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A Summary of the VOLTAIRE-RA Trial for Physicians, Patients Considering RA Treatment Options


Authors of a plain-language summary of the VOLTAIRE-RA study examined how to help patients with rheumatoid arthritis (RA), their families, patient advocates, and health care professionals learn about potential new treatment options as the United States prepares for the introduction of adalimumab biosimilars.

The authors of a plain-language summary of the VOLTAIRE-RA study, published in Immunotherapy, aimed to help patients with rheumatoid arthritis (RA), their families, patient advocates, and healthcare professionals to “learn about scientific discoveries and potential new treatment options.”

The original study results were published in Annals of the Rheumatic Diseases in 2018. VOLTAIRE-RA investigated the efficacy and safety of the adalimumab biosimilar BI 695501 (Cyltezo; Boehringer Ingelheim) compared to the reference product (Humira) in moderate-to-severe RA.

The authors explained that the results of VOLTAIRE-RA showed that both Cyltezo and Humira could be used to treat RA, “as very similar treatment outcomes could be expected.”

Cyltezo was first approved by the FDA in 2017, but is not yet commercially available in the United States due to patent disputes between Boehringer Ingelheim and AbbVie, the maker of the reference product. Then in 2021, following an interchangeability study (VOLTAIRE-X), Cyltezo was granted interchangeable status by the FDA. Cyltezo will be the first interchangeable adalimumab biosimilar available in the US, with a scheduled launch date of July 1, 2023. This will allow pharmacy-level substitution of Cyltezo for the reference product and is expected to expand access to adalimumab therapy for patients.

The 8-page downloadable PDF, in addition to explaining the purpose of the VOLTAIRE-RA study and summarizing the results, defines key terms, such as biologics, biosimilars, randomized, and double-blind. It includes graphical representations of the study design and provides links to the original trial and to more information about the use of biosimilars in RA from the National Rheumatoid Arthritis Society.

In VOLTAIRE-RA, each group was treated with the biosimilar or reference product once every 2 weeks for 24 weeks, after which the participants in the reference product group were randomized again to either continue the same treatment or switch to the biosimilar. The educational pamphlet described how the effectiveness of the treatments was assessed, explaining the American College of Rheumatology 20% response (ACR20) score and the Disease Activity Score in 28 Joints (DAS28).

The authors explained that effectiveness was similar across the three treatment groups. Also, there were “no key differences in safety,” and similar proportions of patients in the 2 groups developed anti-drug antibodies (47% in Cyltezo group vs 53% in Humira group).

The VOLTAIRE-RA plain-language summary is an educational resource for health care professionals and patients with RA making treatment decisions and considering adalimumab. Much research has suggested that patient education is of paramount importance for both increasing biosimilar uptake and preventing treatment failures or adverse events due to the nocebo effect. Furthermore, studies suggest increasing physicians’ knowledge of and confidence in biosimilars could also help increase their prescription of biosimilars and in turn, improve patient education.


Cohen SB, Lee EC. Plain language summary of the VOLTAIRE-RA in patients with moderate-to-severe rheumatoid arthritis. Immunotherapy. 2022;14(15):1183-1190. doi:10.2217/imt-2022-0106

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