TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
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TREMFYA – Treatment of Ulcerative Colitis with Subcutaneous Induction (ASTRO Study)
Last Updated: 10/09/2025
SUMMARY
CLINICAL DATA
PHASE 3 SUBCUTANEOUS INDUCTION STUDY IN ULCERATIVE COLITIS - ASTRO
Study Design/Methods
- Adults with moderately to severely active UC and a history of inadequate response (IR) or intolerance to corticosteroids, immunosuppressants (azathioprine, 6-mercaptopurine), biologics, Janus kinase inhibitors, and/or sphingosine 1-phosphate inhibitors (BIO/JAKi/S1Pi-IR) or BIO/JAKi/S1Pi-naïve were included in the study.1
- Patients had a modified Mayo score of 5-9, a rectal bleeding subscore ≥1, and a MES ≥2.2
, 3 - A total of 418 patients were randomized 1:1:1 to receive:
- TREMFYA 400 mg SC every 4 weeks (q4w) x3→TREMFYA 200 mg SC q4w (n=140)
- TREMFYA 400 mg SC q4w (x3)→TREMFYA 100 mg SC every 8 weeks (q8w; n=139)
- Placebo (n=139)
- Patients who met rescue criteria at week 16 were switched to the following: placebo patients were switched to TREMFYA, while TREMFYA patients remained on their assigned dose regimen (sham rescue).2,3
- The primary endpoint was clinical remission at week 12, defined as a Mayo stool frequency subscore of 0 or 1 (not increased from baseline), a rectal bleeding subscore of 0, and a Mayo endoscopic subscore (MES) of 0 or 1 without friability.
- Multiplicity-controlled secondary endpoints at week 12 and week 24 included clinical response, symptomatic remission, and endoscopic improvement. Other mulitplicity controlled secondary endpoints included histo-endoscopic mucosal improvement (HEMI) at week 12 and clinical remission (week 24).
Results through Weeks 12 and 24
- Baseline characteristics were similar across treatment groups; overall mean age, 41.7 years; mean UC duration, 7.6 years; mean modified Mayo score, 6.7; MES, 3 (56.0%); and BIO/JAKi/S1Pi-IR, 40.2%.
- At week 12, primary and secondary endpoints were achieved by a significantly higher proportion of patients treated with TREMFYA 400 mg SC induction vs placebo. For details on primary and secondary endpoints, see Table: Primary and Secondary Endpoints at Week 12 and Week 24.
| Endpoints | TREMFYA 400 mg SC Induction (%) | Placebo (%) | P-Value | |
|---|---|---|---|---|
| Primary Endpoint - Week 12 | ||||
| Clinical remissiona | 27.6 | 6.5 | <0.001 | |
| Secondary Endpoints - Week 12 | ||||
| Clinical responseb | 65.6 | 34.5 | <0.001 | |
| Symptomatic remissionc | 51.3 | 20.9 | <0.001 | |
| Endoscopic improvementd | 37.3 | 12.9 | <0.001 | |
| HEMIe | 30.5 | 10.8 | <0.001 | |
| Endpoints | TREMFYA 100 mg SC q8w (%) | TREMFYA 200 mg SC q4w (%) | Placebo (%) | P-Value |
| Secondary Endpoints - Week 24 | ||||
| Clinical remissiona | 35.3 | 36.4 | 9.4 | <0.001 |
| Clinical Responseb | 63.3 | 61.4 | 30.9 | <0.001 |
| Symptomatic remissionc | 54.7 | 50.0 | 25.2 | <0.001 |
| Endoscopic improvementd | 40.3 | 45.0 | 12.2 | <0.001 |
| Abbreviations: BL, baseline; HEMI, histo-endoscopic mucosal improvement; MES, Mayo endoscopic subscore; RBS, rectal bleeding subscore; SC, subcutaneous; SFS, stool frequency subscore. aClinical remission was defined as Mayo SFS 0 or 1 and not increased from BL, a Mayo RBS=0, and MES 0 or 1 with no friability. bClinical response was defined as ≥30% and ≥2 point decrease from BL in modified Mayo score with ≥1 point decrease from BL in RBS or RBS 0 or 1. cSymptomatic remission was defined as SFS 0 or 1 and not increased from BL and RBS=0. dEndoscopic improvement was defined as MES 0 or 1 with no friability. eHEMI was defined as histologic improvement (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue per Geboes grading system) and endoscopic improvement. | ||||
- In prespecified analyses of subpopulations defined by prior history of BIO/JAKi/S1Pi, greater proportion of patients treated with TREMFYA vs placebo achieved the endpoints at weeks 12 and 24, see Table: Primary Endpoint and Secondary Endpoints at Weeks 12 and 24 in BIO/JAKi/S1Pi-naive and BIO/JAKi/S1Pi-IR Subgroups.
