Phase III SELECT trials show Rinvoq efficacy continues to week 84 in rheumatoid arthritis.- AbbVie

AbbVie 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 phase III SELECT-COMPARE (15 mg in combination with methotrexate [MTX]) and SELECT-MONOTHERAPY (15 mg and 30 mg) clinical trials, respectively. The safety profile of upadacitinib (15 mg and 30 mg) monotherapy was consistent with that observed in the previously reported integrated Phase III safety analysis in rheumatoid arthritis, with no new safety risks detected.

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 show that upadacitinib monotherapy resulted in continued improvements in rheumatoid arthritis signs and symptoms through 84 weeks. The safety profile of upadacitinib (15 mg) in combination with MTX was generally consistent with that observed in the previously reported integrated Phase III safety analysis in rheumatoid arthritis, with no new safety risks detected. Through the data cut-off, serious adverse events occurred at 12.7 events/100PY (per 100 patient years) on upadacitinib 15 mg in combination with MTX, compared to 15.9 events/100PY on adalimumab in combination with MTX.

Finally there was an assessment of radiographic inhibition at approximately two years for both SELECT-EARLY and SELECT-COMPARE. Both trials enrolled rheumatoid arthritis patients at high risk for progressive structural damage with baseline erosive joint damage and/or seropositivity. Upadacitinib inhibited structural joint damage in MTX naïve patients receiving upadacitinib monotherapy and in patients with an inadequate response to MTX in combination with MTX. Full results were presented at the 2020 Annual European E-Congress of Rheumatology (EULAR).