Scottish Medicines Consortium accepts RINVOQ®▼(upadacitinib) for the treatment of moderately to severely active ulcerative colitis in adults

MAIDENHEAD, UNITED KINGDOM, OCTOBER 10, 2022: AbbVie (NYSE: ABBV) today announced that the Scottish Medicines Consortium (SMC) has accepted RINVOQ® (upadacitinib) for use within NHS Scotland* for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to conventional therapy or an agent organic. Upadacitinib offers an additional treatment choice within the Janus Kinase Inhibitor therapeutic class.1

UC is estimated to affect approximately 23,500 people across Scotland,2 the capital city with the second highest rate in the world.3 Living with UC affects all aspects of a person’s life, largely due to unpredictable symptoms such as bowel urgency, abdominal pain, bleeding rectal and faecal incontinence.[viii] The severity of symptoms and the uncertainty surrounding flare-ups can cause considerable burden and often lead to disability for people living with the disease.5,6

“Daily life with ulcerative colitis is difficult due to the debilitating and unpredictable nature of its symptoms,” said Dr Jonathan Macdonald, consultant gastroenterologist at NHS Greater Glasgow and Clyde. “Clinical trials have shown that upadacitinib in once-daily pill form controls symptoms within eight weeks for many patients and provided sustained responses after one year. The SMC’s decision is good news for people with ulcerative colitis in Scotland, as it provides an additional treatment option to help bring their condition under control.

This SMC decision is based on data from the U-ACHIEVE and U-ACCOMPLISH induction studies,seven as well as the U-ACHIEVE Phase 3 maintenance study, which demonstrated the efficacy of upadacitinib over placebo in its ability to achieve clinical remission.seven The SMC’s decision follows the granting of marketing authorization for upadacitinib in UC in July 2022.[ix]

“This lifelong condition impacts every aspect of the lives of people with ulcerative colitis and we are seeing it firsthand from those who need our support,” said Ruth Wakeman, Director of Services, advocacy and evidence, Crohn’s & Colitis UK. “We welcome this decision by SMC as there is a clear need for more treatment options to help improve the lives of people with ulcerative colitis and their families.”

“Many people are still significantly affected by ulcerative colitis despite currently available treatments,” said Belinda Byrne, Medical Director at AbbVie UK. “We strongly welcome the SMC’s abbreviated submission pathway, which has enabled us to make upadacitinib available so quickly in Scotland as an additional option to support these people and continue our commitment to improving the lives of people with dementia. disease.”

The safety and efficacy profile of upadacitinib has been evaluated in adults with moderate to severe active UC.[x],[xi] The safety results of upadacitinib were consistent with the known safety profile of upadacitinib in other approved indications, with no significant new risks observed.seven In placebo-controlled UC induction and maintenance clinical trials, the most commonly reported adverse events with upadacitinib 45 mg, 30 mg, or 15 mg were upper respiratory tract infection, increased creatine blood phosphokinase, acne, neutropenia, rash, shingles, hypercholesterolemia, folliculitis, herpes simplex and influenza. The most common serious adverse events were serious infections.9

*This SMC advice only applies in the context of an approved NHSScotland Patient Access Scheme (PAS) agreement providing the cost-effectiveness results on which the decision was based, or an equivalent or lower PAS/list price.1


[viii] National Institute of Diabetes and Digestive and Kidney Diseases. Hemorrhagic rectocolitis. 2020. Available at: https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis. [Last accessed: October 2022] [ix] RINVOQ (upadacitinib) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/10972 [Last Accessed: October 2022] [x] A study to evaluate the safety and efficacy of ABT-494 for induction and maintenance treatment in subjects with moderately to severely active ulcerative colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. [Last accessed: October 2022] [xi] A study of the efficacy and safety of upadacitinib (ABT-494) in participants with moderately to severely active ulcerative colitis (U-Accomplish). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03653026. [Last accessed: October 2022]

About Antoine L. Cassell

Check Also

A life-saving treatment on the other side of the world

TAKING FLIGHT: Sarah McDowell has been battling multiple sclerosis for nearly five years and hopes …