SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• The safety of TREMFYA was assessed in adult patients with moderately to severely active Crohn's disease (CD) through GALAXI 2 and 3. GALAXI 2 and 3 were 2 identically designed, randomized, double-blind, active comparator, placebo-controlled treat-through trials.
  • Through 48 weeks of treatment with TREMFYA, there was one report of active tuberculosis (1/296, 0.3%) in a patient who received TREMFYA 200 mg intravenous (IV) induction therapy at weeks 0, 4, and 8 followed by TREMFYA 100 mg subcutaneous (SC) every 8 weeks (q8w).¹
• The safety of TREMFYA was evaluated in adult patients with moderately to severely active ulcerative colitis (UC) through two phase 3 clinical studies, including a 12-week induction study and a 44-week maintenance study.
  • Through 56 weeks of treatment with TREMFYA, there were no reports of active tuberculosis.²

POOLED SAFETY ANALYSIS - CROHN’S DISEASE

Panaccione et al (2024)¹ reported the safety of TREMFYA in adult patients with moderately to severely active CD through GALAXI 2 and GALAXI 3 trials.

• One active tuberculosis (1/296, 0.3%) was reported in a patient who received TREMFYA 200 mg IV induction therapy at weeks 0, 4, and 8 followed by TREMFYA 100 mg SC q8w.

CLINICAL DATA - ULCERATIVE COLITIS

Rubin et al (2024)² evaluated the efficacy and safety of TREMFYA as maintenance therapy in a phase 3, randomized-withdrawal, double-blind, placebo-controlled study (QUASAR maintenance study) through week 44 in adult patients with moderately to severely active UC who achieved clinical response to TREMFYA IV induction.

• Among patients included in the randomized safety analysis set (TREMFYA 100 mg SC q8w [n=186]; TREMFYA 200 mg SC q4w [n=190]; placebo [TREMFYA withdrawal, n=192]), no cases of active tuberculosis were reported in any of the study groups.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 27 June 2024.