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RINVOQ SELECT-BEYOND clinical trial results
Hear Dr. Bernard Combe discuss study results in patients with moderate to severe active RA and an inadequate response to bDMARDs.1,2
SELECT-BEYOND: Study design
A Phase 3 study investigating the efficacy and safety of RINVOQ + csDMARDs compared to placebo + csDMARDs in patients with moderate to severe RA and an inadequate response to bDMARDs1
Patients continued stable csDMARD therapy for the first 24 weeks of the study, restricted to oral or parenteral MTX, chloroquine, hydroxychloroquine, sulfasalazine, or leflunomide. Patients could be taking a maximum of 2 background csDMARDs, except the combination of MTX and leflunomide, which was not allowed.
*Randomization was stratified by prior failed bDMARDs (1-2 with same mechanism of action vs ≥3 with the same mechanism of action or at least 2 biologics with different mechanisms of action).
Primary
RINVOQ 15 mg + csDMARD(s) and upadacitinib 30 mg + csDMARD(s) vs placebo + csDMARD(s) at Week 12 for DAS28 (CRP) ≤3.2 (EMA) or ACR20 (FDA)
Safety
Adverse events, serious adverse events, adverse events of special interest (e.g., serious infections, opportunistic infections, MACEs, VTEs, malignancies)
- Patients ≥18 years of age were eligible to participate.
- Diagnosis of RA for ≥3 months fulfilling the 2010 ACR/EULAR classification for RA with active disease (at least 6 swollen joints out of 66, at least 6 tender joints out of 68, and hsCRP of 3 mg/L or more).
- Patients must have had an inadequate response for at least 3 months with at least one bDMARD or an intolerance or toxicity to bDMARDs.
- Patients were on csDMARD therapy for at least 3 months and on stable doses for at least 4 weeks before study entry.
- No previous exposure to a JAK inhibitor.
The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose.
ACR: American College of Rheumatology; ACR20: improvement of at least 20% in the American College of Rheumatology core criteria; bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); EMA: European Medicines Agency; EULAR: European League Against Rheumatism; FDA: Food and Drug Administration; hsCRP: high-sensitivity C-reactive protein; JAK: Janus kinase; MACE: major adverse cardiovascular event; MTX: methotrexate; QD: once daily; VTE: venous thromboembolic event.
RINVOQ: Efficacy across endpoints
SELECT-BEYOND: Low disease activity and remission at Week 12 in patients with an inadequate response to bDMARDs (NRI)1,2
*P≤0.001 vs placebo + csDMARD(s)
bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); NRI: nonresponder imputation.
SELECT-BEYOND: Adverse events through 12 weeks of treatment1
No patients reported tuberculosis, nonmelanoma skin cancer, or lymphoma.
*These were oral candidiasis.
†Most cases were mild and all but 1 was a single dermatome; 2 cases were serious.
‡One malignant melanoma in RINVOQ 15-mg group, Weeks 0–12.
§One ischemic stroke in Weeks 0–12 in RINVOQ 15-mg group.
Safety Information2
MayReferences
- 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
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021.