| Endpoints | BIO/JAKi/S1Pi-naive | BIO/JAKi/S1Pi-IR | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| TREMFYA 400 mg SC Induction, (N=164) | Placebo, (N=79) | TREMFYA 400 mg SC Induction, (N=112) | Placebo, (N=56) | |||||||
| Primary endpoint - Week 12 (%) | ||||||||||
| Clinical remissiona | 36.0 | 8.9 | 16.1 | 3.6 | ||||||
| Secondary endpoints - Week 12 (%) | ||||||||||
| Clinical responseb | 71.3 | 41.8 | 57.1 | 25.0 | ||||||
| Symptomatic remissionc | 59.1 | 25.3 | 41.1 | 14.3 | ||||||
| Endoscopic improvementd | 45.7 | 17.7 | 24.1 | 7.1 | ||||||
| HEMIe | 38.4 | 13.9 | 18.8 | 7.1 | ||||||
| Endpoints | BIO/JAKi/S1Pi-naive | BIO/JAKi/S1Pi-IR | ||||||||
| TREMFYA 100 mg SC q8w, (N=81) | TREMFYA 200 mg SC q4w, (N=83) | Placebo, (N=79) | TREMFYA 100 mg SC q8w, (N=57) | TREMFYA 200 mg SC q4w, (N=55) | Placebo, (N=56) | |||||
| Secondary endpoints - Week 24 (%) | ||||||||||
| Clinical remissiona | 49.4 | 43.4 | 12.7 | 15.8 | 27.3 | 5.4 | ||||
| Clinical responseb | 74.1 | 72.3 | 36.7 | 47.4 | 47.3 | 21.4 | ||||
| Symptomatic Remissionc | 64.2 | 57.8 | 30.4 | 42.1 | 40.0 | 16.1 | ||||
| Endoscopic Improvementd | 54.3 | 51.8 | 17.7 | 19.3 | 36.4 | 5.4 | ||||
| Abbreviations: BIO/JAKi/S1Pi, biologics, Janus kinase inhibitors, and/or sphingosine 1-phosphate inhibitors; BL, baseline; HEMI, histo-endoscopic mucosal improvement; IR, inadequate response; MES, Mayo endoscopic subscore; RBS, rectal bleeding subscore; SC, subcutaneous; SFS, stool frequency subscore. aClinical remission was defined as Mayo SFS 0 or 1 and not increased from BL, a Mayo RBS=0, and MES 0 or 1 with no friability. bClinical response was defined as ≥30% and ≥2 point decrease from BL in modified Mayo score with ≥1 point decrease from BL in RBS or RBS 0 or 1. cSymptomatic remission was defined as SFS 0 or 1 and not increased from BL and RBS=0. dEndoscopic improvement was defined as MES 0 or 1 with no friability. eHEMI was defined as histologic improvement (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue per Geboes grading system) and endoscopic improvement. | ||||||||||
Bowel Urgency and Abdominal Pain
- An analysis was conducted to assess the severity of bowel-related symptoms using the validated UC-PRO/SS instrument.2
- Clinically meaningful improvements (CMI) were evaluated in bowel signs and symptoms and abdominal symptoms scales.2
- Complete resolution of individual core symptoms (bowel urgency and abdominal pain) was also assessed.2
Results
- Baseline mean UC-PRO/SS domain scores were similar among treatment groups2
- At baseline, the proportions of patients experiencing bowel urgency were2:
- TREMFYA 100 mg q8w: 81.3%
- TREMFYA 200 mg q4w: 84.3%
- TREMFYA combined: 82.8%
- Placebo: 87.1%
- At baseline, the proportions of patients experiencing abdominal pain were2:
- TREMFYA 100 mg q8w: 78.4%
- TREMFYA 200 mg q4w: 74.3%
- TREMFYA combined: 76.3%
- Placebo: 78.4%
- Rates of bowel urgency resolution (no bowel urgency) were2:
- At week 12, TREMFYA combined vs placebo: 45.0% vs 23.1% (nominal P-value)
- At week 24, TREMFYA 100 mg and 200 mg vs placebo: 47.8% and 41.5% vs 22.3% (nominal P-value)
- Rates of abdominal pain resolution (no abdominal pain) were2:
- At week 12, TREMFYA combined vs placebo: 48.8% vs 23.9% (nominal P-value)
- At week 24, TREMFYA 100 mg and 200 mg vs placebo: 45.9% and 45.2% vs 25.7% (nominal P-value)
- Greater proportions of patients treated with TREMFYA vs placebo had no bowel urgency, no abdominal pain, and clinically meaningful improvement,2 see Table: Change from Baseline and Clinical Meaningful Improvement from Baseline in Bowel-Related Symptoms.
