RESUMO
OBJECTIVE: To study the knowledge of patients with chronic inflammatory rheumatic diseases (CIRD) about biosimilars (bsDMARDs), assess patients' satisfaction after being educated about switching of bsDMARDs by rheumatologists compared to nurse specialists, and to explore the impact of multiple switches on patient satisfaction. METHODS: Adult patients with CIRD who underwent a non-medical switch from the adalimumab bsDMARDs GP2017 to the adalimumab bsDMARDs MSB 11022 were 1:1 randomized with randomly selected block sizes into two groups in which information about multiple switching of bsDMARDs 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 bsDMARDs and the efficacy and safety of switching in routine care. Patients' satisfaction with care was assessed by the Leeds Satisfaction Questionnaire. A structured questionnaire was used to assess the patient's knowledge. RESULTS: A total of 102 patients was randomized, with 40 educated by rheumatologists (39.2%) and 62 by nurse specialists (60.8%). Patients had moderate to low disease activity and limited impairment of physical function without progression on follow-up, implying that switching did not affected disease activity. Almost half of the patients (n = 50, 49%) had undergone one and 52 multiple switches (51%), respectively. Less than one-third of patients were able to correctly answer questions on manufacturing, effectiveness, clinical trial evidence, and cost of bsDMARDs. 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. Efficacy and safety results were consistent with previously published data. CONCLUSION: Patient satisfaction after education about bsDMARDs and multiple switching by nurses and rheumatologists was equally good. Multiple switches had no negative impact on patient satisfaction, and outcomes after switching of bsDMARDs did not significantly worsen. Patients' knowledge about bsDMARDS was limited.
