Scottish Medicines Consortium Accepts RINVOQ®▼(upadacitinib) For Treatment of Moderately to Severely Active Ulcerative Colitis in Adults

MAIDENHEAD, UK, 10 OCTOBER 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 either conventional therapy or a biologic agent. Upadacitinib offers an additional treatment choice in the therapeutic class of janus kinase inhibitors.¹

UC is estimated to affect around 23,500 people across Scotland,2 with the capital having the world’s second highest rate.3 Living with UC impacts all aspects of a person’s life, largely due to unpredictable symptoms such as bowel urgency, abdominal pain, rectal bleeding and bowel incontinence.[viii] The severity of symptoms and uncertainty surrounding flares can lead to a substantial burden and often cause disability for those 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 as a once daily pill controls symptoms in eight weeks for many patients and provided sustained responses at 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 them gain control of their condition.”

This SMC decision is based on data from the induction studies U-ACHIEVE and U-ACCOMPLISH,⁷ as well as the Phase 3 U-ACHIEVE maintenance study, which demonstrated the efficacy of upadacitinib versus placebo in its ability to achieve clinical remission.⁷ The SMC’s decision follows the granting of Marketing Authorisation for upadacitinib in UC in July 2022.[ix]

“This lifelong disease impacts all aspects of life for people with ulcerative colitis and we see this first hand from those who need our support,” said Ruth Wakeman, Director of Services, Advocacy and Evidence, Crohn’s & Colitis UK. “We welcome this decision by the 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 impacted by ulcerative colitis despite currently available treatments,” said Belinda Byrne, Medical Director at AbbVie UK. “We very much welcome the SMC’s abbreviated submission route, which has enabled us to make upadacitinib available in Scotland so quickly as an additional option to support these people and continue our dedication to improving the lives of those with the condition.”

The safety and efficacy profile of upadacitinib has been evaluated in adults with moderately to severely active UC.[x]^,[xi] Safety results of upadacitinib were consistent with the known safety profile of upadacitinib in other licenced indications, with no new important safety risks observed.⁷ In the 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 blood creatine phosphokinase, acne, neutropenia, rash, herpes zoster, hypercholesterolaemia, folliculitis, herpes simplex and influenza. The most common serious adverse events were serious infections.⁹

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

[viii] National Institute of Diabetes and Digestive and Kidney Diseases. Ulcerative Colitis. 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 Therapy 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]