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(guselkumab)

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TREMFYA® (guselkumab)

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TREMFYA - Outcomes by Maintenance Doses in Ulcerative Colitis and Crohn's Disease

Last Updated: 03/18/2026

SUMMARY

  • QUASAR (NCT04033445) was a randomized, double-blind (DB), placebo (PBO)-controlled, parallel-group, multicenter, clinical trial program designed to evaluate the efficacy and safety of TREMFYA through a phase 2b (N=313) and phase 3 (N=701) 12-week induction study and a 44-week phase 3 maintenance study (N=568) in adult patients with moderately to severely active ulcerative colitis (UC).1,2
    • A significantly greater proportion of patients treated with TREMFYA vs PBO achieved the primary endpoints (clinical remission at week 12 [induction] and clinical remission at week 44 [maintenance]).2,3
    • Numerically greater efficacy rates at week 44 of maintenance were observed with TREMFYA 200 mg subcutaneous (SC) every 4 weeks (Q4W) compared with TREMFYA 100 mg SC every 8 weeks (Q8W) across several clinical, endoscopic, and histologic endpoints among patients with extensive disease at induction baseline and among patients with C-reactive protein (CRP) >3 mg/L at maintenance baseline.2,3
  • GALAXI 2 and 3 (NCT03466411) were two identical, 48 week, phase 3, randomized, DB, triple-dummy, PBO- and active-controlled, treat-through clinical trials designed to evaluate the efficacy and safety of TREMFYA in adults with moderately to severely active Crohn’s disease (CD).4,5
    • The composite coprimary endpoints (clinical response at week 12 + clinical remission at week 48, and clinical response at week 12 + endoscopic response at week 48) were met with TREMFYA vs PBO.5
    • A prespecified subgroup analysis of GALAXI 2 and 3 at week 48 showed that, among patients with elevated baseline disease activity markers (CRP >5 mg/L, Crohn’s Disease Activity Index score [CDAI] >300, and Simple Endoscopic Score for Crohn’s Disease [SES-CD] >12), a numerically greater proportion of those treated with TREMFYA 200 mg SC Q4W experienced clinical remission at week 48 and endoscopic response at week 48 vs 100 mg SC Q8W.6
  • GRAVITI (NCT05197049) was a phase 3, randomized, DB, PBO-controlled, parallel-group, multicenter clinical trial designed to evaluate the efficacy and safety of SC induction treatment with TREMFYA followed by SC maintenance therapy in adult patients with moderately to severely active CD (N=347).7,8
    • The coprimary endpoints (endoscopic response at week 12 and clinical remission at week 12) were met with TREMFYA vs PBO.7
    • Among patients with fecal calprotectin (fCal) >250 μg/g at baseline, a numerically greater rate of normalization of fCal (<100 μg/g) was observed with TREMFYA 200 mg SC Q4W compared with TREMFYA 100 mg SC Q8W at week 48.3
    • At week 48, numerically greater rates of corticosteroid (CS)-related endpoints were observed with TREMFYA 200 mg SC Q4W compared with TREMFYA 100 mg SC Q8W.9

PRODUCT LABELING

TREMFYA is indicated for the treatment of adult patients with moderately to severely active Ulcerative colitis (UC) or moderately to severely active Crohn's disease (CD).10

Recommended Dosage for Moderately to Severely Active Ulcerative Colitis and Crohn’s Disease

  • Induction: 200 mg administered by intravenous (IV) infusion over at least one hour at week 0, week 4, and week 8 or 400 mg administered by SC injection (given as two consecutive injections of 200 mg each) at week 0, week 4, and week 8.
  • Maintenance: 100 mg administered by SC injection at week 16, and every 8 weeks thereafter, or 200 mg administered by SC injection at week 12, and every 4 weeks thereafter. Use the lowest effective recommended dosage to maintain therapeutic response.

