SAT0688 PATIENT STATE OF KNOWLEDGE ON BIOSIMILARS – DO PHYSICIANS NEED TO IMPROVE EDUCATION SKILLS?

Background: Biosimilars are highly similar to original biological medicines1.Worldwide prescription of biosimilars is still low because of the lack of understanding in manufacturing and approval process together with mistrust in the extrapolation of indication in clinical use2.Lack of biosimilar awareness throughout rheumatic patients results in an unjustified underuse2. Objectives: To assess patients’ current knowledge and concerns on biosimilars and to investigate their expectations when receiving such a treatment following the principle of shared-decision making. Methods: A national,cross-sectional survey was conducted in Romanian patients with rheumatoid arthritis(RA),spondyloarthritis(SpA),psoriatic arthritis(PsA)currently on a bio-originator or biosimilar.336 patients responded to a survey distributed from August to December 2018,main topics being patient basic information on biosimilars,their efficacy,safety,price or differences to original drugs. Results: Out of 336 patients,47.3% had RA,39.8% SpA,12.5% PsA with a mean age of 52.5.In the study cohort,13% received approved biosimilars while 87% bio-originators with different mechanisms of action.A yes/no type of question divided patients into those aware or not of biosimilars with further exclusion of those with lack of information.Half of the patients(48.8%) stated they never heard of biosimilars.Surprisingly, four of them were already on this type of treatment.Out of the 172 remaining patients,28.4% feared the risk of adverse events like infections or cancer while almost 20% expressed either insecurity on drug tolerability or the possibility that the biosimilar might be less efficient that the original drug.Another 19.7% certified they had no concerns related to these products and only 15.1% stated confusion regarding the potentially difference in the pharmacological structure of the drugs.Most patients(48.2%) are convinced that the price of a drug should not exceed its efficacy or safety.Half of the respondents say they could accept a switch from an original to a biosimilar if their rheumatologist advises them and 30% might agree but only after being informed.8.7% are interested in scientific proof of the drug and only 1% would consent to a change directly from the pharmacist.When handling prescription,37.7% of patients would want to know if it is an original drug or a biosimilar while 20% do not mind if they receive either.Another 30% trust their rheumatologist and 12.7% would feel more secure if receiving a patient card and written information.Most patients(73.2%)say that they feel completely confident in their rheumatologist if they would want to prescribe a biosimilar,18.6% will have doubts but they will accept the drug and 4% would ask for another medical opinion.After biosimilar initiation,45.9% would be cautious when administrating it,23.2% would stop the drug if an adverse event occured and 15% would have no fears. Conclusion: Study results confirm there is still a significant information gap concerning biosimilars in patient population.Most concerns on biosimilars are related to adverse event occurrence.There is a need to improve patient education on biosimilars involving patients and health professionals.Shared-decision principle is more of a myth since most patients rely entirely on their physician for prescribing the most appropriate product. Reference [1] Declerck P, et al. The Language of Biosimilars:Clarification,Definitions and Regulatory Aspects.Drugs 2017. 2.O’Callaghan J, et al. Regulatory Science Ireland:bridging the information gap on biosimilar medicines.GaBI J 2016. Disclosure of Interests: CLAUDIA COBILINSCHI: None declared, Daniela Opris-Belinski Grant/research support from: GLORIA, Speakers bureau: multiple, Catalin Codreanu: None declared, Razvan Ionescu Speakers bureau: multiple, Claudia Mihailov Speakers bureau: Abbvie, Pfizer, Novartis, MSD, Roche, Biogen, UCB, Lilly, Magda Parvu: None declared, Horatiu Popoviciu: None declared, Elena Rezus: None declared, Ruxandra Ionescu: None declared