Date: 10-Jun-2020

AbbVies SELECT-CHOICE Phase 3 Trial Of Rinvoq Versus Orencia Meets Primary And Key Secondary Endpoints In Rheumatoid Arthritis Patients

AbbVie, a research-based global biopharmaceutical company, announced new phase 3 data from the SELECT-CHOICE clinical trial, showing that Rinvoq (upadacitinib, 15 mg, once daily) met the primary endpoint of non-inferiority versus Orencia (abatacept) on change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at week 12.

In addition, Rinvoq met the key secondary endpoints of superiority versus Orencia on change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission at week 12 as measured by DAS28-CRP<2.6.

The study evaluated Rinvoq in adult patients with moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs (DMARDs).

SELECT-CHOICE is the sixth and final phase 3 study from the robust SELECT rheumatoid arthritis clinical trial programme. Rinvoq, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is approved 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 DMARDs.

"Despite tremendous progress in the treatment of rheumatoid arthritis, about 70 percent of patients are still not achieving clinical remission with established therapies," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are pleased with the results as they add to our growing body of evidence that Rinvoq may offer more adult patients with rheumatoid arthritis a better chance at achieving clinical remission, including those who have already failed a prior biologic."

"These data show that upadacitinib was superior to abatacept with regard to the proportion of patients achieving remission," said Professor Andrea Rubbert-Roth, M.D., deputy director, Division of Rheumatology, Cantonal Hospital St. Gallen, Switzerland. "SELECT-CHOICE represents the first head-to-head study in rheumatoid arthritis patients who have failed biologic DMARDs and compares upadacitinib to a different biologic DMARD. Studies like this are important for daily decision-making in practice."

In this study, Rinvoq met both the primary (non-inferiority) and secondary (superiority) endpoints, with a change from baseline in DAS28-CRP at week 12 of -2.52 compared to -2.00 in patients treated with Orencia. In addition, 30 percent of patients receiving Rinvoq achieved clinical remission at week 12 (DAS28-CRP<2.6) compared to 13 percent of patients receiving Orencia (p<0.001).

ACR20/50/70 responses were also higher in the Rinvoq group compared to the Orencia group (76/46/22 percent versus 66/34/14 percent, respectively, nominal p<0.05) at week 12.1 Improvements in disease activity and remission rates were maintained through 24 weeks.

SELECT-CHOICE is a phase 3, multicenter, randomized, double-blind, active-controlled study designed to evaluate the safety and efficacy of Rinvoqin combination with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) compared to Orencia (abatacept) in combination with csDMARDs in adult patients with moderate to severe active rheumatoid arthritis who have an inadequate response to or intolerance to biologic DMARDs. Patients were randomized to once daily Rinvoq (15 mg) or intravenous Orencia (at day 1, weeks 2, 4, 8, 12, 16 and 20 [<60 kg: 500 mg; 60-100 kg: 750 mg; >100 kg: 1,000 mg]), with all patients continuing background stable csDMARDs.

The primary endpoint was change from baseline in DAS28-CRP at week 12 showing non-inferiority in patients receiving Rinvoq (15 mg) compared to those receiving Orencia. Ranked secondary endpoints included superiority to Orencia in terms of change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission, as defined by DAS28-CRP<2.6 at week 12.

Rinvoq (upadacitinib) is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In August 2019, Rinvoq received US FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

In December 2019, Rinvoq was approved by the European Commission 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. The approved dose for Rinvoq in rheumatoid arthritis is 15 mg. Phase 3 trials of Rinvoq in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.