Tofacitinib Ointment For Chronic Plaque Psoriasis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with mild (PGA-C score of 2), moderate (PGA-C score of 3), or severe (PGA-C score of 4) chronic plaque psoriasis were recruited for this study. The primary analysis population for this study included only the participants with mild and moderate disease.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)	Participants with a baseline Calculated Physician’s Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g BID	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Mild/Moderate: Placebo (Vehicle) BID	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g QD	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Mild/Moderate: Placebo (Vehicle) QD	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Severe: Tofacitinib 20 mg/g BID	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Severe: Tofacitinib 10 mg/g BID	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Severe: Placebo (Vehicle) BID	Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
Severe: Tofacitinib 20 mg/g QD	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Severe: Tofacitinib 10 mg/g QD	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Severe: Placebo (Vehicle) QD	Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.

Participant Flow:   Overall Study

	Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (Vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (Vehicle) QD	Severe: Tofacitinib 20 mg/g BID	Severe: Tofacitinib 10 mg/g BID	Severe: Placebo (Vehicle) BID	Severe: Tofacitinib 20 mg/g QD	Severe: Tofacitinib 10 mg/g QD	Severe: Placebo (Vehicle) QD
STARTED	71 [1]	70 [1]	71 [1]	70 [1]	74 [1]	74 [1]	7 [1]	7 [1]	7 [1]	7 [1]	6 [1]	7 [1]
COMPLETED	55	52	48	51	57	48	6	5	4	2	4	3
NOT COMPLETED	16	18	23	19	17	26	1	2	3	5	2	4
Protocol Violation	1	1	2	0	0	1	0	0	0	0	0	0
Not specified	2	3	2	2	2	1	0	0	0	0	0	0
Non-compliance with study treatment	2	1	1	0	0	1	0	0	0	0	0	0
Death	0	1	0	0	0	0	0	0	0	0	0	0
Withdrawal by Subject	6	3	3	3	3	5	0	0	0	1	0	1
Lost to Follow-up	0	1	4	2	0	3	0	0	0	1	0	1
Lack of Efficacy	5	8	7	6	9	8	1	1	2	2	2	0
Adverse Event	0	0	4	6	3	7	0	1	1	1	0	2

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS) - included all participants who were randomized to the study, received at least one dose of the randomized investigational drug (tofacitinib or vehicle), and were in a baseline PGA-C category of mild (2), moderate (3) or severe (4).

Reporting Groups

	Description
Mild/Moderate: Tofacitinib 20 mg/g BID	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g BID	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Mild/Moderate: Placebo (Vehicle) BID	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Mild/Moderate: Tofacitinib 20 mg/g QD	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Mild/Moderate: Tofacitinib 10 mg/g QD	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Mild/Moderate: Placebo (Vehicle) QD	Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Severe: Tofacitinib 20 mg/g BID	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
Severe: Tofacitinib 10 mg/g BID	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Severe: Placebo (Vehicle) BID	Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
Severe: Tofacitinib 20 mg/g QD	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Severe: Tofacitinib 10 mg/g QD	Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Severe: Placebo (Vehicle) QD	Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
Total	Total of all reporting groups

Baseline Measures

	Mild/Moderate: Tofacitinib 20 mg/g BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (Vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (Vehicle) QD	Severe: Tofacitinib 20 mg/g BID	Severe: Tofacitinib 10 mg/g BID	Severe: Placebo (Vehicle) BID	Severe: Tofacitinib 20 mg/g QD	Severe: Tofacitinib 10 mg/g QD	Severe: Placebo (Vehicle) QD	Total
Overall Participants Analyzed  [Units: Participants]	71	70	71	70	74	74	7	7	7	7	6	7	471
Age, Customized  [Units: Participants]
< 18 years	0	0	0	0	0	0	0	0	0	0	0	0	0
18-44 years	30	23	25	21	30	25	2	0	1	3	3	2	165
45-64 years	28	34	34	38	35	39	4	6	4	2	2	2	228
>= 65 years	13	13	12	11	9	10	1	1	2	2	1	3	78
Gender  [Units: Participants]
Female	28	23	30	33	24	32	1	3	1	1	0	0	176
Male	43	47	41	37	50	42	6	4	6	6	6	7	295

1.  Primary:

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Primary:

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8   [ Time Frame: Baseline, Week 8 ]

3.  Secondary:

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12   [ Time Frame: Week 12 ]

4.  Secondary:

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8   [ Time Frame: Week 8 ]

5.  Secondary:

Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:

Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8   [ Time Frame: Baseline, Week 8 ]

7.  Secondary:

Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:

Percent Change From Baseline to Week 8 in PASI   [ Time Frame: Baseline, Week 8 ]

9.  Secondary:

Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:

Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8   [ Time Frame: Baseline, Week 8 ]

11.  Secondary:

Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis   [ Time Frame: Baseline, Week 12 ]

12.  Secondary:

Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis   [ Time Frame: Baseline, Week 8 ]

13.  Secondary:

Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:

Change From Baseline to Week 8 in Clinic-Based ISI Scores   [ Time Frame: Baseline, Week 8 ]

15.  Secondary:

Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:

Change From Baseline to Week 8 in the DLQI Total Score   [ Time Frame: Baseline, Week 8 ]

17.  Secondary:

Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline   [ Time Frame: Baseline, Week 12 ]

18.  Secondary:

Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline   [ Time Frame: Baseline, Week 8 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Efficacy results for participants in the severe population were not reported since this was considered an exploratory population.