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TREMFYA®

(guselkumab)

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TREMFYA® (guselkumab)
Medical Information

TREMFYA - Treatment of Adult Patients with Ulcerative Colitis - Real-World Evidence

Last Updated: 06/30/2026

SUMMARY

  • Summarized in this response is data focused on the clinical effectiveness and safety of TREMFYA in adult patients with ulcerative colitis (UC).1

Real-world data in adult patients with UC


Summary of Real-World Data in Adult Patients with UC1
Study Description
Results
Prospective Study
Shafrir et al (2026)1 evaluated the real-world effectiveness and safety of TREMFYA in adult patients with moderately to severely active UC from a large tertiary IBD center.

Patients with UC who initiated treatment with TREMFYA were prospectively followed.

Assessments were conducted at weeks 0, 2, 4, 8, and 12.

Outcomes evaluated included disease activity (using SCCAI), corticosteroid use, and safety.

Laboratory parameters, including CRP and FCP, were measured at baseline and at weeks 4, 8, and 12.

Patients with ≥12 weeks of follow-up were included in the study.
Baseline characteristics
  • Of the 61 patients who started TREMFYA treatment, 59 (97%) patients remained on TREMFYA at week 12.
  • At baseline, the mean (SD) age was 42.95 (16.29) years.
Effectiveness
  • The median (IQR) SCCAI decreased from 3.5
    (1-6) at baseline to 0.5 (0-1) at week 12.
  • At baseline, 46.4% (26/56) of patients were in clinical remission (SCCAI ≤2), which increased to 88.9% (48/54) at week 12.
  • At week 12, among 30 patients with active disease at baseline, 83% (n=25) achieved clinical remission.
  • At week 12, the steroid-free remission increased from 45.5% at baseline to 71.7%.
  • At week 12, among patients with elevated baseline CRP (n=12), the median CRP reduced from 6.75 mg/L to <3 mg/L.
  • At week 12, median FCP reduced from 977 μg/g to 322 μg/g.
  • Remission rates with TREMFYA treatment were comparable between UST-naïve and UST-exposed patients.
  • In a univariate analysis, age, prior TNF or UST therapy, and sex were not associated with steroid-free remission at weeks 8 or 12.
Safety
  • No treatment-related serious adverse events were observed.
Abbreviations: CRP, C-reactive protein; FCP, fecal calprotectin; IBD, inflammatory bowel disease; IQR, interquartile range; SCCAI, Simple Clinical Colitis Index; SD, standard deviation; TNF, tumor necrosis factor; UC, ulcerative colitis; UST, ustekinumab.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 24 June 2026.

References

Show
1 Shafrir A, Mathew A, Tanouye JM, et al. Guselkumab efficacy and safety in moderately to severely active ulcerative colitis: real-world data from a large tertiary center. J Crohns Colitis. 2026;20(Suppl_1):jjaf231.913. Abstract P0732.  

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