AbbVie Updates Long-Term Phase 3 Data for Rinvoq (Upadacitinib) in Rheumatoid Arthritis

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AbbVie Recently Announces New Long-Term Results of Oral JAK Inhibitor Rinvoq (upadacitinib) for the Treatment of Rheumatoid Arthritis (RA): Data from Two Phase III Clinical Trials, SELECT-COMPARE (Rinvoq 15 mg Combined with Methotrexate [MTX]) and SELECT-MONOTHERAPY (Rinvoq 15 mg and 30 mg), Show That Once-Daily Oral Rinvoq Continues to Improve Symptoms and Signs in RA Patients at 72 and 84 Weeks. The Safety Profile of Rinvoq Monotherapy and Rinvoq in Combination with MTX Is Consistent with Previously Reported Pooled Phase III Safety Analyses in RA, with No New Safety Risks Identified.

Furthermore, two-year (96-week) data from the SELECT-EARLY (Rinvoq 15 mg and 30 mg) and SELECT-COMPARE trials demonstrated that Rinvoq, either as monotherapy or in combination with methotrexate (MTX), effectively inhibits structural joint damage. These results were presented at the 2020 European Alliance of Associations for Rheumatology (EULAR) Annual Congress.

Rinvoq is a selective and reversible JAK inhibitor discovered and developed by AbbVie, which has been approved in the United States and the European Union for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Currently, AbbVie is evaluating Rinvoq for the treatment of various immune-mediated inflammatory diseases. Those in Phase III clinical trials include RA, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis, and giant cell arteritis.

The new long-term data presented at this conference demonstrate the potential of Rinvoq, both as monotherapy and in combination with methotrexate (MTX), in treating the signs and symptoms of rheumatoid arthritis (RA).

The detailed results announced at the meeting are as follows:

SELECT-COMPARE Study: 72-Week Results

The long-term extension (LTE) results of this study showed that, over 72 weeks, Rinvoq + MTX combination therapy maintained higher levels of clinical response, including clinical remission, compared to adalimumab + MTX.

SELECT-MONOTHERAPY Study: 84-Week Results

In the LTE of this study, patients who continued MTX treatment during Phase 1 were assigned at Week 14, based on their pre-specified baseline allocation, to receive blinded Rinvoq (15 mg or 30 mg) treatment. The LTE results demonstrated that Rinvoq monotherapy continued to improve the signs and symptoms of RA through Week 84.

2-Year Radiographic Inhibition Results from SELECT-EARLY and SELECT-COMPARE:

Two studies enrolled RA patients at high risk for progressive structural joint damage, characterized by baseline erosive joint damage and/or seropositivity.

The results showed that Rinvoq inhibited structural joint damage in MTX-naïve patients receiving Rinvoq monotherapy, as well as in patients with an inadequate response to MTX receiving Rinvoq in combination with MTX.

Reference Source: New Long-term Data from RINVOQ® (upadacitinib, 15 mg) Phase 3 Studies in Rheumatoid Arthritis Presented at the 2020 Annual European E-Congress of Rheumatology (EULAR)