Open-label extension study builds database on long-term adalimumab treatment

May 1, 2007

-->

Washington - Interim analyses of data in a 120-week open-label extension study are providing positive news about the safety and efficacy of ongoing treatment with adalimumab (Humira, Abbott) for moderate-to-severe chronic plaque psoriasis, says Kenneth B. Gordon, M.D., head, division of dermatology, Evanston Northwestern Healthcare, and associate professor of dermatology, Northwestern University, Feinberg School of Medicine, Chicago.

The open-label extension study included 92 patients who had originally participated in double-blind studies of adalimumab. All patients in the 120-week extension study received adalimumab, 40 mg, every other week. Data were reported from 78 patients who were treated for at least 48 weeks and 53 patients who were treated through week 120.

There was a single malignancy - a case of squamous cell carcinoma in an ex-smoker who had lymphadenopathy at screening - and there were no cases of tuberculosis, demyelinating disorder, lupus-like syndrome, lymphoma or congestive heart failure.

"The favorable safety and tolerability profile observed so far in this open-label extension trial is no surprise. However, it is important to evaluate those features as fully as possible, and the findings are reassuring," Dr. Gordon says.

The 92 patients who entered the open-label extension had a mean Psoriasis Area and Severity Index (PASI) score of 16 and 28.6 percent body surface area involvement. Analyses of improvement in PASI score corroborated the rapid onset of response to adalimumab, showed PASI score improvement continued on average through week 36, and generally remained stable thereafter.

"These efficacy data are encouraging, but need to be considered carefully because the study is not complete and the efficacy outcomes cannot be fully analyzed," Dr. Gordon says.

DISCLOSURES: Dr. Gordon is a consultant to Abbott and to other companies that market biologic treatments for psoriasis.