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.
A Phase 3 trial program involving 3 studies:1
2 induction studies (U-EXCEL and U-EXCEED) and 1 maintenance study (U-ENDURE). 1,021 moderately to severely active CD patients evaluating RINVOQ 45 mg QD vs placebo for induction, and RINVOQ 15 mg QD or 30 mg QD vs placebo for maintenance treatment (N=502).1*
*Patients who achieved clinical response (≥30% decrease in average daily stool frequency and/or in abdominal pain score, neither worse than baseline) to 12 weeks of RINVOQ 45 mg QD induction treatment entered maintenance.
RAPID RESPONSE, DURABLE CLINICAL REMISSION1,2
Clinical response (CR-100) as early as Week 2 in Induction and clinical remission (SF/APS) maintained to Maintenance Week 521,2
The Week 12 analysis evaluated randomized patients who received at least one dose of study drug in the randomized induction.3 The efficacy analysis at Week 52 evaluated 502 patients who achieved clinical response (SF/APS) with the 12-week RINVOQ 45 mg QD induction treatment.1 Clinical response (CR-100) at Week 2 and Week 12 and maintenance of clinical remission (SF/APS) at Week 52 were multiplicity-controlled secondary endpoints.
*P<0.001; RINVOQ vs placebo.
Clinical response (CR-100) as early as Week 2 in Induction and clinical remission (SF/APS) maintained to Maintenance Week 521,2
The Week 12 analysis evaluated randomized patients who received at least one dose of study drug in the randomized induction.3 The efficacy analysis at Week 52 evaluated 502 patients who achieved clinical response (SF/APS) with the 12-week RINVOQ 45 mg QD induction treatment.1 Clinical response (CR-100) at Week 2 and Week 12 and maintenance of clinical remission (SF/APS) at Week 52 were multiplicity-controlled secondary endpoints.
*P<0.01; †P<0.001; RINVOQ vs placebo.
EARLY AND LONG-TERM STEROID-FREE CLINICAL REMISSION (SF/APS) ACHIEVED AT INDUCTION WEEK 12 AND MAINTENANCE WEEK 521
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. The post hoc analysis data corresponding to “97% of patients in clinical remission (SF/APS) at 52 weeks were steroid-free” is data on file. Please assess if this data and reference can be used to support inclusion of “97% of patients in clinical remission (SF/APS) at 52 weeks were steroid-free” in the AbbVie Pro site, according to local standards, codes, and regulations. In ALL-RNQG-220127 Rinvoq CD CVA, this data is approved by Global for reactive use only.
INDUCTION WITH THE POSSIBILITY TO DISCONTINUE STEROIDS QUICKLY1
Steriod-free clinical remission (SF/APS)1
The Week 12 analysis evaluated randomized patients who received at least one dose of study drug in the randomized induction.3 The efficacy analysis at Week 52 evaluated 502 patients who achieved clinical response (SF/APS) with the 12-week RINVOQ 45 mg QD induction treatment.1
*P<0.001; RINVOQ vs placebo. †Percentage of patients on steroids at baseline who achieved clinical remission and were not on steroids at Week 52.
Percentage calculated from post hoc analysis
of patients in clinical remission (SF/APS) at 52 weeks were steroid-free5†
The percentage shown here is based on a post hoc calculation [134/138 (97%)] performed on the subpopulation patients who achieved clinical remission (SF/APS) at Week 52. The proportion (and 95% CI) of patients without steroid use at Week 52 was calculated for the combined RINVOQ treatment group (15 mg QD or 30 mg QD). This calculation differs from the graph on the left showing the pre-ranked, multiplicity-controlled secondary endpoint of steroid-free clinical remission (SF/APS) at Week 52, which achieved significance for RINVOQ vs placebo.5
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
Induction steroid-free clinical remission (secondary multiplicity-controlled endpoint; SF/APS): discontinuation of steroids 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). Clinical response (CR-100): decrease of at least 100 points in CDAI from baseline. Maintenance of clinical remission (secondary, multiplicity-controlled endpoint; SF/APS): achievement of clinical remission (SF/APS) at Week 52 in patients who achieved clinical remission at the entry of the maintenance study. Clinical remission (co-primary endpoint; SF/APS): average daily SF ≤2.8 and APS ≤1.0 and neither greater than baseline.
UP NEXT
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]
[Affiliates to insert local summary of safety]
REFERENCES
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; April 2023.
- Loftus EV Jr, Panés J, Lacerda AP, et al. Upadacitinib induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2023;388(21):1966-1980. doi:10.1056/NEJMoa2212728
- 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.
- Panes J, Loftus EV Jr, Lacerda AP, et al. Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active Crohn’s disease: results from a randomized phase 3 U-ENDURE maintenance study. Presented at: American College of Gastroenterology Annual Meeting; October 21-26, 2022; Charlotte, NC.
- Data on file, AbbVie Inc. ABVRRTI75033.
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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
MAINTENANCE OF CLINICAL REMISSION (CDAI) AT MAINTENANCE WEEK 524
Maintenance of clinical remission (CDAI) at Week 52 was a ranked secondary, multiplicity-controlled endpoint in the US.
*P<0.0001; RINVOQ vs placebo.