Elan and Biogen Idec announce results from Phase III maintenance trial of Antegren®


Clinical response and remission rates sustained

Concomitant use of corticosteroids were reduced or eliminated in the study

NEW ORLEANS, MAY 18, 2004 – Elan Corporation, plc and Biogen Idec announced that in a Phase III maintenance study, ANTEGREN® (natalizumab) maintained clinical response and remission rates throughout six months among patients with Crohn's disease (CD) who had previously achieved clinical response. Additionally, a majority of natalizumab-treated patients who were also on chronic corticosteroid therapy were able to withdraw from corticosteroids and maintain response in contrast to those patients on placebo. The findings of ENACT-2 (Evaluation of Natalizumab As Continuous Therapy) will be presented for the first time at the Digestive Disease Week (DDW) annual meeting in New Orleans.

Crohn's disease, a chronic, progressive immune-mediated disease of the gastrointestinal tract, can cause a range of debilitating symptoms such as severe diarrhea, cramping or abdominal pain and malnutrition. Current treatment options for the disease are limited.

"The results of ENACT-2 suggest the potential of natalizumab as a maintenance therapy for patients with Crohn's disease," said William J. Sandborn, MD, professor of medicine at the Mayo Medical School. "This study demonstrated sustained clinical response and remission rates throughout six months on natalizumab. It also showed that natalizumab may help patients eliminate or reduce concomitant use of corticosteroids from their chronic treatment regimen. These results and the other clinical data presented at DDW are very exciting, and support the continued development of natalizumab as both an induction and maintenance treatment."

ENACT-2 assessed 339 natalizumab-responders from the induction study ENACT-1 (a 3-month study in patients with active CD) for the effect of natalizumab as a maintenance therapy. In the international, multi-center, double-blind, placebo-controlled trial, patients were re-randomized to receive 300 mg of natalizumab (n=168) or placebo (n=171), both administered monthly for 12 months. The primary endpoints of maintenance of response and remission were assessed through six months.

Throughout six months of treatment with natalizumab, 61 percent of patients (103/168) continued to respond to therapy (assessed monthly) compared with 29 percent (49/170) of patients on placebo (p<0.001). In addition to meeting the primary endpoint of clinical response, 44 percent of patients (57/130) maintained clinical remission versus 26 percent of patients (31/120) on placebo (p=0.003). Fifty-four percent of natalizumab-treated patients (36/67) taking corticosteroids in ENACT-1, re-randomized in ENACT-2, were able to withdraw from corticosteroids and maintain response and remission, compared to 25 percent (19/76) of patients on placebo (p=0.002). There were no notable differences in the rate of serious or non-serious adverse events between treatment groups. The most common drug-related adverse events encountered in either treatment group in this trial were headache, fatigue and nausea.

In addition to the presentation of ENACT-2 data, there are six abstracts being presented at DDW on the Phase III induction study, ENACT-1. Highlights of these data will be discussed during a joint conference call on May 19 at 11:00 a.m. Central Time. Details of the call, including playback information, is accessible through Elan's homepage, www.elan.com and Biogen Idec's homepage, www.biogenidec.com.

"We are encouraged by the ENACT-2 data, which continues to build the evidence for the potential of natalizumab as a treatment for Crohn's disease," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "The data suggest that natalizumab maintains response, even in most cases when patients are withdrawn from corticosteroid therapy. Importantly, natalizumab appears to be well tolerated in this trial.

"Natalizumab, with its novel mechanism of action, holds promise as a therapy with a new approach to treating Crohn's disease," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to its continued development in the treatment of Crohn's disease."

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