Trial Outcomes & Findings for Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555)(COMPLETED) (NCT NCT00686686)

Results Overview

The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. "Extent" is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

23 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2017-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab 5 mg/kg Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Overall Study STARTED	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab 5 mg/kg Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Overall Study Non-compliance	1
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	3

Baseline Characteristics

Study to Evaluate the Efficacy of Infliximab Induction Therapy for Patients With Palmoplantar Psoriasis (PPP)(Study P04555)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab 5 mg/kg n=23 Participants Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Age, Continuous	45.5 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Per Protocol population included the 17 subjects who completed the trial.

The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. "Extent" is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement.

Outcome measures

Outcome measures
Measure	Infliximab 5 mg/kg n=17 Participants Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions.	4 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: It was decided that this analysis will not be done.

Moderate response is defined as a 50% to 75% reduction in PPPASI score from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 12 and 18

Population: One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16 for the Week 12 observations (but n=17 for the Week 18 observations).

The Physician Static Global Assessment (PGA) documents the physician's assessment of the subject's psoriasis status according to the following categories: induration, scaling, and erythema. Each category is rated from 0 to 5, where 0 represents no evidence of induration/scaling/erythema ("clear"), 1 represents "minimal" induration/scaling/erythema, and 5 represents the most severe induration/scaling/erythema.

Outcome measures

Outcome measures
Measure	Infliximab 5 mg/kg n=17 Participants Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18. Induration: Week 12	13 participants
Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18. Induration: Week 18	13 participants
Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18. Erythema: Week 12	15 participants
Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18. Erythema: Week 18	9 participants
Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18. Scaling: Week 12	10 participants
Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18. Scaling: Week 18	7 participants

SECONDARY outcome

Timeframe: Week 12 and Week 18

Population: Only three participants received a fourth infusion but according to the protocol they were not suppose to receive it at that time because their improvement in PPPASI score on Week 8 was less than 75%. Therefore, because no participants qualified to be analyzed for this endpoint, no data are given.

\>=25% reduction in PPPASI score would be considered a response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16.

The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a subject's QOL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI was completed by the subject prior to the PPPASI and PGA evaluations. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Outcome measures

Outcome measures
Measure	Infliximab 5 mg/kg n=16 Participants Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Dermatology Life Quality Index (DLQI) Baseline	22.6 scores on a scale Standard Deviation 6.6
Dermatology Life Quality Index (DLQI) Week 12	12.7 scores on a scale Standard Deviation 2.2

Adverse Events

Infliximab 5 mg/kg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab 5 mg/kg n=23 participants at risk Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
Investigations Hepatic enzyme increased	4.3% 1/23 • Number of events 1
Investigations Liver function test abnormal	4.3% 1/23 • Number of events 1
Skin and subcutaneous tissue disorders Psoriasis	4.3% 1/23 • Number of events 1
Skin and subcutaneous tissue disorders Postular psoriasis	8.7% 2/23 • Number of events 4

Other adverse events

Other adverse events
Measure	Infliximab 5 mg/kg n=23 participants at risk Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
General disorders Asthenia	8.7% 2/23 • Number of events 2
Infections and infestations Folliculitis	8.7% 2/23 • Number of events 3
Investigations Hepatic enzyme increased	13.0% 3/23 • Number of events 3
Investigations Liver function test abnormal	8.7% 2/23 • Number of events 2

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All proposed publications/presentations by the investigators or their personnel resulting from or relating to this study must be submitted to Sponsor for review 60 days before submission for publication or presentation. If the proposed publication/presentation contains patentable subject matter which, at Sponsor's sole discretion, warrants intellectual property protection, the Sponsor may delay any publication or presentation for up to 60 days for the purpose of pursuing such protection.
Publication restrictions are in place

Restriction type: OTHER