ABBOTT PARK, Ill., May 21 Results from anopen-label extension study of two Abbott pivotal studies, CHARM and GAIN,demonstrate that adult moderate-to-severe Crohn's patients treated withHUMIRA(R) (adalimumab) achieved long-term clinical remission and clinicalresponse, respectively, according to data presentations today at DigestiveDisease Week(R) (DDW) in San Diego. DDW is the largest internationalgathering of physicians, researchers and academics in the fields ofgastroenterology, hepatology, endoscopy and gastrointestinal surgery.Patients from CHARM and GAIN were followed through into a non-placebocontrolled, ongoing open-label extension (OLE) trial. Patients from CHARMwere followed a total of two years, and patients from the 4-week GAIN studywere followed a total of one year.
The CHARM extension data demonstrated that three out of four patients (77percent) taking HUMIRA, who were in remission at the end of the one-yearpivotal study, maintained clinical remission for an additional year. The GAINdata showed that, of patients with a clinical response at four weeks,approximately 65 percent remained in clinical response at one year, and 40percent were in clinical remission at one year. Response was measured bychange in Crohn's Disease Activity Index (CDAI), a weighted composite score ofeight clinical factors that evaluate patient wellness, including daily numberof liquid or very soft stools, severity of abdominal pain, levels of generalwell-being and other measures. Clinical remission was measured as a score ofless than 150 and clinical response was measured as a decline of at least 70points from baseline.
Crohn's disease is a serious, chronic, inflammatory bowel disease thataffects more than 500,000 Americans. It affects people of all ages but it isprimarily a disease of young adults, with onset typically before age 40.
Common symptoms of the disease include diarrhea, cramping, abdominal pain,weight loss, fever, and in some cases, rectal bleeding. Over the course oftheir disease, up to 75 percent of patients with Crohn's will undergo surgeryfor complications or disease resistant to treatment.
"Crohn's disease is a life-long condition with no known cure. One of thegoals of treatment is to induce and maintain remission, which can helppatients with their chronic symptoms," said Remo Panaccione, M.D., AssociateProfessor, and Director of the Inflammatory Bowel Disease Clinic at theUniversity of Calgary and study author. "In this study, many patients takingHUMIRA during a lengthened treatment period showed clinical response andremission, which translates into improvement of disease symptoms."
About the Open-Label Extension Study
The two analyses from the ongoing extension study focused on the efficacyof HUMIRA in maintaining remission and achieving response during long-termfollow-up periods. A diverse group of patients with moderate to severeCrohn's disease were represented, including those who were naive toanti-TNF agents or who had previously lost response or were unable to tolerateinfliximab.
At the end of CHARM and GAIN, patients were eligible for enrollment in theOLE study (N=467 enrolled). Patients enrolled from the blinded, randomizedarms from CHARM and GAIN received HUMIRA 40 mg every other week (EOW) andpatients enrolled from the open-label arm of CHARM received their previousopen-label regimens [40 mg EOW or every week (EW)]. Patients in the OLE studycould be switched to EW dosage for flare or non-response. The results fromboth HUMIRA doses were pooled for the analyses.
About the CHARM Trial
The CHARM (Crohn's trial of the fully Human antibody Adalimumab forRemission Maintenance) study enrolled 854 patients, both anti-TNF naive andanti-TNF experienced, with moderate to severe Crohn's disease to study thesafety and efficacy of HUMIRA in maintaining clinical remission up to 56week