Table 1.

Definitions of patients’ immunogenicity status

Patient status	Definition
Antidrug antibody negative (ADA‐NEG)	All pretreatment and postdose samples were negative in the ADA assay and the drug concentration in the last postdose sample was < 6 μg mL−1
Inconclusive	All pretreatment and postdose samples were negative in the ADA assay and the drug concentration in the last postdose sample was ≥ 6 μg mL−1. This category represents patients who may have had drug interference in the ADA assay
Treatment emergent positive (TE‐POS)	Pretreatment sample was negative and at least one postdose sample was positive in the ADA assay (treatment induced positive)
	Pretreatment and postdose samples were both positive in the ADA assay and the titre increased postdose by ≥ 2‐fold (treatment boosted positive)
TE‐POS NAb‐POS	Treatment emergent positive and at least one sample was positive for NAbs
TE‐POS NAb‐NEG	Treatment emergent positive and negative for NAbs
Nontreatment emergent positive (non‐TE‐POS)	Pretreatment sample was positive and postdose samples were negative in the ADA assay
	Pretreatment and postdose samples were positive in the ADA assay with a < 2‐fold increase in titre postdose
Non‐TE‐POS NAb‐POS	Nontreatment emergent positive and at least one sample was positive for NAbs
Non‐TE‐POS NAb‐NEG	Nontreatment emergent positive and negative for neutralizing antibodies

NAb, neutralizing antibody.