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Title: Remicade (Infliximab) Appears to Rapidly and Significantly Reduce Pain in Patients with Crohn's Disease: Presented at UEGW

"Remicade (Infliximab) Appears to Rapidly and Significantly Reduce Pain in Patients with Crohn's Disease: Presented at UEGW"

PRAGUE, CZECH REPUBLIC -- September 29, 2004 -- New data from the ACCENT I (A Crohn's disease Clinical trial Evaluating infliximab in a New long-term Treatment regimen) trial, the largest study of a biologic therapy ever conducted in Crohn's disease (CD), demonstrate that treatment with Remicade® (infliximab) results in a highly significant and substantial rapid reduction of pain in patients with CD. Patients who received a three-dose induction regimen of Remicade experienced a median 50 percent reduction in abdominal pain and cramps rating, known as the Crohn's Disease Activity Index (CDAI), after ten weeks. The results were presented today at the 12th United European Gastroenterology Week. Remicade has previously been shown to significantly and rapidly reduce the inflammation associated with CD, to promote mucosal healing, and to reduce surgeries and hospitalizations. "The painful and debilitating symptoms of Crohn's disease flare up regularly and can have a measurable impact on a patient's quality of life," said Jean-Frederic Colombel, MD, Hospital Huriez, University Hospital of Lille, Lille, France, and study author. "The ACCENT I trial demonstrated that Remicade is an effective maintenance treatment for moderately-to-severely active Crohn's disease, and this new analysis demonstrates an added benefit of Remicade in rapidly breaking the cycle of pain." About the ACCENT I Sub-analysis To assess the early benefit of pain reduction with Remicade therapy, 573 CD patients were randomized to receive one of three different treatment regimens of Remicade during the 54-week trial. Wilcoxon signed rank test was used to detect the change in four pain measures (one in each of the CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ), and two in the SF-36) in all treatment groups. T-test on van der Waerden scores was used to compare the change from baseline to week 10 between the single-dose (group 1) and the 3-dose (groups 2 and 3) induction regimens.: 1) single-dose: placebo at weeks 2 and 6 and then every 8 weeks, 2) 5 mg/kg maintenance: 5 mg/kg infliximab at weeks 2 and 6 and then every 8 weeks, and 3) 10 mg/kg maintenance: 5 mg/kg infliximab at weeks 2 and 6 and then 10 mg/kg infliximab every 8 weeks. Wilcoxon signed rank test was used to detect the change in four pain measures (one in each of the Crohn's Disease Activity Index (CDAI) and Inflammatory Bowel Disease Questionnaire (IBDQ), and two in the SF-36) in all treatment groups. T-test on van der Waerden scores was used to compare the change from baseline to week 10 between the single-dose (group 1) and the 3-dose (groups 2 and 3) induction regimens. There was a highly significant reduction (p < 0.0001) from baseline to weeks 10, 30, and 54 in all four pain measures in the three treatment groups, including patients treated with the approved dosing regimen - put in approved dosing regimen. The median reduction at week 10 was significantly (p < 0.05) greater in the 3-dose regimen than in the single-dose regimen, with a 50 percent reduction in abdominal pain and cramps ratings over a seven-day period, a 33 percent reduction in abdominal pain over a one-week period, a 25 percent reduction in bodily pain over four weeks and a 33 percent reduction in the extent to which pain interfered with normal work. At week 10, those treated with a single-dose of Remicade experienced a 39 percent reduction in abdominal pain and cramps rating over a seven-day period. This group also achieved a 25 percent reduction in abdominal pain over a one-week period, a 20 percent reduction in bodily pain over four weeks and a 25 percent reduction in the extent to which pain interfered with normal work. About Crohn's disease CD is a chronic inflammatory bowel disorder that commonly affects the lower part of the small intestine and the large intestine and typically begins in late childhood or early adulthood. The disease causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. It is estimated that 500,000 Americans and more than 400,000 people in Europe and Canada suffer from this gastrointestinal disorder. About Remicade® Remicade is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha which has been shown to play a role in CD, rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriasis, and may also be important in a wide range of other immune- mediated inflammatory disorders. Remicade is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, Remicade is the only anti-TNF biologic administered directly under supervision and monitoring of specialized physicians. In RA and CD patients, Remicade is administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, Remicade patients may require as few as six treatments each year. The safety and efficacy of Remicade have been well established in clinical trials conducted over the past 10 years and through commercial experience with more than 500,000 patients treated worldwide. Remicade is the only biologic indicated for the treatment of both RA and CD. In the EU, Remicade is also approved for the treatment of AS, a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine. In CD patients, Remicade is indicated for the treatment of severe, active CD in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Remicade is also indicated for the treatment of fistulizing, active CD in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). For RA patients, Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in patients with active disease when the response to disease- modifying drugs, including methotrexate, has been inadequate, and in the EU, in patients with severe active and progressive disease not previously treated with methotrexate or other DMARDS. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated. In the EU, Remicade is also indicated for treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy. Important Information Regarding Labeling for Remicade People with heart failure should not take Remicade. Prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor immediately if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of feet). There are reports of serious infections associated with Remicade therapy, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Patients should tell their doctor if they have had recent or past exposure to people with TB. Their doctor will evaluate them for TB. If a patient has latent (inactive) TB, his or her doctor should begin TB treatment before starting Remicade. If a patient is prone to or has a history of infections, currently has one, or develops one while taking Remicade, he or she should tell his or her doctor immediately. Patients should also tell their doctor if they have or have had a disease that affects the nervous system, or if they experience any numbness, tingling or visual disturbances. There are also reports of serious infusion reactions with hives, difficulty breathing and low blood pressure. In clinical studies, some people experienced the following common side effects: upper respiratory infections, headache, nausea, cough, sinusitis or mild reactions to the infusion such as rash or itchy skin. Please read important information about Remicade, including full U.S. prescribing information at http://www.remicade.com. For complete Remicade EU prescribing information, call Schering-Plough Corporation at +1 908-298-7616. SOURCE: Schering-Plough Europe

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