Abbott’s Humira found effective in Crohn’s disease extension study

Patients from Charm and Gain were followed through into a non-placebo controlled, ongoing open-label extension (OLE) trial. Patients enrolled from the blinded, randomized arms from Charm and Gain received Humira 40mg every other week (EOW) and patients enrolled from the open-label arm of Charm received their previous open-label regimens (40mg EOW or every week (EW)). Patients from Charm were followed a total of two years, and patients from the four-week Gain study were followed a total of one year. Patients in the OLE study could be switched to EW dosage for flare or non-response. The results from both Humira doses were pooled for the analyses.

The Charm extension data demonstrated that three out of four patients (77%) taking Humira, who were in remission at the end of the one-year pivotal study, maintained clinical remission for an additional year. The Gain data showed that, of patients with a clinical response at four weeks, approximately 65% remained in clinical response at one year, and 40% were in clinical remission at one year.

Response was measured by change in Crohn’s Disease Activity Index (CDAI), a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well-being and other measures. Clinical remission was measured as a score of less than 150 and clinical response was measured as a decline of at least 70 points from baseline.

Remo Panaccione, director of the Inflammatory Bowel Disease Clinic at the University of Calgary and study author, said: “In this study, many patients taking Humira during a lengthened treatment period showed clinical response and remission, which translates into improvement of disease symptoms.”