Plain language summary of the VOLTAIRE-RA in patients with moderate-to-severe rheumatoid arthritis

Abstract

What is this summary about?: Here, we summarize the results from the VOLTAIRE-RA study, originally published in the journal Annals of the Rheumatic Diseases. The VOLTAIRE-RA study looked at how effective and safe BI 695501 is in treating people with rheumatoid arthritis (also known as RA). BI 695501 is a biosimilar whose reference product is adalimumab (known by the brand name Humira). A biosimilar is one that is made to be very similar to, and less expensive than the original biologic, also known as the reference product. The VOLTAIRE-RA study aimed to show that BI 695501 is as effective and safe as Humira in treating people with moderate-to-severe RA.

What were the results?: Participants of the VOLTAIRE-RA study took either Humira for 24 weeks and then switched to taking BI 695501 for a further 24 weeks, or BI 695501 for 48 weeks. The participants treated with BI 695501 and Humira had very similar outcomes in terms of reducing symptoms, as well as experiencing side effects. This was also seen for those participants who switched from taking Humira to BI 695501.

What do the results mean?: These results show that both Humira and BI 695501 could be used to treat people with RA as very similar treatment outcomes could be expected. Clinical Trial Registration: NCT02137226 (ClinicalTrials.gov).

Keywords: BI 695501; adalimumab; biosimilar; humira; lay summary; plain-language summary; rheumatoid arthritis.