Background Biological drugs represents today a major therapeutic line in many rheumatic diseases. Introduced in current practice about ten years ago these molecules have been considered much more difficult to manage than classical DMARDs. In addition, a whole new kind of potentially associated adverse reactions increased both patients' and doctors' anxiety. From clinical point of view the decision to initiate such a therapy is very well standardized; so is the decision to switch from one biologic to a different one. However recent studies performed in USA and replicated in EU by our group have shown that rheumatic patients decide to start and follow such a treatment for quite different reasons. Little is known about the way our patient decide what drug he/she prefers in case of switch (same class? different class? a biosimilar?) and what are the values that determine such selection.
Objectives To evaluate the perceived importance from the switchers' point of view of 24 aspects of a new biological therapy.
Methods 24 aspects of biological therapy already tested in USA patients have been tested in a pilot study performed in one single European tertiary rheumatology unit. 30 consecutive patients previously exposed to a switch of their biologic therapy received a structured questionnaire developed to capture on a four points Likert scale the patients' perceived importance of each aspect. SPSS 19.0 have been used for statistical analysis.
Results 22 women and 8 men mainly living in urban areas (73.3%) and most of them with at least 12 years of formal education (73.3%) have been included in the study. Mean age was 56.8 (sd: 12.7) years and mean duration on biological therapy was 49 (20.2) months. In 22 cases (73.3%) patients received a new treatment because of the lack of efficacy of the previous one, in two cases it was an allergic reaction and in 6 cases (20%) an administrative reason determined this change. The aspects our patients considered as being most important when select a 2nd biologic are: the efficacy of new drug compared with the previous one, treatment schedule, the impact of new treatment on previous comorbidities, the global efficacy of new drug. On the opposite side are: the route of administration, the potential role of a health worker in drug administration, the possible financial aid (co-reimbursement) schemes. We also evaluated how deep every of these 24 aspects have been discussed with the rheumatologists at the moment of switch and found significant differences between what patients consider important and the attention paid by the rheumatologist to that particular aspect.
Conclusions This pilot study revealed a large difference between various aspects of biological therapy as is it perceived by the final users. In order to standardize the informed consent process across the EU it will be mandatory to understand how our patients rank these aspects not just at the moment they come in contact with this therapyfor the first time but aslo in the moment they have to change the biological molecule.
Bolge, Susan C., Goren, Amir PhD; Brown, Duncan; Meyer, Roxanne; Ginsberg, Seth - Initiation of biologic therapy - the patient perspective - ACR Meeting 2013
Disclosure of Interest None declared