Revue systématique des registres de polyarthrites rhumatoïdes sous biothérapie dans le monde et méta-analyse sur les données de tolérance

Public Health Impact of Using Biosimilars, Is Automated Follow up Relevant?

“…However, clinical trials can only offer a limited assessment of the safety of biosimilars in real-life. The patients being may have more comorbidities than those recruited for clinical trials [ 15 ]. Moreover, clinical trials focus on populations with little genetic variability, while patients treated in real-life may have greater genetic variability [ 14 ].…”

“…Moreover, clinical trials focus on populations with little genetic variability, while patients treated in real-life may have greater genetic variability [ 14 ]. As a result, rare or delayed adverse events may not be observed and assessed during clinical trials [ 15 ]. For these reasons, they cannot provide a full picture of the safety profile when using a drug on the long run.…”

“…Real-life data are collected after clinical trials during non-interventional studies on approved drugs that are being used under real-life conditions [ 14 ]. These data can be collected on a regular basis by healthcare professionals with respect to treatments, patient information or clinical outcomes [ 15 ]. Because clinical trials are expensive [ 21 ] and have their limitations with respect to assessment, real-life data can supplement their findings [ 14 ].…”

“…They can be processed to obtain answers to clinical questions concerning the assessment of unwanted immunogenicity in real-life use and the importance of economic incentives. For instance, an analysis could focus on determining whether the concomitant use of biosimilars and other medications might cause an increase in unwanted immunogenicity [ 15 ]. Numerous databases could be involved to assess such clinical questions by supplying relevant data from medical records or registries [ 22 ].…”