TREMFYA®
(guselkumab)
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TREMFYA® (guselkumab)
Medical Information
TREMFYA – Treatment of Ulcerative Colitis with Subcutaneous Induction (ASTRO Study)
Last Updated: 05/12/2025
SUMMARY
CLINICAL DATA
PHASE 3 SUBCUTANEOUS INDUCTION STUDY IN ULCERATIVE COLITIS - ASTRO
Study Design/Methods
- Patients with a history of inadequate response or intolerance to corticosteroids, immunosuppressants, 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
- 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)
- 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
- 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 imporvementd | 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: 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. | ||||||||
- 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 TREMFYAbThe 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. | |||
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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