Patient satisfaction survey: substitution of reference etanercept with a biosimilar product.

OBJECTIVES: To assess patient satisfaction after pharmacy-mediated replacement of the originator etanercept prefilled syringe with its biosimilar prefilled pen. METHODS: Prospective observational study from March to May 2018, to assess satisfaction with the new drug dispensed. Patients were asked to answer a paper questionnaire with three questions: pain at injection site, ease of administration, and overall patient satisfaction with the change, rated on a scale from 1 (not satisfied) to 5 (extremely satisfied). RESULTS: The questionnaire was given to 134 patients (74 men, 60 women), with an average age of 55 years. 118 patients (88%) were from the Rheumatology Service and 16 patients (12%) from Dermatology. The median treatment duration with etanercept was 61 months. 87 (65%) completed questionnaires were collected. The mean pain score was 3.4. Most patients found administration easy with the biosimilar pen, with an average score of 3.7. Mean overall satisfaction was rated at 3.3, being higher among men, younger patients, and those with shorter duration of treatment. CONCLUSIONS: The change of the original product from etanercept to a biosimilar product was acceptable for most of the patients who responded to the survey. Surveys allow us to determine the opinion and preferences of patients, thus achieving higher satisfaction with their treatment. Further research is needed to evaluate the effect of automatic replacement. A collaborative multidisciplinary switching programme should be implemented based on the feedback provided by patients.

Natalizumab: safety and risk in patients with relapsing-remitting multiple sclerosis.

OBJECTIVE: To estimate the risk of progressive multifocal leukoencephalopathy (PML) and the safety of natalizumab administration in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: A descriptive retrospective observational study including all patients with RRMS treated with natalizumab followed-up after 10 years.The likelihood of developing PML was estimated based on three risk factors: anti-John Cunningham virus antibody index, previous immunosuppressive therapy, and duration of treatment. Patients were classified into five categories: minimum probability (<0.1/1000); low (0.1/1000); medium-low (0.2-0.6/1000); medium-high (0.8-3/1000); high probability (3-10/1000). RESULTS: 34 patients were included. The probability of PML in the last cycle was: 55.9% minimum, 8.8% low, 11.8% medium-low, 3% medium-high, and 20.5% high. 12 patients continue with active treatment with natalizumab. No cases of PML have been confirmed. Adverse effects were detected in 50% of patients. CONCLUSIONS: Quantifying risk factors allows us to estimate the probability of PML appearance, thus assessing the maintenance or suspension of natalizumab.