September 19, 2008

Abbott’s Humira Demonstrates Efficacy in Psoriasis Study

Abbott has announced new positive data from a sub-analysis of the company's pivotal, 52-week study, Reveal, which demonstrated that more psoriasis patients achieve efficacy when they receive continuous treatment with Humira compared to patients who interrupt their therapy.

The sub-group analysis was designed to determine whether interrupting Humira treatment would affect efficacy in psoriasis patients who had already achieved good response to Humira. After 33 weeks, patients who had achieved adequate response to Humira (as measured by PASI 75, or greater than 75% clearance) were randomized into two groups. One group continued to receive Humira and the other was given placebo. Beginning at week 52, all patients received Humira during the open-label extension period.

Patients who had maintained adequate response after Humira was discontinued were more likely to achieve a PASI 75 response when they were restarted on treatment. Among those who discontinued and then re-started Humira, 84% of the 161 patients who had maintained adequate response achieved PASI 75 after 24 weeks of re-treatment, compared to 55% of the 66 patients who had lost adequate response after stopping treatment. A loss of adequate response was defined as less than PASI 50 response relative to baseline and at least a six-point increase in PASI score relative to week 33.

A separate analysis of Reveal evaluated whether specific patient characteristics would affect the efficacy of Humira therapy. This second sub-group analysis found that Humira effectively treats adults with psoriasis regardless of a patient's age, disease duration, whether the patient has a diagnosis of psoriatic arthritis (PsA), or if he or she has a recent history of systemic therapy, including biologic treatments. At 16 weeks, 71% of patients treated with Humira achieved a PASI 75 response, compared with 6.5% of patients treated with placebo, with similar results seen among the patient subgroups.

The Reveal study was a double blind, randomized, placebo-controlled Phase III trial to evaluate the efficacy and safety of Humira in 1,212 patients with moderate to severe chronic psoriasis in the US and Canada.

Rebecca Hoffman, divisional vice president of Immunology at Abbott, said: "These studies pertain to the efficacy of Humira and provide further evidence for physicians and patients regarding Humira's ability to clear the frequently-painful skin lesions associated with psoriasis."