New Data Help Delineate the Role of Biosimilar Infliximab and JAK Inhibitors in Pediatric IBD

Data on the safety and efficacy of biosimilar infliximab CT-P13 (Inflectra, Remsima) in treating inflammatory bowel disease (IBD) continue to accrue, in both adult patients and in pediatric patients, and a study from Finland adds to that body of knowledge, while another study in pediatric patients shows that Janus kinase (JAK) inhibitors may be an option for those who do not respond adequately to infliximab or other biologic treatment.
Kelly Davio
November 29, 2019
Data on the safety and efficacy of biosimilar infliximab CT-P13 (Inflectra, Remsima) in treating inflammatory bowel disease (IBD) continue to accrue, in both adult patients and in pediatric patients.

Recently, a study of patients treated for pediatric IBD at a single center in Finland added to that body of knowledge, finding that first-year therapy outcomes for patients treated with the biosimilar were comparable with those of patients treated with the reference drug.1

The investigators collected data on the outcomes of 51 patients who were naïve to anti–tumor necrosis factor therapy who started infliximab at a single center in Finland between 2015 and 2016. These patients had a median age of 12 years (range, 4-16 years) and 65% of them had Crohn disease (CD).

In total, 23 of the patients were treated with the reference infliximab, and the remaining 28 patients were given the biosimilar option; during 2015, the authors note, the reference infliximab was the option used for treatment-naïve patients, while during 2016, all new patients were given the biosimilar.

The researchers found no statistically significant differences between the 2 drugs in terms of therapy outcomes at 1 year, and there were no significant differences in tough levels between the 2 groups, nor were there notable differences in safety.

While that is reassuring news for health systems seeking to use cost-saving biosimilars in this patient population, some patients may not respond adequately to infliximab or other biologic treatment. In such cases, Janus kinase (JAK) inhibitors may be an option, and in other recent developments in the treatment of pediatric IBD, researchers from a different center reported on using tofacitinib in pediatric patients who did not have an adequate response to infliximab.2

The 12 patients treated with the JAK inhibitor tofacitinib included 5 patients with CD, 5 with ulcerative colitis (UC), and 2 with unclassified IBD, had all failed infliximab therapy, and 6 had failed 3 or more biologics before initiating treatment with the JAK inhibitor.

A clinical response during the observational period of 9.7 weeks (range, 8.3-12.0), measured using a weighted Pediatric Crohn's Disease Activity Index improvement of 17.5 points or more for CD and a decrease in the Pediatric Ulcerative Colitis Activity Index of 20 points or more for UC and unclassified IBD, was observed in 8 of the 12 patients. At the time of the last follow-up, 5 patients were in clinical remission, and 3 were in steroid-free clinical remission.

The researchers add that there have been no serious adverse events—including thromboembolic events—in this patient group.

“In our small pediatric cohort, tofacitinib appeared safe and provided a significant clinical benefit for a select group of refractory IBD patients,” write the authors.

References
1. Nikkonen A, Kolho K-L. Infliximab and its biosimilar produced similar first‐year therapy outcomes in patients with inflammatory bowel disease [published online September 19, 2019].  Acta Paediatr. doi: 10.1111/apa.15026.

2. Dollinger MT, Rolfes P, Phan BL, Dubinsky MC. Letter: tofacitinib use for biologic-refractory paediatric inflammatory bowel disease [published online October 7. 2019]. Aliment Pharmacol Ther. doi: 10.1111/apt.15496.

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