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We thank Dr Moots and colleagues1 for the questions regarding the immunogenicity results in our study.2
While it seems that there was much concern about the details of the methods and results of the immunogenicity data, the authors would like to reassure Dr Moots and colleagues that the presented data are valid and reliable and follow standard reporting procedures. We provide the following explanations and that they are helpful in this respect.
The proportion of patients who tested positive for antidrug antibodies (ADAs) at least once up to Week 24 was significantly lower in SB4 compared with the etanercept reference product (ETN) (2 patients (0.7%) in SB4 and 39 patients (13.1%) in ETN, p<0.001). Only one in the ETN group had neutralising capacity.2 The incidence of patients with positive ADA by titre up to Week 24 is presented in table 1. Almost all ADAs were transient, which is consistent with the previous studies with ETN.3 ,4 All patients were reported as positive only once throughout the …