| Placebo | TREMFYA | |||
|---|---|---|---|---|
| 400 mg SC q4w → 100 mg SC q8w | 400 mg SC q4w → 200 mg SC q4w | 400 mg SC Combined | ||
| Bowel domain | ||||
| Baseline (0-27) | 13.2 (4.4), N=132 | 13.1 (4.3), N=131 | 13.1 (4.1), N=130 | 13.1 (4.2), N=261 |
| Change from baseline at week 12, mean (SD) | -3.9 (5.4), N=127 | - | - | -7.5 (5.5)a, N=249 |
| Change from baseline at week 24, mean (SD) | -3.4 (5.3), N=128 | -7.1 (6.0)a, N=127 | -6.9 (5.8)a, N=125 | - |
| Clinically meaningful improvementb at week 12, n (%) | 50 (36), N=139 | - | - | 171 (61.3)a, N=279 |
| Clinically meaningful improvementb at week 24, n (%) | 37 (26.6), N=139 | 76 (54.7)a, N=139 | 77 (55.0)a, N=140 | - |
| Abdominal symptoms domain | ||||
| Baseline (0-12), mean (SD) | 5.2 (2.5), N=132 | 5.3 (2.5), N=131 | 5.1 (2.5), N=130 | 5.2 (2.5), N=261 |
| Change from baseline at week 12, mean (SD) | -1.3 (2.1), N=127 | - | - | -2.1 (2.8)a, N=249 |
| Change from baseline at week 24, mean (SD) | -1.2 (2.0), N=128 | -2.1 (2.4)d, N=127 | -2.3 (2.7)a, N=125 | - |
| Clinically meaningful improvementc at week 12, n (%) | 50 (36.0), N=139 | - | - | 128 (45.9)a, N=279 |
| Clinically meaningful improvementc at week 24, n (%) | 37 (26.6), N=139 | 68 (48.9)a, N=139 | 68 (48.6)a, N=140 | - |
| Bowel urgency | ||||
| Baseline (0-4) | 2.3 (1.1), N=132 | 2.2 (1.1), N=131 | 2.3 (1.0), N=130 | 2.2 (1.1), N=261 |
| Change from baseline at week 12, mean (SD) | -0.7 (1.2), N=127 | - | - | -1.2 (1.2)a, N=249 |
| Change from baseline at week 24, mean (SD) | -0.6 (1.1), N=128 | -1.2 (1.2)a, N=127 | -1.1 (1.2)a, N=125 | - |
| No bowel urgencyd at week 12, n (%) | 33 (23.7), N=139 | - | - | 138 (49.5)a, N=279 |
| No bowel urgencyd at week 24, n (%) | 29 (20.9), N=139 | 71 (51.1)a, N=139 | 63 (45.0)a, N=140 | 138 (49.5)a, N=279 |
| Abdominal pain | ||||
| Baseline (0-4) | 1.7 (1.1), N=132 | 1.8 (1.1), N=131 | 1.6 (1.1), N=130 | 1.7 (1.1), N=261 |
| Change from baseline at week 12, mean (SD) | -0.6 (1.1), N=127 | - | - | -1.0 (1.1)a, N=249 |
| Change from baseline at week 24, mean (SD) | -0.5 (0.9), N=128 | -0.9 (1.0)a, N=127 | -0.9 (1.0)a, N=125 | - |
| No abdominal paine at week 12, n (%) | 43 (30.9), N=139 | - | - | 156 (55.9)a, N=279 |
| No abdominal paine at week 24, n (%) | 34 (24.5), N=139 | 72 (51.8)a, N=139 | 68 (48.6)b, N=140 | - |
| Note: All endpoints assessed through week 12 compared the combined TREMFYA 400 mg SC treatment arm to placebo; assessments after week 12 compared each TREMFYA SC maintenance regimen to placebo. Patients who, prior to the designated timepoint, had an ostomy or colectomy, a prohibited change in UC medications, discontinued study intervention due to lack of efficacy or an AE of worsening of UC, or met rescue criteria had their baseline value carried forward from the time of the event onward or were considered not to have met the dichotomous endpoint. For participants who discontinued study intervention due to COVID-19 related reasons (excluding COVID-19 infection) or regional crisis prior to the designated timepoint, their observed values were used, if available. Participants who discontinued study intervention due to reasons other than those described above prior to the designated timepoint had their baseline value carried forward from the time of the event onward or were considered not to have met the dichotomous endpoint. Abbreviations: AE, adverse event; CMI, clinically meaningful improvement; SC, subcutaneous; SD, standard deviation; q4w, every 4 weeks; q8w, every 8 weeks; UC, ulcerative colitis; UC-PRO/SS, Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms. 