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We sincerely appreciate the interest shown by Dr Francesca Meacci and colleagues in the comparative immunogenicity evaluations of reference infliximab and CT-P13 (biosimilar infliximab) that were performed in the PLANETAS and PLANETRA clinical trials and their trial extension studies.1–7 In addition, we acknowledge their specific comments regarding the potential value of the Gyrolab platform and its many practical advantages as a laboratory method.7
In order to provide robust antidrug antibody (ADA) data, both electrochemiluminescence and Gyrolab (Gyros AB, Uppsala, Sweden) were used for PLANETRA and PLANETAS studies. To ensure a thorough evaluation of an ADA response (or absence of such a response), it is usually necessary to perform the following three procedures: (1) screening, (2) confirmation and (3) characterisation. The screening assay determines overall ADA status, categorising samples as ADA positive or ADA negative according to the presence or absence …