NICE recommends Celgene’s Ozanimod to treat ulcerative colitis

The new treatment with ozanimod (also known as zeposia) will benefit over 12,000 adults who suffer from moderate to severe active ulcerative colitis (UC).

NICE’s final draft guidance will see ozanimod – an immunomodulatory medication made by Celgene, a Bristol Myers Squibb Company – recommended in cases where conventional therapies or biological treatments “are not tolerated or working well enough to control the disease”. The FDA had approved the drug for use as UC treatment in the US in May 2021.

A lifelong condition, UC results in inflamed and ulcerated rectal and colonic lining.  Symptoms include abdominal pain, explosive diarrhoea with blood loss, fatigue, and weight loss, and can flare up quickly, before easing off only after several weeks or even months.

Given the unpredictability of when flare-ups occur, UC patients often exhibit symptoms of stress and anxiety as well, negatively impacting their daily lives overall.

Ozanimod (RPC1063) – a once-a-day pill also used in the treatment of multiple sclerosis – is a sphingosine-1-phosphate (S1P) receptor agonist that reduces the number of white blood cells freely circulating the body and prevents those white blood cells reaching the intestinal lining, thereby reducing inflammation in UC patients’ colon and rectum.

Clinical trial results showed a significant reduction in symptoms when people took ozanimod, as compared with a placebo. The recommended initial dosage is low, with a gradual build up in dosage, so as to reduce possible side effects such as upper respiratory infection, urinary tract infection, and hypertension.

Standard treatment for moderately to severely active UC has been with conventional therapies, such as corticosteroids, mesalazine, or thiopurines (azathioprine and mercaptopurine).

If conventional therapy is unsuccessful, then biological treatment is prescribed.  Normally, this is a tumour necrosis factor (TNF)-alpha inhibitor (usually, infliximab).  Clinical experts recommend that TNF-alpha inhibitors be used alongside thiopurines for maximum efficacy.

Other biological treatments include adalimumab, golimumab, ustekinumab, vedolizumab, or filgotinib, as well as tofacitinib oral treatment (also used to treat rheumatoid and psoriatic arthritis).  However, such biological treatments often come with serious side effects, including deep vein thrombosis (DVT).

If conventional therapy is not working, infliximab is more cost-effective than ozanimod, but in cases where infliximab is not suitable, NICE’s final appraisal document (FAD) now recommends treatment with ozanimod in cases where there has been an intolerance or inadequate response or lost response to conventional therapy or biological treatment.

Celgene, which develops innovative therapies for cancer and immune-inflammatory related diseases, has a commercial arrangement of a “simple discount patient access scheme”, which will make ozanimod available to the NHS with “a confidential discount”.

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