TREMFYA - Switching from Other Biologics or Advance Therapy to TREMFYA in Crohn's Disease

SUMMARY  

• The safety and efficacy of TREMFYA in adult patients with moderately to severely active Crohn's disease (CD) 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 the GALAXI clinical program and a prospective study.⁵

Clinical Data

GALAXI Clinical Trial Program

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

Prospective Study

Shafrir et al (2026)⁵ evaluated the effectiveness and safety, of TREMFYA in patients with refractory CD previously exposed to risankizumab.

Methods

• Patients initiating TREMFYA were prospectively monitored at weeks 0, 2, 4, 8, and 12 and data from patients who received therapy for ≥8 weeks was analyzed.⁵
• Assessments included disease activity using the Harvey‑Bradshaw Index (HBI) score, steroid use, adverse events (AEs), and laboratory parameters (C-reactive protein [CRP] and fecal calprotectin [FCP]).⁵
• Data extracted from medical records included the following⁵:
  • Prior risankizumab exposure (start and stop dates, duration, maintenance intervals, dose intensification, and reason for treatment discontinuation)
  • Therapies administered between risankizumab and TREMFYA

Results

• Twenty‑eight patients with CD were included (50.8 years [standard deviation (SD), 14.9 years]; and disease duration, 21.2 years [SD, 11.8 years]).⁵
• Baseline characteristics included stricturing phenotype (54%), ileocolonic location (48%), prior surgery (71%) and 89% of patients received ≥3 advanced therapies.⁵
• The mean duration of prior risankizumab therapy was 15.4 months (SD, 10.4 months).⁵
• Baseline characteristics are summarized in Table: Baseline Characteristics.

Efficacy

• At baseline, the median HBI score was 5 (interquartile range [IQR], 3-8), and the median FCP level was 653 µg/g (IQR, 99.9-1138.8).⁵
• At weeks 4 and 12, the median HBI score decreased to 4 (IQR, 2-6) and 2.5 (IQR, 0-5), respectively, from baseline.⁵
• At week 12:
  • The steroid-free remission rate increased from 35.7% at baseline to 68.2%.
  • The median HBI score decreased from 9 (quartile range [QR], 7.5-10.5) to 5 (QR,
    1-7) in patients with active disease at baseline (n=11).
  • The median FCP level decreased from 653.5 µg/g at the baseline to 165.5 µg/g (IQR, 82.3-552.8).
• No statistically significant changes in CRP were observed over time.⁵
• A univariate analysis showed no significant associations between age, sex, duration of disease, prior biologic therapies, reasons for discontinuation of risankizumab, or baseline inflammatory markers and steroid-free clinical remission.⁵

Safety

• No treatment-emergent adverse events were reported.⁵

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 30 March 2026.