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, 73% of Patients
Were
in Clinical Remission at Week 98
(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 cut-off date (September 30, 2020). Mean ZEPOSIA exposure in the OLE was 1.5 years.3,4 For full study design, click here.
Clinical remission, clinical response, endoscopic improvement, and CS-free remission were evaluated at Week 46 for all patients who entered the OLE from the TRUE NORTH parent study and in a subset of patients in clinical remission at Week 52 and had continuous ZEPOSIA exposure.2,3
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.3
In the NRI analysis of a subset of patients in clinical remission at Week 52 and had continuous ZEPOSIA exposure, 53% (n=30/57) were in clinical remission at Week 98 (Week 46 of OLE).2
For all patients in OLE (N=823)3:
ITT=intent-to-treat; NRI=nonresponder imputation; OC=observed case; OLE=open-label extension; RBS=rectal bleeding subscore; 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, 97% of Patients Were
in
Clinical Response at Week 98
(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 cut-off date (September 30, 2020). Mean ZEPOSIA exposure in the OLE was 1.5 years.3,4
Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)-free remission were evaluated at Week 46 for all patients who entered the OLE from the TRUE NORTH parent study and in a subset of patients in clinical response at Week 52 and had continuous ZEPOSIA exposure.2,3
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.3
In the NRI analysis of a subset of patients in clinical response at Week 52 and had continuous ZEPOSIA exposure, 64% (n=61/95) were in clinical response at Week 98 (Week 46 of OLE).2
For all patients in OLE (N=823)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.1,7
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.6
Efficacy analyses of symptomatic response were not prespecified.6
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, 71% of Patients Were in
CS-Free Remission at Week 98
(Observed Cases)2n,o
In the NRI analysis of a subset of patients who were in clinical remission at Week 52 and who had continuous ZEPOSIA exposure, 51% (n=29/57) were in CS-free remission at Week 98 (Week 46 of OLE).2
CS=corticosteroid; ITT=intent-to-treat; NRI=non-responder imputation; OC=observed case; 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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