Infliximab is Effective and Well Tolerated in Pediatric Patients With CD, Study Finds

September 3, 2018
The Center for Biosimilars Staff

Pediatric Crohn disease (CD), which can have serious impacts on children’s growth, is increasing in incidence. Current treatments for pediatric patients with CD—such as corticosteroids or immunomodulators—may be particularly difficult for children to tolerate. Infliximab, however, has been shown to be effective and well tolerated in children, as a newly published phase 3 study in Japanese pediatric patients with CD found that infliximab improved clinical outcome measures from week 2 to week 56.

Pediatric Crohn disease (CD), which can have serious impacts on children’s growth, is increasing in incidence. Current treatments for pediatric patients with CD—such as corticosteroids or immunomodulators—may be particularly difficult for children to tolerate. Infliximab, however, has been shown to be effective and well tolerated in children, as a newly published phase 3 study in Japanese pediatric patients with CD found that infliximab improved clinical outcome measures from week 2 to week 56.

The open-label, uncontrolled, multicenter phase 3 study, conducted at 9 sites between 2012 and 2015, enrolled 14 patients, aged 6 to 17 years. All of the patients had CD and an inadequate response to other therapies. All patients received 5 mg/kg of infliximab at weeks 0, 2, and 6, followed by 8-week administration intervals until week 46. The 5 patients who had inadequate responses as measured by the Pediatric Crohn’s Disease Activity Index (PCDAI) after week 14 received dose escalations to 10 mg/kg. One patient in the 5-mg group discontinued treatment after being identified as having a surgical indication for fistulas.

Click to read more about using biologics to treat pediatric patients.

The median (interquartile range) PCDAI score decreased from 35.0 at baseline to 13.75 (10.0-17.5) at week 2, 10.0 (5.0-10.0) at week 6, and 5.0 (0.0-12.5) at week 10, then ranged from 0.0 to 10.0 from week 14 to week 54. The overall median PCDAI score at week 54 was 6.25 (0.00-20.0), the PCDAI response rate at week 54 was 85.7%, and the overall remission rate at week 54 was 64.3%. For patients whose doses were escalated, by 8 weeks after the dose increase, PCDAI response rates and remission rates were both 60.0%.

Notably, 2 of 3 patients who had used corticosteroids at baseline were able to withdraw from steroid treatment, and both achieved remission. Withdrawal from steroids is an important objective in management of CD in children because of their potential to inhibit growth.

All of the patients experienced adverse events (AEs), with the most common AEs being infection and infestation, and 14.3% of patients had serious AEs. No differences in safety were observed between the 5-mg and 10-mg groups.

“Administration of [infliximab] was well tolerated and rapidly improved clinical symptoms, and the effects were maintained for up to 54 weeks,” the authors concluded.

Reference

Tajiri H, Motoya S, Kinjio F, et al. Infliximab for pediatric patients with Crohn’s disease: a phase 3, open-label, uncontrolled, multicenter trial in Japan [published online August 16, 2018.] PLOS One. doi: 10.1371/journal.pone.0201956.