Phase 3 trial finds infliximab effective in pediatric UC

May 20, 2011

Pediatric patients with moderately to severely active ulcerative colitis demonstrated a clinical response with infliximab (Remicade, Centocor Ortho Biotech), according to data from a phase 3 randomized, multicenter, open-label study.

Pediatric patients with moderately to severely active ulcerative colitis (UC) demonstrated a clinical response with infliximab (Remicade, Centocor Ortho Biotech), according to data from a phase 3 randomized, multicenter, open-label study.  The findings, which were presented during Digestive Disease Week, showed that infliximab has a safety profile similar in pediatric patients as in adults.

The study’s primary results showed that a 5 mg/kg dose of infliximab at 0, 2, and 6 weeks induced a clinical response at week 8 in 73.3% of 60 patients aged 6 to 17 years.  The patients had previously not responded or could not tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids, and/or 5-aminosalicylate (5-ASA).  The Mayo score-a 12-point clinical assessment and colonoscopy-based measurement-was used to determine disease activity.

At week 8, 40% of patients were in clinical remission according to the Mayo score and 33.3% were in remission using the Pediatric UC Activity Index (PUCAI), the validated, non-invasive clinical assessment of disease activity in children.  In addition, by week 8 more than two-thirds of patients achieved mucosal healing.

Forty-five patients who achieved a clinical response were randomly assigned to receive infliximab 5 mg/kg every 8 weeks through week 46 (22 patients) or every 12 weeks through week 42 (23 patients).  At week 54, twice as many patients in the group that received infliximab every 8 weeks (38.1%) achieved remission according to the PUCAI compared with the group that received the drug every 12 weeks (18.2%).  Also at week 54, more patients in the maintenance group that received infliximab every 8 weeks (38.5%) and who had been taking corticosteroids at baseline were in remission and off corticosteroids than in the every 12-week maintenance group (0%).

The proportions of patients experiencing serious adverse events were similar across the maintenance groups (18.2% and 21.7% in the every 8-week and every 12-week groups, respectively).  The proportions of patients experiencing infusion reactions were also similar (18.2% and 13.0% in the every 8-week and every 12- week groups, respectively).  There were no reports of deaths, malignancies, opportunistic infections, tuberculosis, or delayed hypersensitivity reactions.

“The results of this study are consistent with findings from the Active Ulcerative Colitis (ACT) trials, which evaluated Remicade, in the treatment of adults with ulcerative colitis,” said Jeffrey Hyams, head of the Division of Digestive Diseases and Nutrition at Connecticut Children’s Medical Center and professor of pediatrics at the University of Connecticut School of Medicine, and the lead study investigator.  “UC can be a devastating disease, particularly for children and adolescents.  It is encouraging to see such promising results in a patient population that is in need of additional treatment options.”