Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients
NORTH CHICAGO, Ill., Feb. 22, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase 3 induction study, U-ACCOMPLISH.1 In the study, 33 percent of patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week 8 compared to 4 percent of patients receiving placebo (p<0.001).1 U-ACCOMPLISH is the second of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.1
"We remain steadfast in our pursuit of transforming the treatment landscape for people living with ulcerative colitis," said Tom Hudson, senior vice president of research and development, AbbVie. "These positive results confirm the findings of the previous induction study and underscore the potential impact upadacitinib could have on patients struggling to manage their disease."
In this study, all ranked secondary endpoints were met, including clinical, endoscopic and histologic outcomes.1 A greater proportion of patients treated with upadacitinib achieved clinical response compared to placebo, with 74 percent of upadacitinib-treated patients experiencing clinical response (per Adapted Mayo Score) at week 8 versus 25 percent of patients receiving placebo (p<0.001).1 Additionally, 63 percent of patients treated with upadacitinib achieved clinical response (per partial Adapted Mayo Score) at week 2 versus 26 percent of those receiving placebo (p<0.001).1 At week 8, 44 percent of patients treated with upadacitinib achieved endoscopic improvement versus 8 percent of patients receiving placebo (p<0.001).1 And significantly more upadacitinib-treated patients achieved histologic-endoscopic mucosal improvement at week 8 compared to patients receiving placebo (37 percent versus 6 percent; p<0.001).1
"People living with moderate to severe ulcerative colitis continue to suffer from the significant burden of this disease," said Silvio Danese, M.D., lead study investigator and head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy. "I am very impressed with the consistent results seen in both ulcerative colitis induction studies, suggesting that upadacitinib could be a potential new treatment option for patients."
The safety profile of upadacitinib (45 mg) was consistent with the safety findings in the previously reported Phase 3 induction study in ulcerative colitis and safety findings in previous studies across indications, with no new safety risks observed.1-6 During the 8-week study period, the most common adverse events observed in the upadacitinib group were acne, blood creatine phosphokinase increase and anemia.1 The increases in blood creatine phosphokinase were non-serious and did not lead to study drug discontinuation.1 Patients with blood creatine phosphokinase increase were usually asymptomatic and no cases of rhabdomyolysis were reported.1 Serious adverse events occurred in 3.2 percent of patients in the upadacitinib group and 4.5 percent of patients in the placebo group.1 Similar rates of serious infections (0.6 percent) were observed in the two treatment groups.1 No deaths, gastrointestinal perforation, malignancy, major cardiovascular or thromboembolic events were reported in the upadacitinib group.1 One case of venous thromboembolism (deep vein thrombosis and pulmonary embolism) and one case of gastrointestinal perforation was reported in the placebo group.1
Full results from the U-ACCOMPLISH study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Top-line results from the Phase 3 portion of the first induction study, U-ACHIEVE, were announced in December 2020 and the maintenance study for both is ongoing. Use of upadacitinib in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
About Ulcerative Colitis
Ulcerative colitis is a chronic, systemic, inflammatory disease caused by inflammation of the large intestine, which triggers abdominal pain, bloody diarrhea, severe urgency for a bowel movement, weight loss and fatigue.15-17 The severity of symptoms and uncertainty surrounding flares cause a substantial burden and often disability among those living with the disease.18
About the U-ACCOMPLISH Study1,9
U-ACCOMPLISH is a Phase 3 multicenter, randomized, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of upadacitinib 45 mg once daily for induction therapy compared to placebo in subjects with moderate to severe ulcerative colitis. U-ACCOMPLISH is the second of two Phase 3 induction studies.
The primary endpoint is achievement of clinical remission (per Adapted Mayo Score) at week 8. Ranked secondary endpoints included clinical response (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), endoscopic improvement (endoscopic subscore ≤1) and histologic-endoscopic mucosal improvement (endoscopic subscore of 0 or 1 and Geboes score ≤3.1) at week 8. More information can be found on www.clinicaltrials.gov (NCT03653026).
About the Upadacitinib Ulcerative Colitis Program9,19,20
The global upadacitinib ulcerative colitis program evaluates more than 1,300 patients with moderately to severely active ulcerative colitis across three pivotal studies. These studies include assessments of efficacy and safety of upadacitinib. Key measures of efficacy include clinical remission (per Adapted Mayo Score), clinical response (per Adapted Mayo Score), endoscopic improvement and endoscopic response. More information on these trials can be found at www.clinicaltrials.gov (NCT03653026, NCT02819635, NCT03006068).
About Upadacitinib (RINVOQ)
Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.1,7-14 It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.3 In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is also approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis and giant cell arteritis are ongoing.8-14 Use of RINVOQ in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
Important Safety Information about RINVOQ (upadacitinib)21
RINVOQ U.S. Use and Important Safety Information
What is the most important information I should know about RINVOQ?
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.
What should I tell my HCP AFTER starting RINVOQ?
What are the common side effects of RINVOQ?
RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.
This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.
Globally, prescribing information varies; refer to the individual country product label for complete information.
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.
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.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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