CLINICAL DATA - UC

QUASAR Study

QUASAR (NCT04033445) is a randomized, DB, PBO-controlled, multicenter clinical trial program consisted of a phase 2b study (N=313), phase 3 induction study (N=701), and phase 3 maintenance study (N=568) that evaluated the efficacy and safety of TREMFYA in adults with moderately to severely active UC. In this program, clinical responders to TREMFYA IV induction therapy from the phase 2b study or phase 3 induction study were randomized into the phase 3 maintenance study.2,11

Phase 3 Study Summary

Study Design/Methods2,11

  • Enrolled patients were adults (≥18 years) with moderately to severely active UC (baseline modified Mayo score of 4-9 [inclusive] with a baseline Mayo rectal bleeding subscore ≥1 and a baseline Mayo endoscopy subscore ≥2 [based on central review]) and inadequate response and/or intolerance to conventional (CSs, thiopurines) or advanced therapy (tumor necrosis factor [TNF] antagonists, vedolizumab, tofacitinib).
  • A total of 701 patients were randomized 3:2 during induction study to:
    • TREMFYA 200 mg IV at weeks 0, 4, and 8 (n=421)
    • PBO IV (n=280)
  • Patients who achieved a clinical response at week 12 to TREMFYA IV induction in either the phase 2b or phase 3 studies were randomized at maintenance week 0 (1:1:1) to receive:
    • TREMFYA 200 mg SC Q4W (n=190)
    • TREMFYA 100 mg SC Q8W (n=188)
    • PBO (n=190)
  • Primary endpoints: clinical remission at week 12 (induction) and clinical remission at week 44 (maintenance).
  • Major secondary endpoints at week 44: maintenance of clinical remission, clinical response, symptomatic remission, endoscopic improvement, endoscopic remission, CS-free clinical remission, and histologic-endoscopic mucosal improvement.

Results

Efficacy
  • At week 12, a significantly greater proportion of patients treated with TREMFYA 200 mg IV Q4W achieved clinical remission vs those receiving PBO (23% vs 8%; adjusted treatment difference, 15%; 95% confidence interval, 10-20; P<0.0001).2,3,11
  • Results of maintenance primary and secondary endpoints at week 44, which were achieved in a greater proportion of TREMFYA patients compared with PBO, are presented in Table: Primary and Selected Secondary Endpoints at Week 44.12
  • At week 44, a numerically greater proportion of patients treated with TREMFYA 200 mg SC Q4W maintained clinical remission vs those receiving 100 mg SC Q8W (72% vs 61%).2

Primary and Selected Secondary Endpoints at Week 442,11
Outcome
TREMFYA
100 mg SC
Q8W
(n=188)
TREMFYA 200 mg SC
Q4W
(n=190)
Placebo
(n=190)
Adjusted
Treatment
Difference
(TREMFYA
100 mg vs
Placebo), %a
Adjusted
Treatment
Difference
(TREMFYA
200 mg vs
Placebo), %a
Primary endpoint, n (%)
   Clinical remissionb
85 (45)
95 (50)
36 (19)
25; P<0.0001
30; P<0.0001
Selected secondary endpoints, n (%)
   Corticosteroid-free
   clinical remissionc
85 (45)
93 (49)
35 (18)
26; P<0.0001
29; P<0.0001
   Maintenance of clinical
   remission, n/n (%)b
40/66 (61)
50/69 (72)
20/59 (34)
26; P=0.0036
38; P<0.0001
   Maintenance of Clinical
   responsed
146 (78)
142 (75)
82 (43)
34; P<0.0001
31; P<0.0001
   Symptomatic remissione
70
69
37
32; P<0.0001
30; P<0.0001
   Endoscopic improvementf
93 (49)
98 (52)
36 (19)
30; P<0.0001
31; P<0.0001
   Endoscopic remission
   (normalization)g
65 (35)
64 (34)
29 (15)
18; P<0.0001
17; P<0.0001
   HEMIh
82 (44)
91 (48)
32 (17)
26; P<0.0001
30; P<0.0001
Abbreviations: CI, confidence interval; CMH, Cochran-Mantel-Haenszel; HEMI, histo-endoscopic mucosal improvement; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
aBased on the Wald statistic with CMH weight.
bClinical remission was defined as a Mayo stool frequency subscore of 0 or 1 that did not increase from induction baseline; a Mayo rectal bleeding subscore of 0; and a Mayo endoscopy subscore of 0 or 1, with no friability observed on endoscopy.
cCorticosteroid-free clinical remission was defined as not requiring any treatment with corticosteroids for ≥8 weeks prior to week 44 and also meeting the criteria for clinical remission.
dClinical response was defined as a decrease from induction baseline in modified Mayo score by ≥30% and ≥2 points, with either a ≥1-point decrease from induction baseline in Mayo rectal bleeding subscore or a Mayo rectal bleeding subscore of 0 or 1.
eSymptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 that had not increased from induction baseline and a Mayo rectal bleeding subscore of 0.
fEndoscopic improvement was defined as an Mayo endoscopy subscore of 0 or 1, with no friability observed on endoscopy.
gEndoscopic remission (normalization) was defined as an Mayo endoscopy subscore of 0.
hHEMI was defined as achievement of histologic (neutrophil infiltration in <5% of crypts; no crypt destruction; and no erosions, ulcerations, or granulation tissue based on the Geboes grading system [ie, Geboes score of ≤3.1]) and endoscopic improvement.

