Table 1.
Patients with ≥1 event, nP/PY (nP/100 PY) | RR vs placebo (95% CI), p-value | ||
---|---|---|---|
Placebo + TCS (n = 78) | Dupilumab 200/300 mg q4w + TCS (n = 83) | ||
Total infections (SOC) | 40/16.3 (245.7) | 35/18.9 (185.2) |
0.75 (0.48–1.19) 0.223 |
Infections leading to treatment discontinuation (SOC) | 0/24.0 | 0/25.8 |
NE (NE–NE) NE |
Serious or severe infections | 4/23.4 (17.1) | 0/25.8 |
NE (NE–NE) NE |
Serious infections | 3/23.6 (12.7) | 0/25.8 |
NE (NE–NE) NE |
Severe infections | 4/23.4 (17.1) | 0/25.8 |
NE (NE–NE) NE |
Adjudicated skin infections (excluding herpes infections) | 19/20.5 (92.7) | 10/23.4 (42.7) |
0.46 (0.21–0.99) 0.047 |
Non-skin infections1 | 36/17.4 (207.4) | 31/20.3 (152.7) |
0.74 (0.46–1.19) 0.212 |
Herpes viral infections (HLT) | 4/23.3 (17.1) | 5/25.0 (20.0) |
1.17 (0.31–4.35) 0.817 |
Herpes virus infections (PT) | 0/24.0 | 2/25.6 (7.8) |
NE (NE–NE) NE |
Eczema herpeticum (PT) | 1/23.9 (4.2) | 0/25.8 |
NE (NE–NE) NE |
Herpes zoster (PT) | 0/24.0 | 0/25.8 |
NE (NE–NE) NE |
Varicella (PT) | 0/24.0 | 2/25.4 (7.9) |
NE (NE–NE) NE |
Oral herpes (PT) | 2/23.7 (8.4) | 1/25.5 (3.9) |
0.47 (0.04–5.13) 0.532 |
Herpes simplex (PT) | 1/23.7 (4.2) | 0/25.8 |
NE (NE–NE) NE |
Bacterial infections (HLGT) | 10/21.9 (45.6) | 1/25.4 (3.9) |
0.09 (0.01–0.67) 0.019 |
Viral infections (HLGT) | 12/21.7 (55.2) | 15/23.2 (64.8) |
1.17 (0.55–2.50) 0.681 |
Fungal infections (HLGT) | 1/23.8 (4.2) | 0/25.8 |
NE (NE–NE) NE |
Helminthic infections (HLGT) | 0/24.0 | 0/25.8 |
NE (NE–NE) NE |
Skin structures and soft tissue infections (HLT)2 | 9/22.4 (40.2) | 6/24.3 (24.7) |
0.62 (0.22–1.73) 0.357 |
CI confidence interval, HLGT MedDRA High Level Group Term, HLT MedDRA High Level Term, MedDRA Medical Dictionary for Regulatory Activities, NE not estimated, nP number of patients, PT MedDRA Preferred Term, PY patient-years, q4w every 4 weeks, RR rate ratio, SOC MedDRA System Organ Class, TCS topical corticosteroids
1Includes all adverse events in the SOC ‘Total infections’ except adjudicated non-herpetic skin infections and the HLT ‘Herpes viral infections’
2Only includes infections that fall within HLGT category of ’pathogens unspecified’
Significant differences (p < 0.05) are indicated in bold