Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: Updated results from an ongoing trial

• Published in: Journal of the American Academy of Dermatology 2006-04, Vol.54 (4), p.S154-S163
• Main Authors: Gottlieb, Alice B., Hamilton, Tiffani, Caro, Ivor, Kwon, Paul, Compton, Peter G., Leonardi, Craig L.
• Format: Article
• Language: English
• Subjects: Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Combined Modality Therapy; Fluocinolone Acetonide - therapeutic use; Glucocorticoids - therapeutic use; Humans; Immunologic Factors - administration & dosage; Immunologic Factors - adverse effects; Immunologic Factors - therapeutic use; Platelet Count; Psoriasis - drug therapy; Psoriasis - therapy; Treatment Outcome; Ultraviolet Therapy
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2005.12.018

Efalizumab is a T cell–targeted therapy for psoriasis. We sought to evaluate the efficacy and safety of long-term, continuous efalizumab therapy. Of 339 patients enrolled in this ongoing, open-label, phase III study, after 3 months 290 qualified for and entered the maintenance treatment phase. Results for the first 27 months of this 36-month continuous therapy trial are available. At month 3, 41% of patients achieved at least a 75% reduction in Psoriasis Area and Severity Index (PASI) score; at month 27, 47% achieved at least a 75% reduction in PASI score (intent to treat, n = 339). Among patients eligible for maintenance therapy (n = 290), 56% achieved at least a 75% reduction in PASI score at month 27. Moreover, the at least 90% reduction in PASI score rate increased through 18 months (33%). The safety profile with efalizumab was sustained throughout 27 months of continuous treatment with no new common events over time. Because the extended treatment period was not a randomized clinical trial, no formal comparative analyses versus placebo were conducted. Three-month placebo data from randomized, parallel, placebo-controlled studies are briefly discussed. These results suggest that efalizumab maintains, and in some patients continues to improve, efficacy during long-term therapy.