Table 4.
Summary of infection events in the placebo-controlled and all-abrocitinib cohorts
| Placebo-controlled cohort | All-abrocitinib cohort | ||||
|---|---|---|---|---|---|
| Placebo N = 342 |
Abrocitinib 100 mg N = 608 |
Abrocitinib 200 mg N = 590 |
Abrocitinib 100 mg N = 885 |
Abrocitinib 200 mg N = 1971 |
|
| Serious infections | |||||
| N (%) | 2 (0.6) | 6 (1.0) | 2 (0.3) | 17 (1.9) | 24 (1.2) |
| IRs (95% CI) | 2.31 (0.28–8.33) | 3.80 (1.39–8.27) | 1.28 (0.16–4.62) | 2.65 (1.55–4.25) | 2.33 (1.49–3.47) |
| Herpes zoster | |||||
| N (%) | 0 | 3 (0.5) | 8 (1.4) | 13 (1.5) | 44 (2.2) |
| IRs (95% CI) | 0.00 (0.00–4.25) | 1.90 (0.39–5.55) | 5.16 (2.23–10.16) | 2.04 (1.09–3.49) | 4.34 (3.15–5.82) |
| Herpes simplexa | |||||
| N (%) | 6 (1.8) | 19 (3.1) | 25 (4.2) | 54 (6.1) | 116 (5.9) |
| IRs (95% CI) | 7.20 (2.60–14.58) | 12.07 (7.26–18.59) | 16.22 (10.49–23.67) | 8.73 (6.56–11.39) | 11.83 (9.77–14.19) |
| Eczema herpeticum | |||||
| N (%) | 3 (0.9) | 6 (1.0) | 0 (0) | 15 (1.7) | 8 (0.4) |
| IRs (95% CI) | 3.46 (0.71–10.12) | 3.81 (1.40–8.28) | 0.00 (0.00–2.36) | 2.34 (1.31–3.86) | 0.78 (0.34–1.53) |
CI confidence interval, IR incidence rate
aIncludes events of genital herpes, genital herpes simplex, herpes dermatitis, herpes ophthalmic, herpes simplex, nasal herpes, ophthalmic herpes simplex, and oral herpes