AbbVie’s Rinvoq (upadacitinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for adults with moderately to severely active Crohn’s disease, the company announced.
The authorisation, which makes Rinvoq the first oral Janus Kinase (JAK) inhibitor available for this indication in England and Wales, specifically applies to patients who have had an inadequate response, lost response or were intolerant to conventional therapy or a biological agent.
Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is estimated that over 155,000 adults are living with Crohn’s disease in the UK, almost half of which have moderate or severe cases.
Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery.
“The pain, physical symptoms and complications of Crohn’s disease should not be underestimated,” said Sarah Sleet, chief executive officer of Crohn’s and Colitis UK. “It can be difficult for people with Crohn’s disease to find a suitable treatment that works for them or continues to work for them, so new options are of vital importance.”
NICE’s final draft guidance was supported by data from three phase 3 trials, including two induction studies and one maintenance study.
Across all three studies, significantly more Rinvoq-treated patients achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).
Additionally, a higher proportion of patients receiving a once daily 45mg dose of Rinvoq at week 12 in the induction studies or 15mg and 30mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per SF/AP compared to placebo.
Crohn’s disease is one of the two main types of inflammatory bowel disease. NICE recommended Rinvoq for certain patients living with the second type, ulcerative colitis, in November last year.
Belinda Byrne, medical director at AbbVie UK, said: “We are pleased that NICE has recommended [Rinvoq] for eligible people with Crohn’s disease on the NHS in England and Wales. This is another important milestone for the inflammatory bowel disease community, as it follows NICE’s recommendation for [Rinvoq] in ulcerative colitis last year.”