AbbVie Receives EC Approval of RINVOQ for Rheumatoid Arthritis

AbbVie announced 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). 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. 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.

"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."

Across the SELECT Phase 3 studies, RINVOQ met all primary and ranked secondary endpoints. 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.

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.

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).

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.

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.

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.

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