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Efalizumab Well Tolerated by Patients With Moderate-to-Severe Plaque Psoriasis: Presented at EADV By Jenny Powers PARIS -- September 21, 2008 -- Efalizumab is generally well-tolerated and has a safety profile consistent with that seen in previous clinical trials, according to results from a large phase 3B/4, multicentre, open-label study presented here at the European Academy of Dermatology and Venereology (EADV) Congress. Knud Kragballe, MD, Marselisborg Hospital, University of Aarhus, Aarhus, Denmark, and colleagues enrolled 1,266 patients with moderate-to-severe plaque psoriasis and treated them with at least 1 dose of injected efalizumab 1.0 mg/kg over 12 weeks. All patients' data were included in a safety analysis. The primary efficacy endpoint -- a Physician Global Assessment of "good," "excellent," or "cleared" -- was achieved by 68% of the patients by week 12 (95% confidence interval: 65.3-70.5%), the investigators reported here at a poster presentation on September 18. Adverse events (AEs), patient vital signs, and clinical laboratory parameters were monitored throughout the study. AEs that resulted in treatment discontinuation occurred in 7% of patients. Treatment-emergent adverse events (TEAEs) occurred in 62% of patients during the first treatment period (treatment for a median of 78.0 days [range 1-14 days]). The most common patient-reported AEs were headache (25%), pyrexia (9%), and flu-like symptoms (8%). Moderate TEAEs were reported by one-third of patients, and 9.9% of patients experienced severe TEAEs. Fewer TEAEs were experienced by patients who received more prolonged treatment. During the continued treatment (CT) period (median 57.0 days [range 1-266]), 17.7% of patients reported a total of 205 events that consisted of furuncles, infections of the nose and urinary-tract infections (5%), skin and subcutaneous tissue disorders (4.7%), and musculoskeletal disorders (3.1%). Among the group who received retreatment, 40.7% of the patients reported a total of 77 events. There were no reports of serious thrombocytopaenia in any of the treatment groups, and the 1 death that occurred was determined to be unrelated to treatment. There was no increase in malignancies or infections with this treatment, and no new safety concerns arose during the course of efalizumab treatment. This study was conducted at 170 centres in 18 counties throughout Europe. Funding for this study was provided by Merck Serono International, S.A. [Presentation title: Safety of Efalizumab in Patients With Moderate-to-Severe Plaque Psoriasis: Results From a Post-approval, Phase 111B/IV Study (Control II). Abstract FP1355] E-mail this page to a friend or colleague! To print, use this version