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TREMFYA®

(guselkumab)

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TREMFYA® (guselkumab)
Medical Information

TREMFYA - Treatment of Adult Patients with Crohn’s Disease - Real-World Evidence

Last Updated: 06/12/2026

SUMMARY

  • Summarized in this response is data focused on the clinical effectiveness and safety of TREMFYA in adult patients with Crohn’s disease (CD).1,2

Real-world data in adult patients with CD


Summary of Real-World Studies in Adult Patients with CD
Study Description
Results
Prospective Studies
  • Shafrir et al (2026)1 evaluated the real-world effectiveness and safety of TREMFYA in adult patients with CD from a large tertiary IBD center.
  • Patients with CD who initiated treatment with TREMFYA were prospectively followed.
  • Assessments were conducted at weeks 0, 2, 4, 8, and 12.
  • Outcomes evaluated were clinical disease activity (using HBI), corticosteroid use, and safety. Laboratory parameters, including CRP and FCP, were measured at baseline and at weeks 4, 8, and 12.
  • Patients with ostomies were excluded from the efficacy analyses.
Baseline Characteristics
  • A total of 77 patients completed 12 weeks of follow-up and were included in the analysis; and the mean (±SD) age was 47.26 (15.46) years.
  • The mean (±SD) disease duration was 19.01 (13.56) years. A total of 45 patients (58.4%) had a history of previous surgery, and 68.9% (53/77) had a previous exposure to ≥2 ADTs.
Effectiveness
  • Among the 20 patients with active disease at baseline, the median HBI decreased from 8
    (IQR 7-12) to 6.5 (IQR 0.75-8) among the 16 patients assessed at week 12.
  • Among patients with elevated baseline CRP, the median CRP reduced from 8 (IQR 6.95-30) mg/L to <3 (IQR 1.5-10.5) mg/L at week 12.
  • Among patients with baseline FCP >150 µg/g, 60% achieved biochemical remission (FCP
    <150 µg/g) at week 12.
  • The rate of corticosteroid-free clinical remission increased from 56.6% at baseline to 68.6% at week 12.
Safety
  • No treatment related adverse events were observed.
Baseline Characteristics
  • Shafrir et al (2026)2 analyzed the effectiveness, safety, and treatment persistence of TREMFYA in a refractory cohort of patients who were exposed to risankizumab.
  • Patients who initiated treatment with TREMFYA were prospectively monitored at weeks 0, 2, 4, 8, and 12.
  • Outcomes evaluated were clinical disease activity (using HBI), corticosteroid use, CRP/FCP, and safety.
  • Patients who received TREMFYA for ≥8 weeks were included in the analysis. Prior exposure to risankizumab, including initiation and termination dates, duration, dose intensification, treatments administered between risankizumab and TREMFYA, and reasons for treatment discontinuation were analyzed.
  • A total of 28 patients were included in the analysis.
  • The mean (±SD) age was 50.8 (14.9) years, and the mean (±SD) disease duration was 21.2 (11.8) years.
  • A total of 20 patients (71.4%) had a history of past surgery.
  • A stricturing phenotype was observed in 54% of patients, and 48% of patients had ileocolonic disease.
  • The mean (±SD) duration of risankizumab treatment was 15.4 (10.4) months, and the reasons for risankizumab discontinuation included loss of response (53.6%), primary nonresponse (21.4%), and AEs (10.7%).
Effectiveness
  • At baseline, the median HBI was 5 (IQR 3-8), and the median FCP was 653 µg/g (IQR 99.9-1138.8).
  • The median HBI scores were reduced to 4 (IQR 2-6) at week 8 and further to 2.5 (IQR 0-5) at week 12.
  • Corticosteroid-free remission increased from 35.7% at baseline to 68.2% at week 12.
  • Among the 11 patients who had active disease at baseline, the median HBI reduced from 9 (IQR 7.5-10.5) to 5 (IQR 1-7) at week 12.
  • The median FCP decreased from 653.5 µg/g (IQR 82.3-552.8) at baseline to 165.5 µg/g (IQR 82.3-552.8) at week 12.
  • There were no statistically significant changes in the levels of CRP over time.
  • In a univariate analysis, there was no significant association between the baseline characteristics (age, sex, disease duration, prior biologic therapies, reasons for treatment discontinuation, and baseline inflammatory markers) and
    corticosteroid-free clinical remission.
Safety
  • No treatment emergent adverse events were reported.
Abbreviations: ADT, advanced therapy; AE, adverse event; CRP, C-reactive protein; FCP, fecal calprotectin; HBI, Harvey-Bradshaw Index; IBD, inflammatory bowel disease; IL, interleukin; IL23i, interleukin 23 inhibitor; IQR, interquartile range; SD, standard deviation.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 27 April 2026.

 

References

Show
1 Shafrir A, Mathew A, Tanouye JM, et al. Guselkumab is efficacious and safe for moderately-to-severely active Crohn’s Disease: real-world data from a large tertiary center [abstract]. J Crohns Colitis. 2026;20(Suppl 1):i709-i711. Abstract P0641.  
2 Shafrir A, Ayoub M, Mathew A, et al. Guselkumab is safe and effective in patients with Crohn’s disease and past exposure to risankizumab [abstract]. J Crohns Colitis. 2026;20(Suppl1):i2616-i2618. Abstract P1087.  

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