Non-Medical Switch to Infliximab Biosimilar Did Not Impact Remission in Young Patients

In an adolescent and young adult cohort, a one-time non-medical shift to an infliximab biosimilar did not significantly effect clinical remission rates, serious adverse events, tumor necrosis factor inhibitor (TNF) levels, laboratory markers of inflammation, or anti-drug antibodies, according to data presented at Digestive Disease Week (DDW) 2023.¹

Ross Maltz, MD

Credit: NationwideChildrens.org

“Studies in adults with inflammatory bowel disease (IBD) have demonstrated that a one-time switch from the originator to a biosimilar has not resulted in loss of response, increased side effects, or antibody development,” wrote Ross Maltz, MD, associate professor and pediatric gastroenterologist in the Department of Pediatrics at the Ohio State Wexner Medical Center. “Data describing non-medical switching is limited in adolescents and young adults.”

A retrospective review was conducted to evaluate the clinical outcomes of one-time non-medical switches from the infliximab originator to a biosimilar in young patients with IBD. Information, including demographic data, laboratory values (including albumin, C-reactive protein [CRP], TNF level, TNF antibody level, hemoglobin, and erythrocyte sedimentation rate [ESR]), and physician global assessments (PGA) were collected for up to 1 year prior to the biosimilar switch and up to 1 year after the switch. Continuation rates of the biosimilar were reported at 6- and 12-months post-switch. Linear mixed effect models were utilized to compare continuous lab values both before and after switching to the biosimilar.
A total of 53 patients switched from the infliximab originator to the biosimilar and were included in the study. The mean age of patients was 18 years, 53% were female, 74% had a Crohn’s disease diagnosis, and 96% were switched to infliximab-dyyb. Most (98%, n = 52) patients had quiescent disease activity pasted on PGA and 2% (n = 1) were categorized as having mild disease.

At follow-up, after receiving 2 biosimilar infusions, 96% (n = 51) had quiescent disease and 4% (n = 2) had mild disease based on the PGA. At the 6-month mark, 90% (n = 48) were still receiving the biosimilar. Of those who switched back, 6% (n = 3) switched due to worsening symptoms, 2% (n = 1) developed worsening psoriasis, and 2% (n = 1) had issues regarding intravenous access.

Of those who had a full 12 months of follow-up data (n = 33), 91% remained on the biosimilar (n = 30/33), 1 patient switched back due to worsening symptoms, 1 switched to adalimumab because of psoriasis development, and 1 switched due to an underlying social situation.

No statically significant differences in ESR, CRP, TNF levels, and albumin were observed pre- and post-switch. The mean TNF level prior to switching to the biosimilar was 17.3 ug/mL (95% confidence interval [CI]: 13.7-19.0) and 15.1 ug/mL (95% CI: 12.5-17.8) post-switch. None of the patients developed antidrug antibodies or infusion reactions.

References

1. ^{McNicol M, Abdel-RasoulM, MorrisG, Boyle BM, et al. NON-MEDICAL SWITCHING FROM INFLIXIMAB TO A BIOSIMILAR IN PEDIATRICS AND YOUNG ADULTS WITH INFLAMMATORY BOWEL DISEASE. Abstract presented at Digestive Disease Week (DDW) 2023 Annual Meeting. Chicago, IL. May 6-10, 2023.}