Long-term Extension Design
QUASAR LTE assessed efficacy and safety through 2 years1
Open-label long-term extension (LTE) of the phase 3 maintenance study1
QUASAR Trial Design
The QUASAR program was a multicenter, randomized, double-blind, placebo-controlled induction study (N=701) and maintenance study (N=568) in adult patients with moderately to severely active UC who had an inadequate response, loss of response, or intolerance to corticosteroids, conventional immunomodulators (azathioprine, 6-mercaptopurine), biologic therapy (tumor necrosis factor [TNF] blockers, vedolizumab), and/or a Janus kinase (JAK) inhibitor.2 View primary endpoint data
QUASAR LTE
All patients completing the maintenance study were eligible to enter the LTE1
Of the 188 patients randomized to TREMFYA® 100 mg SC q8w and 190 patients randomized to TREMFYA® 200 mg SC q4w in the maintenance study, 82.4% (155/188) and 77.9% (148/190), respectively, continued into the LTE as part of the LTE randomized analysis set. The LTE randomized full analysis set included all patients with an induction baseline modified Mayo score of 5 to 9 who were randomized in the maintenance study and did not experience a dose adjustment (or sham dose adjustment) and received at least 1 (partial or complete) dose of study intervention in the LTE1
Study was unblinded after final Week 44 maintenance analysis was completed. Patients randomized to placebo were discontinued after study unblinding and were not included in the open-label LTE efficacy analysis1
q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.
Symptomatic Remission
Majority of patients were in symptomatic remission at 1 year and through 2 years1*†‡
Of the patients who entered the LTE and remained in the study at Week 92
As-observed (AO) analysis: All observed data were analyzed exactly as collected, with missing data excluded from calculations for that visit, and regardless of whether patients experienced events during the study that could have affected the outcome measurement (such as discontinuing study intervention or having an ostomy or colectomy).1
Symptomatic remission through 2 years*‡
Symptomatic remission at 1 year (QUASAR major secondary endpoint): TREMFYA® 200 mg SC q4w 69% (131/190, P<0.001), TREMFYA® 100 mg SC q8w 70% (132/188, P<0.001), and placebo SC 37% (71/190)
Use the lowest effective recommended dosage to maintain therapeutic response.
DATA LIMITATION: Symptomatic remission through Week 92 during the LTE was prespecified but not controlled. Patients who dropped out of the LTE or who had missing data were not included in this as-observed analysis, which may increase the percentages of responders. No statistical or clinical significance can be made.1
*Week 44 of the maintenance study was defined as 1 year. Week 92 of the LTE was defined as 2 years.1
†LTE randomized full analysis set. Data are shown for participants who were in clinical response to TREMFYA® IV induction dosing and were randomized on entry into the maintenance study and did not experience a dose adjustment (including a sham dose adjustment) from Week 8 through Week 32.1
‡Symptomatic remission was defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0.1
CI=confidence interval; IV=intravenous; LTE=long-term extension; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.
Endoscopic Improvement
90% of patients who were in endoscopic improvement at 1 year were in endoscopic improvement at 2 years1*†‡
Endoscopic improvement‡ at Week 44* of maintenance (Major secondary endpoint):
- TREMFYA® 200 mg SC q4w: 52% (98/190; P<0.001)
- TREMFYA® 100 mg SC q8w: 49.5% (93/188; P<0.001)
- Placebo SC: 19% (36/190)
Endoscopic Improvement‡ in the Open-label LTE
(As-observed Analysis)
Of the patients who entered the LTE and
remained in the study at Week 92
90% of patients on TREMFYA® who showed endoscopic improvement‡ at 1 year maintained endoscopic improvement at 2 years
As-observed (AO) analysis: All observed data were analyzed exactly as collected, with missing data excluded from calculations for that visit, and regardless of whether patients experienced events during the study that could have affected the outcome measurement (such as discontinuing study intervention or having an ostomy or colectomy).
Use the lowest effective recommended dosage to maintain therapeutic response.
DATA LIMITATION: Maintenance of endoscopic improvement at Week 92 during the LTE was prespecified but not controlled. Patients who dropped out of the LTE or who had missing data were not included in this as-observed analysis, which may increase the percentages of responders. No statistical or clinical significance can be made.
*Week 44 of the maintenance study was defined as 1 year. Week 92 of the LTE was defined as 2 years.
†LTE randomized full analysis set. Data are shown for participants who were in clinical response to TREMFYA® IV induction dosing and were randomized on entry into the maintenance study and did not experience a dose adjustment (including a sham dose adjustment) from Week 8 through Week 32.
‡Endoscopic improvement was defined as endoscopy subscore of 0 or 1 with no friability as assessed by a central reader. After Week 44 of maintenance study, only the local read, without friability, was available.
IV=intravenous; LTE=long-term extension; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.