Additional Endpoints at Week 44 Between 2 Maintenance Doses

Maintenance of Endoscopic Improvement and Maintenance of Endoscopic Remission at Week 443

Abbreviations: Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
Note: Maintenance of endoscopic improvement and maintenance of endoscopic remission endpoints at week 44 were not adjusted for multiple comparisons. Therefore, these P-values are nominal, and statistical significance has not been established.
aEndoscopic improvement is defined as an Mayo endoscopy subscore of 0 or 1 with no friability present on endoscopy.
bEndoscopic remission (normalization) is defined as an Mayo endoscopy subscore of 0.

Efficacy Rates at Week 44 of Maintenance Among Patients Who Had Extensive Disease at Induction Baseline

Clinical, Endoscopic, and Histological Endpoints at Week 44 in Patients with Extensive Diseasea at Induction Baseline2,3,11

Abbreviations: CS, corticosteroid; HEMI, histo-endoscopic mucosal improvement; MES, Mayo endoscopic subscore; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; UC, ulcerative colitis.
Note: Data are from a prespecified subgroup analysis and are not adjusted for multiplicity. No statistical significance can be made. The relationship of HEMI at week 44 with long-term outcomes was not evaluated in the clinical trials. The QUASAR program was powered to analyze the maintenance doses of TREMFYA vs placebo. The program was not powered for a statistical analysis of the TREMFYA 100 mg SC Q8W dose vs the TREMFYA 200 mg SC Q4W dose.3
aExtensive disease for UC means involvement extends proximally to the splenic flexure.13
bAmong patients in clinical remission at maintenance week 44.3

Efficacy Rates at Week 44 of Maintenance Among Patients with CRP >3 mg/L at Maintenance Baseline

Clinical, Endoscopic, and Histological Endpoints at Week 44 Among Patients with CRP >3 mg/L at Maintenance Baselinea,2,3,11

Abbreviations: CRP, C-reactive protein; CS, corticosteroid; HEMI, histo-endoscopic mucosal improvement; MES, Mayo endoscopic subscore; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
Note: Data are from a prespecified subgroup analysis and are not adjusted for multiplicity. No statistical significance can be made. The relationship of HEMI at week 44 with long-term outcomes was not evaluated in the clinical trials.
aAmong patients with maintenance baseline CRP >3 mg/L.
bAmong patients in clinical remission at maintenance baseline.

Safety
  • Across both the induction and maintenance studies, safety outcomes were similar among the treatment groups. The overall safety outcomes from the induction and maintenance studies are presented in Table: Summary of Safety Results.

