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

University of Roma La Sapienza

Status: Completed

Conditions: Pediatric Acute Severe Colitis

Treatments: Other: Clinical and laboratory assessment

Study type: Observational

Funder types: Other

Identifiers

NCT02170714

16062014

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

31 participants in 1 patient group

ASC

Description:

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.

Treatment:

Other: Clinical and laboratory assessment