CLinical Experience Acquired with Raptiva® (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: Results from extended treatment in an international, Phase III, placebo-controlled trial

Wolfram Sterry, Georg Stingl, Richard G.B. Langley, Hugh Zacharie, Morad Lahfa, Alberto Giannetti, Carlos Ferrándiz, Rodney Sinclair, Jean Hilaire Saurat

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27 Citations (Scopus)

Abstract

Background: The 12-week, double-blind, placebo-controlled, first-treatment (FT) CLEAR trial period demonstrated the efficacy/safety of efalizumab in moderate-to-severe plaque psoriasis, including refractory or contraindicated patients unsuitable for other systemic treatments. This study assessed the efficacy/safety of open-label extended treatment (up to 24 weeks' continuous treatment) in patients not achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI-75) at week 12 of the FT period. Time to relapse after treatment cessation, and efficacy/safety of 12 weeks' open-label re-treatment in patients achieving PASI-75 at week 12 FT were also assessed. Patients and methods: Patients with PASI-75 at week 12 FT were observed without treatment until relapse, then re-treated with open-label efalizumab (1.0 mg/kg/week for 12 weeks). Others received open-label extended treatment without intervening observation. Results: Among efalizumab-treated patients (n = 308) who had < 75% PASI improvement at week 12 FT, extended treatment led to PASI-75 in 26.6%. Among patients with between ≥ 50 and < 75% PASI improvement at week 12 FT (n = 118), 47.5% improved to PASI-75 with extended treatment. Forpatients achieving PASI-75 at week 12 FT (n = 164), median time to relapse was 58 days. Re-treatment after relapse led to mean PASI improvement of 62.3% from study baseline (n = 145). Safety results were consistent with pre-vious studies, with no new safety concerns. Conclusions: These results demonstrate additional benefit of continuing efali-zumab. Re-treatment re-established disease control in patients with PASI-75 who relapsed following treatment cessation. The safety profile remained consistent with that seen at 12 weeks. © 2006 The Authors.
Original languageEnglish
Pages (from-to)947-957
JournalJDDG - Journal of the German Society of Dermatology
Volume4
Issue number11
DOIs
Publication statusPublished - 1 Nov 2006

Keywords

  • Anti-CD11a
  • Efalizumab
  • Monoclonal antibody
  • Plaque psoriasis
  • Rebound
  • Refractory patients

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