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-EARLY at Weeks 12 and 24 in MTX-naïve patients (secondary endpoint)1
Clinical remission (DAS28-CRP<2.6)
* 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
DAS28-CRP: 28-joint disease activity score using C-reactive protein.
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-EARLY at Week 12 in MTX-naïve 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.
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.
Demonstrated results for the inhibition of progression of structural joint damage (mTSS and its components) in SELECT-EARLY at Week 24 in MTX-naïve patients (secondary endpoint)1*
Inhibition of progression of structural joint damage was assessed using the mTSS and its components, the erosion score, and joint space narrowing score
Progression of structural joint damage (mTSS)
* Analyses are based on linear extrapolation
† p≤0.01 RINVOQ vs. MTX
‡ p≤0.001 RINVOQ vs. MTX
§ p≤0.05 RINVOQ vs. MTX
Adapted from the Product Monograph and van Vollenhoven, et al.1,2
mTSS: modified total Sharp score; 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.
References
1. RINVOQ Product Monograph. AbbVie Corporation.
2. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and safety of upadacitinib monotherapy in methotrexate-naive patients with moderately-to-severely active rheumatoid arthritis (SELECT-EARLY): a multicenter, multi-country, randomized, double-blind, active comparator–controlled trial. Arthritis Rheumatol 2020;72(10):
1607-20.
SELECT-EARLY: Study design1
A 48-week trial assessing the efficacy and safety profile of RINVOQ monotherapy compared with MTX in MTX-naïve patients with moderately to severely active RA.
Adapted from the Product Monograph and van Vollenhoven, et al.1,2
Proportion of patients who achieved an ACR 50 response at Week 12
- Patients ≥18 years of age were eligible to participate.
- Diagnosis of RA for ≥6 weeks 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 ≥5 mg/L) and ≥1 erosion on x-ray OR positive for both RF and ACCP.
- Patients were naive to MTX or received no more than 3 weekly MTX doses and completed a 4-week MTX washout.
- Prior intolerance to MTX, or prior exposure to a JAK inhibitor or bDMARD.
ACCP: anti-cyclic citrullinated protein; 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; RF: rheumatoid factor.
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. Van Vollenhoven R, Takeuchi T, Pangan AL, et al. Efficacy and safety of upadacitinib monotherapy in methotrexate-naive patients with moderately-to-severely active rheumatoid arthritis (SELECT-EARLY): a multicenter, multi-country, randomized, double-blind, active comparator–controlled trial. Arthritis Rheumatol 2020;72(10):
1607-20.
