Briefs

Remicade® Data Shows Promise for Pediatric Crohn’s Patients

HORSHAM, Pa. — New data show that nearly 90 percent of pediatric patients with moderate to severe active Crohn’s disease (CD) with an inadequate response to conventional therapy achieved clinical response at week 10 when treated with REMICADE® (infliximab). Nearly two-thirds of these patients maintained that response through one year when they continued receiving REMICADE every eight weeks. Moreover, more than half of the patients treated with REMICADE every eight weeks were in clinical remission at the end of one year. The results of the REACH (A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody REMICADE in Pediatric Subjects with Moderate to Severe Crohn’s Disease) trial are the first Phase 3 results to show the efficacy of a biologic therapy for children with moderate to severe active CD. The data were presented at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN).

REMICADE has received a fast track designation from the Food and Drug Administration (FDA) for the treatment of moderately to severely active pediatric Crohn’s disease, a chronic inflammatory disease of the gastrointestinal tract that affects nearly 100,000 children under the age of 18 in the United States. There are currently no FDA-approved biologic therapies to treat moderately to severely active pediatric CD. REMICADE is not currently indicated for the treatment of pediatric CD.

REMICADE is an anti-tumor necrosis factor alpha (TNF-alpha) therapy and has demonstrated broad clinical utility in CD, rheumatoid arthritis (RA), psoriatic arthritis, ulcerative colitis and ankylosing spondylitis. REMICADE is the only biologic indicated for the treatment of patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD. Additionally, on Sept. 15, REMICADE was approved for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.

Source: Centocor

By Dolly Ahles and Kathy Dix

HONOLULU — Patients with sleep complaints but no heartburn symptoms suffered episodes of nighttime acid reflux, according to research presented at the 70th annual scientific meeting of the American College of Gastroenterology (ACG), held Oct. 28 - Nov. 2. In a separate study, researchers found that symptoms of gastroesophageal reflux (GER) are common and frequently severe in patients with obstructive sleep apnea.

Patients with gastroesophageal reflux commonly report poor sleep, waking at night because of acid reflux. Some individuals who have respiratory problems exacerbated by acid reflux may frequently be without symptoms of heartburn. In a study of 81 patients with documented sleep complaints at least three nights per week who underwent polysomnographic sleep evaluations, 26 percent had acid reflux. Of those who suffered with reflux, 94 percent of the recorded reflux events were associated with arousal from sleep or awakening.

“These are patients without significant heartburn symptoms, who are experiencing acid reflux during sleep,” explained William C. Orr, PhD, of Lynn Health Science Institute in Oklahoma City, Okla. “‘Silent reflux” may be the cause of sleep disturbances in patients with unexplained sleep disorders.”

In another study on GERD and sleep by researchers at Duke University Medical Center, also presented at the ACG meeting, GER symptoms were common and frequently severe in 168 patients undergoing sleep studies who reported symptoms consistent with sleep apnea. These patients had frequent daytime and nighttime heartburn symptoms. Those with sleep apnea reported much lower quality of life on a self-administered questionnaire. Those patients with sleep apnea who also reported moderate to severe nighttime GER reported even worse quality of life.

“All patients with sleep apnea should be evaluated for gastroesophageal reflux,” said J. Barry O’Connor, MD, of Duke University Medical Center, one of the investigators.

Source: American College of Gastroenterology

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