Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva CLEAR trial NCT00256139Report as inadecuate




Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: results of the international, randomized, placebo-controlled Phase III Clinical Experience Acquired with Raptiva CLEAR trial NCT00256139 - Download this document for free, or read online. Document in PDF available to download.

BMC Dermatology

, 5:13

First Online: 16 December 2005Received: 03 August 2005Accepted: 16 December 2005

Abstract

BackgroundChronic psoriasis can negatively affect patients- lives. Assessing the impact of treatment on different aspects of a patient-s health-related quality of life HRQOL is therefore important and relevant in trials of anti-psoriasis agents. The recombinant humanized IgG1 monoclonal antibody efalizumab targets multiple T-cell-dependent steps in the immunopathogenesis of psoriasis. Efalizumab has demonstrated safety and efficacy in several clinical trials, and improves patients- quality of life. Objective: To evaluate the impact of efalizumab on HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis, including a large cohort of High-Need patients for whom at least 2 other systemic therapies were unsuitable because of lack of efficacy, intolerance, or contraindication.

MethodsA total of 793 patients were randomized in a 2:1 ratio to receive efalizumab 1 mg-kg-wk n = 529 or placebo n = 264 for 12 weeks. The study population included 526 High-Need patients 342 efalizumab, 184 placebo. The treatment was evaluated by patients using the HRQOL assessment tools Short Form-36 SF-36 and Dermatology Life Quality Index DLQI. Other patient-reported assessments included the Psoriasis Symptom Assessment PSA, a visual analog scale VAS for itching, and the Patient-s Global Psoriasis Assessment PGPA.

ResultsEfalizumab was associated with improvements at Week 12 from baseline in patient-reported outcomes, both in the total study population and in the High-Need cohort. Among all efalizumab-treated patients, the DLQI improved by 5.7 points from baseline to Week 12, relative to an improvement of 2.3 points for placebo patients P < .001. Corresponding improvements in DLQI in the High-Need cohort were 5.4 points for efalizumab compared to 2.3 for placebo P < .001. Improvements from baseline on the SF-36, PSA, PGPA, and itching VAS at Week 12 were also significantly greater in efalizumab-treated patients than for placebo.

ConclusionA 12-week course of efalizumab improved HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis. The benefits of efalizumab therapy in High-Need patients were similar to those observed in the total study population, indicating that the beneficial impact of efalizumab on QOL is consistent regardless of disease severity, prior therapy, or contraindications to previous therapies.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-5945-5-13 contains supplementary material, which is available to authorized users.

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Author: Jean-Paul Ortonne - Neil Shear - Stephen Shumack - Eric Henninger - the CLEAR Multinational Study Group

Source: https://link.springer.com/







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