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. 2016 Mar 10;9(4):239–249. doi: 10.1177/1756285616633967

Table 3.

Incidence of treatment-emergent antipeginterferon beta1a NAbs at year 1 and over 2 yearsa.

Year 1
Over 2 years
Placebo (n = 489) Peginterferon beta1a Peginterferon beta1a Peginterferon beta1a Peginterferon beta1a
every 2 weeks (n = 491) every 4 weeks (n = 492) every 2 weeks (n = 715) every 4 weeks (n = 716)
Patients with ⩾1 positive antipeginterferon beta1a NAbs result, n (%)b 2 (<1) 4 (<1) 2 (<1) 7 (<1) 6 (<1)
 Transient positive, n (%)c 1 (<1) 2 (<1) 2 (<1) 2 (<1) 5 (<1)
 Persistent positive, n (%)c 1 (<1) 2 (<1) 0 5 (<1) 1 (<1)
 Low titer, n (%) 1 (<1) 3 (<1) 1 (<1) 2 (<1) 3 (<1)
 Medium titer, n (%) 1 (<1) 1 (<1) 1 (<1) 3 (<1) 3 (<1)
 High titer, n (%) 0 0 0 1 (<1) 0
a

All patients who received peginterferon beta1a at any point during the study.

b

NAb assay was performed only in anti-IFN BAb-positive samples, per tiered assay design; percentages are given as a proportion of the total number of patients at risk (the number of patients whose baseline antibody was not positive and who had at least one post-baseline immunogenicity assessment).

c

Transient positive defined as a single positive evaluation, or more than one positive evaluation occurring less than 74 days apart; persistent positive defined as at least two consecutive positive evaluations that occurred at least 74 days apart or a positive evaluation at the final assessment. Results reported as ‘positive titer not determinable’ were considered titer missing. Antipeginterferon NAbs titer levels: low (⩽50), medium (>50 and ⩽700), or high (>700).

BAb, binding antibody; IFN, interferon; NAb, neutralizing antibody.