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

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.Original Abstract: Hintergrund: Die 12-woechige, doppelblinde, placebokontrollierte Phase mit erstmaliger Therapie (first treatment [FT]) in der CLEAR-Studie zeigte die Wirk-samkeit-Sicherheit von Efalizumab bei maessiger bis schwerwiegender Psoriasis en plaques, auch bei Patienten, die therapierefraktaer waren oder bei denen andere systemische Therapien kontraindiziert waren. In dieser Studie wurde die Wirksamkeit-Sicherheit einer offenen verlaengerten Therapie (bis zu 24-woechige kontinuierliche Therapie) bei Patienten untersucht, die im Psoriasis Area and Severity Index in Woche 12 der FT-Phase keine .75%ige Verbesserung (PASI-75) erreicht hatten. Der Zeitraum bis zum Eintreten eines Rezidivs nach Absetzen der Therapie und Wirksamkeit-Sicherhe