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. bCMI is defined as ≥5 point improvement from baseline in the bowel domain. cCMI is defined as ≥1.5 point improvement from baseline in the abdominal symptoms domain. dNo bowel urgency is defined as the rounded weekly average UC-PRO/SS item 7 score=0 over eligible days within 7 days prior to the designated timepoint. UC-PRO/SS Question 7: In the past 24 hours, did you feel the need to have a bowel movement right away? eNo abdominal pain is defined as the rounded weekly average UC-PRO/SS item 8 score=0 over eligible days within 7 days prior to the designated timepoint. UC-PRO/SS Question 8: In the past 24 hours, did you feel pain in your belly? | ||||
- For safety through week 24, see Table: Safety through Week 24.
| TREMFYA 400 mg SC→TREMFYA 100 mg q8w | TREMFYA 400 mg SC→TREMFYA 200 mg q4w | Placeboa | |
|---|---|---|---|
| Safety analysis set, N | 139 | 140 | 139 |
| Average duration of follow-up, weeks | 24.0 | 24.2 | 20.7 |
| Deaths, n (%) | 0 | 0 | 1 (0.7) |
| Patients with ≥1, n (%) | |||
| AE | 74 (53.2) | 85 (60.7) | 91 (65.5) |
| AE by severityb | |||
| Mild | 42 (30.2) | 48 (34.3) | 49 (35.3) |
| Moderate | 27 (19.4) | 30 (21.4) | 30 (21.6) |
| Severe | 5 (3.6) | 7 (5.0) | 12 (8.6) |
| SAE | 5 (3.6) | 6 (4.3) | 17 (12.2) |
| AE leading to discontinuation of study agent | 3 (2.2) | 4 (2.9) | 12 (8.6) |
| Infectionc | 33 (23.7) | 32 (22.9) | 36 (25.9) |
| Serious infectionc,d | 1 (0.7) | 3 (2.1) | 1 (0.7) |
| Most common AEs, n (%)e | |||
| Colitis ulcerative | 14 (10.1) | 9 (6.4) | 29 (20.9) |
| Arthralgia | 11 (7.9) | 7 (5.0) | 3 (2.2) |
| Headache | 10 (7.2) | 5 (3.6) | 9 (6.5) |
| Note: Patients are counted only once for any given event under a specific column, regardless of the number of times they actually experienced the event. AEs are coded using MedDRA Version 26.1. Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious AE; SC, subcutaneous. aIncludes all placebo patients excluding data after a patient is rescued with TREMFYA. bThe worst severity event experienced by the patient is used. cInfections were defined as any AE that was coded to the MedDRA system organ class 'Infections and infestations’. dSerious infections in the TREMFYA groups were pilonidal disease and gastroenteritis. Both events were of moderate intensity, did not interrupt study drug, and resolved. The other 2 serious infections were appendicitis. eMost common AEs are reported by Preferred Terms and were defined as incidence of >5% in either TREMFYA group. | |||
Results through Week 48
- For efficacy results through week 48 in the overall population and in subpopulations defined by prior history of BIO/JAKi/S1Pi, see Table: Efficacy at Week 48.3
n (%) | Overall Population | BIO/JAKi/S1Pi-naive | BIO/JAKi/S1Pi-IR | ||||||
|---|---|---|---|---|---|---|---|---|---|
| TREMFYA 400 mg SC → TREMFYA 100 mg q8w (N=139) | TREMFYA 400 mg SC → TREMFYA 200 mg q4w (N=140) | Placebo (N=139) | TREMFYA 400 mg SC → TREMFYA 100 mg q8w (N=81) | TREMFYA 400 mg SC → TREMFYA 200 mg q4w (N=83) | Placebo (N=79) | TREMFYA 400 mg SC → TREMFYA 100 mg q8w (N=57) | TREMFYA 400 mg SC → TREMFYA 200 mg q4w (N=55) | Placebo (N=56) | |
