RINVOQ® (upadacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1
RINVOQ achieved the primary endpoints of clinical remission per adapted Mayo score at Induction Week 8 and Maintenance Week 521,2
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
| * | Total patient number was calculated from adding the number of patients randomized in 20 trials. 13,557 patients includes all patients across all arms (active treatment and placebo) in the following Phase 3 trials in RA (SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE), PsA (SELECT-PsA 1, SELECT-PsA 2), AS (SELECT-AXIS 1, SELECT-AXIS 2), nr-axSpA (SELECT-AXIS 2), AD (MEASURE UP 1, MEASURE UP 2, AD UP, HEADS UP), UC (U-ACHIEVE [UC-1 and UC-3], U-ACCOMPLISH [UC-2]), and CD (U-EXCEED [CD-1], U-EXCEL [CD-2], and U-ENDURE [CD-3]). 7,932 |
| † | Beginning in RA. First patients dosed December 2015 in an RA Phase 3 clinical trial. |
| ‡ | 124,829 RA patients, 34,900 axSpA and PsA patients, 36,808 AD patients, 11,180 UC patients, and 13 CD patients taking RINVOQ globally. Global patient numbers include OUS+US through March 2023. Numbers are subject to change based on local market data adjustments. |
| § | 32,656 patient-years exposure. |
6 trials in RA: SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE*
2 trials in PsA: SELECT-PsA 1, SELECT-PsA 2
2 trials in AS: SELECT‑AXIS 1,† SELECT-AXIS 2 (AS bDMARD-IR)
1 trial nr-axSpA: SELECT‑AXIS 2
4 trials in AD: MEASURE-UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP*
2 trials in UC: U-ACCOMPLISH (induction), U-ACHIEVE (induction, maintenance, and long-term extension)
3 trials in CD: U-EXCEL induction, U-EXCEED induction, U-ENDURE maintenance
*Non-registrational clinical trial. †Phase 2b/3 clinical trial.
6 trials in RA: SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE*
2 trials in PsA: SELECT-PsA 1, SELECT-PsA 2
2 trials in AS: SELECT‑AXIS 1,† SELECT-AXIS 2 (AS bDMARD-IR)
1 trial nr-axSpA: SELECT‑AXIS 2
4 trials in AD: MEASURE-UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP*
2 trials in UC: U-ACCOMPLISH (induction), U-ACHIEVE (induction, maintenance, and long-term extension)
3 trials in CD: U-EXCEL induction, U-EXCEED induction, U-ENDURE maintenance
*Non-registrational clinical trial. †Phase 2b/3 clinical trial.
6 trials in RA: SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE*
2 trials in PsA: SELECT-PsA 1, SELECT-PsA 2
2 trials in AS: SELECT‑AXIS 1,† SELECT-AXIS 2 (AS bDMARD-IR)
1 trial nr-axSpA: SELECT‑AXIS 2
4 trials in AD: MEASURE-UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP*
2 trials in UC: U-ACCOMPLISH (induction), U-ACHIEVE (induction, maintenance, and long-term extension)
3 trials in CD: U-EXCEL induction, U-EXCEED induction, U-ENDURE maintenance
*Non-registrational clinical trial. †Phase 2b/3 clinical trial.
6 trials in RA: SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE*
2 trials in PsA: SELECT-PsA 1, SELECT-PsA 2
2 trials in AS: SELECT‑AXIS 1,† SELECT-AXIS 2 (AS bDMARD-IR)
1 trial nr-axSpA: SELECT‑AXIS 2
4 trials in AD: MEASURE-UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP*
2 trials in UC: U-ACCOMPLISH (induction), U-ACHIEVE (induction, maintenance, and long-term extension)
3 trials in CD: U-EXCEL induction, U-EXCEED induction, U-ENDURE maintenance
*Non-registrational clinical trial. †Phase 2b/3 clinical trial.
6 trials in RA: SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE*
2 trials in PsA: SELECT-PsA 1, SELECT-PsA 2
2 trials in AS: SELECT‑AXIS 1,† SELECT-AXIS 2 (AS bDMARD-IR)
1 trial nr-axSpA: SELECT‑AXIS 2
4 trials in AD: MEASURE-UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP*
2 trials in UC: U-ACCOMPLISH (induction), U-ACHIEVE (induction, maintenance, and long-term extension)
3 trials in CD: U-EXCEL induction, U-EXCEED induction, U-ENDURE maintenance
*Non-registrational clinical trial. †Phase 2b/3 clinical trial.
