Common symptoms of the disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Over the course of their disease, up to 75 percent 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, M.D., 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."
About the Open-Label Extension Study
The two analyses from the ongoing extension study focused on the efficacy of HUMIRA in maintaining remission and achieving response during long-term follow-up periods. A diverse group of patients with moderate to severe Crohn's disease were represented, including those who were naive to anti-TNF agents or who had previously lost response or were unable to tolerate infliximab.
At the end of CHARM and GAIN, patients were eligible for enrollment in the OLE study (N=467 enrolled). Patients enrolled from the blinded, randomized arms from CHARM and GAIN received HUMIRA 40 mg every other week (EOW) and patients enrolled from the open-label arm of CHARM received their previous open-label regimens [40 mg EOW or every week (EW)]. 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.
About the CHARM Trial
The CHARM (Crohn's trial of the fully Human antibody Adalimumab for
Remission Maintenance) study enrolled 854 patients, both anti-TNF naive and
anti-TNF experienced, wi
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