1. Dichotomous outcomes.
| Outcome |
IVIg n (%) |
Control n (%) |
RR (95% CI) |
ARR/ARI % |
NNT/H | P‐Value |
| All‐cause mortality | 0/17 (0) | 2/17 (12) | 0.20 (0.01 to 3.88) | n/a | n/a | P = 0.29 |
| Serious adverse events | 3/17 (18) | 2/17 (12) | 1.50 (0.29 to 7.87) | n/a | n/a | P = 0.63 |
| Time to remission | Not Reported | |||||
| Length of remission (reported as number of patients relapsed after 3 months) | 5/17 (29 ) | 4/17 (24 ) | 1.25 (0.40 to 3.87) | n/a | n/a | P = 0.70 |
| End‐organ damage | Not reported | |||||
| Steroid/immunosuppressant sparing open‐label: treatment for worsening vasculitis | ||||||
| Open‐label IVIg within 3 months | 0/17 (0) | 1/17 (6) | 0.33 (0.01 to 7.65) | n/a | n/a | P = 0.49 |
| Open‐label CYC within 3 months | 0/17 (12) | 1/17 (6) | 0.33 (0.01 to 7.65) | n/a | n/a | P = 0.49 |
| Open‐label IVIg after 3 months | 2/17 (12 ) | 1/17 (6) | 2.00 (0.20 to 20.04) | n/a | n/a | P = 0.56 |
| Open‐label CAMPATH‐1 after 3 months | 1/17 (6) | 1/17 (6) | 3.00 (0.13 to 68.84) | n/a | n/a | P = 0.49 |
| Infection rates (n = 1 aseptic meningitis in IVIg group, included in serious adverse events) | 1/17 (6) | 0/17 (0) | 3.0 (0.13 to 68.84) | n/a | n/a | P = 0.49 |
| Total adverse events | 14/17 (82) | 4/17 (24) | 3.50 (1.44 to 8.48) | 59 (95% CI 32 to 86) | 2 | P < 0.01 |
| Withdrawal due to adverse events | Not reported |
CYC: cyclophophamide IVIg: intravenous immunoglobulin NNT/H: number needed to harm RR: relative risk