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-COMPARE at Weeks 12 and 26 in MTX-IR patients (secondary endpoint)1‡
From Week 14, non-responding patients on RINVOQ could be rescued to adalimumab, and non-responding patients on adalimumab or placebo could be rescued to RINVOQ in a blinded manner.
Clinical remission (DAS-CRP<2.6)
* p≤0.001 RINVOQ vs. placebo comparison; included in multiplicity adjustment for overall type I error control
† p≤0.001 RINVOQ vs. placebo comparison; not included in multiplicity adjustment for overall type I error control
‡ No conclusions can be drawn regarding the superiority of upadacitinib + MTX vs. adalimumab + MTX.
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-COMPARE at Week 12 in MTX-IR patients1‡
ACR 20/50/70
* p≤0.001 RINVOQ vs. placebo comparison; included in multiplicity adjustment for overall type I error control
† p≤0.001 RINVOQ vs. placebo comparison; not included in multiplicity adjustment for overall type I error control
‡ No conclusions can be drawn regarding the superiority of upadacitinib + MTX vs. adalimumab + MTX.
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.
ACR response data shown in SELECT-COMPARE at Week 26 in
MTX-IR patients (secondary endpoints)1†
ACR 20/50/70
* p≤0.001 RINVOQ vs. placebo comparison; included in multiplicity adjustment for overall type I error control
† No conclusions can be drawn regarding the superiority of upadacitinib + MTX vs. adalimumab + MTX.
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.
Demonstrated results for the inhibition of progression of structural joint damage (mTSS and its components) in SELECT-COMPARE at Week 26 (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≤0.001 RINVOQ vs. placebo
Adapted from the Product Monograph and Fleischmann, 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. Fleischmann R, Pangan AL, Song IH, et al. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: Results of a phase III, double-blind, randomized controlled trial. Arthritis Rheumatol 2019;71(11):1788-1800.
HAQ-DI, pain, and fatigue (FACIT-F) outcomes shown in SELECT-COMPARE at Week 12 in MTX-IR patients (secondary endpoints)1,2‡
Mean change from baseline in:
* p≤0.001 RINVOQ vs. placebo
† No conclusions can be drawn regarding the superiority of upadacitinib + MTX vs. adalimumab + MTX.
‡ Data shown are least square means of change from baseline for HAQ-DI and pain.
§ HAQ-DI: 0=best, 3=worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities
¶ VAS: 0=best, 100=worst
Adapted from the Product Monograph and Fleischmann, et al.1,2
FACIT-F: Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score; HAQ-DI: Health Assessment Questionnaire Disability Index; IR: inadequate responder; MTX: methotrexate; VAS: visual analog scale.
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. Fleischmann R, Pangan AL, Song IH, et al. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: Results of a phase III, double-blind, randomized controlled trial. Arthritis Rheumatol 2019;71(11):1788-1800.
SELECT-COMPARE: Study design1,2
A 48-week trial assessing the efficacy and safety profile of RINVOQ + MTX compared with placebo + MTX and adalimumab + MTX for the treatment of moderate to severe RA in patients who had an inadequate response to MTX.
Adapted from the Product Monograph and Fleischmann, et al.1,2
From Week 14, non-responding patients on RINVOQ 15 mg could be rescued to adalimumab in a blinded manner, and non-responding patients on adalimumab or placebo could be rescued to RINVOQ 15 mg in a blinded manner. At Week 26, all patients randomized to placebo were switched to RINVOQ 15 mg once daily in a blinded manner.
Proportion of patients who achieved an ACR 20 response at Week 12 vs. placebo
- 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 (≥6 swollen joints of 66, ≥6 tender joints of 68 examined, hsCRP ≥5 mg/L), and at least one of the following at screening: ≥3 erosions on x-rays of hands and feet, or ≥1 erosion and positivity for RF or ACCP.
- Patients must have had an inadequate response to MTX.
- Patients with prior exposure to at most 1 bDMARD (except adalimumab) 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.
- Patients with inadequate response to prior bDMARDs or prior exposure to a JAK inhibitor were excluded.
ACCP: anti-cyclic citrullinated protein; ACR: American College of Rheumatology; bDMARD: biological disease-modifying antirheumatic drug; EOW: every other week; 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. Fleischmann R, Pangan AL, Song IH, et al. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: Results of a phase III, double-blind, randomized controlled trial. Arthritis Rheumatol 2019;71(11):1788-1800.
