TREMFYA - Immunogenicity in Adult Patients with Ulcerative Colitis or Crohn’s Disease

SUMMARY

• Please refer to your local labeling for relevant information regarding immunogenicity with TREMFYA. Summarized in this response are relevant data on immunogenicity from the QUASAR/ASTRO and GALAXI/GRAVITI clinical programs in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), respectively.

TREMFYA U.S. Prescribing information

Ulcerative colitis

QUASAR Studies and ASTRO Study

The safety and efficacy of TREMFYA in adult patients with moderately to severely active UC was evaluated through two randomized, double-blind clinical trial programs (QUASAR and ASTRO).

• Up to week 56 in the QUASAR program, 11% (48/435) of patients treated with TREMFYA at the recommended dosage developed antidrug antibodies.¹
  • Of these patients who tested positive for anti-guselkumab antibodies and were evaluable for neutralizing antibodies, 16% (6/38) had antibodies that were classified as neutralizing antibodies.¹
  • Two patients with the highest antibody titers exhibited low trough levels of guselkumab.¹
• Up to week 24 in the ASTRO study, 9% (24/279) of patients treated with TREMFYA developed antidrug antibodies.¹
  • Of these patients who tested positive for anti-guselkumab antibodies and were evaluable for neutralizing antibodies, 13% (2/16) had antibodies were classified as neutralizing antibodies.¹
• There was no identified clinically significant effect of antidrug antibodies on injection site reactions, or effectiveness of guselkumab, over the treatment duration of 56 weeks.¹

Crohn’s Disease

The safety and efficacy of TREMFYA in adult patients with moderately to severely active CD was evaluated through two randomized, double-blind clinical trial programs (GALAXI and GRAVITI) for a total duration of up to 48 weeks.

GALAXI and GRAVITI Clinical Programs

• Up to week 48 in the GALAXI program; 5% (30/634) of patients treated with TREMFYA at the recommended dosage developed antidrug antibodies.¹ 
  • Of these patients who tested positive for anti-guselkumab antibodies and were evaluable for neutralizing antibodies, 5% (1/22) had antibodies that were classified as neutralizing antibodies.¹ 
• Up to week 48 in the GRAVITI program; 9% (24/273) of patients treated with TREMFYA at the recommended dosage developed antidrug antibodies.¹ 
  • Of these patients who tested positive for anti-guselkumab antibodies and were evaluable for neutralizing antibodies, none had antibodies that were classified as neutralizing antibodies.¹ 
• There was no identified clinically significant effects of antidrug antibodies on pharmacokinetics, injection site reactions, or effectiveness of guselkumab, over the treatment duration of 48 weeks.¹ 

Company Core Data Sheet

Pharmacological Properties

Immunogenicity

Ulcerative Colitis

In pooled phase 2/3 (QUASAR) analyses up to week 56, 12% (58/501) of patients treated with TREMFYA developed antidrug antibodies. Of these patients who developed antidrug antibodies, 16% (9/58) had antibodies that were classified as neutralizing which equates to 2% of all patients treated with TREMFYA.²

In a phase 3 (ASTRO) analysis up to week 24, 9% (24/279) of patients treated with TREMFYA developed antidrug antibodies. Of these patients who developed antidrug antibodies, 12% (3/24) had antibodies that were classified as neutralizing antibodies, which equates to 1% (3/279) of TREMFYA-treated patients.²

Most of the patients who were positive for antibodies to guselkumab had low titers. Antibodies to guselkumab were not associated with changes in pharmacokinetics, clinical efficacy or development of injection-site reactions.²

Crohn’s Disease

In pooled phase 2/3 (GALAXI) analyses up to week 48, 5% (30/634) of patients treated with TREMFYA developed antidrug antibodies. Of these patients who developed antidrug antibodies, 7% (2/30) had antibodies that were classified as neutralizing antibodies, which equates to 0.3% (2/634) of TREMFYA-treated patients.²

In a phase 3 (GRAVITI) analysis up to week 48, 9% (24/273) of patients treated with TREMFYA developed antidrug antibodies. Of these patients who developed antidrug antibodies, 13% (3/24) had antibodies that were classified as neutralizing antibodies, which equates to 1% (3/273) of TREMFYA-treated patients.²

Most of the patients who were positive for antibodies to guselkumab had low titers. Antibodies to guselkumab were not associated with changes in pharmacokinetics, clinical efficacy or development of injection-site reactions.²

NOTE: Numerical differences in anti-drug antibody rates between the U.S. Prescribing Information and the Company Core Data Sheet are due to differences in the data sets used for analysis.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 September 2026.