TABLE 3.
Treatment‐emergent infections (by PT) by incidence rate: number of patients per 100 PY (includes any PT reported in ≥5 patients) a
| Patients with infection, nP (nP/100 PY) | Comparison with placebo, p‐value | ||||||
|---|---|---|---|---|---|---|---|
| Placebo | Dupilumab b | ||||||
| Pooled placebo groups (n = 205) | Pooled approved doses (n = 261) | Pooled other doses studied (n = 146) | Pooled all doses (n = 407) | Pooled approved doses (n = 261) | Pooled other doses studied (n = 146) | Pooled all doses (n = 407) | |
| Upper respiratory tract infection cluster c | 50 (93.0) | 57 (80.3) | 36 (93.9) | 93 (85.1) | 0.483 | 0.997 | 0.625 |
| Upper respiratory tract infection | 27 (47.1) | 28 (36.8) | 11 (25.8) | 39 (32.8) | 0.440 | 0.071 | 0.153 |
| Nasopharyngitis | 12 (19.8) | 20 (25.8) | 15 (35.3) | 35 (29.2) | 0.587 | 0.087 | 0.252 |
| Pharyngitis streptococcal | 3 (4.8) | 5 (6.3) | 4 (9.0) | 9 (7.3) | 0.698 | 0.443 | 0.535 |
| Viral upper respiratory tract infection | 7 (11.2) | 4 (5.0) | 4 (9.0) | 8 (6.4) | 0.257 | 0.545 | 0.277 |
| Rhinitis | 3 (4.8) | 3 (3.7) | 1 (2.2) | 4 (3.2) | 0.852 | 0.431 | 0.595 |
| Sinusitis | 1 (1.6) | 1 (1.2) | 3 (6.7) | 4 (3.2) | 0.910 | 0.278 | 0.540 |
| Other infections | |||||||
| Conjunctivitis | 4 (6.5) | 10 (12.6) | 9 (20.6) | 19 (15.4) | 0.311 | 0.043 | 0.115 |
| Molluscum contagiosum d | 1 (1.6) | 4 (5.0) | 4 (9.1) | 8 (6.4) | 0.462 | 0.043 | 0.191 |
| Conjunctivitis bacterial | 1 (1.6) | 2 (2.5) | 5 (11.3) | 7 (5.6) | 0.908 | 0.031 | 0.246 |
| Gastroenteritis viral | 2 (3.2) | 6 (7.5) | 1 (2.2) | 7 (5.6) | 0.259 | 0.698 | 0.484 |
| Herpes simplex | 2 (3.2) | 2 (2.5) | 5 (11.3) | 7 (5.6) | 0.764 | 0.118 | 0.479 |
| Impetigo | 9 (14.8) | 4 (5.0) | 3 (6.8) | 7 (5.6) | 0.115 | 0.145 | 0.056 |
| Bronchitis | 0 (0) | 5 (6.2) | 0 (0) | 5 (4.0) | 1.000 | 1.000 | 1.000 |
| Folliculitis | 5 (8.1) | 3 (3.7) | 2 (4.5) | 5 (4.0) | 0.260 | 0.588 | 0.267 |
| Furuncle | 4 (6.5) | 3 (3.7) | 2 (4.5) | 5 (4.0) | 0.463 | 0.697 | 0.471 |
| Gastroenteritis | 1 (1.6) | 2 (2.5) | 2 (4.5) | 4 (3.2) | 0.666 | 0.477 | 0.537 |
| Influenza | 8 (13.0) | 4 (5.0) | 0 (0) | 4 (3.2) | 0.186 | 1.000 | 0.022 |
| Otitis media | 3 (4.8) | 3 (3.7) | 1 (2.2) | 4 (3.2) | 0.882 | 0.383 | 0.574 |
| Urinary tract infection | 2 (3.2) | 3 (3.7) | 1 (2.2) | 4 (3.2) | 0.892 | 0.796 | 0.992 |
| Oral herpes | 3 (4.8) | 1 (1.2) | 2 (4.5) | 3 (2.4) | 0.272 | 0.826 | 0.393 |
| Dermatitis infected | 6 (9.7) | 1 (1.2) | 0 (0) | 1 (0.8) | 0.058 | 1.000 | 0.020 |
| Ear infection | 5 (8.1) | 0 (0) | 0 (0) | 0 (0) | 1.000 | 1.000 | 1.000 |
Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; nP, number of patients with ≥1 event; nP/100 PY, number of patients with ≥1 event per 100 PY; PT, MedDRA preferred term; PY, patient‐years; q2w, every 2 weeks; SOC, MedDRA System Organ Class.
At each level of patient summarization, a patient is counted once if the patient reported ≥1 event. TEAEs included in the analysis were those that occurred during the study treatment period. PTs fall under the Infections and infestations SOC.
In LIBERTY AD PEDS, 1 patient with baseline weight <30 kg who was mis‐randomized to 200 mg dupilumab q2w was summarized in baseline weight <30 kg 100 mg dupilumab q2w group. One patient with baseline weight ≥30 kg who was randomized to placebo, but received 100 mg dupilumab inadvertently was summarized in baseline weight ≥30 kg 200 mg dupilumab q2w group.
Includes PT: upper respiratory tract infection, pharyngitis streptococcal, viral upper respiratory tract infection, rhinitis, nasopharyngitis, and sinusitis.
Treatment‐emergent AEs (PT) of molluscum contagiosum (MC) occurred in one patient in the placebo group and seven patients in the dupilumab treatment groups in LIBERTY AD PEDS, and in one patient in LIBERTY AD ADOL, dupilumab 300 mg q4w group. All treatment‐emergent AEs of molluscum contagiosum were non‐serious, mild to moderate in severity, and non‐recurrent (ie, observed only once for each patient), with all patients reported as recovered or recovering.