P1014 Anti-TNF-alpha biosimilar cross and reverse-switching in pediatric IBD: Preliminary real-world data from the SIGENP IBD Working Group
Authors: Dipasquale V , Fioretti L , Morello R , Pochesci S , Scarallo L , Graziano F , Citrano M , Lionetti P , Romano C 
Published: January 2025

Background

Due to the increasing number of pediatric IBD patients receiving anti-TNF-alpha, multiple switching between biosimilars has become part of everyday clinical practice, although it is not yet officially recommended. A multicenter, nationwide retrospective study to determine the safety and effectiveness of multiple switching is currently underway within the IBD Working Group of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP).

Methods

Data from all pediatric IBD patients on anti-TNF-alpha treatment (IFX, ADA) who made one or more switches from one biosimilar to another (cross-switch) or from one biosimilar to the originator (reverse-switch) from 2013 to present have been collected. Safety was the primary study objective. These data are preliminary as data collection is still ongoing in additional centers.

Results

To date, three centers have collected data on 89 patients who underwent at least one cross- or reverse-switch 13.7 months (7-23.5) after starting biologic therapy: 51 with IFX (significantly more for UC and IBDU patients than CD patients, p&lt;0.01) and 38 with ADA (significantly more in CD than in UC/IBDU patients, p&lt;0.01). Twenty-one (23.6%) patients were switched twice, four (4.5%) three times, at 5.2 months (2-14.7) and 16.4 months (5.1-18.7), respectively since the previous switch. 84 were cross-switches and 5 were reverse-switches. The switch was non-medical in most cases (n=86, 89%) and medical in the remaining cases (due to adverse events). The median follow-up time was 3.6 years (2.2–6.4) from the start of biologic therapy. An acute infusion reaction occurred in 6/89 (6.7%), 1/21 (4.8%) and 1/4 (25%) patients after the first, second and third switches, respectively. Multiple switching was associated with a relapse in 2/89 (2.2%) and 2/21 (9.5%) after the first and second switching, respectively. No between-group differences in reactions or flares were noted between IFX and ADA.

Conclusion

Multiple switching biosimilars are a reality in the current practice in pediatric IBD. This practice does not appear to have any effect on the course of the disease, but further data are pending.

References

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