IV Study Design | IV Induction (GALAXI)
Phase 3 randomized, double-blind, controlled trials that assessed TREMFYA® superiority vs both STELARA® (ustekinumab) and placebo in Crohn’s disease1
GALAXI 2 and GALAXI 3 were a
treat-through trial design
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Crohn’s Disease Specialist
Clinical remission at Week 12‡§:
GALAXI 2: TREMFYA® 200 mg IV q4w 47% (N=285) vs 20% placebo (N=76), P<0.001; GALAXI 3: TREMFYA® 200 mg IV q4w 47% (N=288) vs 15% placebo (N=72), P<0.001
Endoscopic response at Week 12§||:
GALAXI 2: TREMFYA® 200 mg IV q4w 36% (N=285) vs 9% placebo (N=76), P<0.001; GALAXI 3: TREMFYA® 200 mg IV q4w 34% (N=288) vs 13% placebo (N=72), P<0.001
A total of 1021 patients in GALAXI 2 (N=508) and GALAXI 3 (N=513) were randomized 2:2:2:1 into each treatment arm2
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
Only patients randomized to placebo and who did not achieve clinical response at Week 12 were crossed over to STELARA® treatment2
*Combined N values for GALAXI 2 and GALAXI 3.
†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 4 additional years of treatment, during which time the longer-term efficacy and safety of TREMFYA® will be evaluated.
‡Clinical remission is defined as CDAI score <150.
§N values for clinical remission and endoscopic response at Week 12 derived from the TREMFYA® Prescribing Information. N values listed in the study
design scheme above represent the numbers of patients in the GALAXI primary analysis set.
||Endoscopic response is defined as >50% improvement from baseline in SES-CD score.
CDAI=Crohn’s Disease Activity Index; IV=intravenous; LTE=long-term extension; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease; 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 ≥220 but ≤450 and either
- Mean daily SF count >3 or
- Mean daily AP score >1
- Screen 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
- Currently has or is suspected to have an abscess
- Bowel resection within 6 months, or any other intra-abdominal or major surgery within 12 weeks
- Draining (ie, functioning) stoma or ostomy
- Prior exposure to IL-12/23 or IL-23 agents, except for participants who have had limited exposure to, and who had not demonstrated failure or intolerance to, ustekinumab
AP=abdominal pain; CDAI=Crohn’s Disease Activity Index; IL=interleukin; SES-CD=Simplified Endoscopic Activity Score for Crohn’s Disease; SF=stool frequency; TNF=tumor necrosis factor.
TREMFYA®
200 mg IV q4w→
100 mg SC q8wTREMFYA®
200 mg IV q4w→
200 mg SC q4wPlacebo
SC
200 mg IV q4w→
100 mg SC q8wTREMFYA®
200 mg IV q4w→
200 mg SC q4w
STELARA®
(ustekinumab)
~6 mg/kg IV 
90 mg
SC q8w
SC
Total
| Analysis set: randomized full | N=143 | N=146 | N=143 | N=76 | N=508 |
| Biologic- naïve, n (%) | 58 (40.6%) | 63 (43.2%) | 58 (40.6%) | 34 (44.7%) | 213 (41.9%) |
| Biologic- failure, n (%) | 77 (53.8%) | 73 (50.0%) | 79 (55.2%) | 39 (51.3%) | 268 (52.8%) |
| Age, years— mean (SD) | 37.2 (12.92) | 36.1 (13.09) | 36.9 (12.70) | 34.2 (11.86) | 36.4 (12.76) |
| Male, n (%) | 69 (48.3%) | 87 (59.6%) | 84 (58.7%) | 41 (53.9%) | 281 (55.3%) |
| Race—white, n (%) | 103 (72.0%) | 115 (78.8%) | 104 (72.7%) | 55 (72.4%) | 377 (74.2%) |
| Crohn’s disease duration, years— mean (SD) | 7.91 (7.23) | 7.30 (6.70) | 6.58 (6.51) | 6.36 (7.48) | 7.13 (6.93) |
| CDAI Score— mean (SD) | 297.3 (52.57) | 294.2 (51.69) | 295.3 (52.35) | 292.0 (51.70) | 295.0 (52.00) |
| SES-CD Score— mean (SD) | 13.0 (7.03) | 12.4 (7.14) | 13.3 (7.50) | 13.9 (7.80) | 13.1 (7.31) |
Severe Endoscopic Disease (SES-CD score >16) | 39 (27.3%) | 38 (26.0%) | 42 (29.4%) | 24 (31.6%) | 143 (28.1%) |
| C-reactive protein (CRP) concentration in mg/L—median (IQR) | 7.1 (1.9; 17.1) | 5.9 (2.1; 17.1) | 7.5 (2.8; 17.8) | 4.6 (1.7; 15.8) | 6.1 (2.2; 16.9) |
Abnormal CRP (>3 mg/L), n (%) | 100 (69.9%) | 99 (67.8%) | 105 (73.4%) | 49 (64.5%) | 353 (69.5%) |
| Fecal calprotectin in µg/g— median (IQR) | 856.0 (388.0; 1751.0) | 962.0 (272.0; 1790.0) | 1003.0 (351.0; 1852.0) | 961.0 (257.5; 2763.5) | 966.0 (344.0; 1921.0) |
Abnormal fecal calprotectin (>250 µg/g), n (% - N) | 119 (83.8% - 142) | 111 (76.6% - 145) | 114 (82.6% - 138) | 57 (75.0% - 76) | 401 (80.0% - 501) |
| Involved GI areas (assessed by central reader)—ileum only | 29 (20.3%) | 39 (26.7%) | 25 (17.5%) | 17 (22.4%) | 110 (21.7%) |
CDAI=Crohn’s Disease Activity Index; GI=gastrointestinal; IQR=interquartile range; IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks;
SC=subcutaneous; SD=standard deviation; SES-CD=Simple Endoscopic Score for Crohn’s Disease.
