Abstract
This Summary of Research overviews the results of the VOLTAIRE-X study (NCT03210259), which looked at what happened when people with plaque psoriasis continually took the adalimumab reference product (adalimumab RP; known by the brand name Humira®) or switched three times between taking the adalimumab RP and BI 695501 (adalimumab-adbm, known by the brand name Cyltezo®), an adalimumab biosimilar. The VOLTAIRE-X study showed that the pharmacokinetics of adalimumab were similar in people who stayed continuously on adalimumab RP and people who switched between adalimumab RP and adalimumab-adbm. There were no differences in effectiveness, side effects, or antibodies to adalimumab when comparing people who stayed continuously on adalimumab RP with those who switched between adalimumab RP and the adalimumab biosimilar adalimumab-adbm. On the basis of these results, adalimumab-adbm was approved by the US Food and Drug Administration (FDA) as interchangeable with adalimumab RP, meaning that a pharmacist can substitute the biosimilar adalimumab-adbm for adalimumab RP without requiring permission from the original prescriber (unless required to by state law).
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Reference
Menter A, Cohen S, Kay J, et al. Switching between adalimumab reference product and BI 695501 in patients with chronic plaque psoriasis (VOLTAIRE-X): a randomized controlled trial. Am J Clin Dermatol. 2022;23:719–28. https://doi.org/10.1007/s40257-022-00708-w.
Acknowledgements
The authors would like to thank the patients who participated in this study and their families, as well as investigators and staff at all the clinical sites.
Funding
The Rapid Service Fee was funded by Boehringer Ingelheim. The original publication was funded by Boehringer Ingelheim.
Medical Writing and Editorial Assistance
Writing support was provided by Marissa Buttaro, RPh, MPH, and Andy Shepherd, PhD of Envision Pharma Group, and Disha Dayal, PhD on behalf of Envision Pharma Group. Medical writing was contracted and funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the summary for medical and scientific accuracy as well as intellectual property considerations.
Author Contributions
Dr Menter, an author of the original article, reviewed and approved the summary.
Conflict of Interest
Please see original article for full author disclosures.
Ethical Approval
This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by the author.
Data Availability
Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.
Prior Publication
This is a summary of a peer-reviewed article previously published in the journal The American Journal of Clinical Dermatology. 2022 23:719–728.
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Menter, A. Summary of Research: Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial. Dermatol Ther (Heidelb) 13, 2929–2932 (2023). https://doi.org/10.1007/s13555-023-00995-z
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DOI: https://doi.org/10.1007/s13555-023-00995-z