Natalizumab use cuts hospitalization rates with Crohn's disease

Last Updated: 2009-10-28 15:42:44 -0400 (Reuters Health)

By Anthony J. Brown, MD

NEW YORK (Reuters Health) - During both induction and maintenance treatment, use of natalizumab reduces all-cause and Crohn's disease (CD)-related hospitalization rates in patients with moderate to severe CD, according to study findings presented this week at the American College of Gastroenterology meeting in San Diego, California.

"Our previous data have shown that natalizumab reduces hospitalizations in the induction setting, but now we also see that this continues on in maintenance phase, which is of course clinically relevant to keep patients out of the hospital longer term," lead researcher Dr. Corey Siegel, from Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told Reuters Health.

The findings are derived from an analysis of data for CD patients who were randomized to receive intravenous natalizumab 300 mg or placebo in 3 doses every 4 weeks as part of the ENACT-1 and ENCORE trials. In the maintenance analysis, subjects who responded to natalizumab in ENACT-1 were re-randomized and followed for 48 additional weeks in ENACT-2.

During the 84-day induction period, all-cause and CD-related hospitalization rates were lower in the natalizumab group than in the placebo group. The difference was most pronounced in subjects who had received prior anti-TNF therapy. For instance, the all-cause hospitalization rate per 100 patients was 7.3 for natalizumab vs. 11.2 for placebo in the overall analysis compared with 9.4 vs. 21.5 in anti-TNF patients.

Similar findings were observed during the 336-day maintenance period. The all-cause hospitalization rate per 100 patients was 12.0 for natalizumab vs. 21.3 for placebo in the overall analysis and 16.8 vs. 41.6 among anti-TNF patients.

"Natalizumab is effective in inducing and maintaining remission, and effective in keeping patients out of the hospital, which is important for direct patient care and overall health care costs," Dr. Siegel emphasized.

"We are happy to have these one year data," he added, "but longer term data will be even more important for these patients with a life-long disease. In addition, we will need to continue to critically evaluate the long-term benefit to risk balance."