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

  • RINVOQ (upadacitinib) is now approved by the European Commission for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent1
  • The approval is based on the results of three Phase 3 studies: two for induction and one for maintenance1,2
  • In these clinical trials, RINVOQ achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8 in induction studies and week 52 in the maintenance study, and all secondary endpoints, including clinical response and mucosal healing1,2
  • Safety results in ulcerative colitis were generally consistent with the known safety profile of RINVOQ, with no new important safety risks observed2,3-6
  • Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease (IBD) that can lead to substantial burden and often disability among patients.7-9 At least 6.8 million people worldwide live with IBD, including ulcerative colitis10
  • The approval represents RINVOQ’s fifth therapeutic indication in the EU

 AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ® (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.*

“Our years of experience and long-term investment in IBD research have given us invaluable insights into the challenges that ulcerative colitis patients face, and a deep understanding of the ongoing need for additional treatment options to help those still suffering,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “We celebrate today’s approval of RINVOQ by the EC as it meaningfully expands our ability to help indicated patients in need of relief from ulcerative colitis.”

The EC approval is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance.2 Statistical significance was achieved for the primary endpoint and all secondary endpoints with RINVOQ 45 mg in the two induction studies and both RINVOQ 15 mg and 30 mg in the maintenance study.

Clinical Remission†

During the U-ACHIEVE and U-ACCOMPLISH induction trials, 26 percent and 33 percent of patients treated with RINVOQ 45 mg achieved clinical remission at week 8, the primary endpoint, compared to 5 percent and 4 percent of patients who received placebo.2,11,12
During the U-ACHIEVE maintenance trial, 42 percent and 52 percent of patients treated with RINVOQ 15 mg or 30 mg, respectively, achieved clinical remission at week 52, the primary endpoint, compared to 12 percent of patients who received placebo.2,13
Additionally, 57 percent and 68 percent of patients receiving RINVOQ 15 mg or 30 mg, respectively, achieved corticosteroid-free remission, defined as clinical remission (per Adapted Mayo Score) and corticosteroid free for ≥90 days immediately preceding week 52 among patients who achieved clinical remission at the end of the induction treatment, compared to 22 percent of patients on placebo.2,13
Clinical Response & Mucosal Healing‡§

About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies2,6,15,16

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).

About RINVOQ® (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1,2,3-6,17,18 In human cellular assays, RINVOQ preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.1

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.4-6,15-22

EU Indications and Important Safety Information about RINVOQ® (upadacitinib)1

Indications

Ulcerative colitis

RINVOQ is indicated 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.

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Ankylosing spondylitis

RINVOQ is indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

About AbbVie in Gastroenterology

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.

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