NCT02170714

Efficacy of Infliximab as a Rescue Therapy in Pediatric Acute Severe Colitis

Managing Pediatric Acute Severe Colitis According to the 2011 ECCO-ESPGHAN Guidelines: Efficacy of Infliximab as a Rescue Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a second line therapy. This study was performed in consecutively observed pediatric patients with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)- European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN) guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical predictors of poor outcome. Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All patients were treated according to the above mentioned guidelines for ASC and received intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy rate and the efficacy of IFX in avoiding colectomy were evaluated.

Conditions

• Pediatric Acute Severe Colitis

Interventions

Type	Name	Description
OTHER	Clinical and laboratory assessment	Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) were recorded at admission and at day 3 and 5. All patients were treated according to the 2011 ECCO-ESPGHAN guidelines for ASC: all patients received intravenous (iv) corticosteroids (methylprednisolone 1.5-2 mg/Kg/day) for 5 days. Patients not responding to corticosteroids (i.e. PUCAI\>65 at day 5) started Infliximab (IFX, 5 mg/Kg 0,2,6 then every 8 weeks) as second-line therapy. All therapies were decided at the discretion of the referral gastroenterologist and recorded on standardized case report forms

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-05-01
• Completion: 2014-05-01
• First posted: 2014-06-23
• Last updated: 2014-06-23

Locations

1 site across 1 country: Italy