SAT0690 HOW TO REDUCE THE NOCEBO EFFECT WHEN SWITCHING FROM ORIGINATOR INFLIXIMAB TO A BIOSIMILAR: POSITIVE RESULTS OF A MULTIDISCIPLINARY TEAM INTERVENTION
Authors: Juliette Petit, Marie Antignac, Rose Marie Poilverd, Sylvie Dartout, Regine Baratto, Karine Louati, Nathalie Deparis, Francis Berenbaum, Catherine Beauvais
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Nonspecific subjective adverse effects (NSAE), usually considered as related to a nocebo effect (NE), have been identified as a barrier to the acceptability of switches from biologic originators (BO) to biosimilars (BS). <h3>Objectives:</h3> To assess the efficacy of a multidisciplinary team intervention to reduce the NE among inflammatory arthritis (IA) patients concerned by systematic switch from originator Infliximab (OI) to the biosimilar infliximab (BI) SB2. <h3>Methods:</h3> The intervention was part of a multidisciplinary patient education (PE) program. It was developed in 4 steps. Step 1: we conducted first semi-directive qualitative interviews with 5 patients treated by other intravenous (IV) biologics. Interviews showed: fears about efficacy and tolerability of BSs, need for information (particularly on the difference between BSs and generics), importance of sharing their experience of adverse effects (AE) with health practitioners (HP), and having the opportunity to switch back. The wish to discuss the nurses' own experience of BSs was prominent. Step 2: a meeting with the multidisciplinary team (3 rheumatologists, 1 resident, 1 pharmacist, 3 nurses, 1 peer-patient from a patient's association) was set up for designing the intervention based on the interviews, on non-systematic literature review about switches and on patients' perspective regarding NE. Step 3: Consensual agreement on the intervention and the chosen pieces of language to be used by all HPs. The intervention included written and oral information by the nurses; nurse-led PE; if necessary, distribution of an informative leaflet made by the team. Step 4: Implementation of the intervention. The rheumatologist had the entire appreciation for discontinuing the BS or not. Inclusion criteria were all IA patients treated with OI. The primary outcome was SB2 retention rate (RT) at 34 weeks, secondary outcomes were the number of NSAEs leading to SB2 discontinuation; the comparison of the RT and NSAE rate of the cohort with 1) RT and NSAEs rate of a systematic switch from another Infliximab BS (CT-P13) to SB2 made at the same period in the same rheumatology department 2) RT and NSAEs rate of switches in other published European cohorts (1,2,3). <h3>Results:</h3> Fourty-five patients were included from March 12<sup>th</sup>, 2018 to May 25<sup> th</sup>, 2018, median follow up was 34 weeks, 17 rheumatoid arthritis (RA), 23 spondyloarthritis (SpA) and 5 psoriatic arthritis (PSA) patients were included. Mean OI duration before switch was 9.4 years. The switch RT from OI to SB was 41/45 (91,2%) and NSAE (1/45). RT was significantly higher than in other European cohorts (p&lt;0.05) (table 1). Reasons for discontinuation were uveitis (1); demyelinating disorder (1) and peripheral synovitis (1) already present before the switch; 1 patient had NSAE (increased fatigue and pain). During the same period, 18 patients switched from CT-P13 to SB2 with a RT of 12/18 (66,7%) and 1 NSAE. <h3>Conclusion:</h3> An intervention based on a multidisciplinary patient education team where nurses have a prominent role is effective in reducing the NE when switching from the originator infliximab to its biosimilar. <h3> Disclosure of Interests:</h3> None declared