SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the TREMFYA Prescribing Information for relevant information regarding immunogenicity with TREMFYA. Summarized in this response are relevant data on immunogenicity from phase 3 clinical trials in adults with ulcerative colitis (UC).¹

Clinical Data in UC

Phase 3 Clinical Trials - QUASAR Studies

The safety and efficacy of TREMFYA in adult patients with moderately to severely active UC was evaluated through two phase 3 clinical studies, including a 12-week induction study and a 44-week maintenance study.

• Up to week 56, 11% (n=48) 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% (n=6) had antibodies that were classified as neutralizing antibodies.¹
• Most of the patients who were positive for antibodies to guselkumab had low titers. Two patients with the highest antibody titers exhibited low trough levels of guselkumab.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

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 11 September 2024.