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Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results. | LitMetric

AI Article Synopsis

  • - Psoriasis is a chronic inflammatory disease affecting about 2% of people in South America, and biological therapies like efalizumab can provide effective long-term treatment.
  • - A Phase IIIb/IV study involved 189 adult patients with moderate-to-severe psoriasis, where 48.7% achieved an excellent or cleared status by week 24 after receiving efalizumab.
  • - While side effects were common (85.2% reported), the treatment provided effective and sustained results, aligning with earlier research from North America and Europe.

Article Abstract

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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2805872PMC
http://dx.doi.org/10.1111/j.1753-5174.2009.00024.xDOI Listing

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