Abstract
Introduction
Clinical data on the efficacy and safety of non-medical switch between adalimumab(ADA)
biosimilars are limited.
Aims
The aim of this study was to evaluate medium-term clinical efficacy, drug sustainability
and safety comparing non-medical switches from the originator to biosimilar ADA, and
between ADA biosimilars.
Methods
276 consecutive patients on maintenance ADA therapy (n = 205 Crohn's disease, n = 71 ulcerative colitis) were included. Data on clinical efficacy, biomarkers and
adverse events were collected at four time points: 8–12 weeks prior switch, at baseline/switch,
8–12 weeks and 20–24 weeks after switch. Drug survival was evaluated after a median
40(IQR:35–42) weeks follow-up.
Results
A total 174 patients underwent a non-medical switch from the originator to a biosimilar,
and 102 patients had a biosimilar-to-biosimilar switch. No significant difference
was found in clinical remission rates at any time point in patients switching from
originator to biosimilar(87.3%/88.5%/86.5%/85.7%) or biosimilar to biosimilar(74.5%/78.4%/85.3%/79.8%).
Mean C-reactive protein levels remained unchanged in both cohorts(p = 0.856 and p = 0.525). Drug survival was similar between the two cohorts with a probability of
91.6%(SE: 2.2) and 87.0%(SE:3.4) to stay on drug after 40 weeks(log-rank:0.96; p = 0.327). Five cases of injection related adverse events were reported.
Conclusion
Clinical benefit was sustained following non-medical switch from originator to biosimilar,
or between biosimilars in adalimumab treated IBD patients.
Key words
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Article info
Publication history
Published online: August 02, 2022
Accepted:
July 9,
2022
Received:
May 4,
2022
Identification
Copyright
© 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