Summary of Safety Results2,11
Outcome
Induction Study
Maintenance Study
TREMFYA
200 mg
IV Q4W
(N=421)
Placebo
IV Q4W
(N=280)
TREMFYA
100 mg
Q8W SC
(N=186)
TREMFYA
200 mg
Q4W SC
(N=190)
Placebo SC
(N=192)
Mean duration of follow-up, weeks
12.2
11.9
40.5
39.2
34.0
Mean exposure (number of administrations)
2.9
2.9
9.9
9.6
8.2
AEs, n (%)
208 (49)
138 (49)
120 (65)
133 (70)
131 (68)
SAEs, n (%)
12 (3)
20 (7)
5 (3)
12 (6)
1 (1)
Deaths, n (%)
1 (0.2)a
2 (1)b
0
0
0
AEs leading to discontinuation of study agent, n (%)
7 (2)
11 (4)
7 (4)
5 (3)
13 (7)
Most frequent AEs (≥5% of patients in any treatment group), n (%)
   UC
10 (2)
23 (8)
17 (9)
25 (13)
57 (30)
   Anemia
21 (5)
19 (7)
4 (2)
6 (3)
5 (3)
   COVID-19
21 (5)
12 (4)
24 (13)
18 (9)
27 (14)
   Headache
13 (3)
8 (3)
7 (4)
8 (4)
12 (6)
   Arthralgia
6 (1)
6 (2)
8 (4)
15 (8)
13 (7)
   Upper RTI
3 (1)
1 (0.4)
6 (3)
13 (7)
8 (4)
Targeted AEs, n (%)
   Serious infectionsc
3 (1)
1 (0.4)
1 (1)
2 (1)
0
   OIsc
0
1 (0.4)d
0
0
0
   Active tuberculosis
0
0
0
0
0
   MACE
2 (0.5)e
2 (1)b
0
1 (1)f
0
   Clinically important hepatic
   disordersg
0
0
0
0
0
   Malignanciesh
0
0
0
1 (1)i
2 (1)j
   Nonmelanoma skin cancer
2 (0.5)
0
0
0
2 (1)
Anaphylactic reactions, n (%)
0
0
0
0
0
Serum sickness reactions, n (%)
0
0
0
0
0
Abbreviations: AE, adverse event; COVID-19, coronavirus disease 2019; IV, intravenous; MACE, major adverse cardiovascular event; MedDRA, Medical Dictionary for Regulatory Activities; MI, myocardial infarction; mMayo, modified Mayo; OI, opportunistic infection; Q4W, every 4 weeks; Q8W, every 8 weeks; RTI, respiratory tract infection; SAE, serious adverse event; SC, subcutaneous; UC, ulcerative colitis.
Note: For both studies, the primary safety populations included randomized, treated patients with an mMayo score from 4 to 9 at induction baseline. For the maintenance study, 2 patients who were randomly assigned to the TREMFYA 100 mg SC Q8W only received placebo at maintenance week 0 and discontinued the study intervention before their first scheduled TREMFYA dose at maintenance week 4; these patients were included in the placebo SC treatment group for safety analyses. For the maintenance study, data are from maintenance week 0 to maintenance week 44 or up to the time of dose adjustment in patients who had a dose adjustment.
aFatal acute MI in a patient with pre-existing cardiac risk factors.
bNatural causes and cardiac arrest.
cInfections were defined as any AE that was coded to the MedDRA system organ class (version 26.0).
dCytomegalovirus colitis.
eNonfatal MI and fatal acute MI in patients with pre-existing cardiac risk factors.
fHemorrhagic stroke.
gDefined as hepatic AEs reported as SAEs or AEs leading to study drug discontinuation.
hExcludes nonmelanoma skin cancer.
iRectal adenocarcinoma.
jBreast cancer.

Clinical data - cD

GALAXI Studies

GALAXI 2 and GALAXI 3 (NCT03466411) were two identical, 48 week, phase 3, randomized, DB, triple-dummy, PBO- and active-controlled, treat-through clinical trials designed to evaluate the efficacy and safety of TREMFYA in adults with moderately to severely active CD and an inadequate response or intolerance to conventional (CSs or immunomodulators) and/or biologic (TNF antagonists or vedolizumab) therapies.5

Study Design/Methods5

  • Enrolled patients had a moderately to severely active CD, inadequate response or intolerance to ≥1 biologic, and mean daily stool frequency >3 and mean daily abdominal pain score >1.
  • Patients were randomized 2:2:2:1 to receive:
    • TREMFYA 200 mg IV at weeks 0, 4, and 8 followed by 200 mg SC Q4W starting at week 12
    • TREMFYA 200 mg IV at weeks 0, 4, and 8 followed by 100 mg SC Q8W at week 16
    • Ustekinumab (UST) ~6 mg/kg IV x1 followed by UST 90 mg SC Q8W at week 8
    • PBO
  • Composite co-primary endpoints: clinical response at week 12 and clinical remission at week 48, and clinical response at week 12 and endoscopic response at week 48.

