Clinical Remissiona at Weeks 10 and 521
Clinical Remissiona
at Weeks 10 and 521
In the Subset Of Patients in
Clinical Remission at Week 52 and
Had Continuous ZEPOSIA
Exposure, 82% of Patients
Were
in Clinical Remission at Week 98 and 76% of Patients Were in Clinical Remission at Week 146 (Observed Cases)2,3d
OLE Study Design:
The TRUE NORTH OLE is an ongoing trial that enrolled participants who were nonresponders at the end of induction, experienced disease relapse during maintenance, or completed maintenance treatment in the Phase 3 TRUE NORTH study or remained at study closure and received once-daily oral ZEPOSIA 0.92 mg in the Phase 2 TOUCHSTONE OLE. A total of 823 patients from TRUE NORTH entered the TRUE NORTH OLE as of the cutoff date (January 10, 2022). Mean ZEPOSIA exposure through the OLE was 2.7 years.2,4,5 For full study design, click here.
OLE endpoints were evaluated at Week 46 and Week 94 for a subset of patients who were in clinical remission or clinical response at Week 52 of the TRUE NORTH parent study and who had continuous ZEPOSIA exposure. Endpoints include clinical remission, clinical response, endoscopic improvement, and CS-free remission. Safety was evaluated for all 823 patients who entered the OLE from the TRUE NORTH parent study. The mean exposure to ZEPOSIA through the OLE was 2.7 years.2-4,6
Data were analyzed in the ITT population using OC and NRI. OC used the number of patients remaining in the study at the corresponding time point. NRI used the number of patients remaining in the study at the corresponding time point and those who withdrew before the time point but would have reached the time point if they had stayed.4
These analyses were not prespecified and represent a subgroup of all patients from TRUE NORTH who entered OLE.3
In the NRI analysis of a subset of patients in clinical remission at Week 52 and had continuous ZEPOSIA exposure, 65% (54/83) were in clinical remission at Week 98 (Week 46 of OLE) and 49% (41/83) were in clinical remission at Week 146 (Week 94 of OLE).2,3
Clinical remission is defined as: rectal bleeding subscore (RBS)=0, stool frequency subscore (SFS) 0 or 1 (and a decrease of ≥1 point from baseline SFS), and endoscopy subscore 0 or 1 without friability.1
ITT=intent-to-treat; NRI=nonresponder imputation; OLE=open-label extension; SFS=stool frequency subscore; TNFI=tumor necrosis factor inhibitor.
Clinical Responsee
at Weeks 10 and 521
In the Subset Of Patients in Clinical Response at Week 52 and Had Continuous ZEPOSIA Exposure, 96% Were in Clinical Response at Week 98 and 91% Were in Clinical Response at Week 146 (Observed Cases)2d
OLE Study Design: The TRUE NORTH OLE is an ongoing trial that enrolled participants who were nonresponders at the end of induction, experienced disease relapse during maintenance, or completed maintenance treatment in the Phase 3 TRUE NORTH study or remained at study closure and received once-daily oral ZEPOSIA 0.92 mg in the Phase 2 TOUCHSTONE OLE. A total of 823 patients from TRUE NORTH entered the TRUE NORTH OLE as of the cutoff date (January 10, 2022). Mean ZEPOSIA exposure through the OLE was 2.7 years.2,4,5
OLE endpoints were evaluated at Week 46 and Week 94 for a subset of patients who were in clinical remission or clinical response at Week 52 of the TRUE NORTH parent study and who had continuous ZEPOSIA exposure. Endpoints include clinical remission, clinical response, endoscopic improvement, and CS-free remission. Safety was evaluated for all 823 patients who entered the OLE from the TRUE NORTH parent study.2-4,6
Data were analyzed in the ITT population using OC and NRI. OC used the number of patients remaining in the study at the corresponding time point. NRI used the number of patients remaining in the study at the corresponding time point and those who withdrew before the time point but would have reached the time point if they had stayed.4
In the NRI analysis of a subset of patients in clinical response at Week 52 and had continuous ZEPOSIA exposure, 71% (n=93/131) were in clinical response at Week 98 (Week 46 of OLE) and 56% (74/131) were in clinical response at Week 146 (Week 94 of OLE)2,3
These analyses were not prespecified and represent a subgroup of all patients from TRUE NORTH who entered the OLE.3
CS=corticosteroid; ITT=intent-to-treat; OLE=open-label extension; RBS=rectal bleeding subscore; SFS=stool frequency subscore; TNFi=tumor necrosis factor inhibitor.
In a post-hoc analysis, patients treated
with ZEPOSIA observed a decrease
in RBS and SFS as early as Week 2,
1 week after completing the 7-day
dose titration.1,8
RBS=rectal bleeding subscore; SFS=stool frequency subscore.
This analysis examined ZEPOSIA efficacy in patients from TRUE NORTH who were treated with double-blind ZEPOSIA but did not achieve clinical response at Week 10 and subsequently continued ZEPOSIA in the OLE (N=150) and observed extended treatment with ZEPOSIA for an additional 10 weeks.9
Efficacy analyses of symptomatic response were not prespecified.8,9
OLE=open-label extension; RBS=rectal bleeding subscore; SFS=stool frequency subscore.
The relationship of endoscopic-histologic mucosal improvement, as defined in UC Study 1 and UC Study 2 at Weeks 10 and 52, to disease progression and long-term outcomes, was not evaluated.1
EHMI=endoscopic-histologic mucosal improvement; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis.
Remission at Week 52
In The Subset Of Patients in Clinical Remission at Week 52 and Had Continuous ZEPOSIA Exposure, 80% Were in CS-free remission at Week 98 and 74% Were in CS-free remission at Week 146 (Observed Cases)2,3op
In the NRI analysis of a subset of patients in clinical remission at Week 52 and had continuous ZEPOSIA exposure, 64% (n=53/83) were in CS-free remission at Week 98 (Week 46 of OLE) and 48% (n=40/83) were in CS-free remission at Week 146 (Week 94 of OLE).2
These analyses were not prespecified and represent a subgroup of all patients from TRUE NORTH who entered OLE.3
CS=corticosteroid; ITT=intent-to-treat; NRI=non-responder imputation; OLE=open-label extension; RBS=rectal bleeding subscore; SFS=stool frequency subscore.
TNFi-naїve patients at Week 10
TNFi-exposed patients at Week 10
TNFi-naїve patients at Week 52
TNFi-exposed patients at Week 52
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