title: Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results.
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.
authors.forename: Fernando M
authors.initials: FM
authors.lastname: Stengel
authors.forename: Valeria
authors.initials: V
authors.lastname: Petri
authors.forename: Gladys Am
authors.initials: GA
authors.lastname: Campbell
authors.forename: Gladys Leon
authors.initials: GL
authors.lastname: Dorantes
authors.forename: Magdalina
authors.initials: M
authors.lastname: López
authors.forename: Ricardo L
authors.initials: RL
authors.lastname: Galimberti
authors.forename: Raúl P
authors.initials: RP
authors.lastname: Valdez
authors.forename: Lucia F
authors.initials: LF
authors.lastname: de Arruda
authors.forename: Mario Amaya
authors.initials: MA
authors.lastname: Guerra
authors.forename: Edgardo N
authors.initials: EN
authors.lastname: Chouela
authors.forename: Daiana
authors.initials: D
authors.lastname: Licu