Table 1.
Summary of data, HLA genotype distribution and treatment regimens as evaluated in the analysis
| Ludvigsson et al, 2008 (NCT00435981) [4] | Wherrett et al, 2011 (NCT00529399) [3] | Ludvigsson et al, 2012 (NCT00723411) [2] | |
|---|---|---|---|
| Participants eligible for analysis, n | 69 | 139 | 313 |
| All participants | 70 | 145 | 334 |
| With baseline and at least one post-baseline value missing | 1 | 4 | 7 |
| With missing HLA information | 0 | 2 | 14 |
| HLA distribution, n (%) | |||
| HLA-DR3-DQ2 | 34 (49%) | 71 (50%) | 161 (50%) |
| HLA-DR3-DQ2/not HLA-DR4-DQ8 | 17 (24%) | 36 (25%) | 74 (23%) |
| Treatment schedulea | |||
| Low dose | Two doses of 20 μg GAD-alum (days 1 and 30) | Two doses of 20 μg GAD-alum (days 1 and 30), one dose of alum (day 90) | Two doses of 20 μg GAD-alum (days 1 and 30), two doses of alum (days 90 and 180) |
| High dose | - | Three doses of 20 μg GAD-alum (days 1, 30 and 90) | Four doses of 20 μg GAD-alum (days 1, 30, 90 and 180) |
| Placebo | Two doses of alum (days 1 and 30) | Three doses of alum (days 1, 30 and 90) | Four doses of alum (days 1, 30, 90 and 180) |
aFor Wherrett et al 2011 the treatment schedule was defined as baseline, week 4 and week 12, while Ludvigsson 2008 and 2012 defined the schedule based on days from baseline (1, 30, 90 and 180). For consistency, days from baseline are used in the table. For a detailed description on the similarities and differences between the clinical trials, please see [1]