| Clinical remissiona | 51 (36.7)b Δ 29.5c | 60 (42.9)b Δ 35.6c | 10 (7.2) | 39 (48.1)b Δ 40.3c | 42 (50.6)b Δ 43.0c | 6 (7.6) | 12 (21.1)b Δ 13.7c | 18 (32.7)b Δ 25.2c | 4 (7.1) |
| Clinical responsed | 78 (56.1)b Δ 37.4c | 83 (59.3)b Δ 40.6c | 26 (18.7) | 52 (64.2)b Δ 39.5c | 54 (65.1)b Δ 40.8c | 19 (24.1) | 25 (43.9)b Δ 30.9c | 29 (52.7)b Δ 39.3c | 7 (12.5) |
| Endoscopic improvemente | 62 (44.6)b Δ 33.1c | 66 (47.1)b Δ 35.6c | 16 (11.5) | 46 (56.8)b Δ 44.0c | 45 (54.2)b Δ 41.7c | 10 (12.7) | 16 (28.1)b Δ 16.0c | 21 (38.2)b Δ 26.8c | 6 (10.7) |
| Endoscopic remissionf | 36 (25.9)b Δ 20.9c | 37 (26.4)b Δ 21.4c | 7 (5.0) | 27 (33.3)b Δ 26.9c | 28 (33.7)b Δ 27.5c | 5 (6.3) | 9 (15.8)b Δ 11.5c | 9 (16.4)b Δ 12.6c | 2 (3.6) |
| Symptomatic remissiong | 66 (47.5)b Δ 33.1c | 75 (53.6)b Δ 39.2c | 20 (14.4) | 47 (58.0)b Δ 38.6c | 51 (61.4)b Δ 42.3c | 15 (19.0) | 19 (33.3)b Δ 24.3c | 24 (43.6)b Δ 34.0c | 5 (8.9) |
| Histologic improvementh | 65 (46.8)b Δ 33.8c | 73 (52.1)b Δ 39.2c | 18 (12.9) | 45 (55.6)b Δ 38.6c | 50 (60.2)b Δ 43.8c | 13 (16.5) | 20 (35.1)b Δ 26.8c | 23 (41.8)b Δ 34.1c | 4 (7.1) |
| Histologic remissioni | 52 (37.4)b Δ 26.6c | 63 (45.0)b Δ 34.2c | 15 (10.8) | 35 (43.2)b Δ 29.1c | 41 (49.4)b Δ 35.5c | 11 (13.9) | 17 (29.8)b Δ 21.5c | 22 (40.0)b Δ 32.4c | 4 (7.1) |
| Note: The adjusted treatment difference was based on the common risk difference by use of the Mantel-Haenszel stratum weights and the Sato variance estimator. In the overall population, the P-values were based on the Mantel-Haenszel test, stratified by BIO/JAKi/S1Pi-IR status (Yes/No) and MES at baseline (Moderate [2]/Severe [3]). For the BIO/JAKi/S1Pi-naive/-IR subgroups, the P-values were stratified only by the MES at baseline. Patients who, prior to week 48, had an ostomy or colectomy, a prohibited change in UC medications, discontinued study agent due to lack of efficacy or an adverse event of worsening of UC, or met rescue criteria per IWRS were considered not to have achieved any of the key efficacy endpoints shown at week 48. For patients who discontinued study agent due to COVID-19-related reasons (excluding COVID-19 infection) or regional crisis, their observed values were used, if available. Patients who discontinued study agent prior to week 48 due to other reasons were considered not to have achieved any of the efficacy endpoints shown at week 48. Patients who were missing one or more of the components pertaining to an endpoint at week 48 were considered not to have achieved the endpoint. Abbreviations: BIO/JAKi/S1Pi, biologics, Janus kinase inhibitors, and/or sphingosine 1-phosphate inhibitors; BL, baseline; IR, inadequate response; IRS, Interactive Web Response System; MES, Mayo endoscopic subscore; q4w, every 4 weeks; q8w, every 8 weeks; RBS, rectal bleeding subscore; SC, subcutaneous; SFS, stool frequency subscore; UC, ulcerative colitis. aClinical remission was defined as Mayo SFS 0 or 1 and not increased from BL, a Mayo RBS=0, and MES 0 or 1 with no friability. bNominal 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. cΔ% (adjusted treatment difference) vs placebo. dClinical response was defined as ≥30% and ≥2 point decrease from BL in modified Mayo score with ≥1 point decrease from BL in RBS or RBS 0 or 1. eEndoscopic improvement was defined as MES 0 or 1 with no friability. fEndoscopic remission was defined as MES of 0. gSymptomatic remission was defined as SFS 0 or 1 and not increased from BL and RBS=0. hHistologic improvement was defined as neutrophil infiltration in <5% of crypts; no crypt destruction; and no erosions, ulcerations, or granulation tissue per Geboes grading system iHistologic remission was defined as absence of neutrophils from the mucosa (both lamina propria and epithelium); no crypt destruction; and no erosions, ulcerations, or granulation tissue per Geboes grading system. | |||||||||
