Subjects with psoriasis will receive intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 (induction therapy) to evaluate the efficacy of infliximab at Week 18. Subjects who achieved \>=75% improvement in Psoriasis Pustulosa Palmoplantaris Area and Severity Index (PPPASI) score at Week 8 AND had deterioration of PPPASI score of 50% from Week 8 until Week 12 were to receive an additional infusion at Week 12.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
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.
Time frame: Baseline and Week 8
Number of Participants Who Achieve a Moderate Response.
Moderate response is defined as a 50% to 75% reduction in PPPASI score from baseline.
Time frame: Baseline and Week 8
Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18.
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.
Time frame: Weeks 12 and 18
Number of Participants Who Respond to the Fourth Infusion.
\>=25% reduction in PPPASI score would be considered a response.
Time frame: Week 12 and Week 18
Dermatology Life Quality Index (DLQI)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and Week 12