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SC Study Design | SC Induction (GRAVITI)

The only IL-23 inhibitor approved for Crohn’s disease with SC induction dosing assessed in a treat-through study to resemble clinical practice†

GRAVITI was a randomized, double-blind, placebo-controlled, phase 3, treat-through study1,2

Induction

Induction timeline
Long-term extension
  • GRAVITI was a randomized, double-blind, placebo-controlled, phase 3, treat-through study1,2
  • A total of 340 patients were randomized 1:1:1 into each treatment arm1
  • Patients with a history of inadequate response, loss of response, or intolerance to oral corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), and/or biologic therapy (TNF blockers or vedolizumab) were enrolled1
  • Participants in all treatment groups who met rescue criteria were considered not to have met endpoints after Week 162

†"Only" based on approved selective IL-23 inhibitors for moderately to severely active Crohn’s disease as of March 2025. Compared to Skyrizi® (risankizumab-rzaa) and Omvoh® (mirikizumab-mrkz) induction and maintenance dosing. Skyrizi® and Omvoh® are not available as SC injection for induction therapy in Crohn's disease.1,3,4

‡All participants who, in the opinion of the investigator, will continue to benefit from treatment (ie, based on Week 48 clinical and endoscopic evaluations) are eligible to enter the LTE to receive approximately 1 additional year of treatment, during which time the longer-term efficacy and safety of TREMFYA® will be evaluated.2

IL-23=interleukin 23; LTE=long-term extension; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; TNF=tumor necrosis factor.

Inclusion criteria1,2

  • Aged ≥18 years
  • Have moderately to severely active Crohn’s disease of at least 3 months’ duration, defined as:
    • Active Crohn’s disease at baseline, defined as baseline CDAI score ≥200 but ≤450 and either:
      • Mean daily SF count ≥4 or
      • Mean daily AP score ≥2
    • Screening endoscopy SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease)
  • Patients with a history of inadequate response, loss of response, or intolerance to oral corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), and/or biologic therapy (TNF blockers or vedolizumab) were enrolled

Exclusion criteria2

  • Had complications of Crohn’s disease (eg, symptomatic strictures or short gut syndrome) that might require surgery or confound the ability to assess treatment effect
  • Had a current abscess or was suspected to have an abscess
  • Bowel resection within 24 weeks, or other intra-abdominal or major surgery within 12 weeks
  • Had a draining (ie, functioning) stoma or ostomy
  • Prior exposure to IL-12/23 or IL-23 agents

AP=abdominal pain; CDAI=Crohn’s Disease Activity Index; IL-12/23=interleukin 12/23; IL-23=interleukin 23; SES-CD=Simple Endoscopic Score for Crohn’s Disease; SF=stool frequency; TNF=tumor necrosis factor.

TREMFYA®
400 mg SC q4w→100 mg SC q8wTREMFYA®
400 mg SC q4w→200 mg SC q4wPlacebo
SCTotal
Analysis set: randomized fullN=114N=111N=115N=340
Biologic-
naïve, n (%)		53 (46.5%)51 (45.9%)54 (47.0%)158 (46.5%)
Biologic-
failure, n (%)		54 (47.4%)50 (45.0%)53 (46.1%)157 (46.2%)
Age, years—mean (SD)37.4 (13.37)39.2 (12.70)36.1 (12.82)37.5 (12.99)
Male, n (%)65 (57.0%)68 (61.3%)66 (57.4%)199 (58.5%)
Race—white, n (%)79 (69.3%)75 (67.6%)69 (60.0%)223 (65.6%)
Crohn’s disease duration, years—mean (SD)9.23 (9.096)7.69 (6.819)7.04 (7.793)7.99 (7.996)
CDAI Score—mean (SD)300.8 (54.33)299.7 (53.79)294.3 (48.54)298.3 (52.19)
SES-CD Score—mean (SD)12.2 (6.86)11.6 (6.77)11.9 (6.93)11.9 (6.84)
Severe Endoscopic Disease (SES-CD score >16)26 (22.8%)25 (22.5%)24 (20.9%)75 (22.1%)
C-reactive protein (CRP) concentration in mg/L—median (IQR)5.2 (1.7; 13.3)5.8 (1.6; 16.2)8.0 (2.1; 15.7)6.0 (1.8; 15.2)
Abnormal CRP (>5 mg/L), n (%)58 (50.9%)60 (54.1%)69 (60.0%)187 (55.0%)
Fecal calprotectin in µg/g—median (IQR)649.5
(228.0; 1554.0)		578.0
(235.0; 1650.0)		702.0
(237.0; 1772.0)		626.0
(235.0; 1665.0)
Abnormal fecal calprotectin (>250 µg/g), n (%)83 (72.8%)76 (69.1%)84 (73.0%)243 (71.7%)
Involved GI areas (assessed by central reader)—ileum only25 (21.9%)27 (24.3%)22 (19.1%)74 (21.8%)

Individual patient coverage may vary.

CDAI=Crohn’s Disease Activity Index; GI=gastrointestinal; IQR=interquartile range; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; SD=standard deviation;
SES-CD=Simple Endoscopic Score for Crohn’s Disease.

12-Week Results

TREMFYA® SC induction demonstrated significant clinical and endoscopic results at Week 12 across both co-primary endpoints1

View Data for IV Induction

*Clinical remission defined as CDAI score <150.1

†Endoscopic response was defined as >50% improvement from baseline in SES-CD score.1

CDAI=Crohn’s Disease Activity Index; IV=intravenous; q4w=every 4 weeks; SC=subcutaneous; SES-
CD=Simple Endoscopic Score for Crohn’s Disease.

Both TREMFYA® SC and IV induction separated from placebo in clinical response as early as Week 42

GALAXI 2 and GALAXI 3 were randomized, double-blind, placebo- and active-controlled, parallel-group,
treat-through studies designed to resemble clinical practice

These are separate studies with different endpoint assessments. Cross-trial comparisons are not meant 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 or clinical significance can be made.2

Clinical response: ≥100-point reduction from baseline in CDAI score1

CDAI=Crohn’s Disease Activity Index; CI=confidence interval; q4w=every 4 weeks; SC=subcutaneous.

See IV Induction Study Design (GALAXI)

Induction Results in SC (GRAVITI) and IV (GALAXI)

Both TREMFYA® SC and IV induction demonstrated clinical remission and endoscopic response at Week 121*†

See IV Induction Study Design (GALAXI)

GALAXI 2 and GALAXI 3 were randomized, double-blind, placebo-controlled trials
designed to resemble clinical practice1

These are separate studies with different endpoint assessments. Cross-trial comparisons are not meant to be made.

*Clinical remission defined as CDAI score <150.1

†Endoscopic response was defined as >50% improvement from baseline in SES-CD score.

‡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

CDAI=Crohn’s Disease Activity Index; IV=intravenous; q4w=every 4 weeks; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease.

48-Week Results

With TREMFYA®, patients were in deep remission at 1 year

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 or clinical significance can be made.

*Clinical remission defined as CDAI score <150.1

†Endoscopic response was defined as >50% improvement from baseline in SES-CD score.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; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease.

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References: 1. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie Inc. 4. Omvoh® [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.