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European Commission Approves RINVOQ® (upadacitinib) for the Treatment of Adults With Moderate to Severe Ulcerative Colitis

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis. Malignancies, including nonmelanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Clinical Response & Mucosal Healing‡§

In the placebo-controlled ulcerative colitis induction and maintenance clinical trials, the overall safety findings were generally consistent with the known safety profile of upadacitinib; no new important safety risks were observed.¹ The rates of overall adverse events (AE), serious AEs, and AEs resulting in treatment discontinuation were lower with upadacitinib compared to placebo.¹ The most commonly reported adverse reactions (≥5 percent of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, blood CPK increased, acne, neutropaenia, and rash.¹ In the overall clinical program, major cardiovascular events, thrombotic events, malignancy excluding non-melanoma skin cancer, and gastrointestinal perforation were reported infrequently (all <1.0 cases per 100 patient-years in patients who received at least one RINVOQ dose).¹

About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies^2,6,15,16

The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of RINVOQ 45 mg once daily as induction therapy, and RINVOQ 15 mg and 30 mg once daily as maintenance therapy in subjects with moderate to severe ulcerative colitis. The results of these studies were published in The Lancet in May 2022. More information can be found on http://www.clinicaltrials.gov (NCT03006068, NCT03653026, NCT02819635).

Immunosuppressive medicinal products

Upadacitinib should be used with caution in patients with diverticular disease and especially in patients chronically treated with concomitant medications associated with an increased risk of diverticulitis.

Cardiovascular risk

Venous thromboembolisms

See RINVOQ full summary of product characteristics (SmPC) at www.ema.europa.eu.

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. 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 on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.

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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Abbvie, Ltd. RINVOQ (upadacitinib) [summary of product characteristics]. Accessed April 12, 2022. https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf
Danese S, Vermeire S, Zhou W, 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. 2022;399(10341):2113- 2128. doi:10.1016/S0140-6736(22)00581-5
Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Annals of the Rheumatic Diseases. 2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870
Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. The Lancet. 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019;394(10214):2108- 2117. doi:10.1016/S0140-6736(19)32534-6
A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants with Ulcerative Colitis (UC). Clinicaltrials.gov; 2022. Accessed March 31, 2022. https://clinicaltrials.gov/ct2/show/NCT03006068
Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65(12):100851. doi:10.1016/j.disamonth.2019.02.004
Crohn's & Colitis Foundation. The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation. Published November 2014. Accessed August 13, 2021. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016;22(3 Suppl):s51-60.
Alatab S, Sepanlou SG, Ikuta K, et al. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(1):17-30. doi:10.1016/S2468-1253(19)30333-4
Second phase 3 induction study confirms upadacitinib (RINVOQTM) improved clinical, endoscopic and histologic outcomes in ulcerative colitis patients. AbbVie News Center. Published February 22, 2021. Accessed April 17, 2022. https://news.abbvie.com/news/press-releases/second-phase-3-induction-study-confirms-upadacitinib-rinvoq-improved-clinical-endoscopic-and-histologic-outcomes-in-ulcerative-colitis-patients.htm
RINVOQ® (upadacitinib) receives FDA approval for the treatment of adults with moderately to severely active ulcerative colitis. AbbVie News Center. Published March 16, 2022. Accessed April 7, 2022. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-receives-fda-approval-for-treatment-adults-with-moderately-to-severely-active-ulcerative-colitis.htm
Upadacitinib (RINVOQ®) met the primary and all secondary endpoints in the 52-week phase 3 maintenance study in ulcerative colitis patients. AbbVie News Center. Published June 29, 2021. Accessed April 17, 2022. https://news.abbvie.com/news/press-releases/upadacitinib-rinvoq-met-primary-and-all-secondary-endpoints-in-52-week-phase-3-maintenance-study-in-ulcerative-colitis-patients.htm
Upadacitinib (RINVOQTM) meets primary and all ranked secondary endpoints in first phase 3 induction study in ulcerative colitis. AbbVie News Center. Published December 9, 2020. Accessed April 1, 2022. https://news.abbvie.com/alert-topics/immunology/upadacitinib-rinvoq-meets-primary-and-all-ranked-secondary-endpoints-in-first-phase-3-induction-study-in-ulcerative-colitis.htm
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants with Moderately to Severely Active Ulcerative Colitis. clinicaltrials.gov; 2022. Accessed March 31, 2022. https://clinicaltrials.gov/ct2/show/NCT03653026
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis (UC). clinicaltrials.gov; 2022. Accessed March 31, 2022. https://clinicaltrials.gov/ct2/show/NCT02819635
AbbVie. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects with Takayasu Arteritis (TAK) (SELECT-TAK). clinicaltrials.gov; 2021. Accessed May 19, 2022. https://clinicaltrials.gov/ct2/show/NCT04161898
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants with Axial Spondyloarthritis. clinicaltrials.gov; 2021. Accessed May 9, 2022. https://clinicaltrials.gov/ct2/show/NCT04169373
Burmester GR, Kremer JM, Van den Bosch F, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double- blind, placebo-controlled phase 3 trial. Lancet. 2018;391(10139):2503-2512. doi:10.1016/S0140-6736(18)31115-2
Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. Published online October 28, 2020:annrheumdis-2020-218510. doi:10.1136/annrheumdis-2020-218510
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis. clinicaltrials.gov; 2022. Accessed May 19, 2022. https://clinicaltrials.gov/ct2/show/NCT03725202
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants with Crohn's Disease Who Completed the Studies M14-431 or M14-433. clinicaltrials.gov; 2022. Accessed April 12, 2022. https://clinicaltrials.gov/ct2/show/NCT03345823

* This approval is without prejudice to the final conclusions of the ongoing referral procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data.

† Clinical remission (per Adapted Mayo Score) is defined as stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1 without friability.

‡ Clinical response (per Adapted Mayo Score) is defined as a decrease from baseline in the Adapted Mayo score ≥2 points and ≥30 percent from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1.

§ Mucosal healing is defined as endoscopic subscore ≤1 without friability.

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SOURCE AbbVie

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