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-MONOTHERAPY at Week 14 in MTX-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
DAS28-CRP: 28-joint disease activity C-reactive protein score; IR: inadequate responder; MTX: methotrexate.
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-MONOTHERAPY at Week 14 in MTX-IR patients1
ACR 20/50/70
* p≤0.001 RINVOQ vs. MTX; included in multiplicity adjustment for overall type I error control
† p≤0.001 RINVOQ vs. MTX; not included in multiplicity adjustment for overall type I error control
Adapted from the Product Monograph1
ACR: American College of Rheumatology; MTX: methotrexate; 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-MONOTHERAPY: Study design1
A 14-week trial assessing the efficacy and safety profile of RINVOQ monotherapy after switching from MTX compared with continued MTX for the treatment of moderate to severe RA in patients who had an inadequate response to MTX.
Adapted from the Product Monograph and Smolen, et al.1,2
Proportion of patients who achieved an ACR 20 response at Week 14
- Patients ≥18 years of age were eligible to participate.
- Diagnosis of RA 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.
- Prior exposure to a JAK inhibitor or bDMARD.
ACR: American College of Rheumatology; bDMARD: biological 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. Smolen JS, Pangan AL, Rigby W, 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):2303-11.
