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

Archives of Drug Information
Fernando M StengelInternational IMP25161 Study Group

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...Continue Reading

References

Nov 25, 2003·The New England Journal of Medicine·Mark LebwohlUNKNOWN Efalizumab Study Group
Dec 18, 2003·JAMA : the Journal of the American Medical Association·Kenneth B GordonUNKNOWN Efalizumab Study Group
Jun 5, 2004·Dermatology : International Journal for Clinical and Investigative Dermatology·D JullienP Natta
Mar 12, 2005·Journal of the American Academy of Dermatology·Craig L LeonardiUNKNOWN Efalizumab Study Group
Feb 21, 2006·Journal of the American Academy of Dermatology·Alice B GottliebUNKNOWN Efalizumab Study Group
May 16, 2006·Journal of Cutaneous Medicine and Surgery·Kim A Papp, Eric Henninger
Sep 21, 2006·BMC Dermatology·Kim A Papp, Eric Henninger
Apr 1, 2008·The British Journal of Dermatology·C LeonardiA B Gottlieb

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Citations

Oct 11, 2011·Therapeutic Delivery·Chuda ChittasuphoCory Berkland
Apr 30, 2010·Archives of Drug Information·María Denise TakahashiDaiana Licu
Jun 7, 2011·American Journal of Therapeutics·Benesa S BabyDipak Chandy

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BETA
contraception

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NCT00287118

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