- Safety events per 100 patient-years were lower in TREMFYA groups vs placebo, see Table: Safety at Week 48.3
| TREMFYA 400 mg SC→TREMFYA 100 mg q8w (N=139) | TREMFYA 400 mg SC→TREMFYA 200 mg q4w (N=140) | Placebo (N=139) | |
|---|---|---|---|
| Adverse events | 308.3 | 310.7 | 357.1 |
| Serious adverse events | 6.5 | 8.2 | 38.4 |
| Serious infections | 0.8 | 2.5 | 3.7 |
| Discontinuations due to adverse events | 4.9 | 4.1 | 19.8 |
Additional Analyses
Venkat et al (2025) evaluated the impact of SC TREMFYA induction on molecular inflammation from baseline (week 0) to week 12 in patients with UC.4
- Analyses were conducted to assess molecular changes from baseline to week 12 among patients in the ASTRO randomized population. Specifically, transcriptional profiling of colonic biopsies from 339 patients was performed.
- A comparative analysis with biopsy samples from 593 patients from the QUASAR induction study was also performed.
- Correlation between Geboes score and changes in transcriptional gene modules were evaluated in colonic biopsies from 413 patients.
- Molecular changes were assessed in the context of clinical remission and histologic-endoscopic mucosal improvement (HEMI) at week 12.
Results
- At week 12, treatment with TREMFYA SC induction (ASTRO) resulted in significant downregulation of inflammatory transcriptional modules in colon tissue, representing T-helper 17 [Th17], interferon-gamma [IFN-γ] signaling, inflamed epithelium, plasma cell, neutrophil and inflammatory fibroblast biology, and upregulation of healthy epithelium-related gene modules including goblet cells and healthy epithelium (all false discovery rate [FDR]<0.05)
- Response to TREMFYA SC induction showed significant correlation with changes observed with transcriptional genes modules with TREMFYA 200 mg IV induction in QUASAR (R=0.98, P<0.0001).
- Patients achieving clinical remission or HEMI at week 12 showed robust changes in gene module expression, nearing non-inflammatory bowel disease (non-IBD) control levels (P<0.0001) compared to non-remitters. This molecular response was consistent across subgroups defined by prior exposure to BIO/JAKi/S1Pi, in both treatment-naïve and treatment-resistant patients (R=0.93, P<0.0001).
- At week 12, serum and tissue IL-22 levels were significantly decreased (P<0.05) in 355 patients, nearing non-IBD control levels both with TREMFYA SC induction and IV induction.
- Patients who achieved clinical remission at week 12 showed a robust reduction in Geboes histologic scores (P<0.05) compared to non-remitters.
Literature Search
A literature search of MEDLINE®
References
| 1 | Long M, Allegretti JR, Danese S. Efficacy and safety of subcutaneous guselkumab induction therapy in patients with ulcerative colitis: results through week 24 from the phase 3 ASTRO study. Abstract presented at: Congress of DDW; 3-6 May 2025; San Diego, California. |
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