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(guselkumab)

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TREMFYA® (guselkumab)

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TREMFYA - Impact of Weight on Efficacy in the Treatment of Adult Patients with Crohn’s Disease or Ulcerative Colitis

Last Updated: 03/13/2026

SUMMARY  

  • Please refer to TREMFYA local labeling for any relevant information on this topic.
  • The efficacy and safety of TREMFYA in adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) were evaluated in the QUASAR (intravenous [IV] induction followed by SC maintenance)/ASTRO (subcutaneous [SC] induction followed by SC maintenance) and GALAXI (IV induction followed by SC maintenance)/GRAVITI (SC induction followed by SC maintenance) clinical trial programs, respectively.1-4
    • A subgroup analysis of the GRAVITI study assessing the impact of weight on efficacy is reported below.5
    • Additionally, post hoc analyses were conducted to evaluate the impact of body mass and body mass index (BMI) on the efficacy of TREMFYA SC vs TREMFYA IV induction in the GRAVITI, GALAXI, QUASAR, and ASTRO studies and are summarized below.6,7 

CLINICAL DATA

Phase 3 Subcutaneous Induction Study in Crohn's Disease – GRAVITI

Study design/Methods

  • GRAVITI is a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through study which evaluates SC induction therapy followed by SC maintenance therapy in adults with moderately to severely active CD through week 48.8
  • A total of 347 patients were randomized 1:1:1 to5:
    • TREMFYA 400 mg SC at weeks 0, 4, and 8 followed by 200 mg SC every 4 weeks (q4w; N=115)
    • TREMFYA 400 mg SC at weeks 0, 4, and 8 followed by 100 mg SC every 8 weeks (q8w; N=115)
    • Placebo (N=117)
  • The efficacy of SC induction based on body weight was evaluated.5
  • Clinical remission (Crohn’s Disease Activity Index [CDAI] <150) and endoscopic response at week 12 (≥50% improvement from baseline in the Simple Endoscopic Score for Crohn’s Disease [SES-CD]) were evaluated by predefined subgroups including baseline weight quartiles: <57.5, ≥57.5 to <68.5, ≥68.5 to <80.5, and ≥80.5 kg.5

Results


Clinical Remission and Endoscopic Response at Week 12 by Baseline Weight Quartiles5
Clinical Remission
Endoscopic Response
TREMFYA
400 mg SC
% (n)
Placebo
% (n)
Rate Difference (95% CI)
TREMFYA
400 mg SC
% (n)
Placebo
% (n)
Rate Difference (95% CI)
All patients
56.1 (N=230)
21.4 (N=117)
34.9
(25.1, 44.6)
41.3 (N=230)
21.4 (N=117)
19.9
(10.2, 29.6)
Weight (kg)
   <57.5
46.4 (n=56)
10.0 (n=30)
29.5
(12.3, 46.8)
42.9 (n=56)
20.0 (n=30)
19.2
(-1.5, 40.0)
   ≥57.5
   to <68.5
62.7 (n=51)
22.2 (n=36)
42.7
(24.4, 61.0)
43.1 (n=51)
22.2 (n=36)
24.7
(5.1, 44.3)
   ≥68.5
   to <80.5
55.4 (n=56)
25.8 (n=31)
35.0
(15.7, 54.3)
42.9 (n=56)
19.4 (n=31)
28.8
(8.7, 48.9)
   ≥80.5
59.7 (n=67)
30.0 (n=20)
34.2
(9.4, 59.1)
37.3 (n=67)
25.0 (n=20)
20.6
(1.6, 39.6)
Abbreviations: BIO, biologic; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CI, confidence interval; COVID-19, coronavirus disease 2019; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease.
Note: Patients who had a CD-related surgery (with the exception of minor procedures, such as drainage of a superficial abscess or seton placement) or a prohibited change in CD medication or for whom the study intervention was discontinued for any reason (other than COVID-19-related reasons [excluding COVID-19 infection] or regional crisis) were considered not to have met the endpoint at the designated timepoint. Patients for whom the study intervention was discontinued due to COVID-19-related reasons (excluding COVID-19 infection) or regional crisis had their observed data used, if available. After accounting for the aforementioned data handling rules, patients who were missing data pertaining to an endpoint at a designated timepoint were considered not to have achieved the endpoint. The 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 BIO-failure status (yes or no). Subgroup analyses were not evaluated (ie, rate difference, 95% CI, and P-value were not calculated) whenever there were less than 10 patients in at least 1 treatment group.

Post Hoc Analyses – GALAXI and GRAVITI Studies

Deepak et al (2026)6 performed post hoc analyses of the phase 3 GALAXI and GRAVITI studies to evaluate the impact of body mass and BMI on the efficacy of TREMFYA SC (GRAVITI) vs TREMFYA IV (GALAXI) induction in patients with CD.

