The RINVOQ study program1
See the data:
RINVOQ demonstrated consistent clinical remission rates across patient populations studied1
*RINVOQ is not indicated for MTX-naive patients.
†Primary endpoint: clinical remission (DAS28 [CRP]<2.6) compared to placebo.
bDMARD: biological disease-modifying antirheumatic drug; csDMARD-IR: inadequate responder to conventional synthetic DMARDs; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); DMARD: disease-modifying antirheumatic drug; MTX: methotrexate.
RINVOQ met every primary and ranked secondary endpoint in its Phase 3 registrational studies1-7
Endpoints across all studies
See the data:
RINVOQ is not indicated for MTX-naive patients. All primary and ranked key secondary endpoints were multiplicity-controlled and met statistical significance denoted by a P-value ≤0.05. All endpoints were assessed at Week 12, if not indicated otherwise:
*Assessment at Week 14.
†Assessment at Week 24.
‡Assessment at Week 26.
§In SELECT-COMPARE, all comparisons were for RINVOQ + MTX vs placebo + MTX, unless indicated otherwise.
ACR20/50: improvement of at least 20%/50% in the American College of Rheumatology core criteria; CDAI: Clinical Disease Activity Index; CR: clinical remission; CRP: C-reactive protein; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); EMA: European Medicines Agency; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; FDA: Food and Drug Administration; HAQ-DI: Health Assessment Questionnaire-Disability Index; LDA: low disease activity; mTSS: modified total Sharp score; MTX: methotrexate; PCS: physical component summary; SF-36: Short Form-36.
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
- Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019;393(10188):2303-2311. doi:10.1016/S0140-6736(19)30419-2
- van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and safety of upadacitinib monotherapy in methotrexate-naïve patients with moderately to severely active rheumatoid arthritis (SELECT-EARLY): a randomized, double-blind, active-comparator, multi-center, multi-country trial. Arthritis Rheumatol. 2020;72(10):1607-1620. doi:10.1002/art.41384
- Burmester GR, Kremer JM, Van den Bosch F, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018;391(10139):2503-2512. doi:10.1016/S0140-6736(18)31115-2
- Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513-2524. doi:10.1016/S0140- 6736(18)31116-4
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