https://orcid.org/0000-0001-7496-5575
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ABSTRACT
Background
Switch patterns among different biologics and from originators to biosimilars (and vice versa) can be complex in patients with psoriasis (PsO) and psoriatic arthritis (PsA).
Objective
The aim of this study was to describe switching patterns of biological drugs in PsO/PsA patients and to explore predictors of multiple switches and switch-back.
Research design and methods
A large-scale retrospective cohort study was conducted using the Italian VALORE database. Bio-naïve users treated for PsO/PsA during 2010–2022 were included. Time to switch/swap and predictors of multiple switches and switch-back were analyzed.
Results
Thirty-thousand seven hundred bio-naïve users were included. At 3 and 5 years of follow-up, patients with at least one switch/swap were 37.1% and 47.8%, respectively. The median time to first switch/swap was significantly shorter (p< 0.001) for TNF-α inhibitors (2,068 days) than anti-IL (2,780 days). At 1 year of follow-up patients starting with IL-23 switched/swapped biological therapy less frequently than those with anti-IL-12/23 and anti-IL-17 (4.9% vs. 8.7% and 9.4%, respectively). Patients starting with anti-IL-12/23 reported a significantly lower risk of multiple switches and switch-back (0.74, 95% CI, 0.67–0.83; 0.58, 95% CI, 0.44–0.77, respectively) than those with TNF-α inhibitors.
Conclusions
Patients with PsO/PsA starting with TNF-α inhibitors switch/swap more rapidly and frequently than those with anti-IL, which are also associated with a reduced risk of multiple switches during follow-up.
Declaration of interest
G Trifirò participated to advisory boards and seminars as lecturer on topics not related to the paper and sponsored by the following pharmaceutical companies in the last 2 years: Eli Lilly; Sanofi; Amgen; Novo Nordisk; Sobi; Gilead; Celgene; Daiichi Sankyo, Takeda and MSD. He is also scientific coordinator of the pharmacoepidemiology team at the University of Verona and of the academic spin-off ‘INSPIRE srl’ that carried out in the last two years observational studies/systematic reviews on topics not related to the content of this article and which were funded by PTC Pharmaceutics, Kyowa Kirin, Shionogi, Shire, Chiesi and Daiichi Sankyo. Y Ingrasciotta is the CEO of the academic spin-off ‘INSPIRE srl,’ which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.) and from pharmaceutical Companies (Chiesi Italia, Kyowa Kirin s.r.l., Daiichi Sankyo Italia S.p.A.). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
A reviewer on this manuscript has disclosed work as an advisor, consultant, and/or speaker for AbbVie, Actelion, Amgen, Apogee Therapeutics, Aralez, Arcutis, Aspen, Bausch Health, BioScript Solutions, Boehringer Ingelheim, Bristol Myers Squibb, Canadian Psoriasis Network, Celgene, Cipher, Concert, CorEvitas, Eczema Society of Canada, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, J&J Innovative Medicine, Janssen, Johnson & Johnson, LEO Pharma, Medexus, Novartis, Organon, Pediapharm, Pfizer, Sanofi Genzyme, Sun Pharma, Tribute, UCB, and Valeant; work as an investigator for AbbVie, AnaptysBio, Arcutis, Arena, Asana, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, CorEvitas, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Nektar Therapeutics, Nimbus Lakshmi, Novartis, Pfizer, RAPT Therapeutics, Regeneron, Reistone, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; and receipt of grants from: AbbVie, Bausch Health, Janssen, LEO Pharma, Novartis, and Sanofi Genzyme.
Ethics statement
The protocol was submitted to the EU-PAS register (EUPAS50139) and approved by the Ethical Committee of Verona Academic Hospital. A fully anonymized dataset was used for central analysis, in compliance with EU General Data Protection Regulation regulations.
Author contributions
A Spini and G Trifirò contributed to the conception, the design and the writing of the study. G Pellegrini and L L’Abbate contributed to the analysis and interpretation of the data. Y Ingrasciotta, C Bellitto, and M Carollo contributed to the drafting of the paper and revising it critically for intellectual content. M Massari, SS Alegiani contributed to the software development. O Leoni, M Zanforlini, D Ancona, P Stella, A Cavazzana, A Scapin, S Lopes, V Belleudi, S Ledda, P Carta, P Rossi, L Ejlli, E Sapigni, A Puccini, contributed with data extraction and data interpretation. C Guarneri, P Gisondi contributed clinical insights on protocol development and data interpretation. All authors revised and approved the final version and agreed to be accountable for all aspects of the work.
Acknowledgment
The authors would like to acknowledge all members of the VALORE project. The abstract of this study has been submitted for evaluation at the International Congress of Pharmacoepidemiology (Berlin, August 2024)
Data availability statement
The datasets generated and/or analyzed during the current study are not publicly available due to privacy reasons.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2024.2357381