RINVOQ, a once-daily oral selective JAK inhibitor1
*Remission: DAS28 (CRP) <2.6.
ACR50: improvement of at least 50% in the American College of Rheumatology core criteria; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); HAQ-DI: Health Assessment Questionnaire-Disability Index; JAK: Janus kinase; MTX: methotrexate.
SELECT-COMPARE: 48-week, double-blind, active comparator–controlled study of 1,629 adult patients with moderate to severe active RA and an inadequate response to MTX. Patients on stable background MTX were randomized 2:2:1 to RINVOQ 15 mg QD (n=651), placebo (n=651), or adalimumab 40 mg EOW (n=327). The primary endpoint was the proportion of patients achieving clinical remission (DAS28 [CRP] <2.6) for RINVOQ + MTX vs placebo + MTX at Week 12. The proportion of patients achieving low disease activity (DAS28 [CRP] ≤3.2) was a ranked secondary endpoint for RINVOQ + MTX vs placebo + MTX and vs adalimumab + MTX at Week 12.
Safety Information1
References
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021.
- Fleischmann R, Pangan AL, Song IH, et al. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III, double-blind, randomized controlled trial. Arthritis Rheumatol. 2019;71(11):1788-1800. doi:10.1002/art.41032
- European Medicines Agency (EMA). RINVOQ assessment report. https://www.ema.europa.eu/en/documents/assessment-report/rinvoq-epar-public-assessment-report_en.pdf. Updated March 2020. Accessed October 9, 2020.