)

−3.0 (−11.8, 5.8)

−17.9 (55)

−12.5 (60)

−8.0 (−16.7, 0.7)

−10.1 (67)

−5.7 (−14.2, 2.8)

−4.5 (58)

12

−31.2 (58)

−4.5 (−13.8, 4.9)

−26.0 (57)

0.8 (−8.5, 10.0)

−26.7 (55)

−22.8 (53)

−20.0b (−31.4, −8.7)

−12.3 (62)

−9.5 (−20.6, 1.6)

−2.8 (52)

  1. aDifference active – vehicle; bmeets specification for statistical significance
  2. PASI excluded the scalp, palms, and soles from the assessment/scoring, even if these areas were being treated with study drug. BSA excluded the head, neck, palms, and soles, even if these areas were being treated with study drug
  3. PGA-C and PASI75 responses were analyzed using a Generalized Mixed Model for Repeated Measures without imputation for missing values; percent changes from baseline in PASI and BSA were analyzed using a Mixed Model for Repeated Measures without imputation for missing values; QD and BID data were analyzed separately
  4. BID twice daily, BSA body surface area, CI confidence interval, LSM least squares mean, PASI Psoriasis Area and Severity Index, PGA-C Calculated Physician’s Global Assessment, QD once daily