Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results.
Bottom Line: Biological therapies offer the possibility of long-term therapy with improved safety and efficacy.Safety outcomes were adverse events (AEs), serious AEs (SAEs) and abnormalities on laboratory tests.RESULTS: Of 189 patients included in the intent-to-treat and safety populations, 104 (55.0%) were of Hispanic or Latino ethnicity.
INTRODUCTION: Psoriasis is a debilitating, chronic inflammatory systemic disease affecting around 2% of the South American population. Biological therapies offer the possibility of long-term therapy with improved safety and efficacy. METHODS: We conducted a multicentre, open-label, single-arm, Phase IIIb/IV study of adult patients (18-75 years) with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. Patients received efalizumab subcutaneously (1.0 mg/kg/wk). The primary endpoint was the proportion of patients achieving a Physician Global Assessment (PGA) rating of "excellent" or "cleared" at Week 24. Safety outcomes were adverse events (AEs), serious AEs (SAEs) and abnormalities on laboratory tests. RESULTS: Of 189 patients included in the intent-to-treat and safety populations, 104 (55.0%) were of Hispanic or Latino ethnicity. At Week 24, 92/189 (48.7%) patients achieved or maintained a PGA rating of "excellent" or "cleared". AEs were reported by 161/189 (85.2%) patients, SAEs by 21/189 (11.1%). One patient died during the study (meningoencephalitis). Laboratory findings were consistent with previous experience. CONCLUSIONS: Efalizumab demonstrated sustained control of psoriasis up to 24 weeks in patients from Latin America, confirming results seen in Phase III studies conducted in North America and Europe.
No MeSH data available.
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Mentions: In the ITT population, 48.7% (92/189) of patients achieved or maintained a PGA score of “excellent” or “cleared” (95% confidence interval [CI] 41.6–55.8%; Fig. 1a) at Week 24 (nonresponder imputation analysis 46.0% [87/189]; 95% CI 38.9–53.1%); in the PP population this rate was 65.3% (81/124; 95% CI 56.9–73.7%). At Week 24, 67.7% (128/189) in the ITT population achieved or maintained a PGA score of “good” or better (Fig. 1a).
No MeSH data available.