Open-label long-term extension (LTE): GALAXI 2 & 3
GALAXI Trial Design1,2
GALAXI 2 & 3 were randomized, double-blind, controlled treat-through studies (pooled GALAXI 2 & 3; N=1021) that assessed TREMFYA superiority vs both STELARA® (ustekinumab) and placebo in adult patients with moderately to severely active Crohn’s disease who had a history of inadequate response, loss of response, or intolerance to oral corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), and/or biologic therapy (ie, TNF blockers or vedolizumab).
GALAXI 2 & 3 Open-Label LTE
- All participants who, in the opinion of the investigator, will continue to benefit from treatment were eligible to enter the LTE
- Of the 286 patients randomized to TREMFYA 100 mg SC q8w and 296 patients randomized to TREMFYA 200 mg SC q4w, 88% (251/286) and 86% (256/296), respectively, continued into the LTE as part of the LTE efficacy analysis set
- Study was unblinded after final Week 48 maintenance analysis was completed. Patients randomized to placebo were discontinued after study unblinding and were not included in the open-label efficacy analysis
GALAXI LTE assessed efficacy and safety through 3 years2
Open-label Long-Term Extension
Majority of patients were in clinical remission at 1 year, 2 years, and 3 years2*†
‡AO for Week 144 included only patients who entered the LTE and remained in the study at Week 144.
DATA LIMITATION: Clinical remission from Week 48 through Week 144 was prespecified but not multiplicity 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 significance can be made.
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 intercurrent events.
Use the lowest effective recommended dosage to maintain therapeutic response.
With TREMFYA, 56% of patients were in deep remission at 3 years2*§
¶AO for Week 144 included only patients who entered the LTE and remained in the study at Week 144.#
DATA LIMITATION: Deep remission at Week 144 among patients who entered the LTE and remained in the study was a prespecified exploratory endpoint but not multiplicity 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 significance can be made.
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 intercurrent events.
Use the lowest effective recommended dosage to maintain therapeutic response.
*Week 48 was defined as 1 year. Week 96 was defined as 2 years. Week 144 was defined as 3 years.
†Clinical remission was defined as CDAI score <150.2
§Deep remission is defined as achieving both clinical remission and endoscopic remission. Clinical remission is defined as CDAI score <150. Endoscopic remission is defined as SES-CD score ≤4 and at least a 2-point reduction from baseline and no subscore greater than 1 in any individual component.
||Based on a pooled analysis of GALAXI 2 and GALAXI 3.2
#LTE Efficacy Analysis Set. Data shown are from patients who received continuous treatment up to the analysis timepoint and had data available at the analysis timepoint. Participants who had a dose adjustment are not included from the day after the date of dose adjustment.
CDAI=Crohn’s Disease Activity Index; DDD=Drug Distribution Data; IL-23i=interleukin-23 inhibitor; IV=intravenous; LTE=long-term extension; NPA=National Prescription Audit; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn's Disease; UC=ulcerative colitis.
