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Long-Term Clinical Remission Demonstrated in Two Adalimumab for Patients With Crohn's Disease

ABBOTT PARK, Ill., May 21 /PRNewswire-FirstCall/ -- 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 today at Digestive Disease Week(R) (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 percent 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 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, with moderate to severe Crohn's disease to study the safety and efficacy of Humira in maintaining clinical remission up to 56 weeks. After week four, 778 patients were randomized to placebo, Humira 40 mg every other week (EOW) or 40 mg weekly (EW) in blinded fashion. At or after week 12, patients with flares or non-responders could receive open-label 40 mg EOW and 40 mg EW for continued flare or nonresponse.

The co-primary endpoints evaluated the maintenance of clinical remission at weeks 26 and 56 for each Humira group compared to those on placebo. A significantly greater percentage of patients treated with Humira maintained clinical remission at one year compared to placebo.

About the GAIN Trial
In the GAIN (Gauging Adalimumab effectiveness in Infliximab Nonresponders) study, a four-week induction trial of 325 patients who lost response or were intolerant to infliximab, three times as many patients taking Humira achieved clinical remission at week four versus placebo (21 percent versus 7 percent, respectively).

"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, M.D., 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.

The recommended Humira dose regimen for adult patients with Crohn's disease is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) patients begin a maintenance dose of 40 mg every other week. 5-aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g. 6-mercaptopurine and azathioprine) may be continued during treatment with Humira.

Source: Abbott

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