A Phase 3 RINVOQ clinical trial program in Crohn's disease
A Phase 3 clinical trial program involving 3 studies: 2 replicate induction studies (U-EXCEED and U-EXCEL) and 1 maintenance study (U-ENDURE) evaluated RINVOQ 45 mg vs placebo for induction, and RINVOQ 15 mg and 30 mg vs placebo for maintenance treatment. The co-primary endpoints of disease control were endoscopic response (per simple endoscopic score for Crohn’s disease [SES-CD]) and clinical remission (per stool frequency and abdominal pain score [SF/APS]) at Week 12 and Week 52.1,2*
*Patients who achieved clinical response (SF/APS) with the 12-week RINVOQ 45 mg QD induction treatment entered the maintenance phase. Clinical non-responders (per SF/APS) entered extended induction with RINVOQ 30 mg QD for a further 12 weeks. EMA protocol.1
ENDOSCOPIC HEALING IS A KEY TARGET IN THE TREATMENT OF CROHN’S DISEASE3
Endoscopic healing is a STRIDE-II long-term target of CD treatment.3 In a Phase 3 clinical trial program evaluating the efficacy and safety of RINVOQ in CD, 3 different endpoints were used to measure the extent of endoscopic healing: endoscopic response, endoscopic remission and mucosal healing.1,2
ENDPOINTS DEFINED
Endoscopic response
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).
Significant 
1,2
Endoscopic response = 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) at Week 12 and Week 52; co-primary endpoint (NRI-C).1
*P<0.001; RINVOQ vs placebo. Multiplicity-controlled analysis.
RINVOQ induction and maintenance studies achieved the co-primary endpoints of clinical remission
(SF/APS; average daily SF ≤ 2.8 and APS ≤ 1.0 and neither greater than baseline) and endoscopic response at Week 12 and Week 52.1,2
Significant 1,2
Endoscopic response = 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) at Week 12 and Week 52; co-primary endpoint (NRI-C).1
*P<0.001; RINVOQ vs placebo. Multiplicity-controlled analysis.
RINVOQ induction and maintenance studies achieved the co-primary endpoints of clinical remission
(SF/APS; average daily SF ≤ 2.8 and APS ≤ 1.0 and neither greater than baseline) and endoscopic response at Week 12 and Week 52.1,2
in year 24
Endoscopic response = 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); as observed analysis.4
Abstract data; from the U-ENDURE long-term extension study.
Error bars show 95% CI based on the normal approximation to the binomial distribution. As-observed analyses did not impute values for missing data.
All comparisons are non-ranked and not controlled for multiplicity; p-values not reported.
ENDOSCOPIC HEALING IS A KEY TARGET IN THE TREATMENT OF CROHN’S DISEASE3
Endoscopic healing is a STRIDE-II long-term target of CD treatment.3 In a Phase 3 clinical trial program evaluating the efficacy and safety of RINVOQ in CD, 3 different endpoints were used to measure the extent of endoscopic healing: endoscopic response, endoscopic remission and mucosal healing.1,2
ENDPOINTS DEFINED
Endoscopic remission
SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore >1 in any individual variable.
Significant 
1,2
Endoscopic remission (SES-CD) = SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore >1 in any individual variable at Week 12 and Week 52; secondary endpoints (NRI-C).1
*P<0.001; RINVOQ vs placebo. Multiplicity-controlled analysis.
maintained in Year 24
Endoscopic remission (SES-CD) = SES-CD ≤4 and at least a 2-point reduction versus baseline and no subscore >1 in any individual variable; as-observed analysis. Maintenance of endoscopic remission = endoscopic remission at Week 0 and Week 48 of the extension study; as-observed analysis.
U-ENDURE Extension Week 0 and Week 48
(year 2 of RINVOQ treatment)
Abstract data; from the U-ENDURE long-term extension study.
Error bars show 95% CI based on the normal approximation to the binomial distribution.
As-observed analyses did not impute values for missing data.
All comparisons are non-ranked and not controlled for multiplicity; p-values not reported.
ENDOSCOPIC HEALING IS A KEY TARGET IN THE TREATMENT OF CROHN’S DISEASE3
Endoscopic healing is a STRIDE-II long-term target of CD treatment.3 In a Phase 3 clinical trial program evaluating the efficacy and safety of RINVOQ in CD, 3 different endpoints were used to measure the extent of endoscopic healing: endoscopic response, endoscopic remission and mucosal healing.1,2
ENDPOINTS DEFINED
Mucosal healing
Mucosal healing (ulcer-free endoscopy) = SES-CD ulcerated surface subscore of 0 at Week 12 and Week 52 among patients with SES-CD ulcerated surface subscore ≥1 at baseline; exploratory endpoints.2
1,2
Mucosal healing (ulcer-free endoscopy) = SES-CD ulcerated surface subscore of 0 at Week 12 and Week 52 among patients with SES-CD ulcerated surface subscore ≥1 at baseline; exploratory endpoints (NRI-C).2
All comparisons are non-ranked and not controlled for multiplicity; p-values not reported.
APS, abdominal pain score; CD: Crohn’s disease; CI, confidence interval; EMA, European Medicines Association; ITT, intention to treat; NRI-C, non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; QD, once daily; SES-CD, simple endoscopic score for Crohn's disease; SF, stool frequency.
REFERENCES
- RINVOQ Product Information.
- Loftus EV, et al. N Engl J Med. 2023;388:1966–80 (incl. supplementary appendix).
- Turner D, et al. Gastroenterology 2021;160(5):1570–83.
- D’Haens G, et al. Presented at the 19th Congress of ECCO, 21–24 Feb 2024, Stockholm, Sweden: OP10.
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AU-RNQG-240040. March 2024