MAIDENHEAD, UK, 25 NOVEMBER 2022: AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has issued positive Final Draft Guidance (FDG) recommending RINVOQ^® (upadacitinib)* within its marketing authorisation as an option for moderately to severely active ulcerative colitis (UC) in adults when conventional or biologic treatment cannot be tolerated or the condition has not responded well enough or has stopped responding to these treatments.¹ This recommendation for England and Wales closely follows the Scottish Medicines Consortium acceptance of upadacitinib in October 2022,⁹ extending access for people with UC across the UK.

UC is estimated to affect nearly 300,000 people in the UK² and the burden of disease is substantial due to the severity of the symptoms and uncertainty surrounding flares.⁵ The annual cost of treating a flare (relapse) may be up to six times greater than for treating a person in remission⁶ and despite there being a number of treatments available for UC, there are many people affected that do not respond well to therapy and others for which there is a loss of treatment efficacy.¹⁰

“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,” said Dr Gareth Parkes, Consultant Gastroenterologist at the Royal London Hospital, Barts Health NHS Trust. “It is good news for people with ulcerative colitis that NICE has recommended upadacitinib as an additional treatment option that can be taken as a once-daily pill.”

The NICE recommendation is based on data from the induction studies U-ACHIEVE and U-ACCOMPLISH, 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 at weeks 8 and 52.⁸ NICE’s recommendation follows the granting of Marketing Authorisation for upadacitinib in UC in July 2022.¹¹

“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 upadacitinib available as an additional treatment option for people with the condition,” said Belinda Byrne, Medical Director at AbbVie UK. “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.”

The efficacy and safety profile of upadacitinib has been evaluated in adults with moderately to severely active UC.^12,13 Safety results of upadacitinib were consistent with the known safety profile of upadacitinib in other licenced indications.⁸ 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.¹¹

^*NICE recommendation applies when the company provides upadacitinib according to the commercial arrangement.

-Ends- 

For more information about upadacitinib please follow this link: https://www.medicines.org.uk/emc/product/10972/smpc

▼ This medicine is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple AppStores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com.

AbbVie UK Media:                                       Four Health Communications:

Sophie Thompson                                       Natalie Adams

+44 (0)7811 032320                                      +44(0) 7385 031 077

sophie.e.thompson@abbvie.com                  natalie.adams@four.health

NOTES TO EDITORS:

About ulcerative colitis

Ulcerative colitis (UC) is a chronic, systemic, inflammatory disease characterised by inflammation of the large intestine, which triggers abdominal pain, bloody diarrhoea, severe urgency for a bowel movement, weight loss and fatigue.^2,3,5 The severity of symptoms and uncertainty surrounding flares can lead to a substantial burden and often cause disability for those living with the disease.^3,5

About upadacitinib

Upadacitinib is a janus kinase (JAK) inhibitor indicated for the treatment of certain people diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, non-radiographic axial spondyloarthritis and ulcerative colitis.¹¹

The JAK family of enzymes contains four members, JAK1, JAK2, JAK3 and TYK2, which work in pairs.¹¹ In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.¹¹ The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

U-ACHIEVE induction, U-ACCOMPISH and U-ACHIEVE maintenance phase 3 clinical trials

The three Phase 3 clinical trials (U-ACHIEVE induction, U-ACCOMPLISH and U-ACHIEVE maintenance) are multicentre, randomised, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg once daily as induction therapy, and upadacitinib 15 mg and 30 mg once daily as maintenance therapy in people with moderate to severe UC.^8,11

During the U-ACHIEVE and U-ACCOMPLISH induction trials, 26 percent (n=319) and 33 percent (n=341) of participants treated with upadacitinib 45 mg achieved the primary endpoint of clinical remission at week 8, respectively, compared to 5 percent (n=154) and 4 percent (n=174) of participants who received placebo (p<0.0001 vs placebo in both studies).⁸

During the U-ACHIEVE maintenance trial, 42 percent (n=148) and 52 percent (n=154) of participants treated with upadacitinib 15 mg or 30 mg, respectively, achieved the primary endpoint of clinical remission at week 52, compared to 12 percent (n=149) of participants who received placebo (p<0.0001 vs placebo for both doses).⁸

About AbbVie in Gastroenterology

For more than 20 years, AbbVie has been dedicated to improving care for people living with immune disorders. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with inflammatory conditions reach their treatment goals.

AbbVie is committed to cutting-edge research to drive developments in inflammatory bowel diseases (IBD) like UC. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information, please visit www.abbvie.co.uk.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter.

November 2022 | UK-UPAD-220274

References

1. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Upadacitinib - Final draft guidance. Available from: https://www.nice.org.uk/guidance/conditions-and-diseases/digestive-tract-conditions/inflammatory-bowel-disease/products?ProductType=Guidance&Recent=NewInLast6Months [Last accessed: November 2022]

2. NHS.uk Ulcerative colitis Available from: https://www.nhs.uk/conditions/ulcerative-colitis/#:~:text=It's%20estimated%20around%201%20in,15%20to%2025%20years%20old [Last accessed: November 2022]

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4. Crohn’s and Colitis Foundation, The facts about Inflammatory Bowel Disease, Available at https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf [Last accessed: November 2022]

5. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.

6. Ghosh, Nivedita, and Purushothaman Premchand. “A UK Cost of Care Model for Inflammatory Bowel Disease.” Frontline Gastroenterology, vol. 6, no. 3, 24 Feb. 2015, pp. 169–174, www.ncbi.nlm.nih.gov/pmc/articles/PMC5369575/, 10.1136/flgastro-2014-100514. [Last accessed: November 2022]

7. UK Parliament Public Accounts Committee. Inquiry on NHS Backlogs and Waiting Times. December 2021.Written response from Crohn’s & Colitis UK. https://committees.parliament.uk/writtenevidence/41475/pdf/ [Last accessed: November 2022]

8. Danese, Silvio et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. The Lancet, Volume 399, Issue 10341, 2113 – 2128.

9. SMC. upadacitinib (Rinvoq). Available from: https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-abb-smc2510/ [Last accessed: November 2022]

10. Danese S, et al.: Unmet Medical Needs in Ulcerative Colitis: An Expert Group Consensus. Dig Dis 2019;37:266-283. doi: 10.1159/000496739

11. RINVOQ (upadacitinib) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/10972 [Last Accessed: November 2022]

12. 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: November 2022]

13. 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: November 2022]