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Results of a Randomized, Placebo-Controlled, Phase 2 Trial

Alexa B. Kimball, MD, MPH; Kenneth B. Gordon, MD; Richard G. Langley, MD; Alan Menter, MD; Elliot K. Chartash, MD; Joaquin Valdes, MD; for the ABT-874 Psoriasis Study Investigators

Arch Dermatol. 2008;144(2):200-207.

Objective  To investigate the efficacy and safety of ABT-874, an interleukin 12/23 monoclonal antibody, in psoriasis.

Design  Phase 2, 12-week, multicenter, randomized, double-blind, placebo-controlled trial.

Setting  Outpatient dermatology clinics.

Patients  One hundred eighty patients with clinically stable moderate to severe chronic plaque psoriasis.

Interventions  Patients were randomized in groups of 30 to receive 1 of 6 treatments with ABT-874 provided as a subcutaneous injection: one 200-mg dose at week 0; 100 mg every other week for 12 weeks; 200 mg weekly for 4 weeks; 200 mg every other week for 12 weeks; 200 mg weekly for 12 weeks; or placebo.

Main Outcome Measure  At least a 75% reduction in the Psoriasis Area and Severity Index.

Results  The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index at week 12 was statistically significantly greater in all of the ABT-874 treatment groups than in the placebo group (200 mg once, 63% [19 of 30]; 100 mg every other week for 12 weeks, 93% [28 of 30]; 200 mg weekly for 4 weeks, 90% [27 of 30]; 200 mg every other week for 12 weeks, 93% [28 of 30]; 200 mg weekly for 12 weeks, 90% [27 of 30]; placebo, 3% [1 of 30]; P < .001). Treatment with ABT-874 was well tolerated. The most common adverse event was injection-site reaction, and the most common infectious adverse events were nasopharyngitis and upper respiratory tract infection. There were no serious infectious adverse events.

Conclusions  ABT-874, an interleukin 12/23 monoclonal antibody, was highly effective and well tolerated in the treatment of psoriasis. Longer-term studies are required to confirm these findings.

Trial Registration  clinicaltrials.gov Identifier: NCT00292396

Author Affiliations: Clinical Unit for Research Trials in Skin (CURTIS), Massachusetts General and Brigham and Women's Hospitals, Harvard Medical School, Boston, Massachusetts (Dr Kimball); Division of Dermatology, Evanston Northwestern Healthcare, Evanston, Illinois (Dr Gordon); Division of Dermatology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada (Dr Langley); Division of Dermatology, Department of Internal Medicine, Baylor Research Institute, Dallas, Texas (Dr Menter); Immunoscience, New Products, New Discovery, Abbott Laboratories, Parsippany, New Jersey (Dr Chartash); and Immunology Development, Abbott Laboratories, Abbott Park, Illinois (Dr Valdes).