New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR

• Data from SELECT-EARLY and SELECT-COMPARE show a significantly higher proportion of patients treated with upadacitinib monotherapy or in combination with methotrexate (MTX) maintaining clinical remission compared with MTX or adalimumab plus MTX, respectively, at 48 weeks^1,2
• Findings from an integrated safety analysis across five studies in the SELECT Phase 3 clinical program support the well-characterized safety profile of upadacitinib in patients with moderately to severely active rheumatoid arthritis³
• Upadacitinib, an investigational oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in moderately to severely active rheumatoid arthritis and across multiple other immune-mediated inflammatory diseases^4-17

NORTH CHICAGO, Ill., June 12, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results from the Phase 3 clinical trials SELECT-EARLY and SELECT-COMPARE showing that patients receiving upadacitinib once-daily (15 mg or 30 mg, SELECT-EARLY; 15 mg plus methotrexate (MTX), SELECT-COMPARE) through 48 weeks continue to demonstrate improved signs and symptoms of rheumatoid arthritis, as measured by ACR20/50, and clinical remission based on Disease Activity Score 28 C-Reactive Protein (DAS28-CRP)<2.6.^1,2 The studies evaluate upadacitinib, an investigational, once-daily JAK1-selective inhibitor, in patients with moderately to severely active rheumatoid arthritis.^1,2 Additionally, data from an integrated safety analysis across five Phase 3 SELECT clinical trials show that treatment with upadacitinib in patients with moderately to severely active rheumatoid arthritis demonstrates a consistent safety profile.³

These results are being presented at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, June 12-15, in Madrid.

“These data continue to support the potential of upadacitinib to help maintain consistent disease control for patients living with moderately to severely active rheumatoid arthritis,” said Professor Ronald van Vollenhoven, M.D., Ph.D., Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands. “While remission is the primary treatment goal, in accordance with the American College of Rheumatology and the European League Against Rheumatism recommendations, a majority of patients do not achieve clinical remission today, despite currently available treatment options.”

Rheumatoid arthritis is a chronic and debilitating disease that affects an estimated 23.7 million people worldwide.¹⁸ Many patients with rheumatoid arthritis still do not achieve clinical remission or low disease activity targets.^19-21

“Over the past decade, important advances have been made in the understanding of rheumatoid arthritis and its management, looking beyond treating symptoms to achieving remission,” said Marek Honczarenko, M.D., Ph.D., vice president, immunology development, AbbVie. “As data continue to emerge from the SELECT program, we look forward to deepening our understanding of the benefits and risks of JAK inhibition on treatment outcomes in different patient populations with moderately to severely active rheumatoid arthritis.”

Upadacitinib is an investigational oral agent and has not been approved by any regulatory authorities.

About the SELECT Study Program^4-9

The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,900 patients with moderately to severely active rheumatoid arthritis in six studies. The studies include assessments of safety, efficacy, and tolerability in rheumatoid arthritis patients across a broad spectrum of subjects including those who were naïve to MTX and those who had an inadequate response or intolerance to one or more csDMARDs or bDMARDs. Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression. More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426).

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor being studied for moderately to severely active rheumatoid arthritis and other immune-mediated inflammatory diseases.^4-17 Phase 3 trials of upadacitinib in psoriatic arthritis, Crohn’s disease, atopic dermatitis and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis and giant cell arteritis.^12-17 Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements

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, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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.

References:

1. van Vollenhoven R, et al. Monotherapy with Upadacitinib in MTX-naïve Patients with Rheumatoid Arthritis: Results at 48 Weeks from the SELECT-EARLY Study. 2019 EULAR; THU0197.
2. Fleischmann R, et al. Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 48 weeks from the SELECT-COMPARE Study. 2019 EULAR; FRI0147.
3. Cohen S, et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. 2019 EULAR; THU0167.
4. Burmester GR, 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 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
5. Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
6. Smolen, J. et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019 May 23. pii: S0140-6736(19)30419-2. doi: 10.1016/S0140-6736(19)30419-2. [Epub ahead of print].
7. van Vollenhoven, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.
8. Fleischmann R, et al. A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib to Placebo and to Adalimumab, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Methotrexate. 2018 ACR/ARHP Annual Meeting; 890.
9. A Phase 3 Study to Compare ABT-494 to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE). Clinicaltrials.gov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03086343. Accessed on April 5, 2019.
10. Voss, J, et al; Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. doi: 10.1002/art.2013.65.issue-s10.
11. Pipeline – Our Science | AbbVie. AbbVie. 2018. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on April 5, 2019.
12. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on April 5, 2019.
13. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on April 5, 2019.
14. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on April 5, 2019.
15. 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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on April 5, 2019.
16. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on April 5, 2019.
17. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on April 24, 2019.
18. World Health Organization. The Global Burden of Disease, 2004 Update. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed on April 5, 2019.
19. Nagy G, van Vollenhoven RF. Sustained biologic-free and drug-free remission in rheumatoid arthritis, where are we now? Arthritis Res Ther 2015; 17:181.
20. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 2017. pii: annrheumdis-2016-210715. [Epub ahead of print].
21. Singh JA, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016 Jan;68(1):1-26. doi: 10.1002/art.39480. Epub 2015 Nov 6.

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