Study design/Methods

  • Patients received TREMFYA 200 mg IV in GALAXI 2 & 3 (N=582) or 400 mg SC in GRAVITI (N=230) at weeks 0, 4, and 8, with matching IV or SC placebo (N=148 and N=117, respectively) as comparators.
  • Clinical response (≥100-point reduction from baseline in CDAI or CDAI <150), clinical remission (CDAI <150), and endoscopic response (≥50% improvement from baseline SES-CD) were assessed at week 12 across baseline weight quartiles and standard BMI subgroups in GALAXI and GRAVITI studies:
    • Underweight (<18 kg/m2)
    • Healthy weight (≥18 to <25 kg/m2)
    • Overweight (≥25 to <30 kg/m2)
    • Obese (≥30 kg/m2)
  • Weight quartiles were calculated separately for GRAVITI and pooled GALAXI 2 & 3.

Results

Clinical Response (A), Clinical Remission (B), and Endoscopic Response (C) at Week 12 by Baseline Weight Quartiles6 

Abbreviations: BIO, biologic; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CI, confidence interval; COVID-19, coronavirus disease 2019; IV, intravenous; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease.
Note: In GALAXI, weight quartiles are based on patients in the primary analysis set as follows: 1st Q=57 kg, 2nd Q=67.1 kg, 3rd Q=79 kg. In GRAVITI, weight quartiles are based on patients in the full analysis set as follows: 1st Q=59 kg, 2nd Q=69.5 kg, 3rd Q=81 kg. Patients who had a CD-related surgery (with the exception of minor procedures such as drainage of a superficial abscess or seton placement, etc.), a prohibited change in CD medication, or discontinued study intervention for any reason (other than COVID-19 related reasons [excluding COVID-19 infection] or regional crisis) were considered not to have met the endpoint at the designated timepoint. Patients who discontinued study intervention due to COVID-19 related reasons (excluding COVID-19 infection) or regional crisis had their observed data used, if available. After accounting for the aforementioned data handling rules, patients who were missing data pertaining to an endpoint at week 12 were considered not to have achieved the endpoint. The adjusted treatment difference(s) and CIs were based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator. The stratification factors are baseline CDAI score (≤300 or >300), baseline SES-CD score (≤12 or >12), BIO-failure status at baseline (yes or no), and baseline corticosteroid use (yes or no; GALAXI only).

Clinical Response (A), Clinical Remission (B), and Endoscopic Response (C) at Week 12 by Baseline BMI6

Abbreviations: BIO, biologic; BMI, body mass index; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CI, confidence interval; COVID-19, coronavirus disease 2019; IV, intravenous; SC, subcutaneous; SES-CD, Simple Endoscopic Score for Crohn’s Disease.
Note: BMI categories were defined as follows: underweight (<18 kg/m2), healthy weight (≥18 to <25 kg/m2), overweight (≥25 to <30 kg/m2), and obese (≥30 kg/m2). Patients who had a CD-related surgery (with the exception of minor procedures such as drainage of a superficial abscess or seton placement, etc.), a prohibited change in CD medication, or discontinued study intervention for any reason (other than COVID-19 related reasons [excluding COVID-19 infection] or regional crisis) were considered not to have met the endpoint at the designated timepoint. Patients who discontinued study intervention due to COVID-19 related reasons (excluding COVID-19 infection) or regional crisis had their observed data used, if available. After accounting for the aforementioned data handling rules, patients who were missing data pertaining to an endpoint at week 12 were considered not to have achieved the endpoint. The adjusted treatment difference(s) and CIs were based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator. The stratification factors are baseline CDAI score (≤300 or >300), baseline SES-CD score (≤12 or >12), BIO-failure status at baseline (yes or no), and baseline corticosteroid use (yes or no; GALAXI only).

Post Hoc Analyses – QUASAR and ASTRO Studies

Yarur et al (2026)7 performed post hoc analyses of the phase 3 QUASAR and ASTRO studies to evaluate the impact of body mass and body mass index (BMI) on the efficacy of TREMFYA SC (ASTRO) vs TREMFYA IV (QUASAR) induction in patients with UC.

Study Design/Methods

  • Patients received TREMFYA 200 mg IV in QUASAR (N=421) or 400 mg SC in ASTRO (N=279) at weeks 0, 4, and 8, with matching IV or SC placebo (N=280 and N=139, respectively) as comparators.
  • Clinical response (≥30% and ≥2‑point decrease from baseline in the modified Mayo score, with either a ≥1‑point decrease in rectal bleeding subscore or a rectal bleeding subscore of 0-1) and clinical remission (stool frequency subscore 0 or 1 without increase from baseline, rectal bleeding subscore 0, and endoscopy subscore 0 or 1 without friability) were assessed at week 12 across baseline weight quartiles and standard BMI subgroups in QUASAR and ASTRO studies:
    • Underweight (<18 kg/m2)
    • Healthy weight (≥18 to <25 kg/m2)
    • Overweight (≥25 to <30 kg/m2)
    • Obese (≥30 kg/m2)
  • Weight quartiles and BMI subgroups were calculated for QUASAR and ASTRO separately.

