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

Completed

• Conditions: Pediatric Acute Severe Colitis
• Interventions: Other: Clinical and laboratory assessment

• Registration Number: NCT02170714
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Diagnosis of ASC
• Confirmed diagnosis of ulcerative colitis (UC)
• Age 1-18 years

Exclusion Criteria

• Not confirmed diagnosis of UC
• Contraindications for infliximab therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASC	Clinical and laboratory assessment	Consecutive children hospitalized for an episode of acute ASC, defined as a PUCAI \> 65. 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. A follow-up of 2 years for the colectomy risk was evaluated for all patients.

Primary Outcome Measures

Name	Time	Method
The number of patients with ASC treated with IFX requiring colectomy	24 months	The surgical need will be evaluated in the group of patients treated with IFX during a 24-month follow-up

Secondary Outcome Measures

Name	Time	Method
The number of patients with ASC requiring colectomy	1,6,12,18,24 months
To identify clinical predictive factors at the diagnosis of ASC of surgical need at follow-up	First day of the hospitalization	Clinical variables at the diagnosis of ASC (i.e. duration of the disease before the episode of SC, past and ongoing therapies, age, family history, Perinuclear Anti-Neutrophil Cytoplasmic Antibodies - pANCA, PUCAI) were evaluated in the group of children needed colectomy at follow-up versus those not requiring surgery.

Trial Locations

Locations (1)

Department of Pediatrics, Sapienza University of Rome; 🇮🇹 Rome, Italy