Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jan;7(1):e001396.
doi: 10.1136/rmdopen-2020-001396.

Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar

Juliette Petit  1 , Marie Antignac  2 , Rose-Marie Poilverd  3 , Régine Baratto  3 , Sylvie Darthout  3 , Sandra Desouches  3 , Karine Louati  3 , Nathalie Deparis  4 , Francis Berenbaum  3 , Catherine Beauvais  3
Affiliations

Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar

Juliette Petit et al. RMD Open. 2021 Jan.

Abstract

Objectives: To evaluate an intervention to reduce the nocebo effect (NE) when switching from the originator infliximab (OI) to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease (CIRD).

Methods: An intervention was built with healthcare professionals (HPs) and a patient representative, based on a systematic review of interventions reducing the NE in musculoskeletal diseases and semi-directed questioning of five patients. Our strategy consisted of training HPs, switch information given by the nurses, a consistent vocabulary. All CIRD patients switched from OI to SB2 were included for the intervention. The primary outcome was the SB2 retention rate (RR) at 34 weeks. Secondary outcomes were the SB2 RR at 12 months, discontinuation rates due to a possible NE and comparison with a historical cohort of CIRD patients receiving the OI and 6 published European cohorts.

Results: 45 patients were included from March 2018 (rheumatoid arthritis, n=17, spondylarthritis, n=28). After 34 weeks, the SB2 RR was 91.2%, similar to the historical cohort RR (p=0.41) but higher than the 3 European cohort RRs (p<0.05). At 12 months, the SB2 RR was 84.5% vs 88.4% for the historical cohort (p=0.52). SB2 discontinuation due to a possible NE was 6.6% after 12 months.

Conclusions: A tailored communication with a prominent role of nurses reduced the NE in non-medical switches from the OI to SB2 as compared to published results. The RR was similar to the historical cohort RR. The methodology used to construct this intervention may help improve the outcomes of switches with upcoming biosimilars.

Keywords: Ankylosing; Arthritis; Biosimilar Pharmaceuticals; Infliximab; Rheumatoid; Spondylitis; atient Care Team.

PubMed Disclaimer

Conflict of interest statement

Competing interests: FB reports personal fees from Boehringer, Bone Therapeutics, Expanscience, Galapagos, Gilead, GSK, Merck Sereno, MSD, Nordic, Novartis, Pfizer, Regulaxis, Roche, Sandoz, Sanofi, Servier, UCB, Peptinov, TRB Chemedica, 4P Pharma, outside the submitted work. CB reports grants from Fresenius Kabi and Mylan outside the submitted work and was and occasional speaker for Abbvie, MSD, Roche, UCB, Mylan, Sanofi. KL declares personal fees from Novartis and Abbvie, outside the submitted work. SD declares occasional work as co-investigators with Abbvie and Janssen, outside the submitted work.

Figures

Figure 1
Figure 1
Treatment withdrawal-free survival (SB2 in switched cohort and originator infliximab [OI] in historical cohort).
See this image and copyright information in PMC

References

    1. Araújo FC, Gonçalves J, Fonseca JE. Pharmacoeconomics of biosimilars: what is there to gain from them? Curr Rheumatol Rep 2016;18:50 10.1007/s11926-016-0601-0 - DOI - PubMed
    1. Chevreul K, Haour G, Lucier S, et al. Evolution of direct costs in the first years of rheumatoid arthritis: impact of early versus late biologic initiation - an economic analysis based on the ESPOIR cohort. PLoS ONE 2014;9 10.1371/journal.pone.0097077 - DOI - PMC - PubMed
    1. Sokka T, Kautiainen H, Pincus T, et al. Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST: RA database. Ann Rheum Dis 2009;68:1666 10.1136/ard.2009.109983 - DOI - PMC - PubMed
    1. Kay J, Schoels MM, Dörner T, et al. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 2018;77:165–74. 10.1136/annrheumdis-2017-211937 - DOI - PubMed
    1. Schaeverbeke T, Pham T, Richez C, et al. Biosimilars: an opportunity. Joint Bone Spine 2018;85:399–402. 10.1016/j.jbspin.2018.03.002 - DOI - PubMed

Publication types

LinkOut - more resources