– 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]
NORTH CHICAGO, IL, USA I December 18, 2019 I 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 naïve 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-naïve 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-naïve 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
More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951).
Earlier this year, RINVOQ received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to MTX.9
About RINVOQ (upadacitinib) in the European Union6
RINVOQ (upadacitinib) is indicated for the treatment of moderate to severe active rheumatoid arthritis 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.
About HUMIRA® in the European Union10
HUMIRA, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs, including methotrexate, has been inadequate.
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.
References
- 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-Naïve 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.
SOURCE: AbbVie
Post Views: 21
– 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]
NORTH CHICAGO, IL, USA I December 18, 2019 I 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 naïve 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-naïve 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-naïve 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
More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951).
Earlier this year, RINVOQ received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to MTX.9
About RINVOQ (upadacitinib) in the European Union6
RINVOQ (upadacitinib) is indicated for the treatment of moderate to severe active rheumatoid arthritis 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.
About HUMIRA® in the European Union10
HUMIRA, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs, including methotrexate, has been inadequate.
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.
References
- 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-Naïve 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.
SOURCE: AbbVie
Post Views: 21
