Vedolizumab as the First-Line of Biologicals for Pediatric Patients With Ulcerative Colitis
Toshihiko Kakiuchi1, Masato Yoshiura1
1Department of Pediatrics, Faculty of Medicine, Saga University, Saga, Japan.
Insights
Vedolizumab (VDZ) is a safe and effective first-line biologic for pediatric ulcerative colitis (UC). Early fecal calprotectin (FC) levels may predict long-term remission in these young patients.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease Research
- Biologic Therapies
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease affecting children.
- Vedolizumab (VDZ), a biologic therapy, has shown efficacy in adult UC.
- Limited data exists on VDZ as a first-line treatment in pediatric refractory UC.
Purpose of the Study:
- To evaluate the safety and effectiveness of vedolizumab (VDZ) as a first-line biologic treatment for pediatric patients with refractory ulcerative colitis (UC).
Main Methods:
- Retrospective data extraction from pediatric UC patients receiving first-line VDZ.
- Assessment of baseline characteristics, disease activity markers (fecal calprotectin, CRP, SAA, ESR), and clinical outcomes.
- Investigation of clinical effectiveness, biochemical remission, and safety profiles.
Main Results:
- Eight pediatric patients (median age 12) with refractory UC received first-line VDZ.
- Five patients achieved clinical remission by week 14, with sustained remission in five by week 52.
- All patients achieved corticosteroid-free remission; no adverse events were reported.
Conclusions:
- Vedolizumab (VDZ) demonstrates potential as a safe and effective first-line biologic therapy for pediatric ulcerative colitis (UC).
- Pre-treatment fecal calprotectin (FC) levels may serve as a predictive marker for achieving long-term remission in this population.
Purpose:
Vedolizumab (VDZ) was reported to be effective as a first-line biological in adult ulcerative colitis (UC). The aim of this study was to investigate the safety and effectiveness of VDZ as the first-line biological in pediatric refractory UC.
Methods:
We retrospectively extracted data from pediatric patients with UC who received first-line VDZ. The following were recorded: baseline characteristics; clinical activity of intestinal disease, levels of fecal calprotectin (FC), C-reactive protein, and serum amyloid A; and erythrocyte sedimentation rate. Clinical effectiveness, biochemical remission, and safety of VDZ were also investigated.
Findings:
Eight patients were identified (median age, 12 years). FC levels were abnormal in all cases and were remarkably elevated in 3 patients. C-reactive protein, serum amyloid A, and erythrocyte sedimentation rate values were abnormal in 2, 4, and 5 patients, respectively. According to the pediatric UC activity index score, 1, 5, and 2 patients had mild, moderate, and severe disease. Fourteen weeks after VDZ administration, 5 patients achieved remission, and 3 remained in remission until week 52. Of the 3 patients who did not reach remission in week 14, two achieved remission by week 52. In week 52, five of the eight patients continued receiving VDZ and maintained remission. All patients achieved clinical remission without corticosteroid use. No adverse events were observed in any patient.
Implications:
VDZ may serve as a safe and effective first-line biological option for treating pediatric patients with UC. FC levels before VDZ administration may be predictive of long-term remission.
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