Remicade (infliximab) has been backed as a treatment option for severely active ulcerative colitis (UC) in paediatric patients by the Scottish Medicines Consortium (SMC).

The MSD drug becomes the only biological agent available in Scotland for patients aged from 6 to 17 years after its efficacy and safety were shown by phase 3 trial data.

Dr Richard Russell, Consultant Paediatric Gastroenterologist and Honorary Clinical Senior Lecturer at the Royal Hospital for Sick Children, Glasgow, said Remicade’s approval was “most welcome”.

The SMC acceptance of Remicade will be restricted as an alternative to ciclosporin in patients with acute, severe paediatric UC who have not responded to steoids. 

UC is a debilitating condition that causes inflammation and ulceration in the inner lining of the large intestine or rectum. If it is not adequately controlled, it can lead to surgery being needed to remove the affected colon.

Remicade was licensed to treat UC in the European Union in 2006. It has been used to treat inflammatory bowel disease (IBD) for more than 12 years across Europe, having first been licensed for severely active Crohn’s disease in adults in 1999.

MSD’s Remicade (infliximab) has become the first anti-TNF therapy to be approved in the UK for children aged 6-17 years with severely active ulcerative colitis (UC).

The efficacy and safety of the biological agent were highlighted in a Phase III study that showed 73.3% of patients achieved a response after eight weeks and the overall remission rate was 28.6%.

Dr Richard Russell, Consultant Paediatric Gastroenterologist and Honorary Clinical Senior Lecturer at the Royal Hospital for Sick Children, Glasgow, said Remicade’s new indication is “a significant step forward”.

The European Commission extended Remicade's indication last month. It can now be used in youngsters aged 6 to 17 who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies.

“We welcome the approval of Remicade for treating children with severely active ulcerative colitis, providing doctors with another valuable treatment option for young patients and their families,” commented Dr Paul Robinson, Medical Director, MSD UK. “MSD is committed to offering this important and vulnerable patient group a wider range of therapy choices.”

Remicade was licensed in the European Union in February 2006 for the treatment of moderately to severely active UC in adult patients. 

The CHMP has adopted a positive opinion on MSD’s Remicade (infliximab) for the treatment of severely active ulcerative colitis (UC) in youngsters aged between 6 to 17 years old.

The Committee recommends the monoclonal antibody for those who have had an inadequate response to conventional therapy, or who are intolerant to medical contraindications for such therapies after a Phase III study demonstrated its efficacy.

Rupert Vessey, Senior Vice President, Research Laboratories, Merck, says the positive opinion is “encouraging news and a significant step” for younger patients in Europe.

If the medication if subsequently approved by the European Commission, it will be the first and only biologic therapy approved in the EU for the treatment of paediatric UC.

Paediatric UC is a debilitating condition that causes inflammation and painful swelling of the inner lining of the large intestine.

In clinical trials, Remicade demonstrated its efficacy in a Phase III, 54 week study in 60 youngsters diagnosed with moderately to severe active UC who had experienced an inadequate response to conventional therapies. In March 2006, it was approved in the EU for the treatment of moderately to severely active UC in adults.

Remicade also approved for use in Europe for:

• Severe, active Crohn’s disease in adult patients
• Fistulising, active Crohn’s disease in adult patients
• Rheumatoid Arthritis (in combination with methotrexate)
• in adult patients with active Rheumatoid Arthritis
• Severe, active ankylosing spondylitis in adult patients
• Active and progressive psoriatic arthritis in adults
• Moderate-to-severe plaque PsO in adults
• Moderately-to-severely active UC in adults
• Severe, active Crohn’s disease in paediatric patients aged 6 to 17 years old.

A decision from the European Commission on the CHMP’s recommendation is expected during the first quarter of 2012.

The FDA has approved Remicade to treat moderately to severely active ulcerative colitis (UC) in children older than six years in the US.

Janssen Biotech’s infliximab treatment is indicated to reduce the signs and symptoms of UC in patients whose condition has not responded to conventional therapy, aiming to induce and maintain clinical remission.

The approval was based on findings from a multi-centre, randomised, open-label study involving 60 children aged six to 17 years old with moderately to severely active UC who have failed to respond to or tolerate conventional therapy.

Dr Donna Griebel, Director of the Division of Gastroenterology and Inborn Errors Products at the FDA, said: “With the approval of Remicade, children with moderately to severely active ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option.”

Remicade carries a Boxed Warning for risk of serious infections and cancer. These infections include tuberculosis and those caused by viruses, fungi or bacteria.

The drug is already approved for the treatment of other autoimmune diseases such as Crohn’s disease in adults and children older than six years, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), psoriatic arthritis and plaque psoriasis in adults.

UC is a form of inflammatory bowel disease (IBD) that affects the lining of the large intestine and rectum. Between 50,000 and 100,000 children in the US have IBD, with 40% of this figure having UC.

NICE has failed to recommend Orencia (abatacept) as a second-line treatment for people with rheumatoid arthritis in final guidance.

Both NICE and Orencia’s manufacturer Bristol-Myers Squibb agreed the treatment would not be cost-effective when compared with several other recommended options.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says other recommended treatments offer better value for money as second-line options.

No appeals where received against the Final Appraisal Document released last month.

BMS had asked that Orencia be compared against another recommended option Remicade (infliximab), the only other recommended intravenous treatment options.

But NICE’s independent Appraisal Committee did not consider this to be a relevant comparison since the route of administration rarely determines which drug to prescribe.

The Committee also considered whether Orencia could be a cost-effective treatment option for those with a TNF inhibitor was contraindicated because of congestive heart failure. However, it did not consider it appropriate to provide a second recommendation given there was no evidence of how much clinical benefit the drug may provide in this group of people.

Humira, Enbrel, Cimzia, plus Remicade, and most recently Simponi have all been recommended as treatment options for second-line use on the NHS.