title: Extended efalizumab therapy sustains efficacy without increasing toxicity in patients with moderate to severe chronic plaque psoriasis.
abstract: Agents that safely provide long-term control of psoriasis are needed. To determine the safety and efficacy of extended efalizumab therapy, 339 patients with moderate to severe chronic plaque psoriasis received 2 mg/kg subcutaneous (SC) efalizumab weekly for 12 weeks. At Week 12, 290 patients who achieved > or =50% Psoriasis Area and Severity Index (PASI-50) improvement or a static Physician's Global Assessment grading of "mild," "minimal," or "clear" entered maintenance treatment with weekly SC efalizumab. At Week 12, 82%, 41%, and 13% of 339 patients achieved a PASI-50, PASI-75, and PASI-90 response, respectively. At 15 months, 65%, 50%, and 25% of patients achieved a PASI-50, PASI-75, and PASI-90 response, respectively (intent-to-treat, n = 339). The incidence of adverse events did not increase over time, and no new common adverse events were reported. The majority of patients experienced sustained efficacy with no increase in toxicity. This study is planned to continue; patients will receive up to 36 months of continuous efalizumab.
authors.affiliation: Clinical Research Center, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA. alice.gottlied@umdnj.edu
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: Kenneth B
authors.initials: KB
authors.lastname: Gordon
authors.forename: Mark G
authors.initials: MG
authors.lastname: Lebwohl
authors.forename: Ivor
authors.initials: I
authors.lastname: Caro
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Walicke
authors.forename: Nicole
authors.initials: N
authors.lastname: Li
authors.forename: Craig L
authors.initials: CL
authors.lastname: Leonardi
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens; C472181:efalizumab