Assay | Time point | Key inferential statistics | |||
Baseline | Week 2 | Week 4 | Week 8 | ||
Anti-S-AB, median (95% CI) BAU/mL | |||||
PID | 75 (−3 to 151) | 286 (−236 to 807) | 300 (−60 to 659) | 297 (139 to 455) | At week 2, significantly higher than RTX (p=0.0081) but significantly lower than csDMARD/bDMARD (p=0.0066) |
RTX | 4 (−4 to 4) | 0 (−9 to 9) | 6 (−5 to 16) | 0 (−10 to 10) | |
csDMARD/bDMARD | 84 (45 to 123) | 2712 (1549 to 3830) | 1670 (838 to 2502) | 1179 (681 to 1678) | Significant increase between baseline and week 2 (p<0.001) |
sVNT, median (95% CI) % of patients | |||||
PID | 53% (5 to 100) | ND | 91% (62 to 119) | 95% (89 to 101) | u |
RTX | 0% (0 to 0) | ND | 0% (0 to 0) | 0% (0 to 0) | |
csDMARD/bDMARD | 56% (33 to 79) | ND | 96% (95 to 97) | 97% (96 to 98) | Significant increase between baseline and week 4 (p<0.0001) |
IGRA, median (95% CI) mIU/mL | |||||
PID | 215 (101 to 329) | ND | 965 (163 to 1767) | 664 (−1383 to 2710) | |
RTX | 1290 (511 to 2068) | ND | 2555 (675 to 4435) | 2404 (1794 to 3014) | Higher at baseline than the PID group (p=0.05) or csDMARD/bDMARD group (p=0.06) |
csDMARD/bDMARD | 331 (−53 to 715) | ND | 1765 (1017 to 2512) | 1308 (682 to 1934) |
BAU, binding antibody unit; bDMARD, biological disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; IGRA, interferon gamma release assay; MIU, micro international unit; ND, not determined; PID, primary immunodeficiency; RTX, rituximab; S-AB, spike IgG antibody; sVNT, surrogate virus neutralisation test.