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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
Author(s) -
Sterry Wolfram,
Stingl Georg,
Langley Richard G.B.,
Zacharie Hugh,
Lahfa Morad,
Giannetti Alberto,
Ferrándiz Carlos,
Sinclair Rodney,
Saurat JeanHilaire
Publication year - 2006
Publication title -
jddg: journal der deutschen dermatologischen gesellschaft
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.463
H-Index - 60
eISSN - 1610-0387
pISSN - 1610-0379
DOI - 10.1111/j.1610-0387.2006.06111.x
Subject(s) - efalizumab , medicine , psoriasis area and severity index , placebo , clinical trial , open label , plaque psoriasis , psoriasis , randomized controlled trial , adverse effect , refractory (planetary science) , dermatology , physics , pathology , astrobiology , alternative medicine
Summary 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.