SUMMARY  

• The safety and efficacy of TREMFYA in adult patients with moderately to severely active Crohn's disease were evaluated through a phase 2/3 randomized, double-blind, placebo- and active-controlled (ustekinumab) program (GALAXI) and a phase 3, randomized, double-blind, placebo-controlled treat through study (GRAVITI).¹
• Patients in these studies must have discontinued biologic therapy prior to the first dose of study intervention.^2,3
• During the long-term extension (LTE) of the phase 2b study (GALAXI 1) and phase 3 studies (GALAXI 2&3), patients treated with ustekinumab who lost response could switch directly from ustekinumab 90 mg subcutaneous (SC) every 8 weeks (q8w) to TREMFYA 200 mg SC every 4 weeks (q4w), without TREMFYA intravenous (IV) induction.^1,4
• Summarized below are results from pooled from the GALAXI 1 and GALAXI 2&3 studies.

Clinical Data

Clinical Protocol

• Patients included in the GALAXI phase 2b/3 program were those who had an inadequate response or intolerance to previous conventional therapies (oral corticosteroids, immunomodulators [6-mercaptopurine, azathioprine, or methotrexate]) or biologics (tumor-necrosis factor [TNF] antagonists, vedolizumab).^2,3 
• The following medications/therapies must have been discontinued before the first dose of study intervention:^2,3
  • Anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol, adalimumab, golimumab) received within 8 weeks of baseline.
  • Vedolizumab received within 12 weeks of baseline.
  • Ustekinumab received within 16 weeks of baseline.
  • Please note that for GALAXI, a shorter washout duration for anti-TNF agents, ustekinumab or vedolizumab is acceptable if undetectable drug levels of the biologic can be demonstrated.
• Patients were excluded if previously received a biologic agent targeting interleukin (IL)-12/23 or IL-23, including but not limited to briakinumab, brazikumab, guselkumab, mirikizumab, and risankizumab,^2,3 EXCEPT:
  • Please note that for GALAXI, patients who have had exposure to ustekinumab at its approved labeled dosage AND have met the required washout criterion AND have not demonstrated failure or intolerance to ustekinumab. These patients were not excluded from this protocol provided that other inclusion criteria have been satisfied and no other exclusion criteria are met.²

Clinical Data

• As described above, during the GALAXI program, patients with prior inadequate response or intolerance to ustekinumab were excluded. However, during the phase 2b study (GALAXI 1) LTE (weeks 52-80) and phase 3 studies (GALAXI 2&3) LTE, patients in the ustekinumab arm who lost response were eligible to switch directly from ustekinumab 90 mg SC q8w to TREMFYA 200 mg SC q4w without TREMFYA IV induction.^1,4
  • An inadequate response was defined as not in clinical response (≥100-point reduction in Crohn’s Disease Activity Index [CDAI] score from baseline or CDAI <150) and CDAI ≥220.
• A total of 75 patients treated with ustekinumab who lost response during the LTE were switched to TREMFYA 200 mg SC q4w maintenance. Please note, the results are limited by small sample size and direct treatment adjustment to TREMFYA SC maintenance dosing without IV induction.⁴
  • Approximately two-thirds (65.3%) underwent treatment switch by week 60.
• Clinical response (≥100-point reduction from baseline in CDAI score or CDAI <150) and clinical remission (CDAI <150) were assessed 16 weeks after treatment adjustment.^1,4
• Endoscopic response and endoscopic remission were assessed at LTE Weeks 96 and 144 (approximately 1 and 2 years after treatment adjustment, respectively):^1,4
  • Endoscopic response: ≥50% improvement from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) or SES-CD ≤2.
  • Endoscopic remission: SES-CD ≤4 and at least a 2-point reduction from baseline and no subscore greater than 1 in any individual component.

Pooled Data from GALAXI 1, 2, and 3

• Clinical response and remission 16 weeks after treatment switch in patients who switched from ustekinumab to TREMFYA 200 mg SC every 4 weeks are reported in Table: Clinical Outcomes 16 Weeks After Treatment Switch.¹

• Endoscopic response and remission rates approximately one year after treatment switch (study week 96) are reported in Table: Endoscopic Outcomes at Study Week 96 During the Long-Term Extension.⁴ 

GALAXI 1

• Endoscopic response and remission approximately two years after treatment switch (study week 144) were available from GALAXI 1 at the time of this presentation. See Table: GALAXI 1: Endoscopic Outcomes at Study Week 144 During the Long-term Extension.¹

Safety 

• For a summary of safety from the time of treatment switch through week 96, see Table: Safety through Week 96.⁴

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 29 October 2025.