June 04, 2020: “AbbVie, a research-based global biopharmaceutical company announced new long-term results showing that once daily 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.
Full results were presented today at the 2020 Annual European E-Congress of Rheumatology (EULAR).
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 severely active rheumatoid arthritis.
“These new long-term data showcase the potential of RINVOQ to 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.”
RINVOQ™ (upadacitinib, 15 mg)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.
In August 2019, RINVOQ received U.S. 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 severely 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.
SELECT-COMPARE
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).
The primary endpoints of the first phase included the percentage of subjects achieving ACR20 and clinical remission (based on DAS28-CRP) after 12 weeks of treatment compared to placebo.
Ranked secondary endpoints included change in the mTSS compared to placebo and a comparison versus adalimumab in percentage of subjects achieving ACR50, low disease activity, changes in pain as measured by the Patient’s Assessment of Pain (based on VAS) and changes in physical function, as measured by the Health Assessment Questionnaire-Disability-Index (HAQ-DI).
The trial is ongoing and included a 48-week randomized, double-blind treatment period followed by a long-term extension study of up to five years.”
https://news.abbvie.com/news/press-releases/new-long-term-data-from-rinvoq-upadacitinib-15-mg-phase-3-studies-in-rheumatoid-arthritis-presented-at-2020-annual-european-e-congress-rheumatology-eular.htm
