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

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

The original research 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, “because very similar treatment results 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 litigation between Boehringer Ingelheim and AbbVie, the maker of the reference product. In 2021, Cyltezo was granted interchangeability status by the FDA following an interchangeability study (VOLTAIRE-X). Cyltezo will be the first interchangeable adalimumab biosimilar available in the US, with a planned launch date of July 1, 2023. This will allow for pharmacy-level substitution of Cyltezo for the reference product and is expected to expand patient access to adalimumab therapy .

The 8-page downloadable PDF not only explains the purpose of the VOLTAIRE-RA study and summarizes the results, but also defines key terms, such as biologics, biosimilars, randomized and double-blind. It contains graphical representations of the study design and provides links to the original study 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 re-randomized 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 the effectiveness was comparable in the three treatment groups. There were also “no major differences in safety”, and similar proportions of patients in the 2 groups developed anti-drug antibodies (47% in the Cyltezo group vs. 53% in the Humira group).

The Simple Language Summary of VOLTAIRE-RA is an educational resource for healthcare professionals and patients with RA making treatment decisions and considering adalimumab. Much research has suggested that patient education is paramount to both increasing biosimilar uptake and preventing treatment failures or side effects due to the nocebo effect. In addition, studies suggest that increasing physicians’ knowledge and confidence in biosimilars could also help increase biosimilar prescribing and, in turn, improve patient education.

Reference

Cohen SB, Lee EC. Summary in simple language 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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