AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment

AbbVie has received positive Final Draft Guidance from the National Institute for Health and Care Excellence (NICE) recommending Rinvoq (upadacitinib), within its marketing authorisation, as a once-daily pill treatment for those with moderate-to-severely active ulcerative colitis (UC).

The recommendation is specifically for adults with the immune-mediated inflammatory bowel disease, for whom conventional or biologic treatments cannot be tolerated, or for those who have found that the condition has not responded well enough or have stopped responding to treatments.

NICE’s decision is based on data taken from the induction studies, U-ACHIEVE and U-ACCOMPLISH, as well as the phase 3 U-ACHIEVE maintenance study and covers treatment access for patients in England and Wales. The three studies showed the efficacy of Rinvoq compared to placebo in its ability to achieve clinical remission at weeks eight and 52.

The recommendation allows for further access for UC patients across the UK, as the decision closely follows the Scottish Medicines Consortium’s acceptance of Rinvoq in October 2022.

In the UK, UC affects approximately 300,000 people and the burden of disease is considerable because of the severity of the symptoms and uncertainty surrounding flares.

Per year, the financial cost of treating a flare, or relapse, may be up to six times greater than for treating a person in remission. Although there are a number of treatments available for UC, a significant number of patients do not respond well to therapy still remain, while others can experience a loss of treatment efficacy.

“We’ve seen the importance for people with ulcerative colitis to control symptoms and prevent disease progression, so we are pleased that we have been able to make [Rinvoq] available as an additional treatment option for people with the condition,” said Belinda Byrne, medical director at AbbVie UK.

She added: “We are delighted that, through our two decades of working in gastroenterology and our goal to help people with ulcerative colitis, we are able to contribute to improving the lives of individuals with this life-long condition.”

Evaluations of the efficacy and safety profile of Rinvoq have been conducted in adults with moderately-to-severely active UC, while safety results have proved to be consistent with the known safety profile of Rinvoq in other licenced indications.

Dr Gareth Parkes, consultant gastroenterologist at the Royal London Hospital, Barts Health NHS Trust, said: “We know that there is still an unmet need for people living with moderate-to-severe ulcerative colitis, with a significant proportion living with debilitating symptoms.

“It is good news for people with ulcerative colitis that NICE has recommended [Rinvoq] as an additional treatment option that can be taken as a once-daily pill.”