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 (DAS-CRP<2.6) shown in SELECT-NEXT at Week 12 in csDMARD-IR patients (secondary endpoint)1
Clinical remission (DAS-CRP<2.6)
* p≤0.001 RINVOQ vs. placebo; included in multiplicity adjustment for overall type I error control
Adapted from the Product Monograph1
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-NEXT at Week 12 in csDMARD-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
Adapted from the Product Monograph1
Significantly higher ACR 20 response rates were observed as early as Week 1 with RINVOQ 15 mg vs. placebo.
ACR: American College of Rheumatology; 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-NEXT: 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 to csDMARDs.
Adapted from the Product Monograph and Burmester, 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).
- Received up to two concomitant csDMARDs (except for MTX and leflunomide) for ≥3 months and on a stable dose for ≥4 weeks before study entry.
- Patients must have had an inadequate response to at least 1 prior csDMARD (MTX, sulfasalazine, or leflunomide).
- Patients with prior exposure to at most 1 bDMARD were eligible (up to 20% of total study number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability.
- Prior exposure to a JAK inhibitor or prior inadequate response to bDMARDs.
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; MTX: methotrexate; 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. 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):
2503-12.
