Adalimumab may maintain remission in severe Crohn's disease

NEW YORK (Reuters Health) - In Crohn's disease patients who respond to adalimumab, the agent is significantly more effective than placebo in maintaining remission for more than a year, according to French and North American researchers.

Adalimumab is a monoclonal antibody directed against tumor necrosis factor used in many inflammatory diseases.

As lead investigator Dr. Jean-Frederic Colombel told Reuters Health, "Adalimumab use weekly or bi-monthly effectively maintains clinical remission and response, steroid-free remission, and fistula closure in patients with moderately to severely active Crohn's disease."

As described in the January issue of Gastroenterology, Dr. Colombel of Centre Hospitalier Universitaire de Lille and colleagues studied 778 patients who had initially completed 4 weeks of therapy with adalimumab.

Of this group, 449 were deemed to be responders and 279 were classified as non-responders. They were stratified by response and all were randomized to subcutaneous treatment with adalimumab 40 mg weekly, adalimumab 40 mg every two weeks, or to placebo.

The current analysis focuses on outcomes of patients who were responders in the 4-week trial. At 26 weeks, 47% of responsive patients in the weekly treatment group and 40% of those in the two-weekly treatment group remained disease free. This was true of only 17% of the patients randomized to placebo. At 56 weeks, corresponding proportions were 41%, 36% and 12%.

No significant differences were seen in outcome between the adalimumab regimens, and the agent was well tolerated. In fact, 11.4% of placebo patients discontinued treatment because of adverse events compared to 4.7% of those with weekly treatment and 6.9% of those with twice-monthly treatment.

Summing up, Dr. Colombel added, "I hope that continued trials will confirm the strong tolerability profile of adalimumab and offer patients another reliable option to manage their symptoms."