Results from an open-label extension study of two Abbott pivotal studies, Charm and Gain, demonstrate that adult moderate-to-severe Crohn's patients treated with Humira (adalimumab) achieved long-term clinical remission and clinical response, respectively, according to data presentations at Digestive Disease Week (DDW) in San Diego.
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Patients from Charm and Gain were followed through into a non-placebo controlled, ongoing open-label extension (OLE) trial. Patients from Charm were followed a total of two years, and patients from the 4-week Gain study were followed a total of one year.
The Charm extension data demonstrated that three out of four patients (77 percent) 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 per cent remained in clinical response at one year, and 40 percent 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.
Crohn's disease is a serious, chronic, inflammatory bowel disease that affects more than 500,000 Americans. It affects people of all ages but it is primarily a disease of young adults, with onset typically before age 40. Common symptoms of the disease include diarrhoea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding Over the course of their disease, up to 75 per cent of patients with Crohn's will undergo surgery for complications or disease resistant to treatment.
"Crohn's disease is a life-long condition with no known cure. One of the goals of treatment is to induce and maintain remission, which can help patients with their chronic symptoms," said Remo Panaccione, MD, associate professor, and director of the inflammatory bowel disease clinic at the University of Calgary and study author. "In this study many patients taking Humira during a lengthened treatment period showed clinical response and remission, which translates into improvement of disease symptoms".
"Humira's ability to effectively treat the chronic symptoms of Crohn's disease makes it an important option for gastroenterologists and patients looking for improved disease management," said Eugene Sun, MD, vice president, Global Pharmaceutical Clinical Development, Abbott.
Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Treatment with Humira should not be initiated in patients with active infections. TNF - blocking agents, including Humira, have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Humira.