Observed data are also shown for patients completing week 96.
Twenty-six patients (81%%) completed the study after achieving age and weight termination criteria, with 13 patients completing week 96 and three patients completing week 120.
Additionally, all three subjects completing week 120 had a good and sustained response achieving PedACR90.
Patients completing week 56 of therapy were then eligible to enroll in an open-label extension.
Patients completing week 24 were eligible to receive further courses of rituximab within an open-label extension study.
The proportion of randomised patients completing week 104 was higher in the rituximab 2×500 mg+MTX and 2×1000 mg+MTX groups compared with the placebo+MTX group (85%and85%5% vs 71%, respectively).
A total of 127 subjects (eoJIA n=60, ERA n=38 and PsA n=29) were enrolled (figure 1) with 122 96.1 %) completing week 12. Mean age, weight, height and body mass index (BMI) were lower in the eoJIA subgroup than the ERA and PsA subgroups as per inclusion criteria (table 1).
There were 40 patients per group completing week 12 who provided 90% power to detect a mean 0.6% difference in A1C between the 200-mg group and placebo assuming an Emax dose-response model (13) with a half-maximal stimulation (ED50) of 30 mg and an SD in A1C of 1.2%.
