期刊
RMD OPEN
卷 7, 期 1, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/rmdopen-2020-001396
关键词
Biosimilar Pharmaceuticals; Arthritis; Rheumatoid; Spondylitis; Ankylosing; Infliximab; atient Care Team
类别
The objective of this study was to evaluate an intervention to reduce the nocebo effect when switching from the originator infliximab to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease. Results showed that tailored communication and training led to higher retention and continuation rates of SB2 after switching from OI, compared to historical and other European cohorts.
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.
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