Abstract Background Biosimilar treatment initiation is based on a shared decision-making process, in which the patient’s acceptability to the treatment plays a major role. Indeed, negative perception of the biosimilar by the patient can generate a nocebo effect, which interferes with treatment results, leading to subjective worsening of the disease or poor tolerability. The SAPHIR study aimed to evaluate baseline patients’ characteristics predictive of biosimilar treatment persistence. Methods The SAPHIR study is a prospective, multicentre, observational cohort study. All patients with inflammatory rheumatic diseases and inflammatory bowel diseases were included after initiating treatment with Idacio® (adalimumab biosimilar) and were to be followed over a period of one year with assessments at 1, 6 and 12 months. We present here the patients baseline characteristics and their acceptability to treatment. Results Of the 582 patients enrolled, 18 presented a protocol deviation and were not analysed. The 564 patients analysed were divided into two groups based on the circumstances of the Adalimumab biosimilar prescription: the "initiation" group (n=318) not previously treated with biotherapy and the "switch" group (n=246) previously treated with originator adalimumab. Disease severity was assessed globally on a Likert scale. According to this evaluation, 61% (n=185) of patients in the "initiation" group versus 10% (n=25) in the "switch" group were considered markedly or severely ill. Baseline data from these patients are summarised in Table 1. Patients were questioned about chronic treatment in general: 38% (n=61) of patients in the "initiation" group and 13.5% (n=25) in the "switch" group do not know if their medications are effective or even doubt their benefit. The perception of the biosimilar was assessed by a serie of affirmations (self-completion questionnaire on the acceptability of switching to a biosimilar), summarised in Table 2. Conclusion Biosimilars still meet with reluctance from patients. This situation seems linked to a lack of information on the concept of biosimilarity. Numerous guidelines have been published to promote and facilitate the transition from biotherapy to its biosimilar. These preliminary results show that difficulties with treatment acceptability also exist and seem more pronounced in patients initiating biological treatment with a biosimilar. Table 1: Baseline data: BMI, Body Mass Index; SF-12, 12-Items Short Form Survey; HAD Scale, Hospital Anxiety and Depression Scale. Table 2: Perception of the biosimilar by the patient
Read full abstract