SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• The safety of TREMFYA in adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) were evaluated in the QUASAR, ASTRO, GALAXI, and GRAVITI clinical trial programs, respectively. Summarized below is malignancy data from these programs.^1,2

Clinical Data - CROHN’S DISEASE

Pooled Safety Analysis of Phase 3 GALAXI 2 & 3

Panaccione et al (2024)¹ reported the safety of TREMFYA in adult patients with moderately to severely active CD through GALAXI 2 and 3. GALAXI 2 and 3 were 2 identically designed, randomized, double-blind, active comparator, placebo-controlled treat-through trials.

• Of the 299 patients who received TREMFYA 200 mg intravenous (IV) induction followed by TREMFYA 200 mg subcutaneous (SC) every 4 weeks (q4w) through week 48, malignancy was reported in 1 (0.3%) patient.
• No cases of malignancy were reported through week 48 in the following groups:
  • Placebo IV → SC (N=153)
  • TREMFYA 200 mg IV q4w → 100 mg SC every 8 weeks (q8w) [N=296]
  • Ustekinumab ~6 mg/kg IV → 90 mg SC q8w (N=300)

GRAVITI Phase 3 Study

Hart et al (2025)³ evaluated the safety of TREMFYA in adult patients with moderately to severely active CD through a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through study (GRAVITI). The study included a 12-week TREMFYA SC induction phase, followed by SC maintenance therapy.

• Among the 115 participants who received TREMFYA 400 mg SC q4w during induction, followed by TREMFYA 100 mg SC q8w through week 48, one case of basal cell carcinoma was reported.

CLINICAL DATA - ULCERATIVE COLITIS

QUASAR Phase 3 Studies

The safety of TREMFYA was evaluated through 2 phase 3, randomized, double-blind, placebo-controlled, studies in adult patients with moderately to severely active UC (QUASAR). This included a 12-week induction study and a 44-week randomized, withdrawal maintenance study.²

• Through week 12 of induction, 2 participants in the TREMFYA 200 mg IV group with significant risk factors for skin cancer had treatment-emergent malignancies⁴:
  • Patient 1: On day 23, squamous cell carcinoma was reported in a 66-year-old white participant with a past medical history of previously resected squamous cell carcinoma and concomitant corticosteroid use.
  • Patient 2: On day 32, basal cell carcinoma was reported in a 60-year-old white participant with concomitant corticosteroid use.
• Through week 44 of maintenance, malignancies were reported in 5 participants⁵ :
  • Two participants (60-year-old female and 48-year-old female) in the placebo group each had 1 malignancy of non-melanoma skin cancer (basal cell carcinoma). 
    • One of these participants also reported a basal cell carcinoma (60-year-old female) while receiving TREMFYA during the induction period.
  • Two participants (64-year-old female and 51-year-old female) in the placebo group had breast cancer.
  • One 42-year-old female participant in the TREMFYA 200 mg SC q4w group had adenocarcinoma of the rectum without dissemination or metastasis. This participant had a 9-year history of extensive UC, which is associated with an increased risk of colorectal cancer.
  • Among all treated participants, 4 additional malignancies were reported in 3 participants:
    • One 40-year-old female participant in the nonrandomized placebo group had breast cancer.
    • One 43-year-old male participant in the nonrandomized TREMFYA 200 mg SC q4w group with a risk factor of hypertension had clear cell renal cell carcinoma.
    • One 66-year-old female participant randomized to the maintenance placebo group and then dose adjusted to TREMFYA 200 mg had 2 malignancies of squamous cell carcinoma of skin. This participant also had malignancies of squamous cell carcinoma reported in the placebo-controlled induction period.

ASTRO Phase 3 Study  

TREMFYA was also assessed through a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adults with moderately to severely active ulcerative colitis. This included 12 weeks of TREMFYA SC induction therapy, followed by TREMFYA SC maintenance therapy.^6-8  

• Through week 48, 4 cases of malignancy were reported.^9,10 
  • A 62-year-old female patient receiving TREMFYA 200 mg SC q4w: On day 60, breast cancer was reported, and the patient was permanently discontinued from the study intervention on day 105. On day 141, lymphoma was reported in the same patient; she was a former smoker with a family history of malignancy.  
  • A 33-year-old male patient receiving placebo: On day 157, adenocarcinoma of the colon was reported.
  • A 61-year-old male patient receiving TREMFYA 200 mg SC q4w: On day 223, basal cell carcinoma was reported.   

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 06 November  2025.