Date: Sunday, October 21, 2018
Session Title: 3S115 ACR/ARHP Abstract: Pediatric Rheum (976–981)
Session Type: ACR/ARHP Combined Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: Original Reference Product (ORP) Infliximab lost market exclusivity in europe in early 2015. The Scottish National Health service (SNHS), runs a national procurement system called the Clinical Advisory Panel (CAP). CAP recommended all patients new to Infliximab were commenced on biosimilar Infliximab (BIFX). To encourage switching a project run by NHS Healthcare Improvement Scotland, produced targets for biosimilar uptake and advised the setting up of local drug efficiencies committees. In early 2017 we had a cohort of young people remaining on ORP that we are asked to consider their infliximab preparation.
Methods: The Royal Hospital for Children in Glasgow (RHCG ) had a cohort of children principally with Juvenile Idiopathic Arthritis (JIA) and uveitis remaining on ORP infliximab. This use is off market label both with the European Medicine Agency and the Federal drug administration. After a review of evidence the RHCG Rheumatology team regarding the safety of switching elected to create a patient evaluation protocol for switching and patient information. Patients were identified from the Health-board wide IT system. Within the same time period a trial project for measuring trough drug levels and antibodies was introduced in Scotland using the Grifols promonitor system. It was decided to monitor these variables whilst switching. A drug and antibody level was to be taken immediately preceding the planned dose of Biosimilar Infliximab, then again 3 to 4 doses after switching or not. All patients and families were sent out information regarding the possible swap and met individually by a member of the nursing team to discuss the possible change of preparation. At point of switch offer, 12 young people were identified on ORP; 8 with JIA + Uveitis, 2 with idiopathic Uveitis, 1 with sympathetic Uveitis, 1 with JIA. All had clinically inactive disease, from last clinical review.
Results: Of the young people; 6 completed the switch, however 1 was found clinically flaring with active uveitis 4 days after switching. Their pre switch drug levels were low with high antibodies causing a change of therapy and are now in clinical remission. The five who completed the switch remain in clinical remission, this group is too small for any statistical interpretation but drug levels and antibodies are comparable pre and post switch. The 6 who did not swap at original offer to BIFX; 1 did not qualify for switching to biosimilar, 1 elected not to switch, 1 stopped, 1 changed therapy due to geography, 2 changed therapy due to personal choice. Within this group of 6, 3 maintained no active disease, 2 remaining on ORP and one swapped to Adalimumab. 3 developed active disease, 1 has commenced Adalimumab, 2 have attempted multiple biologics and have returned recently to IFX one on ORP and one BIFX. Both are returning to low disease activity.Of the initial group of 12, 4 are on ORP, 5 on BIFX, 3 are on Adalimumab.Pre and post switch period Infliximab levels and antibodies are available for 8 young people. They are comparable regardless of switch.Conclusion: Switching was not associated with any adverse events. Disease activity measures for those remaining on IFX were unchanged on either ORP or Biosimilar. Stopping Infliximab was associated with disease flare.
To cite this abstract in AMA style:Fell A, Carson E, Coyle G, Martin N, Walsh J, Gardner-Medwin J. Nurse Led Safe Switching from Original Reference Product Infliximab to Biosimalar in Patients with Juvenile Idiopathic Arthritis and Uveitis – a Single Centre Experience Including Baseline and Post Switch Infliximab Levels and Antibodies [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/nurse-led-safe-switching-from-original-reference-product-infliximab-to-biosimalar-in-patients-with-juvenile-idiopathic-arthritis-and-uveitis-a-single-centre-experience-including-baseline-a/. Accessed July 2, 2020.
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