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. 2024 Jan 24;26(2):163–173. doi: 10.1007/s40272-023-00611-9

Table 1.

Exposure-adjusted numbers of patients with treatment-emergent infections during the study treatment period

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