AbbVie Receives European Commission Approval of RINVOQ? (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis
[caption id="attachment_9277" align="aligncenter" width="1079"] Press Release[/caption]
Approval supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating nearly 4,400 patients[1-5]
- In five pivotal Phase 3 studies, RINVOQ?(upadacitinib) met all primary and ranked secondary endpoints across a variety of adult patient populations with moderate to severe active rheumatoid arthritis[1-6] - RINVOQ, given alone or with csDMARDs, demonstrated improved rates of low disease activity (DAS28-CRP?3.2) and clinical remission (DAS28-CRP<2.6) compared to placebo, MTX or adalimumab[1-6]
- Nearly 3 million people in Europe are living with rheumatoid arthritis, the majority of whom don't achieve remission[7,8]
Global Media Jana Umbreit +1 (224) 214-8657 jana.umbreit@abbvie.com U.S. Media: Lindsay Cangemi +1 (224) 244-3808 lindsay.cangemi@abbvie.com Investors Liz Shea +1 (847) 935-2211
liz.shea@abbvie.com
- In five pivotal Phase 3 studies, RINVOQ?(upadacitinib) met all primary and ranked secondary endpoints across a variety of adult patient populations with moderate to severe active rheumatoid arthritis[1-6] - RINVOQ, given alone or with csDMARDs, demonstrated improved rates of low disease activity (DAS28-CRP?3.2) and clinical remission (DAS28-CRP<2.6) compared to placebo, MTX or adalimumab[1-6]
- Nearly 3 million people in Europe are living with rheumatoid arthritis, the majority of whom don't achieve remission[7,8]
NORTH CHICAGO, Ill.,?Dec. 18, 2019?/PRNewswire/ --?AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has?approved RINVOQ??(upadacitinib) 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).6?RINVOQ is a once-daily selective and reversible JAK inhibitor and may be used as monotherapy or in combination with methotrexate (MTX).
"We are proud to offer this once-daily tablet as a new treatment option for patients with moderate to severe active rheumatoid arthritis," said?Michael Severino, M.D., vice chairman and president, AbbVie. "As a company that has been dedicated to discovering and delivering transformative therapies for people living with rheumatic diseases for nearly two decades, RINVOQ expands our portfolio of treatment options for people living with this disease in?Europe."
The EC approval of RINVOQ was supported by data from the global Phase 3 SELECT rheumatoid arthritis program, which evaluated nearly 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies: SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY.1-5?The studies include assessments of efficacy, safety and tolerability across a variety of patients, including those who failed or were intolerant to biologic DMARDs and who were na?ve or inadequate responders (IR) to MTX.1-5
"Nearly 3 million people in?Europe?are living with rheumatoid arthritis, the majority of whom don't reach remission and may be suffering from pain, fatigue, morning joint stiffness and flares," said Professor?Ronald van Vollenhoven, M.D., Ph.D., Amsterdam Rheumatology and Immunology Center,?Amsterdam, The Netherlands. "As seen in this large Phase 3 clinical trial program in rheumatoid arthritis, upadacitinib has the potential to significantly improve signs and symptoms of the disease and help more patients achieve remission or low disease activity."
Highlights From the Phase 3 SELECT Rheumatoid Arthritis Program
Across the SELECT Phase 3 studies, RINVOQ met all primary and ranked secondary endpoints.1-6?Overall, both low disease activity (assessed by DAS28-CRP=3.2) and clinical remission rates (assessed by DAS28-CRP<2.6) were consistent across patient populations, with or without MTX.1-6
Highlights included:
- In SELECT-COMPARE, RINVOQ plus MTX demonstrated significantly higher remission rates (as observed by DAS28-CRP<2.6) versus placebo plus MTX (29 percent vs 6 percent at week 12; multiplicity-controlled p=0.001) and vs HUMIRA??(adalimumab) plus MTX (29 percent vs 18 percent at week 12; nominal p=0.001) in MTX-IR patients.4
- More patients treated with RINVOQ alone achieved remission (as observed by DAS28-CRP<2.6) than those treated with MTX in MTX-IR patients in SELECT-MONOTHERAPY (28 percent vs 8 percent at week 14; multiplicity-controlled p=0.0001) and in MTX-na?ve patients in SELECT-EARLY (48 percent vs 18 percent at week 24; multiplicity-controlled p<0.001).3,5
- RINVOQ also demonstrated significantly greater inhibition of structural joint damage progression, as measured by modified total Sharp score change from baseline, as monotherapy compared to MTX (0.1 vs 0.7 at week 24; multiplicity-controlled p<0.01) in MTX-na?ve patients and in combination with MTX compared to placebo plus MTX (0.2 vs 0.9 at week 26; multiplicity-controlled p=0.001) in MTX-IR patients.4,5
- The most commonly reported adverse drug reactions were upper respiratory tract infections (13.5 percent), nausea (3.5 percent), blood creatine phosphokinase increased (2.5 percent) and cough (2.2 percent).6?The most common serious adverse reactions were serious infections.1-6
- 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 13.
- 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 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 13.
- Smolen JS, 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. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019 May 23.
- Fleischmann R, et al. Upadacitinib versus placebo or adalimumab in rheumatoid arthritis and an inadequate response to methotrexate: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis and Rheumatology. 2019.?Jul 9. doi: 10.1002/art.41032.
- van Vollenhoven R, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Na?ve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG. Available at:?www.ema.europa.eu
- Bevan S, et al. Fit For Work? Musculoskeletal Disorders in the European Workforce. 2009. The Work Foundation.
- Ajeganova S. and Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017 Oct;9(10):249-262. doi: 10.1177/1759720X17720366.
- RINVOQ? (upadacitinib) [Package Insert].?North Chicago, Ill.: AbbVie Inc.
- HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co KG. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Accessed?November 12, 2019.
Contact(s)
Global Media Jana Umbreit +1 (224) 214-8657 jana.umbreit@abbvie.com U.S. Media: Lindsay Cangemi +1 (224) 244-3808 lindsay.cangemi@abbvie.com Investors Liz Shea +1 (847) 935-2211
liz.shea@abbvie.com