Results

Clinical Response (A) and Clinical Remission (B) at Week 12 by Baseline Weight Quartiles7

Abbreviations: CI, confidence interval; COVID-19, coronavirus disease 2019; IV, intravenous; Q, quartile; SC, subcutaneous; UC, ulcerative colitis.
Note: In QUASAR, baseline weight quartiles were: 1st Q=59.2 kg, 2nd Q=70.6 kg, 3rd Q=84.0 kg. In ASTRO, baseline weight quartiles were: 1st Q=59.80 kg, 2nd Q=69.00 kg, 3rd Q=81.60 kg. Patients who had an ostomy or colectomy, a prohibited change in UC medication, or discontinued study intervention for any reason (other than COVID-19 related reasons [excluding COVID-19 infection] or regional crisis) were considered not to have met the endpoint at the designated timepoint. Patients who discontinued study intervention due to COVID-19 related reasons (excluding COVID-19 infection) or regional crisis had their observed data used, if available. After accounting for these intercurrent event rules, patients who were missing data pertaining to an endpoint at a designated timepoint were considered not to have achieved the endpoint. The CIs for the proportion of patients meeting the endpoint in each treatment group were based on the normal approximation confidence limits. The adjusted treatment difference(s) and CIs were based on the Wald statistic with Cochran-Mantel-Haenszel weight. For the “>1Q to ≤2Q” subgroup in ASTRO, treatment differences were unadjusted.

Clinical Response (A) and Clinical Remission (B) at Week 12 by Baseline BMI7

Abbreviations: BMI, body mass index; CI, confidence interval; COVID-19, coronavirus disease 2019; IV, intravenous; SC, subcutaneous; UC, ulcerative colitis.
Note: BMI categories were defined as follows: underweight (<18 kg/m2), healthy weight (≥18 to <25 kg/m2), overweight (≥25 to <30 kg/m2), and obese (≥30 kg/m2). Patients who had an ostomy or colectomy, a prohibited change in UC medication, or discontinued study intervention for any reason (other than COVID-19 related reasons [excluding COVID-19 infection] or regional crisis) were considered not to have met the endpoint at the designated timepoint. Patients who discontinued study intervention due to COVID-19 related reasons (excluding COVID-19 infection) or regional crisis had their observed data used, if available. After accounting for these intercurrent event rules, patients who were missing data pertaining to an endpoint at a designated timepoint were considered not to have achieved the endpoint. The CIs for the proportion of patients meeting the endpoint in each treatment group were based on the normal approximation confidence limits. The adjusted treatment difference(s) and CIs were based on the Wald statistic with Cochran-Mantel-Haenszel weight. For the “Underweight” subgroup in ASTRO, treatment differences were unadjusted.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 28 January 2026.

 

References

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1 Panaccione R, Feagan BG, Afzali A, et al. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn’s disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials. Lancet. 2025;406(10501):358-375.  
2 Danese S, Afzali A, Panaccione R. Week 48 efficacy of guselkumab and ustekinumab in Crohn’s disease based on prior response/exposure to biologic therapy: results from the GALAXI 2 & 3 phase 3 studies. Am J Gastroenterol. 2024;119(10S):S741-S742. Abstract S1053.  
3 Rubin DT, Allegretti JR, Panés J, et al. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025;405(10472):33-49.  
4 Long M, Allegretti JR, Danese S, et al. 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; May 3-6, 2025; San Diego, CA.  
5 Hart A, Hisamatsu T, Steinwurz F, et al. Efficacy of subcutaneous guselkumab induction therapy by baseline demographics and concomitant medications in participants with moderately to severely active Crohn’s disease: results from the phase 3 GRAVITI study. Abstract presented at: 20th Congress of European Crohn’s and Colitis Organisation (ECCO); February 19-22, 2025; Berlin, Germany.  
6 Deepak P, Yarur AJ, Hisamatsu T, et al. Efficacy of intravenous and subcutaneous guselkumab induction by weight and body mass index in patients with Crohn’s disease: results from the phase 3 GALAXI and GRAVITI studies [abstract]. J Crohns Colitis. 20(Supplement_1):i2670-i2672. Abstract P1110.  
7 Yarur AJ, Deepak P, Hisamatsu T, et al. Intravenous and subcutaneous guselkumab induction are similarly efficacious in patients with ulcerative colitis across weight quartile and BMI subgroups: week 12 results from the phase 3 QUASAR and ASTRO studies [abstract]. J Crohns Colitis. 20(Supplement_1):i355-i357. Abstract DOP103.  
8 Hart A, Panaccione R, Steinwurz F, et al. Efficacy and safety of guselkumab subcutaneous induction and maintenance in participants with moderately to severely active Crohn’s disease: results from the phase 3 GRAVITI study. Gastroenterology. 2025;169(2):308-325.