Table 4. Airway infections as an adverse event in phase 3 studies, meta-analyses, and long-term trials (from Vultaggio et al. Allergy 2020 [66]).
| Agent | Indication | Interval/dosage | Study (n) | Adverse events biological/placebo (n/group) |
|---|---|---|---|---|
| Benralizumab (anti-IL-5R) |
Severe, uncontrolled asthma | Q4W + placebo, Q4W + Q4W, Q8W + placebo, Q8W + Q8W | Busse et al. (n = 1,576*) | VURTI 15 – 16%/14 – 15%** (1,030/546) URTI 6%/7 – 8% Pnx < 1 – 1% |
| Dupilumab (anti-IL-4Rα) |
Atopic dermatitis | Various (QW, Q2W, Q4W, Q8W, placebo) | Worm et al. (n = 422) | URTI 5.7 – 8.3/7.3 IFZ 0 – 5.7/1.2 HSV1 1.8 – 6/3.7 VURTI 0 – 1.2/3.7 |
| 200 (adolescents)/300 mg Q2W, 300 mg Q4W, placebo |
Simpson et al. (n = 250) | URTI 7.2 – 12.2/17.6 HSV 1.2 – 4.8/3.5 |
||
| 300 mg QW/Q2W, placebo | Simson et al. (n = 1,379) | URTI 3 – 5/2 HSV 0 – 3/1 HSV1 2 – 4/2 HSV2 1/1 VZV 0 – 1/1 |
||
| 300 mg QW/Q2W, placebo | Blauvelt et al. (n = 740) | URTI 10 – 14/10 IFZ 3 – 4/5 HSV 2 – 3/1 VZV < 1 – 1/2 HSV1 4 – 5/3 |
||
| 300 mg Q2W (open label) | Faiz et al. (n = 241) | URTI 1.2 HSV < 2.4 |
||
| 300 mg Q2W | Deleuran et al. (n = 1,491) | VURTI 2.5 IFZ 2.1 HSV1 4.3 |
||
| CRSwNP | 300 mg Q2W, placebo | Bachert et al. (n = 276) | URTI 5.4 – 6.7/12.7 | |
| Moderate to severe, uncontrolled asthma | 200/300 mg Q2W, placebo | Castro et al. (n = 1,897) | VURTI 18.2/19.6 URTI 11.6/13.6 IFZ 5.9/8.0 |
|
| Severe, steroid-dependent asthma | 300 mg Q2W, placebo | Rabe et al. (n = 210) | VURTI 9/18 IFZ 3/6 |
|
| Mepolizumab (anti-IL-5) |
Severe eosinophilic asthma | 75 mg IV Q4W/ 100 mg SC Q4W | Ortega et al. (n = 576) | IFZ 5/3 (191/191), 3/3 (194/191) VURTI 1/< 1, 0/< 1 HSV1 < 1 all HSV2 < 1/0, < 1/0 VZV < 1/0 – 1/0 |
| 100 mg Q4W | Chupp et al. (n = 551) | IFZ 3/1 (273/278) HSV 1 < 1/0 VZV < 1/< 1 |
||
| Severe, steroid-dependent eosinophilic asthma | 100 mg SC Q4W | Bel et al. (n = 135) | IFZ 4/2 (69/66) VURTI 1/2 VZV 0/2 |
|
| Reslizumab (anti-IL-5) |
Severe eosinophilic asthma | 3 mg/kg IV Q4W | Virchow et al. (n = 1,758) | URTI 9/9 (1,028/730) IFZ 3/5 |
| Omalizumab (anti-IgE) |
Severe allergic asthma | Q2W/Q4W | Esquivel et al. (n = 327) | Rhinovir 3.3/3.4 (243/84) |
*Multi-step design. Total number of all three sub-studies; **patients first received placebo, then active drug. Due to large differences in group sizes percentages are given. Pnx = pneumonia; CRSwNP = chronic rhinosinusitis with nasal polyps; HSV = herpes simplex virus; IFZ = influenza; (V)URTI = (viral) upper respiratory tract infections; VZV = varicella zoster virus.