MAINTENANCE RESULTS IN GALAXI (IV Induction)

TREMFYA® is the only IL-23i to demonstrate superiority vs STELARA® across all pooled endoscopic endpoints in registrational trials1,2*

~1/3 of patients achieved deep remission (clinical and endoscopic remission) at 1 year with TREMFYA®

Overall population: secondary endpoint (pooled GALAXI 2 and GALAXI 3)
(tested for superiority)

TREMFYA® vs STELARA® deep remission data at Week 48
TREMFYA® vs STELARA® deep remission data at Week 48
TREMFYA® vs STELARA® endoscopic response, clinical remission, and endoscopic remission data at Week 48
TREMFYA® vs STELARA® endoscopic response, clinical remission, and endoscopic remission data at Week 48

Use the lowest effective recommended dosage to maintain therapeutic response.

Subsequent endpoints in the prespecified hierarchical testing procedure were not statistically significant and therefore are not reported here.

*Based on a pooled analysis of GALAXI 2 and GALAXI 3.2

Deep remission was defined as achieving both clinical remission (CDAI score <150) and endoscopic remission (SES-CD ≤4 and at least a 2-point reduction from baseline and no subscore greater than 1 in any individual component).2

Patients in both 200 mg SC q4w and 100 mg SC q8w groups also received 3 IV induction doses.

§Endoscopic response was defined as ≥50% improvement from baseline in SES-CD score or SES-CD Score ≤2.2

||Clinical remission defined as CDAI score <150.2

Endoscopic remission defined as SES-CD ≤4 and a ≥2-point reduction from baseline and no subscore greater than 1 in any individual component.2

CDAI=Crohn’s Disease Activity Index; IL-23i=interleukin-23 inhibitor; IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease.

STELARA® is indicated for the treatment of adults with moderately to severely active Crohn’s disease. For more
information on STELARA®, please read the full Prescribing Information and Important Safety Information.

teal vector
teal vector

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References: 1. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.