Figure 3.
Swimmer plot of patients' time to criteria of success and time in each period during the study. ∗Patients were considered to have failed ITI if there was a reduction of inhibitor titer <20% within a 6-month period following the initial 12 weeks of rFVIIIFc ITI, presence of a positive inhibitor (≥0.6 BU/mL) after 48 weeks of ITI with rFVIIIFc, or a negative inhibitor titer without achieving either an IR ≥1.32 IU/dL per IU/kg (representing ≥66% of expected IR) or t1/2 ≥7 hours after 48 weeks of rFVIIIFc ITI; †partial success was defined as receiving 48 weeks of ITI treatment and achieving a negative inhibitor status and 1 normal PK parameter (IR ≥1.32 IU/dL per IU/kg or t1/2 ≥7 hours); ‡successful tolerization was defined as attaining negative inhibitor titer (<0.6 BU/mL), rFVIIIFc IR ≥66% of expected IR, and t1/2 ≥7 hours; §>202 weeks; ||time to negative inhibitor titer was the time interval (in weeks) from the start date of ITI treatment with rFVIIIFc to date of first negative inhibitor titer, which was subsequently confirmed by a sample from a consecutive visit; ¶time to FVIII normal recovery was the time interval (in weeks) from the date of ITI treatment with rFVIIIFc to date of first normal IR (≥66%), which was subsequently confirmed by a sample from a consecutive visit; and #time to FVIII t1/2 of ≥7 hours was the time interval (in weeks) from start date of ITI treatment with rFVIIIFc to date of t1/2 ≥7 hours.