6 trials in RA: SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-MONOTHERAPY, SELECT-BEYOND, SELECT-CHOICE*
2 trials in PsA: SELECT-PsA 1, SELECT-PsA 2
2 trials in AS: SELECT‑AXIS 1,† SELECT-AXIS 2 (AS bDMARD-IR)
1 trial nr-axSpA: SELECT‑AXIS 2
4 trials in AD: MEASURE-UP 1, MEASURE‑UP 2, AD‑UP, HEADS‑UP*
2 trials in UC: U-ACCOMPLISH (induction), U-ACHIEVE (induction, maintenance, and long-term extension)
3 trials in CD: U-EXCEL induction, U-EXCEED induction, U-ENDURE maintenance
*Non-registrational clinical trial. †Phase 2b/3 clinical trial.
AD: atopic dermatitis; ADA: adalimumab; AE: adverse events; AESI: adverse event of special interest; ALT: alanine transaminase; aMs: adapted Mayo score; AS: ankylosing spondylitis; bDMARD: biologic disease-modifying antirheumatic drug; CD: Crohn's disease; COVID-19: coronavirus disease 2019; CPK: creatine phosphokinase; DVT: deep vein thrombosis; EAER: exposure-adjusted adverse event rate; EC: European Commission; ESS: endoscopic subscore; EOW; every other week; GI: gastrointestinal; IR: intolerance or inadequate response; JAK: Janus kinase; MACE: major adverse cardiac event; MTX: methotrexate; NMSC: nonmelanoma skin cancer; nr-axSpA: non-radiographic axial spondyloarthritis; OUS: outside the United States; PE: pulmonary embolism; PsA: psoriatic arthritis; PY: patient-years; QD: once daily; RA: rheumatoid arthritis; RBS: rectal bleeding score; TEAE: treatment-emergent adverse event; UC: ulcerative colitis; VTE: venous thromboembolism.
Study designs: U-ACHIEVE Induction (UC-1) and U-ACCOMPLISH (UC-2) were replicate induction studies, both of which were multicenter, double-blind, placebo-controlled clinical studies. In UC-1 and UC-2, 988 patients (473 and 515 patients, respectively) were randomized to RINVOQ 45 mg QD or placebo for 8 weeks with a 2:1 treatment allocation ratio and included in the efficacy analysis. All enrolled patients had moderately to severely active UC defined as aMs of 5 to 9 with an ESS of 2 or 3 and demonstrated prior treatment failure including inadequate response, loss of response, or intolerance to prior conventional and/or biologic treatment. U-ACHIEVE Maintenance (UC-3) was a multicenter, double-blind, placebo-controlled clinical study with 451 patients who achieved clinical response per aMs (decrease ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from baseline or an absolute RBS ≤1) with 8-week RINVOQ 45 mg QD induction treatment. Patients were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD, or placebo.1,2
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RINVOQ is an oral, once daily, selective and reversible JAK inhibitor now approved for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1
RINVOQ can be taken at any time of the day, with or without food. Tablets should be swallowed whole and should not be split, crushed, or chewed in order to ensure the entire dose is delivered correctly.1
A Phase 3 clinical trial program involving 3 studies: 2 replicate induction studies and 1 maintenance study evaluated RINVOQ 45 mg QD vs placebo for induction and RINVOQ 15 mg QD and 30 mg QD vs placebo for maintenance treatment.1,2
< Affiliate to link to locally approved project ALL-RNQG-220006 >
< Affiliate to link to locally approved project ALL-RNQG-220028 >
Learn more about RINVOQ’s safety profile during a Phase 3 8-week induction and 52-week maintenance clinical study program.1,2
RINVOQ ISI PLACEHOLDER
and
HUMIRA ISI PLACEHOLDER and link to HUMIRA SmPC
[Please insert local summary of safety]
REFERENCES
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; December 2023.
- Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113-2128. doi:10.1016/S0140-6736(22)00581-5
- 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
- Blauvelt A, Teixeira HD, Simpson EL, et al. Efficacy and safety of upadacitinib vs dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2021;157(9):1047-1055. doi:10.1001/jamadermatol.2021.3023
- 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):1607-1620.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
- 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
- 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. 2021;80(3):312-320. doi:10.1136/annrheumdis-2020-218870
- Deodhar A, Van den Bosch F, Poddubnyy D, et al. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022;400(10349):369-379. doi:10.1016/S0140-6736(22)01212-0
- 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 der Heijde D, Baraliakos X, Sieper J, et al. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomised, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022;81(11):1515-1523. doi:10.1136/ard-2022-222608
- Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials Lancet. 2021;397(10290):2151-2168. doi:10.1016/S0140-6736(21)00588-2
- Reich K, Teixeira HD, de Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021;397(10290):2169-2181. doi:10.1016/S0140-6736(21)00589-4
- 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
- Data on file, AbbVie Inc. ABVRRTI76444.
- Data on file, AbbVie Inc. ABVRRTI75395.
- European Commission approves RINVOQ® (upadacitinib) as first JAK inhibitor in the European Union for the treatment of both adults and adolescents with moderate to severe atopic dermatitis. News release. AbbVie. August 24, 2021. Accessed December 6, 2023. https://news.abbvie.com/2021-08-24-European-Commission-Approves-RINVOQ-R-upadacitinib-as-First-JAK-Inhibitor-in-the-European-Union-for-the-Treatment-of-Both-Adults-and-Adolescents-with-Moderate-to-Severe-Atopic-Dermatitis
- European Commission approves AbbVie's RINVOQ™ (upadacitinib) for the treatment of psoriatic arthritis and ankylosing spondylitis. News release. AbbVie. January 25, 2021. Accessed December 6, 2023. https://news.abbvie.com/2021-01-25-European-Commission-Approves-AbbVies-RINVOQ-TM-Upadacitinib-for-the-Treatment-of-Psoriatic-Arthritis-and-Ankylosing-Spondylitis
- European Commission approves RINVOQ® (upadacitinib) for the treatment of adults with moderate to severe ulcerative colitis. News release. AbbVie. July 26, 2022. Accessed December 6, 2023. https://news.abbvie.com/2022-07-26-European-Commission-Approves-RINVOQ-R-upadacitinib-for-the-Treatment-of-Adults-With-Moderate-to-Severe-Ulcerative-Colitis
- AbbVie announces European Commission Approval of RINVOQ® (upadacitinib) for the treatment of moderately to severely active Crohn's disease. News release. AbbVie. April 17, 2023. Accessed December 6, 2023. https://news.abbvie.com/2023-04-17-AbbVie-Announces-European-Commission-Approval-of-RINVOQ-R-upadacitinib-for-the-Treatment-of-Moderately-to-Severely-Active-Crohns-Disease
- RINVOQ® (upadacitinib) approved by European Commission as an oral treatment for adults with active non-radiographic axial spondyloarthritis. News release. AbbVie. July 29, 2022. Accessed December 6, 2023. https://news.abbvie.com/2022-07-29-RINVOQ-R-upadacitinib-Approved-by-European-Commission-as-an-Oral-Treatment-for-Adults-with-Active-Non-Radiographic-Axial-Spondyloarthritis
- Colombel JF, Panaccione R, Nakase H, et al. The safety profile of upadacitinib maintenance therapy in ulcerative colitis in the phase 3 U-ACHIEVE study is consistent with that in approved indications. J Crohns Colitis. 2022;16(suppl 1):i514. doi:10.1093/ecco-jcc/jjab232.699
- Burmester G, Cohen S, Winthrop K, et al. Long-term safety profile of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, or anklosing spondylitis. Poster presented at: American College of Rheumatology (ACR) Virtual Convergence; November 5-9, 2021.
- Simpson EL, Papp KA, Blauvelt A, et al. Efficacy and safety of upadacitinib in patients with atopic dermatitis: results through week 52 from replicate, phase 3, randomized, double-blind, placebo-controlled studies: Measure Up 1 and Measure Up 2. Poster presented at: Dermatology Education Foundation (DEF) Essential Resource Meeting (DERM2021); August 5-8, 2021; Las Vegas, NV.
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ALL-RNQG-220224 Date of preparation: February 2024
Adverse events should also be reported to AbbVie on GBPV@abbvie.com