Extended efalizumab therapy improves chronic plaque psoriasis: Results from a randomized phase III trial

• Published in: Journal of the American Academy of Dermatology Vol. 52; no. 3; pp. 425 - 433
• Main Authors: Leonardi, Craig L., Papp, Kim A., Gordon, Kenneth B., Menter, Alan, Feldman, Steven R., Caro, Ivor, Walicke, Patricia A., Compton, Peter G., Gottlieb, Alice B.
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.03.2005; Elsevier
• Subjects: Adult; Aged; Antibodies, Monoclonal - therapeutic use; Biological and medical sciences; CD11 Antigens; Dermatologic Agents - therapeutic use; Dermatology; Double-Blind Method; Female; Humans; Immunologic Factors - therapeutic use; Male; Medical sciences; Middle Aged; Psoriasis - drug therapy; Psoriasis. Parapsoriasis. Lichen; UVB; PASI; sPGA; LFA-1; PPD; ITT; PGA; IVRS; PASI-90; PASI-50; SC; BSA; HAHA; PASI-75; PUVA; Phase III trial; Human; Immunomodulator; Skin disease; Chemotherapy; Chronic; Randomization; Treatment; Psoriasis; Dermatology; Monoclonal antibody; Efalizumab
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2004.09.029

Efalizumab inhibits multiple T-cell–mediated processes. To evaluate 12- and 24-week efalizumab therapy for psoriasis. In this phase III, randomized, double-blind trial, 498 patients received subcutaneous 1 or 2 mg/kg/wk efalizumab or placebo for 12 weeks. Efalizumab-treated patients who achieved <75% Psoriasis Area and Severity Index improvement (PASI-75) were re-randomized to a second 12-week course of treatment. At week 12, 39% and 27% of efalizumab-treated patients (1 and 2 mg/kg, respectively) achieved PASI-75 (vs 2% placebo; P < .001, both dose groups). At week 24, an additional 20% of efalizumab-treated patients achieved PASI-75 (vs placebo 7%, P = .018). Efalizumab was well tolerated. Twelve-week efalizumab treatment resulted in significant improvement; extension of therapy to 24 weeks resulted in additional improvement in patients who initially had not achieved PASI-75. There were no significant changes in safety profile during weeks 13-24.