RINVOQ is an oral selective and reversible JAK inhibitor indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.1
NOTES TO AFFILIATES: Alternative to "RINVOQ is the first-ever once-daily oral JAK inhibitor approved for the treatment of active PsA, AS, and RA": RINVOQ is a once-daily oral JAK inhibitor approved for the treatment of active PsA, AS, and RA Please evaluate use of ALL claims, graphs/tables, and corresponding references (e.g., Data on File, abstracts, posters, publications) according to local standards, codes, and regulations.
joint efficacy in PsA1,2
Improvement in signs and symptoms as measured by ACR20 from as early as Week 2 and maintained to Week 56, with statistically significantly greater improvement in ACR20 vs placebo at Week 12* and noninferiority vs adalimumab in ACR20 response at Week 12.†‡
See joint efficacy data
across key PsA manifestations1,2
Statistically significantly more patients treated with RINVOQ achieved PASI 75 vs placebo at Week 16,* and resolution of enthesitis and minimal disease activity vs placebo at Week 24,* with responses maintained at Week 56.
See data across PsA manifestations
safety profile established in 9 clinical trials across rheumatology indications1-13
RINVOQ’s safety profile has been established across a robust clinical trial program in PsA, AS, and RA, representing more than 8,500 patient-years of exposure to RINVOQ 15 mg.§
See RINVOQ safety profile
*P≤0.001 vs placebo, statistically significant in the multiplicity-controlled analysis.
†P≤0.001 vs adalimumab for noninferiority, statistically significant in the multiplicity-controlled analysis.
‡Superiority to adalimumab could not be demonstrated.
§Patient-years of exposure are inclusive of all patients in the RINVOQ 15 mg treatment arms in the SELECT-PsA 1, SELECT-PsA 2, SELECT-AXIS 1, SELECT-EARLY, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-NEXT, and SELECT-BEYOND registrational trials, and the SELECT-CHOICE clinical trial.
Rheumatoid arthritis indication1
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
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SELECT-PsA 1: A double-blind, active comparator-controlled Phase 3 study and open-label extension of 1,705 adult patients with active PsA and an inadequate response or intolerance to at least one non-biologic DMARD. Patients were randomized to RINVOQ 15 mg QD (n=429), upadacitinib 30 mg QD (n=423), placebo (n=423), or adalimumab 40 mg EOW (n=429). Stable treatment of NSAIDs, corticosteroids, and ≤2 non-biologic DMARDs were permitted, but not required. At Week 24, all patients randomized to placebo were switched to RINVOQ 15 mg or upadacitinib 30 mg once daily in a blinded manner. The primary endpoint was the proportion of patients achieving ACR20 at Week 12. The approved dose of RINVOQ in active PsA is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose in PsA.
ACR20: American College of Rheumatology 20% improvement in both tender and swollen joint counts, plus three of the following: patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant (high sensitivity C-reactive protein); DMARD: disease-modifying antirheumatic drug; EOW: every other week; JAK: Janus kinase; PASI: Psoriasis Area Severity Index; QD: once daily.
RINVOQ Important Safety Information1
Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Special warnings and precautions for use
Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.
Serious infections
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported with upadacitinib. As there is a higher incidence of infections in patients ≥65 years of age, caution should be used when treating this population.
Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with upadacitinib.
Vaccinations
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.
Malignancy
The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Malignancies, including nonmelanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.
Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.
Cardiovascular risk
RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidemia) managed as part of usual standard of care.
Lipids
Upadacitinib treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Hepatic transaminase elevations
Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.
Venous thromboembolisms
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE.
Adverse reactions
The most commonly reported adverse reactions in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis clinical trials (≥2% of patients in at least one of the indications) with upadacitinib 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, alanine transaminase (ALT) increased, bronchitis, nausea, cough, aspartate transaminase (AST) increased, and hypercholesterolemia. The most common serious adverse reactions were serious infections.
The safety profile of upadacitinib with long term treatment was generally similar to the safety profile during the placebo-controlled period across indications.
Overall, the safety profile observed in patients with psoriatic arthritis or active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with RA.
This is not a complete summary of all safety information.
Please see the RINVOQ Summary of Product Characteristics for complete prescribing information.
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Please see the HUMIRA Summary of Product Characteristics for complete prescribing information.
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Medical Information.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG.
- McInnes IB, Anderson JK, Magrey M, et al. Trial of upadacitinib and adalimumab for psoriatic arthritis. N Engl J Med. 2021;384(13):1227-1239. doi:10.1056/NEJMoa2022516
- Mease PJ, Lertratanakul A, Anderson JK, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2020;80(3):312-320. doi:10.1136/annrheumdis-2020-218870
- van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019;394(10214):2108-2117. doi:10.1016/S0140-6736(19)32534-6
- 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 randomized, double-blind, active-comparator, multi-center, multi-country trial. Arthritis Rheumatol. 2020;72(10):1607-1620. doi:10.1002/art.41384
- 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. doi:10.1002/art.41032
- Smolen JS, Pangan AL, Emery P, 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):2303-2311. doi:10.1016/S0140-6736(19)30419-2
- 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):2503-2512. doi:10.1016/S0140-6736(18)31115-2
- 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):2513-2524. doi:10.1016/S0140- 6736(18)31116-4
- Rubbert-Roth A, Enejosa J, Pangan AL, et al. Trial of upadacitinib or abatacept in rheumatoid arthritis. N Engl J Med. 2020;383(16):1511-1521. doi:10.1056/NEJMoa2008250
- Cohen SB, van Vollenhoven R, Curtis JR, et al. Integrated safety profile of upadacitinib with up to 4.5 years of exposure in patients with rheumatoid arthritis [EULAR abstract POS0220]. Ann Rheum Dis. 2021;80(suppl 1):328-329.
- Burmester GR, Winthrop K, Blanco R, et al. Safety profile of upadacitinib up to 3 years in patients with psoriatic arthritis: an integrated analysis from the Phase 3 program. [EULAR abstract AB0522]. Ann Rheum Dis. 2021;80(suppl 1):1287-1288.
- Deodhar A, van der Heijde D, Sieper J, et al. Upadacitinib in active ankylosing spondylitis: 1-year results from the double-blind, placebo-controlled SELECT-AXIS 1 study and open-label extension [published online July 1, 2021]. Arthritis Rheumatol. doi:10.1002/art.41911