DRAFT FOR INTERNAL USE ONLY
This DRAFT of the Global RINVOQ CD AbbVie Pro (v0.2) has been developed based on the DRAFT RINVOQ CD CLM, ALL-RNQG-220127 (v1.0).
RINVOQ CD was approved by the European Commission in April 2023 and the DRAFT CLM is being updated accordingly but is not final approved. When implemented locally, affiliates must align AbbVie Pro to the forthcoming final approved RINVOQ CD CLM, ALL-RNQG-220127 (version to be determined).
Note to Affiliates: Please evaluate use of ALL claims, graphs/tables, and corresponding references (e.g., data on file, abstracts, posters, manuscripts) according to local standards, codes, and regulations.
RINVOQ® (upadacitinib) is indicated for the treatment of adult patients with moderately to severely active Crohnʼs disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1
RINVOQ achieved its co-primary endpoints of endoscopic response and clinical remission at Week 12 (Induction) and Week 52 (Maintenance)1
▼ 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.
RINVOQ is an oral, once daily, selective and reversible JAK inhibitor now approved for the treatment of adult patients with moderately to severely active Crohn’s disease 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 12-week induction studies evaluated RINVOQ 45 mg QD vs placebo, and 1 52-week maintenance treatment and long-term extension study evaluated RINVOQ 15 mg QD and RINVOQ 30 mg QD vs placebo.1
Learn more about RINVOQ in our quick introductory video.
[Affiliate to link to locally approved project ALL-RNQG-220166]
Week 12 and Week 52†
*Mucosal healing is defined as SES-CD ulcerated surface subscore of 0 in patients with SES-CD ulcerated surface subscore ≥1 at baseline.
†Nominal P<0.001; not multiplicity-controlled.
RINVOQ achieved clinical response as early as Induction Week 2, with clinical remission maintained to Week 521
RINVOQ achieved corticosteroid-free clinical remission at Induction Week 12 and Week 52 (Maintenance)1*
*Steroid taper starting at Week 4.
Early endoscopic response and clinical remission at Week 12 (co-primary endpoints)1
The Week 12 analysis evaluated randomized patients who received at least one dose of sudy drug in the randomized induction.2
*P<0.001; RINVOQ vs placebo.
Long-term endoscopic response and clinical remission at Week 52 (co-primary endpoints)1
The efficacy analysis at Week 52 evaluated 502 patients who acheived clinical response (SF/APS) with the 12-week RINVOQ 45 mg QD induction treatment.1
*P<0.001; RINVOQ vs placebo.
[Affiliates to insert additional safety information here, per local regulations]
Across 7 approved indications in rheumatology, dermatology, and gastroenterology1
APS: abdominal pain score; CDAI: Crohn’s Disease Activity Index; CR-100: clinical response 100; JAK: Janus kinase; QD: once daily; SES-CD: simple endoscopic activity score for Crohn’s disease; SF: stool frequency.
Study designs: the U-EXCEL and U-EXCEED induction studies were both multicenter, double-blind, placebo-controlled clinical studies. In U-EXCEL (N=526 [287 bio-naive, 239 biologic failures]) and U-EXCEED (N=495 biologic failures only), patients were randomized to RINVOQ 45 mg QD or placebo for 12 weeks with a 2:1 treatment allocation ratio and included in the efficacy analysis. In both studies, induction nonresponders were allowed to enter an additional 12-week open-label extended treatment period. All enrolled patients had moderately to severely active CD defined as SF ≥4 and/or APS ≥2, plus an SES-CD ≥6 (≥4 for patients with isolated ileal disease) excluding the narrowing component. U-ENDURE maintenance was a multicenter, double-blind, placebo-controlled clinical study with 502 patients who achieved clinical response (≥30% decrease in average daily SF and/or in APS, neither worse than baseline) to 12 weeks of RINVOQ 45 mg QD induction treatment. These patients were rerandomized 1:1:1 to receive either RINVOQ 15 mg QD, 30 mg QD, or placebo.1
Endoscopic response (co-primary endpoint): decrease in SES-CD >50% from baseline of the induction study (or for patients with an SES-CD of 4 at baseline of the induction study, at least a 2-point reduction from baseline of the induction study). Clinical remission (co-primary endpoint; SF/APS): average daily SF ≤2.8 and APS ≤1.0 and neither greater than baseline. Clinical response (CR-100): decrease of at least 100 points in CDAI from baseline. Induction steroid-free clinical remission (secondary multiplicity-controlled endpoint; SF/APS): discontinuation of steroid and achievement of clinical remission (average daily SF ≤2.8 and APS ≤1.0 and neither greater than baseline) among patients on steroids at baseline. Maintenance of steroid-free clinical remission (secondary endpoint, SF/APS): steroid-free for 90 days prior to Week 52 and achievement of clinical remission (average daily SF ≤2.8 and APS ≤1.0 and neither greater than baseline).
Please consult the Summary of Product Characteristics for further details regarding contraindications, monitoring requirements, and additional prescribing information prior to initiating RINVOQ.
Crohnʼs disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Ulcerative colitis
RINVOQ 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.
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) 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.
Ankylosing spondylitis
(AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) 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.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
[Affiliates to insert local summary of safety]
REFERENCES
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; April 2023.
- Loftus EV Jr, Colombel JF, Lacerda AP, et al. Efficacy and safety of upadacitinib induction therapy in patients with moderately to severely active Crohn’s disease: results from a randomized phase 3 U-EXCEL study. Presented at: United European Gastroenterology Week; October 8-11, 2022; Vienna, Austria.
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[Affiliates to insert local adverse events reporting websites]
ALL-RNQG-220173 Date of preparation: April 2023
Adverse events should also be reported to AbbVie on GBPV@abbvie.com