Trial Outcomes & Findings for Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis (NCT NCT01710046)
NCT ID: NCT01710046
Last Updated: 2015-04-13
Results Overview
Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.
COMPLETED
PHASE2
12 participants
Week 12
2015-04-13
Participant Flow
Participant milestones
| Measure |
Tofacitinib 10 Milligrams (mg) Twice Daily (BID)
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Tofacitinib 10 Milligrams (mg) Twice Daily (BID)
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 21.5 • n=7 Participants
|
45.6 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: FAS
Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=8 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12
|
62.50 percentage of participants
|
33.33 percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: FAS
PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=8 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
|
50.00 percentage of participants
|
33.33 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, and 12Population: FAS; n (number) =number of participants with nonmissing observations at the specified visit.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€"100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Score by Visit
Baseline (n=9,3)
|
21.91 units on a scale
Standard Error 2.86
|
23.33 units on a scale
Standard Error 5.67
|
|
Psoriasis Area and Severity Index (PASI) Score by Visit
Week 1 (n=9,3)
|
17.81 units on a scale
Standard Error 3.10
|
15.53 units on a scale
Standard Error 6.60
|
|
Psoriasis Area and Severity Index (PASI) Score by Visit
Week 2 (n=9,3)
|
13.84 units on a scale
Standard Error 2.71
|
13.13 units on a scale
Standard Error 6.27
|
|
Psoriasis Area and Severity Index (PASI) Score by Visit
Week 4 (n=9,3)
|
11.72 units on a scale
Standard Error 3.51
|
13.37 units on a scale
Standard Error 6.05
|
|
Psoriasis Area and Severity Index (PASI) Score by Visit
Week 12 (n=8,3)
|
5.80 units on a scale
Standard Error 1.80
|
13.40 units on a scale
Standard Error 6.12
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4 and 12Population: Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€"100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€"100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in PASI by Visit
Week 1 (n=9,3)
|
-18.38 percent change from baseline
Standard Error 7.52
|
-39.61 percent change from baseline
Standard Error 19.97
|
|
Percent Change From Baseline in PASI by Visit
Week 2 (n=9,3)
|
-36.95 percent change from baseline
Standard Error 8.28
|
-48.66 percent change from baseline
Standard Error 20.28
|
|
Percent Change From Baseline in PASI by Visit
Week 4 (n=9,3)
|
-47.39 percent change from baseline
Standard Error 11.95
|
-49.66 percent change from baseline
Standard Error 19.41
|
|
Percent Change From Baseline in PASI by Visit
Week 12 (n=8,3)
|
-71.78 percent change from baseline
Standard Error 9.63
|
-49.13 percent change from baseline
Standard Error 19.67
|
SECONDARY outcome
Timeframe: Weeks 1, 2, and 4Population: FAS
Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4
Week 1
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4
Week 2
|
0.00 percentage of participants
|
33.33 percentage of participants
|
|
Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4
Week 4
|
22.22 percentage of participants
|
33.33 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in PGA Score by Visit
Week 4 (n=9,3)
|
-1.2 units on a scale
Standard Error 0.3
|
-1.0 units on a scale
Standard Error 0.6
|
|
Change From Baseline in PGA Score by Visit
Week 12 (n=8,3)
|
-1.5 units on a scale
Standard Error 0.3
|
-1.0 units on a scale
Standard Error 0.6
|
|
Change From Baseline in PGA Score by Visit
Week 1 (n=9,3)
|
-0.6 units on a scale
Standard Error 0.2
|
-0.7 units on a scale
Standard Error 0.3
|
|
Change From Baseline in PGA Score by Visit
Week 2 (n=9,3)
|
-0.8 units on a scale
Standard Error 0.2
|
-1.0 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, and 12Population: Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 12, Moderate (n=8,3)
|
12.5 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Baseline, Moderate (n=9,3)
|
88.9 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Baseline, Severe (n=9,3)
|
11.1 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 1, Mild (n=9,3)
|
44.4 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 1, Moderate (n=9,3)
|
55.6 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 2, Almost clear (n=9,3)
|
11.1 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 2, Mild (n=9,3)
|
44.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 2, Moderate (n=9,3)
|
44.4 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 4, Almost clear (n=9,3)
|
44.4 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 4, Mild (n=9,3)
|
22.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 4, Moderate (n=9,3)
|
33.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 12, Almost clear (n=8,3)
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants by PGA Response Category and Timepoint
Week 12, Mild (n=8,3)
|
37.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk \[including axillae and groin\]=3.33% and lower limbs \[including buttocks\]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Body Surface Area (BSA)
Baseline (n=9,3)
|
34.16 % BSA
Standard Error 8.12
|
30.50 % BSA
Standard Error 10.87
|
|
Body Surface Area (BSA)
Week 1 (n=9,3)
|
31.20 % BSA
Standard Error 7.35
|
24.83 % BSA
Standard Error 10.43
|
|
Body Surface Area (BSA)
Week 2 (n=9,3)
|
24.20 % BSA
Standard Error 5.38
|
24.67 % BSA
Standard Error 10.59
|
|
Body Surface Area (BSA)
Week 4 (n=9,3)
|
19.03 % BSA
Standard Error 4.70
|
23.33 % BSA
Standard Error 10.43
|
|
Body Surface Area (BSA)
Week 12 (n=8,3)
|
7.35 % BSA
Standard Error 3.10
|
23.03 % BSA
Standard Error 10.50
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 12Population: Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.
Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk \[including axillae and groin\]=3.33% and lower limbs \[including buttocks\]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk \[including axillae and groin\]=3.33% and lower limbs \[including buttocks\]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in BSA
Week 1 (n=9,3)
|
-6.87 percent change from baseline
Standard Error 4.97
|
-27.80 percent change from baseline
Standard Error 17.46
|
|
Percent Change From Baseline in BSA
Week 2 (n=9,3)
|
-22.51 percent change from baseline
Standard Error 7.14
|
-29.47 percent change from baseline
Standard Error 19.01
|
|
Percent Change From Baseline in BSA
Week 4 (n=9,3)
|
-35.13 percent change from baseline
Standard Error 10.45
|
-34.93 percent change from baseline
Standard Error 21.80
|
|
Percent Change From Baseline in BSA
Week 12 (n=8,3)
|
-77.40 percent change from baseline
Standard Error 11.98
|
-37.26 percent change from baseline
Standard Error 21.53
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Itch Severity Item (ISI) Score by Visit
Baseline (n=9,3)
|
6.35 units on a scale
Standard Error 0.89
|
3.46 units on a scale
Standard Error 1.94
|
|
Itch Severity Item (ISI) Score by Visit
Week 1 (n=9,3)
|
3.81 units on a scale
Standard Error 0.97
|
3.90 units on a scale
Standard Error 1.73
|
|
Itch Severity Item (ISI) Score by Visit
Week 2 (n=9,3)
|
2.45 units on a scale
Standard Error 0.91
|
1.99 units on a scale
Standard Error 0.73
|
|
Itch Severity Item (ISI) Score by Visit
Week 4 (n=9,3)
|
1.22 units on a scale
Standard Error 0.57
|
2.67 units on a scale
Standard Error 1.20
|
|
Itch Severity Item (ISI) Score by Visit
Week 12 (n=8,3)
|
0.75 units on a scale
Standard Error 0.62
|
6.00 units on a scale
Standard Error 1.53
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4 and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Change From Baseline in ISI by Visit
Week 1 (n=9,3)
|
-2.55 units on a scale
Standard Error 0.59
|
0.45 units on a scale
Standard Error 0.52
|
|
Change From Baseline in ISI by Visit
Week 2 (n=9,3)
|
-3.90 units on a scale
Standard Error 0.67
|
-1.47 units on a scale
Standard Error 1.31
|
|
Change From Baseline in ISI by Visit
Week 4 (n=9,3)
|
-5.13 units on a scale
Standard Error 0.77
|
-0.79 units on a scale
Standard Error 2.35
|
|
Change From Baseline in ISI by Visit
Week 12 (n=8,3)
|
-5.96 units on a scale
Standard Error 0.99
|
2.54 units on a scale
Standard Error 2.61
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Target Plaque Severity Score (TPSS) by Visit
Baseline (n=9,3)
|
8.7 score on a scale
Standard Error 0.6
|
8.3 score on a scale
Standard Error 0.3
|
|
Target Plaque Severity Score (TPSS) by Visit
Week 1 (n=9,3)
|
7.1 score on a scale
Standard Error 0.7
|
7.0 score on a scale
Standard Error 1.2
|
|
Target Plaque Severity Score (TPSS) by Visit
Week 2 (n=9,3)
|
6.0 score on a scale
Standard Error 0.7
|
6.7 score on a scale
Standard Error 1.2
|
|
Target Plaque Severity Score (TPSS) by Visit
Week 4 (n=9,3)
|
4.6 score on a scale
Standard Error 1.1
|
6.7 score on a scale
Standard Error 1.9
|
|
Target Plaque Severity Score (TPSS) by Visit
Week 12 (n=8,3)
|
2.8 score on a scale
Standard Error 1.3
|
6.0 score on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 12Population: FAS; n=number of participants with nonmissing observations at the specified visit.
Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.
Outcome measures
| Measure |
Tofacitinib 10 mg BID
n=9 Participants
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 Participants
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in TPSS by Visit
Week 1 (n=9,3)
|
-16.69 percent change from baseline
Standard Error 7.72
|
-16.67 percent change from baseline
Standard Error 11.02
|
|
Percent Change From Baseline in TPSS by Visit
Week 2 (n=9,3)
|
-29.78 percent change from baseline
Standard Error 8.39
|
-20.83 percent change from baseline
Standard Error 11.02
|
|
Percent Change From Baseline in TPSS by Visit
Week 4 (n=9,3)
|
-47.55 percent change from baseline
Standard Error 12.40
|
-20.83 percent change from baseline
Standard Error 20.83
|
|
Percent Change From Baseline in TPSS by Visit
Week 12 (n=8,3)
|
-67.28 percent change from baseline
Standard Error 15.17
|
-29.17 percent change from baseline
Standard Error 18.16
|
Adverse Events
Tofacitinib 10 mg BID
Placebo
Serious adverse events
| Measure |
Tofacitinib 10 mg BID
n=9 participants at risk
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 participants at risk
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Tofacitinib 10 mg BID
n=9 participants at risk
Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
|
Placebo
n=3 participants at risk
Participants received matching placebo tablets, orally, BID for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
1/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gravitational oedema
|
0.00%
0/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
33.3%
1/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
11.1%
1/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
11.1%
1/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
11.1%
1/9 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/3 • Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place