Results

Efficacy

Composite Coprimary Endpoints5
GALAXI 2
GALAXI 3
TREMFYA
PBO and PBO IV
→UST
(N=76)
TREMFYA
PBO and PBO IV
→UST
(N=72)
200 mg
IV Q4W
→100 mg
SC Q6W
(N=143)
200 mg
IV Q4W
→200 mg
SC Q4W
(N=146)
200 mg
IV Q4W
→100 mg
SC Q8W
(N=143)
200 mg
IV Q4W
→200 mg
SC Q4W
(N=150)
Clinical responsea at week 12 + clinical remissionb at week 48
   Number of
   participants,
   n (%)
70 (49)
80 (55)
9 (12)
67 (47)
72 (48)
9 (13)
   95% CI
41-57
47-63
5-19
39-55
40-56
5-20
   Adjusted
   treatment
   difference
   compared with
   PBO, % (95% CI)
38 (27-49)
43 (32-54)
-
34 (23-45)
35 (24-46)
-
   P-value
<0.0001
<0.0001
-
<0.0001
<0.0001
-
Clinical responsea at week 12 + endoscopic responsec at week 48
   Number of
   participants,
   n (%)
56 (39)
56 (38)
4 (5)
48 (34)
54 (36)
4 (6)
   95% CI
31-47
31-46
0-10
26-41
28-44
0-11
   Adjusted
   treatment
   difference
   compared with
   PBO, % (95% CI)
34 (24-43)
33 (24-42)
-
28 (19-37)
31 (21-40)
-
P-value
<0.0001
<0.0001
-
<0.0001
<0.0001
-
Abbreviations: CDAI, Crohn’s Disease Activity Index; CI, confidence interval; IV, intravenous; PBO, placebo; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease; UST, ustekinumab.
aClinical response: ≥100-point decrease in the CDAI score from baseline or CDAI score <150.
bClinical remission: CDAI score <150.
cEndoscopic response: ≥50% improvement from baseline in SES-CD or SES-CD ≤2.
  • In the pooled analyses at week 48 (GALAXI 2 and 3), both TREMFYA regimens (100 mg and 200 mg) were statistically superior to UST for endoscopic response, endoscopic remission, deep remission, and clinical remission + endoscopic response.5
  • Results are presented in Figure: Efficacy Outcomes at Week 48 of TREMFYA Maintenance Doses vs UST.

Efficacy Outcomes at Week 48 of TREMFYA Maintenance Doses vs UST5

Abbreviations: CI, confidence interval; UST, ustekinumab; Q4W, every 4 weeks; Q8W, every 8 weeks.
Note: Values immediately above the 95% CI bars indicate the percentages of participants attaining the endpoint.

Clinical Remission and Endoscopic Response at Week 48 in Patients with CRP >5 mg/L - Subgroup Analysis6

Abbreviations: CRP, C-reactive protein; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
NOTE: Clinical remission and endoscopic response at week 48 by baseline CRP >5 mg/L were prespecified but not controlled. No statistical significance can be made.

Clinical Remission and Endoscopic Response at Week 48 in Patients with Baseline
CDAI Score >300 - Subgroup Analysis6

Abbreviations: CDAI, Crohn’s Disease Activity Index; IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
NOTE: Clinical remission and endoscopic response at week 48 by baseline CDAI score >300 were prespecified but not controlled. No statistical significance can be made.

Clinical Remission and Endoscopic Response at Week 48 in Patients with Baseline
SES-CD >12 - Subgroup Analysis6

Abbreviations: IV, intravenous; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn's Disease.
NOTE: Clinical remission and endoscopic response at week 48 by baseline SES-CD >12 were prespecified but not controlled. No statistical significance can be made.

