For US Healthcare Professionals
I am a
Crohn’s Disease Specialist
For the treatment of adult
patients with moderately to
severely active Crohn’s disease
In the GRAVITI clinical trial, of
patients receiving TREMFYA1:
- -56% (400 mg SC, N=225) were
in clinical remission at 12 weeks
(co-primary endpoint) - -34% (400 mg SC, N=225) were
in endoscopic response at
12 weeks (co-primary endpoint)
*40% (N=111) of patients taking TREMFYA 200 mg SC
q4w and 31% (N=114) taking TREMFYA 100 mg SC
q8w were in endoscopic
remission at 1 year, based
on areas visualized on colonoscopy, which may not
represent the deeper bowel layer or entire GI tract.
DATA LIMITATION: Endoscopic remission at Week 48
was a prespecified exploratory endpoint not adjusted
for multiplicity.
No statistical significance can be made.
†This is based on information licensed from NPA/DDD with
business rules applied and captured only approved
induction doses of IL-23 inhibitors for
adults with moderately
to severely active Crohn’s disease or ulcerative colitis.
Data used to support this are from 2/21/2026 - 3/27/2026.
GRAVITI and GALAXI are separate studies with different endpoint assessments. Cross-trial comparisons are not to be made.
TREMFYA showed early separation from placebo in clinical
response by Week 4 for both SC and IV induction2
GRAVITI and GALAXI are separate studies with different endpoint assessments. Cross-trial comparisons are not to be made.
DATA LIMITATION: For GRAVITI, clinical response at Weeks 4 and 8 were prespecified but not adjusted for multiplicity. For both GALAXI studies, clinical response at Week 4 was adjusted for multiplicity (with nominal P-value), while data for Weeks 8 and 12 were not. No statistical significance can be made.
Clinical response: ≥100-point reduction from baseline in CDAI score1
CDAI=Crohn’s Disease Activity Index; IV=intravenous; q4w=every 4 weeks; SC=subcutaneous.
MAINTENANCE RESULTS IN GRAVITI (SC Induction)
With TREMFYA, patients were in deep remission at 1 year1
Deep remission was defined as clinical remission and endoscopic remission at 1 year
DATA LIMITATION: Endoscopic remission at Week 48 was a prespecified exploratory endpoint not adjusted for multiplicity. No statistical significance can be made.2
*Clinical remission defined as CDAI score <150.1
†Endoscopic response was defined as >50% improvement from baseline in SES-CD score.1
‡Combined data for both TREMFYA 100 mg SC q8w and 200 mg SC q4w dosing arms. Patients in both arms received the same induction dose of TREMFYA 200 mg
(IV infusion) at Weeks 0, 4, and 8.1
§Endoscopic remission was defined as SES-CD score ≤4 and ≥2-point reduction from baseline and no subscore >1 in any individual component.1
||Patients in both 200 mg SC q4w and 100 mg SC q8w groups also received 3 SC induction doses.
CDAI=Crohn’s Disease Activity Index; DDD=Drug Distribution Data; GI=gastrointestinal; IL-23i=interleukin-23 inhibitor; IV=intravenous; 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.
Schedule a meeting with a local representative or an APP specialist
from Johnson & Johnson
APP=advanced practice provider.
References: 1. TREMFYA [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.