AbbVie announces positive results from phase 3 study of Rinvoq in patients with rheumatoid arthritis
AbbVie, a research-based global biopharmaceutical company, announced new long-term results showing that once daily Rinvoq (upadacitinib) continued to improve signs and symptoms in patients with rheumatoid arthritis at 72 and 84 weeks in the SELECT-COMPARE (upadacitinib, 15 mg in combination with methotrexate [MTX]) and SELECT-MONOTHERAPY (upadacitinib, 15 mg and 30 mg) phase 3 clinical trials, respectively.
The safety profile of upadacitinib (15 mg and 30 mg) monotherapy or upadacitinib (15 mg) in combination with MTX was consistent with that observed in the previously reported integrated Phase 3 safety analysis in rheumatoid arthritis, with no new safety risks detected.
Additionally, approximate two-year data (96 weeks) from the SELECT-EARLY (upadacitinib, 15 mg and 30 mg) and SELECT-COMPARE clinical trials showed that upadacitinib was effective in inhibiting structural joint damage as monotherapy or in combination with MTX.
Rinvoq, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is approved as an oral, once daily, 15 mg therapy for adults with moderate to severe active rheumatoid arthritis.
“These new long-term data showcase the potential of Rinvoqto provide relief from the signs and symptoms of rheumatoid arthritis, both as a monotherapy and in combination with methotrexate,” said Isidro Villanueva, vice president, medical affairs immunology, AbbVie. “We are excited to share these results with the rheumatology community reinforcing Rinvoq as an important treatment option that may help more patients living with rheumatoid arthritis reach their goals in disease management.”
Results of this Long-Term Extension (LTE) of the SELECT-COMPARE study show that Rinvoq plus MTX maintained higher levels of clinical response, including remission compared to adalimumab plus MTX, through week 72.
In this LTE of the SELECT-MONOTHERAPY study, patients who received continued MTX in the first phase of the study were switched to receive blinded upadacitinib (15 mg or 30 mg) at week 14 based on pre-specified assignment at baseline. Results of this LTE show that upadacitinib monotherapy resulted in continued improvements in rheumatoid arthritis signs and symptoms through 84 weeks.
Through week 84, SAEs occurred at 18.5 events/100PY (per 100 patient years) on upadacitinib 15 mg and 16.9 events/100PY on upadacitinib30 mg. The most common SAE was pneumonia. Events of herpes zoster, hepatic disorder and creatine phosphokinase elevations were higher among patients receiving upadacitinib 30 mg, while rates of serious infection and malignancy were comparable between upadacitinib 30 mg and 15 mg.
Seven patients experienced MACE (15 mg, 0.5/100 PY; 30 mg, 1.2/100 PY) and there were five VTE (15 mg, 0.9/100 PY; 30 mg, 0.2/100 PY). All MACE and VTE occurred in patients with underlying risk factors. There were three deaths each (0.7/100PY) on upadacitinib 15 mg and 30 mg, including non-treatment emergent deaths.
Both SELECT-EARLY and SELECT-COMPARE enrolled rheumatoid arthritis patients at high risk for progressive structural damage with baseline erosive joint damage and/or seropositivity. Rinvoq inhibited structural joint damage in MTX-naïve patients receiving Rinvoq monotherapy and in patients with an inadequate response to MTX in combination with MTX.
Rinvoq (upadacitinib, 15 mg) 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 spondylo arthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.
SELECT-COMPARE is a phase 3, multicenter, randomized, double-blind study designed to evaluate the safety and efficacy of RINVOQ compared to placebo and adalimumab in adult patients with moderate to severe active rheumatoid arthritis who had an inadequate response to methotrexate and continued a stable background of MTX. Patients received background MTX and were randomized 2:2:1 to receive Rinvoq (15 mg, once daily), placebo or adalimumab (given as a subcutaneous injection of 40 mg every other week).
SELECT-MONOTHERAPY is a phase 3, multicenter, randomized, double-blind, parallel-group study designed to evaluate the safety and efficacy of upadacitinib monotherapy in adult patients with moderate to severe active rheumatoid arthritis and an inadequate response to a stable dose of methotrexate. Patients were randomized to switch from MTX to upadacitinib monotherapy (15 mg or 30 mg, once daily) or continue on their prior stable dose of MTX in a blinded manner.
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.