Safety

Safety Outcomes in the Pooled GALAXI 2 and 3 Dataset through Week 485
TREMFYA
100 mg SC Q8W
(N=296)
TREMFYA
200 mg SC Q4W
(N=299)
Placebo
(N=153a)
Mean duration of follow-up, weeks
46.2
46.7
21.8
Total PY of follow-up, years
261.8
267.3
64.0
≥1 AE, n (%)
225 (76)
233 (78)
82 (54)
   Incidence rate, events/100 PY
327.3
353.5
499.7
≥1 Serious AEs, n (%)
32 (11)
21 (7.0)
16 (10)
   Incidence rate, events/100 PY
14.9
9.7
32.8
AEs leading to discontinuation, n (%)
21 (7)
19 (6)
13 (8)
   Incidence rate, events/100 PY
8.4
7.5
20.3
≥1 Serious infection, n (%)
1 (<1)
3 (1)
2 (1)
   Incidence rate, events/100 PY
0.4
1.1
6.3
≥1 AE related to hepatic
disordersb, n (%)
12 (4)
14 (5)
3 (2)
Incidence rate, events/100 PY
6.9
8.2
4.7
Common AEs, n (%)c
Worsening of CD
26 (9)
26 (9)
20 (13)
COVID-19
45 (15)
53 (18)
10 (7)
   Upper respiratory tract infection
29 (10)
25 (8)
6 (4)
   Abdominal pain
20 (7)
14 (5)
9 (6)
   Pyrexia
19 (6)
16 (5)
8 (5)
   Arthralgia
23 (8)
25 (8)
5 (3)
   Headache
15 (5)
24 (8)
7 (5)
   Nasopharyngitis
12 (4)
21 (7)
5 (3)
   Anemia
15 (5)
15 (5)
8 (5)
AEs of interest, n (%)
   Active tuberculosis
1 (<1)
0 (0)
0 (0)
   Malignancies
0 (0)
1 (<1)
0 (0)
   Anaphylactic or
   serum-sickness reactions
0 (0)
0 (0)
0 (0)
   Opportunistic infections
1 (<1)
2 (1)
1 (1)
   Major adverse
   cardiovascular eventd
1 (<1)
0 (0)
0 (0)
   Venous thromboembolisme
0 (0)
0 (0)
0 (0)
Abbreviations: AE, adverse event; IV, intravenous; PBO, placebo; PY, patient-years; Q4W, every 4 weeks; Q8W, every 8 weeks; SAE, serious adverse event; SC, subcutaneous; UST, ustekinumab.
Note: The all-treated analysis population included all randomly assigned and treated participants. AEs were coded with MedDRA (version 26.0), unless otherwise noted.
aEvents attributed to patients randomly allocated to PBO only; events occurring after receiving UST rescue therapy are not counted.
bDefined as the narrow terms in the standardised MedDRA query of “Drug Related Hepatic Disorders-Comprehensive Search.”
cPatients with events (by preferred term) with a frequency of ≥5% in any group. Patients are counted only once for any given event, regardless of the number of times they experienced the event.
dOccurrences of major adverse cardiovascular events were identified by clinical review.
eTerms for venous thromboembolism were based on customised MedDRA query.

GRAVITI Study

GRAVITI (NCT05197049) was a phase 3, randomized, DB, PBO-controlled, parallel-group, multicenter clinical trial designed to evaluate the efficacy and safety of SC induction treatment with TREMFYA followed by SC maintenance therapy in adult patients with moderately to severely active CD (N=347).8

Study Design/Methods8

  • Enrolled patients had a history of inadequate response or intolerance to oral CSs, azathioprine, 6-mercaptopurine, methotrexate, or biologics (infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these therapies).
  • A total of 347 patients were randomized 1:1:1 to receive:
    • TREMFYA 400 mg SC at weeks 0, 4, and 8 followed by 200 mg SC Q4W (N=115)
    • TREMFYA 400 mg SC at weeks 0, 4, and 8 followed by 100 mg SC Q8W (N=115)
    • PBO (N=117)
  • The coprimary endpoints were clinical remission at week 12 (CDAI <150) and endoscopic response at week 12 (≥50% improvement from baseline in the SES-CD).
  • Additional multiplicity-controlled secondary endpoints were PRO-2 remission at week 12, clinical response at week 12, clinical remission at week 24, clinical remission at week 48, and endoscopic response at week 48.
  • Other endpoints evaluated at week 48 included endoscopic remission, and deep remission.

