In cohorts of adolescents and young adults, one nonmedical transition to infliximab biosimilars improved clinical remission rates, serious adverse events, tumor necrosis factor inhibitor (TNF) levels, laboratory markers of inflammation, or had no significant effect on antidrugs. According to data presented at Digestive Disease Week (DDW) 2023.1
Ross Maltz, M.D.
Credit: NationwideChildrens.org
“Studies in adults with inflammatory bowel disease (IBD) have demonstrated that a single switch from brand-name to biosimilar does not cause loss of response, increased side effects, or antibody production. ,” writes Associate Professor Ross Maltz, MD. Pediatric Gastroenterologist, Department of Pediatrics, Ohio State Wexner Medical Center. “In adolescents and young adults, data are limited to explain non-medical switching.”
A retrospective review was conducted to evaluate the clinical outcome of a one-time nonmedical switch from brand-name to biosimilar infliximab in younger patients with IBD.Information including demographic data, laboratory values (including albumin and C-reactive protein) [CRP]TNF level, TNF antibody level, hemoglobin, erythrocyte sedimentation rate [ESR]), and Physician Global Assessment (PGA) were collected up to 1 year before biosimilar switching and up to 1 year after switching. Biosimilar retention rates were reported at 6 and 12 months after switching. A linear mixed-effects model was used to compare consecutive test values before and after switching to biosimilars.
A total of 53 patients switched from brand-name infliximab to biosimilars were included in the study. Patients had a mean age of 18 years, 53% were female, 74% were diagnosed with Crohn’s disease, and 96% were switched to her infliximab-dyyb. Most (98%, n = 52) patients had stationary disease activity attached to the PGA and 2% (n = 1) were classified as having mild disease.
At follow-up, 96% (n = 51) were asymptomatic and 4% (n = 2) had mild disease based on PGA after receiving two biosimilar injections. At 6 months, 90% (n = 48) were still receiving biosimilars. Of those who reverted, 6% (n = 3) switched due to worsening symptoms, 2% (n = 1) developed worsening psoriasis, and 2% (n = 1) had problems with venous access. I was holding
Of patients with full 12-month follow-up (n = 33), 91% continued biosimilar (n = 30/33), 1 patient reverted due to worsening symptoms, 1 One person switched to adalimumab for developing psoriasis, and one switched because of an underlying social condition.
No static significant differences in ESR, CRP, TNF levels, and albumin were observed before and after switching.Mean TNF levels before switching to biosimilar were 17.3 ug/mL (95% confidence interval [CI]: 13.7-19.0) and 15.1 ug/mL (95% CI: 12.5-17.8) after switching. No patient developed anti-drug antibodies or infusion reactions.
References
- McNicol M, Abdel-RasoulM, MorrisG, Boyle BM et al Nonmedical switching from infliximab to biosimilars in children and young adults with inflammatory bowel disease. Abstract presented at Digestive Disease Week (DDW) 2023 Annual Meeting. Chicago, Illinois. May 6-10, 2023.