Infliximab (Remicade®) receives EU approval as second-line therapy for patients with Crohn’s disease

Allows patients to benefit from infliximab earlier after not responding to a corticosteroid and/or an Immunosuppressant

9 October 2006, Welwyn Garden City, UK: The European Commission has approved a label change for Remicade® (infliximab) for use as a second-line therapy for the treatment of severe, active Crohn's disease (CD) in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant, or who are intolerant to or have medical contraindications for such therapies.1 Remicade was previously approved in the EU as a third-line therapy. [1]

Crohn's disease is a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss and, complications including intestinal obstruction and fistulas that can result in the need for repeated surgical procedures. CD is estimated to affect approximately 60,000 people in the UK. [2]

"The approval of infliximab as a second-line therapy will give clinicians the option to treat some patients with aggressive disease earlier in the course of their disease. Various emerging new studies indicate that earlier use of the most effective therapies result in the best remission rates and may potentially alter the natural history of the disease" said Subrata Ghosh, Chair in Gastroenterology at London's Imperial College. "However, to achieve the optimal benefit with Remicade, I believe it should be used in a scheduled maintenance protocol."

The approval is based on the ACCENT I and GETAID studies, as well as the TREAT registry and additional post-marketing data which show that treatment with infliximab can significantly impact of the quality of life for CD patients.3,4,5

ACCENT I
• More patients receiving maintenance treatment with infliximab achieved clinical remission at week 30 compared to placebo (39% compared to 21%), as measured by Crohn's disease activity index (CDAI).  Response was defined as a decrease of >= 25 percent and >=70 points in CDAI score.  Remission was defined as CDAI score of less than 150.3

• At week 54, significantly more patients receiving maintenance therapy with infliximab were in clinical remission and able to reduce or eliminate steroid use compared to those treated with placebo (29% compared to 9% percent). Additionally, patients treated with infliximab had a longer time to loss of response than placebo patients. [3]

GETAID
• Patients were treated with either a combination of Azathioprine or 6-mercaptopurine (AZA or 6-MP) in combination with infliximab compared with AZA or 6-MP alone in patients with steroid-dependent CD. [4]

• The percentage of patients in remission and off steroids was higher in the infliximab group than in the placebo group at week 12 (75% vs. 38%), 24 (57% vs. 29%), and 54 (40% vs. 22%). [4]

TREAT registry

• The Treat registry was established to study long-term safety of infliximab in CD. At the time of this analysis, April 2005, the registry included 6,290 patients. Infliximab was not shown to be an independent predictor of serious infection when adjusted for other factors. [5]

- ENDS -

For further press information, please contact:
Kerrie Mitchell or Helen Bridges, Packer Forbes Communications   
Tel: 020 8772 1551 email: kerrie@packerforbes.com, helen@packerforbes.com or Caroline Rattray, Communications Manager, Schering-Plough UK & Ireland Tel: 01707 363656

Notes to Editors
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. CD is estimated to affect approximately 60,000 people in the UK. [2]

Infliximab (Remicade?) is a monoclonal antibody that specifically targets TNF-?. It is administered intravenously over 2 hours as hospital or day care treatment. Available data do not support further infliximab treatment, in patients not responding within 2 weeks to the initial infusion. 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/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.  Remicade also is 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). [1]


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.

References
1. Remicade? Summary of Product Characteristics – 28 February 2006 available at http://www.medicines.org.uk/ Accessed 09.10.06

2. National Association for Colitis and Crohn's Disease website. http://www.nacc.org.uk/content/ibd/crohnsBG.asp. Downloaded 23.08.06

3. Hauauer S B et al Lancet 2002; 359:1541-1549

4. Lemann M et al Gastroenterology. 2006;130:1054-61

5. Lichtenstein GR et al Clin Gastroenterol Hepatol. 2006;4:621-30

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register

Already registered?

Sign in

Before commenting please read our rules for commenting on articles.

If you see a comment you find offensive, you can flag it as inappropriate. In the top right-hand corner of an individual comment, you will see 'flag as inappropriate'. Clicking this prompts us to review the comment. For further information see our rules for commenting on articles.

comments powered by Disqus