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RINVOQ SELECT-MONOTHERAPY clinical trial results
Hear Professor Paul Emery discuss monotherapy study results in patients with moderate to severe active RA and an inadequate response to a stable dose of methotrexate.1,2
SELECT-MONOTHERAPY: Study design
A Phase 3 study investigating the efficacy and safety of RINVOQ monotherapy after switching from MTX compared with cMTX for the treatment of moderate to severe RA in patients who had an inadequate response to MTX2
*For the primary analysis at Week 14, comparisons of RINVOQ 15 mg and upadacitinib 30 mg vs cMTX were done by combining data from the two cMTX groups.
†From Week 14, patients initially randomized to cMTX at baseline were switched to RINVOQ 15 mg or upadacitinib 30 mg per prespecified randomization assignment.
Primary
RINVOQ 15 mg and upadacitinib 30 mg vs cMTX at Week 14 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 more than 3 mg/L hsCRP).
- Patients must have had an inadequate response to MTX.
- No prior exposure to a JAK inhibitor or bDMARD.
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; cMTX: continued methotrexate; 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 monotherapy: Efficacy across endpoints
SELECT-MONOTHERAPY: Low disease activity and remission rates at Week 14 (NRI)1,2
*P≤0.0001 vs cMTX, multiplicity-controlled comparisons
cMTX: continued methotrexate; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); NRI: nonresponder imputation.
SELECT-MONOTHERAPY: Adverse events through 14 weeks of treatment2
*Serious infection: In the methotrexate group, there was 1 case of urosepsis. In the RINVOQ 15-mg group, there was 1 limb abscess.
†Opportunistic infection: In the methotrexate group, there was 1 case of fungal esophagitis.
‡Hepatic disorder: In the methotrexate group, there were 4 cases of liver enzyme elevations. In the RINVOQ 15-mg group, there were 3 cases of liver enzyme elevations and 1 mild hepatic cyst.
§Malignancies: In the methotrexate group, there was 1 basal cell carcinoma. In the RINVOQ 15-mg group, there was 1 non-Hodgkin lymphoma and 1 breast cancer.
IIVenous thromboembolism: In the RINVOQ 15-mg group, there was 1 pulmonary embolism in a patient on estrogen hormone therapy with a body mass index of 44.9; investigator deemed as unrelated to study drug.
¶Major adverse cardiovascular event (adjudicated): In the RINVOQ 15-mg group, there was 1 hemorrhagic stroke due to ruptured aneurysm (fatal); investigator deemed as unrelated to study drug.
#Death: In the RINVOQ 15-mg group, there was 1 hemorrhagic stroke due to ruptured aneurysm.
Safety Information1
References
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021.
- 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