October 22, 2008

Abbott’s Humira Found to Be Effective Against Crohn’s Disease

Abbott Laboratories has reported new positive data from the company's CHARM and CHOICE trials of Humira, a fully human monoclonal antibody approved for the treatment of rheumatoid arthritis, psoriatic arthritis, psoriasis, ankylosing spondylitis, Crohn's disease and juvenile idiopathic arthritis in the US and Europe.

The data showed that Humira provided long-term treatment of fistulas, with more than half of patients with moderate to severe Crohn's disease experiencing fistula healing at three years. Data also showed response to Humira in difficult-to-treat patients - those with fistulas who had failed to respond, lost response to, or were intolerant of infliximab.

Results from an open-label extension of the CHARM study, Abbott's one-year, Phase III trial, showed the effect of Humira on fistula healing for up to three years. More than half of patients (58%) who had fistulas at baseline experienced fistula healing at the one-year completion of CHARM, and this was maintained through year one of the open-label extension.

After a total of two years of treatment, the majority (59%) experienced fistula healing. About two-thirds of patients (68%) who continued treatment through year two of the open-label extension (three total treatment years) experienced fistula healing.

A sub-analysis of the CHOICE trial, Abbott's open-label, single-arm study, assessed Humira in treating patients with moderate to severe Crohn's disease who had failed infliximab. A total of 83 of the 88 patients with fistulas at baseline had data available at their last physician visit. Last visits ranged from week four to week 36.

Results showed that 41% of Humira patients had fistula healing at their last physician visit. Approximately 42% of the 71 initial responders - those who had developed intolerance or lost response to infliximab - had complete fistula healing. Four of the 12 patients who were infliximab primary non-responders experienced complete fistula healing.

Rebecca Hoffman, divisional vice president of global pharmaceutical R&D at Abbott, said: "These data represent the first time we have analyzed results of studies on fistula healing in Humira patients who were primary non-responders to infliximab. We are encouraged by these results and will continue to study Humira in patients with Crohn's disease."