RINVOQ (upadacitinib) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). RINVOQ may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Clinical remission (DAS28-CRP<2.6) shown in SELECT-BEYOND at Week 12 in bDMARD-IR patients (secondary endpoint)1
Clinical remission (DAS28-CRP<2.6)
* p≤0.001 RINVOQ vs. placebo; not included in multiplicity adjustment for overall type I error control
Adapted from the Product Monograph1
bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP: 28-joint disease activity C-reactive protein score; IR: inadequate responder.
Click here for additional information and for a link to the Product Monograph discussing:
- The most serious warnings and precautions regarding serious infections, malignancies, thrombosis and major adverse cardiovascular events.
- Other relevant warnings and precautions regarding lipid parameters; gastrointestinal perforations; hematologic events; liver enzyme elevation; hypersensitivity reactions; patients with severe hepatic impairment; concomitant use with other potent immunosuppressants, biologic DMARDs, or other Janus kinase (JAK) inhibitors; immunizations; viral reactivation, including herpes (e.g. herpes zoster) and hepatitis B; malignancies, including NMSC; increases in creatine phosphokinase; monitoring and laboratory tests; pregnant women; reproductive health; breast-feeding; geriatrics (≥65 years of age); pediatrics (<18 years of age); Asian patients.
- Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.
Reference
1. RINVOQ Product Monograph. AbbVie Corporation.
ACR response data shown in SELECT-BEYOND at Week 12 in bDMARD-IR patients1
ACR 20/50/70
* p≤0.001 RINVOQ vs. placebo; included in multiplicity adjustment for overall type I error control
† p≤0.001 RINVOQ vs. placebo; not included in multiplicity adjustment for overall type I error control
‡ 95% confidence interval (-1,11)
Adapted from the Product Monograph1
Significantly higher ACR 20 response rates were observed as early as Week 1 with RINVOQ 15 mg vs. placebo.
RINVOQ 15 mg + csDMARDs did not achieve significantly higher ACR 70 response rates vs. placebo + csDMARDs
ACR: American College of Rheumatology; bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; IR: inadequate responder.
Click here for additional information and for a link to the Product Monograph discussing:
- The most serious warnings and precautions regarding serious infections, malignancies, thrombosis and major adverse cardiovascular events.
- Other relevant warnings and precautions regarding lipid parameters; gastrointestinal perforations; hematologic events; liver enzyme elevation; hypersensitivity reactions; patients with severe hepatic impairment; concomitant use with other potent immunosuppressants, biologic DMARDs, or other Janus kinase (JAK) inhibitors; immunizations; viral reactivation, including herpes (e.g. herpes zoster) and hepatitis B; malignancies, including NMSC; increases in creatine phosphokinase; monitoring and laboratory tests; pregnant women; reproductive health; breast-feeding; geriatrics (≥65 years of age); pediatrics (<18 years of age); Asian patients.
- Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.
Reference
1. RINVOQ Product Monograph. AbbVie Corporation.
SELECT-BEYOND: Study design1
A 12-week trial assessing the efficacy and safety profile of RINVOQ + csDMARDs compared with placebo + csDMARDs for the treatment of moderate to severe RA in patients who had an inadequate response or intolerance to bDMARDs.
* Randomization was stratified by the number of previous bDMARDs used (stratum 1 consisted of patients with inadequate response or intolerance to 1-2 biologics of the same class, and stratum 2 consisted of patients who had inadequate response or intolerance to ≥3 biologics of the same class or ≥2 biologics with different mechanisms of action).
Adapted from the Product Monograph and Genovese, et al.1,2
Proportion of patients who achieved an ACR 20 response at Week 12
- 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.
- Previous exposure to a JAK inhibitor.
ACR: American College of Rheumatology; bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; EULAR: European League Against Rheumatism; hsCRP: high-sensitivity C-reactive protein; JAK: Janus kinase; QD: once daily.
Click here for additional information and for a link to the Product Monograph discussing:
- The most serious warnings and precautions regarding serious infections, malignancies, thrombosis and major adverse cardiovascular events.
- Other relevant warnings and precautions regarding lipid parameters; gastrointestinal perforations; hematologic events; liver enzyme elevation; hypersensitivity reactions; patients with severe hepatic impairment; concomitant use with other potent immunosuppressants, biologic DMARDs, or other Janus kinase (JAK) inhibitors; immunizations; viral reactivation, including herpes (e.g. herpes zoster) and hepatitis B; malignancies, including NMSC; increases in creatine phosphokinase; monitoring and laboratory tests; pregnant women; reproductive health; breast-feeding; geriatrics (≥65 years of age); pediatrics (<18 years of age); Asian patients.
- Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.
References
1. RINVOQ Product Monograph. AbbVie Corporation.
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):2513-24.
