Abbott Laboratories (ABBOTT PARK, Illinois) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), granted Abbott a positive opinion recommending approval of Humira® (adalimumab) for the treatment of moderate-to-severe plaque psoriasis. Psoriasis will be the fifth disease indication for Humira. Almost 75% of patients in clinical trials achieved 75% clearance at 16 weeks, and almost 20% achieved complete clearance.

Abbott announced on April 2, 2007, it was seeking EU and US regulatory approval for Humira in psoriasis. The European Commission is expected to issue a decision granting the marketing authorization for the drug as a treatment for psoriasis in the EU within the next 60 days. Abbott is awaiting US FDA approval for this indication.

The positive opinion is primarily based on the results of two randomized, controlled, multicenter adult clinical trials: REVEAL and CHAMPION. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the Psoriasis Area and Severity Index (PASI), among other measures.

In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of Humira were evaluated in more than 1200 patients from the US and Canada with moderate-to-severe chronic plaque psoriasis. Fully 71% of patients receiving Humira achieved PASI 75 versus 6.5% of patients receiving placebo. Fully 20% receiving Humira achieved PASI 100 (complete clearance), compared with 1% of patients receiving placebo. Patients who maintained a PASI 75 response after 8 months of continuous Humira therapy were either continued on the drug or administered placebo for the remainder of the study. Only 5% of patients on the drug lost response (<50% improvement in PASI response relative to baseline, with a minimum six-point increase in PASI score compared with week 33, versus 28% of patients on placebo).

CHAMPION was the first head-to-head study comparing a biologic medication to methotrexate, the standard systemic treatment for psoriasis. In the 16-week study that evaluated 271 psoriasis patients from eight European countries and Canada, Humira-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with methotrexate- or placebo-treated patients, with more than twice the percentage (80%) of patients treated with Humira achieving a PASI 75 response vs patients treated with methotrexate (36%), and more than four times the percentage of patients treated with placebo (19%). Nearly 17% of patients treated with the drug achieved a PASI 100 response at week 16, compared with 7% of patients receiving methotrexate and 2% of patients receiving placebo. In addition, a mean percentage PASI improvement of 57% was achieved in Humira patients at week 4 versus baseline.

The most commonly reported adverse events were nasopharyngitis, upper respiratory tract infection, and headache. Serious infections, sepsis, rare cases of tuberculosis, and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including Humira. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA (psoralen and UVA) treatment, should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Humira.

To date, Humira has been approved in 73 countries and more than 190,000 people worldwide are currently being treated with the drug. In May 2007, Abbott announced it had submitted EU and US regulatory applications for Humira to treat juvenile rheumatoid arthritis. Clinical trials are also under way evaluating the potential of the drug in ulcerative colitis.