Herpes zoster events in patients during treatment with anifrolumab 300 mg versus placebo in pooled MUSE, TULIP-1 and TULIP-2 data
| Anifrolumab 300 mg (n=459) n (%) | EAIR (per 100 PY) | Placebo (n=466) n (%) | EAIR (per 100 PY) | EAIR (per 100 PY) risk difference (anifrolumab 300 mg − placebo) (95% CI) | |
| Any AE | 28 (6.1) | 6.9 | 6 (1.3) | 1.5 | 5.4 (2.8 to 8.4) |
| Any AE with outcome of death | 0 | 0 | 0 | 0 | 0 |
| Any SAE | 2 (0.4) | 0.5 | 0 | 0 | 0.5 (−0.5 to 1.7) |
| Any DAE | 2 (0.4) | 0.5 | 0 | 0 | 0.5 (−0.5 to 1.7) |
| Any AE by maximum reported intensity | |||||
| Mild | 9 (2.0) | 2.2 | 1 (0.2) | 0.3 | - |
| Moderate | 17 (3.7) | 4.1 | 5 (1.1) | 1.2 | - |
| Severe | 2 (0.4) | 0.5 | 0 | 0 | - |
EAIR was reported per 100 PY and defined as the number of patients with the specific event divided by the total exposure time in years and then multiplied by 100. The exposure time was defined as the time from the date of first administration of investigational product to the date of first event, death, end of treatment plus 28 days or end of study, whatever came first.
AE, adverse event; DAE, AE leading to discontinuation of investigational product; EAIR, exposure-adjusted incidence rate; PY, patient-years; SAE, serious AE.