TREMFYA®
200 mg IV q4w→
100 mg SC q8wTREMFYA®
200 mg IV q4w→
200 mg SC q4wPlacebo
SC
200 mg IV q4w→
100 mg SC q8wTREMFYA®
200 mg IV q4w→
200 mg SC q4w
STELARA®
(ustekinumab)
~6 mg/kg IV 90 mg
SC q8w
SC
Total
| Analysis set: randomized full | N=143 | N=150 | N=148 | N=72 | N=513 |
| Biologic- naïve, n (%) | 58 (40.6%) | 65 (43.3%) | 63 (42.6%) | 27 (37.5%) | 213 (41.5%) |
| Biologic- failure, n (%) | 76 (53.1%) | 74 (49.3%) | 77 (52.0%) | 39 (54.2%) | 266 (51.9%) |
| Age, years— mean (SD) | 34.9 (11.44) | 37.6 (13.44) | 37.9 (13.69) | 35.4 (12.52) | 36.6 (12.89) |
| Male, n (%) | 85 (59.4%) | 91 (60.7%) | 84 (56.8%) | 47 (65.3%) | 307 (59.8%) |
| Race—white, n (%) | 103 (72.0%) | 117 (78.0%) | 115 (77.7%) | 47 (65.3%) | 382 (74.5%) |
| Crohn’s disease duration, years— mean (SD) | 6.33 (6.08) | 6.84 (7.75) | 8.02 (8.27) | 7.97 (7.55) | 7.20 (7.47) |
| CDAI Score— mean (SD) | 295.3 (56.09) | 297.6 (53.85) | 291.0 (51.73) | 294.9 (54.09) | 294.7 (53.83) |
| SES-CD Score— mean (SD) | 13.4 (7.83) | 12.6 (7.37) | 12.4 (6.55) | 12.7 (7.27) | 12.8 (7.25) |
Severe Endoscopic Disease (SES-CD score >16) | 42 (29.4%) | 41 (27.3%) | 33 (22.3%) | 19 (26.4%) | 135 (26.3%) |
| C-reactive protein (CRP) concentration in mg/L—median (IQR) | 7.8 (3.0; 27.6) | 6.4 (3.0; 22.6) | 6.6 (2.0; 21.5) | 5.5 (1.4; 16.1) | 6.7 (2.4; 22.6) |
Abnormal CRP (>3 mg/L), n (%) | 108 (75.5%) | 111 (74.0%) | 97 (65.5%) | 47 (65.3%) | 363 (70.8%) |
| Fecal calprotectin in µg/g— median (IQR) | 994.0 (499.0; 2394.0) | 1242.0 (361.0; 2167.0) | 773.0 (323.0; 1855.0) | 962.0 (255.0; 2481.0) | 983.0 (357.0; 2169.0) |
Abnormal fecal calprotectin (>250 µg/g), n (% - N) | 116 (82.3% - 141) | 123 (82.6% - 149) | 115 (78.8% - 146) | 54 (76.1% - 71) | 408 (80.5% - 507) |
| Involved GI areas (assessed by central reader)—ileum only | 30 (21.0%) | 41 (27.3%) | 30 (20.3%) | 14 (19.4%) | 115 (22.4%) |
CDAI=Crohn’s Disease Activity Index; GI=gastrointestinal; IQR=interquartile range; IV=intravenous; q4w=every 4 weeks; q8w=every 8 weeks;
SC=subcutaneous; SD=standard deviation; SES-CD=Simple Endoscopic Score for Crohn’s Disease.
48-Week RESULTS
TREMFYA® is the only
IL-23i to demonstrate superiority vs STELARA® across all pooled endoscopic endpoints in registrational trials2*
~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)
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.
References: 1. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.