Remicade® Receives EU Approval As First And Only Biologic Treatment For Paediatric Crohn's Disease

Main Category: Crohn's
Also Included In: Pediatrics / Children's Health;  GastroIntestinal / Gastroenterology
Article Date: 14 Jun 2007 - 1:00 PST

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The European Commission (EC) has approved a new indication for Remicade® (infliximab) allowing for the treatment of severe, active Crohn's disease (CD) in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.1 This approval follows a positive opinion granted in March 2007 by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMEA).

'Infliximab is one of the most significant therapeutic advances in therapy for Crohn's disease in the last decade. Now children with moderate to severe Crohn's disease have access to a treatment previously reserved only for adults. Used appropriately, infliximab can transform the quality of life of children and adolescents struggling with the chronic and disabling symptoms of severe Crohn's disease,' said Dr Robert Heuschkel, Clinical Lead and Consultant Paediatric Gastroenterologist, Centre for Paediatric Gastroenterology, Royal Free Hospital, London.

Infliximab is the first and only biologic therapy approved in the EU for the treatment of paediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhoea, fever, abdominal pain, weight loss and, in some patients, delayed development and stunted growth.2,3

About infliximab

Article Type Normal Article Headline Article Article TypInfliximab (Remicade®) is a monoclonal antibody that specifically targets TNF-a. 3 mg/kg is given as an intravenous infusion over a 2?hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Infliximab must be given concomitantly with methotrexate. Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.1

The label extension will permit physicians to administer a 5 mg/kg intravenous infusion of infliximab over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Available data do not support further infliximab treatment in paediatric patients not responding within the first 10 weeks of treatment.1

The safety and efficacy of infliximab across all indications have been well established in clinical trials over the past 14 years and through commercial experience with nearly 925,000 patients treated worldwide across all indications.

About paediatric Crohn's disease

Crohn's disease is a chronic illness that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhoea, fever, abdominal pain and weight loss.2

Children with Crohn's disease may also experience delayed development and stunted growth. Although it can involve any area of the gastrointestinal tract from the mouth to the anus, it most commonly affects the small intestine and/or colon.2,3

About the clinical trial: REACH

The approval was based on data from the Phase III REACH (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody REMICADE in Paediatric Subjects with Moderate to Severe Crohn's Disease) trial.4

The trial showed that nearly 90% (88.4%) of paediatric patients with moderately to severely active CD who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with infliximab. More than half of the patients treated with infliximab every 8 weeks were in clinical remission at the end of 1 year.4

In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed.4

About Schering-Plough

Schering-Plough is a global science-based healthcare company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its workforce of more than 32,000 people around the world. http://www.schering-plough.com

References

1. Remicade® Summary of Product Characteristics - available at http://www.emc.medicines.org.uk/ . Accessed 12.06.07
2. National Association for Colitis and Crohn's Disease website. Please click here. Accessed 07.06.07
3. National Digestive Disease Information Clearinghouse: Crohn's Disease. Please click here . Accessed 07.06.07
4. Hyams J et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children. Gastroenterology 2007; 132: 863-73