Results

Efficacy
  • The coprimary endpoints and all multiplicity-controlled secondary endpoints were met.
  • TREMFYA 400 mg SC induction demonstrated superiority to PBO at week 12.
  • Both TREMFYA SC maintenance dosage regimens were also superior to PBO at weeks 24 and 48.
  • Results of the coprimary at week 12, selected multiplicity-controlled secondary endpoints and other endpoints at weeks 48 are presented in Figure: Primary and Other Endpoints.

Primary and Other Endpoints8,9

Abbreviations: CI, confidence interval; PBO, placebo; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
aNominal P-value for TREMFYA vs placebo. The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal and statistical significance has not been established.

Proportion of Patients Who Were Corticosteroid-Free at Week 48 Among Those Who Received Corticosteroids at Baseline8,9

Abbreviations: CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CI, confidence interval; COVID-19, coronavirus disease 2019; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease.
aNo patients were receiving beclomethasone at baseline.
bThe adjusted treatment difference(s) and CI(s) were based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator. The stratification factors were the baseline CDAI score (≤300 or >300), baseline SES-CD (≤12 or >12), and baseline biologic-failure status (yes or no).
NOTE: Endpoints presented above were prespecified but not controlled for multiplicity. No statistical significance can be made.
NOTE: All patients in all treatment groups (TREMFYA and placebo) who met the rescue criteria were considered not to have met the efficacy endpoints after week 16. Patients who had a CD-related surgery or a prohibited change in concomitant CD medications or for whom the study agent was discontinued due to a lack of efficacy, an adverse event of worsening CD, COVID-19 infection, or for reasons other than a lack of efficacy or an adverse event of worsening CD (excluding COVID-19-related reasons or regional crisis) before the designated analysis timepoint were considered not to have achieved the binary endpoint from that timepoint onward. Patients for whom the study agent was discontinued due to COVID-19-related reasons (excluding COVID-19 infection) or regional crisis had their observed data used, if available, to determine the responder status from that timepoint onward.

Corticosteroid-Free Clinical Remission Rates at Week 488,9

Abbreviations: CI, confidence interval; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
NOTE: aPre-specified analysis but not controlled for multiplicity. No statistical significance can be made. bPost hoc analysis - no statistical significance can be made.

Corticosteroid-Free Endoscopic Response Rates at Week 488,9

Abbreviations: CI, confidence interval; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.

NOTE: aPre-specified analysis. bPost hoc analysis - no statistical significance can be made.

Safety

Key Safety Events through Week 48: Full Safety Analysis Set3,8
TREMFYA
400 mg SC Q4W
→TREMFYA
100 mg SC Q8W
(N=115)
TREMFYA
400 mg SC Q4W
→TREMFYA
200 mg SC Q4W
(N=115)
Placebo
(N=117a)
Average duration of follow-up, weeks
47.0
48.0
30.0
Total PY of follow-up, years
103.5
105.7
67.3
Average exposure, no. of administration
6.8
11.8
7.1
Death, n (%)b
1 (0.9)
0
0
Participants with 1 or more
   AEs, n (%)
95 (82.6)
92 (80)
77 (65.8)
      Events per 100 PYs of follow-up
307.2
327.2
413.0
   Serious AEs, n (%)
15 (13.0)
9 (7.8)
16 (13.7)
      Events per 100 PYs of follow-up
15.5
13.2
37.1
   AEs leading to DC of study agent, n (%)
4 (3.5)
3 (2.6)
10 (8.5)
      Events per 100 PYs of follow-up
6.8
2.8
14.9
   Infections, n (%)c
56 (48.7)
47 (40.9)
36 (30.8)
      Events per 100 PYs of follow-up
91.8
70.0
81.7
   Serious infection, n (%)c
2 (1.7)
1 (0.9)
0
Abbreviations: AEs, adverse events, DBL, database lock; DC, discontinuation; GUS, guselkumab; MedDRA, Medical Dictionary for Regulatory Activities; PY, patient-years; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.
aIncludes all placebo participants, excluding data after a participant is rescued with GUS.
bFatal gunshot wound (nonsuicidal).
cInfections were defined as any adverse event which was coded to the MedDRA system organ class “Infections and infestations.” No new deaths and cases of serious infections were noted after the week 24 DBL. Serious infections were anal abscess, bronchitis, appendicitis, and gastroenteritis, and none were related to the study intervention.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 25 August 2025.

References

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