gms | German Medical Science

Background and state of research: The prescription of biosimilars in rheumatology differ in Germany and a biosimilar quota of >90% in Westfalia in conjunction with the requirement for cost-effectiveness practically means that switching between several biosimilars is necessary (multiswitch scenario). Even though several studies on the performance of biosimilars in routine care have been recently published [1], there is limited data on patients’ views and knowledge on biosimilars [2].

Research question and objectives, hypothesis: To study the knowledge of patients with chronic inflammatory rheumatic diseases (CIRD) about biosimilars, assess patients' satisfaction after being educated about switching to biosimilars by rheumatologists compared to nurse specialists, and to explore the impact of multiple switches on patient satisfaction.

Method: Adult patients with CIRD who underwent a non-medical switch from the adalimumab biosimilar GP2017 to the adalimumab biosimilar MSB 11022 were 1:1 randomized with randomly selected block sizes into two groups in which information about multiple switching of biosimilars was provided by either a nurse specialist or a rheumatologist. Validated outcome tools and standardized parameters for disease activity and function were assessed at baseline and 12 weeks after the switch. The primary endpoint was to evaluate whether satisfaction with care differs when education about switching is provided by rheumatologists or nurse specialists. Secondary endpoints were patients’ knowledge about biosimilars and the efficacy and safety of switching in routine care. Patients’ satisfaction with care was assessed by the Leeds Satisfaction Questionnaire.

Results: 102 patients were randomized, with 40 educated by rheumatologists and 62 by nurse specialists (60.8%). Patients had moderate disease activity and limited impairment of physical function. 50 patients had undergone one and 52 multiple switches, respectively. Less than one-third of patients were able to correctly answer questions on manufacturing, effectiveness, clinical trial evidence, and cost of biosimilars. Patients were generally satisfied with the education - irrespective of whether the information had been provided by nurses or rheumatologists. No relevant differences in the outcomes assessed were observed.

Discussion: Patient satisfaction after education about biosimilars by nurses and rheumatologists was equally good. Multiple switches had no negative impact on patient satisfaction. Patients’ knowledge about biosimilars was limited.

Implication for care: The study implies two areas of action: (I) improved patient education on drug therapy and (II) and adoption of knowledge transfer by trained nurse specialists.