Table 3. Adverse Events (Safety Analysis Set).
| Adverse Event | No. (%) of Participants | |||
|---|---|---|---|---|
| Placebo (n = 82) | Dupilumab, 300 mg | |||
| Every 8 wk (n = 84) | Every 4 wk (n = 87) | Weekly or Every 2 wk (n = 167) | ||
| Overall TEAEs | ||||
| ≥1 | 67 (81.7) | 63 (75.0) | 64 (73.6) | 118 (70.7) |
| Leading to permanent study treatment discontinuation | 3 (3.7)a | 0 | 2 (2.3)b | 0 |
| Leading to temporary study treatment discontinuation | 10 (12.2) | 7 (8.3) | 7 (8.0) | 6 (3.6) |
| Deathc | 0 | 0 | 1 (1.1) | 0 |
| Treatment-emergent SAEd | 1 (1.2) | 3 (3.6) | 4 (4.6) | 6 (3.6) |
| MedDRA PT occurring in ≥2% of patients in any treatment group | ||||
| Dermatitis atopic | 40 (48.8) | 27 (32.1) | 30 (34.5) | 34 (20.4) |
| Nasopharyngitis | 11 (13.4) | 11 (13.1) | 11 (12.6) | 32 (19.2) |
| Upper respiratory tract infection | 6 (7.3) | 7 (8.3) | 5 (5.7) | 13 (7.8) |
| Headache | 2 (2.4) | 3 (3.6) | 5 (5.7) | 8 (4.8) |
| Herpes simplex virus infectione | 0 | 4 (4.8) | 1 (1.1) | 7 (4.2) |
| Asthma | 3 (3.7) | 4 (4.8) | 2 (2.3) | 4 (2.4) |
| Back pain | 1 (1.2) | 3 (3.6) | 1 (1.1) | 6 (3.6) |
| Oral herpes infection | 3 (3.7) | 5 (6.0) | 2 (2.3) | 3 (1.8) |
| Influenza | 1 (1.2) | 0 | 5 (5.7) | 4 (2.4) |
| Bronchitis | 1 (1.2) | 0 | 5 (5.7) | 3 (1.8) |
| Urticaria | 1 (1.2) | 2 (2.4) | 1 (1.1) | 5 (3.0) |
| Arthralgia | 1 (1.2) | 0 | 2 (2.3) | 5 (3.0) |
| Pharyngitis | 0 | 2 (2.4) | 2 (2.3) | 3 (1.8) |
| Diarrhea | 3 (3.7) | 1 (1.2) | 1 (1.1) | 4 (2.4) |
| Pruritus | 2 (2.4) | 1 (1.2) | 2 (2.3) | 3 (1.8) |
| Sinusitis | 2 (2.4) | 0 | 0 | 6 (3.6) |
| Blood creatine phosphokinase increased | 2 (2.4) | 1 (1.2) | 3 (3.4) | 1 (0.6) |
| Cough | 1 (1.2) | 0 | 1 (1.1) | 4 (2.4) |
| Insomnia | 1 (1.2) | 1 (1.2) | 0 | 4 (2.4) |
| Nasal congestion | 0 | 0 | 1 (1.1) | 4 (2.4) |
| Contact dermatitis | 2 (2.4) | 2 (2.4) | 1 (1.1) | 1 (0.6) |
| Gastroenteritis | 2 (2.4) | 1 (1.2) | 0 | 3 (1.8) |
| Ligament sprain | 0 | 2 (2.4) | 0 | 2 (1.2) |
| Toothache | 0 | 0 | 0 | 4 (2.4) |
| Abdominal pain | 1 (1.2) | 2 (2.4) | 1 (1.1) | 0 |
| Basal cell carcinoma | 0 | 2 (2.4) | 1 (1.1) | 0 |
| Contusion | 1 (1.2) | 2 (2.4) | 0 | 1 (0.6) |
| Folliculitis | 1 (1.2) | 3 (3.6) | 0 | 0 |
| Hordeolum | 1 (1.2) | 0 | 3 (3.4) | 0 |
| Hypertension | 2 (2.4) | 1 (1.2) | 0 | 2 (1.2) |
| Proteinuria | 1 (1.2) | 0 | 2 (2.3) | 1 (0.6) |
| Rhinitis | 2 (2.4) | 1 (1.2) | 1 (1.1) | 1 (0.6) |
| Seasonal allergy | 0 | 2 (2.4) | 1 (1.1) | 0 |
| Tonsillitis | 0 | 0 | 2 (2.3) | 1 (0.6) |
| Urinary tract infection | 2 (2.4) | 1 (1.2) | 0 | 2 (1.2) |
| Viral infection | 3 (3.7) | 1 (1.2) | 0 | 2 (1.2) |
| Colitis | 0 | 0 | 2 (2.3) | 0 |
| Eye allergy | 0 | 0 | 2 (2.3) | 0 |
| Ophthalmic herpes infection | 2 (2.4) | 1 (1.2) | 0 | 1 (0.6) |
| Musculoskeletal pain | 2 (2.4) | 1 (1.2) | 0 | 1 (0.6) |
| Vulvovaginal candidiasis | 2 (2.4) | 0 | 0 | 2 (1.2) |
| Fall | 2 (2.4) | 0 | 0 | 1 (0.6) |
| Eye disorders with the PT conjunctivitisf | 4 (4.9) | 3 (3.6) | 4 (4.6) | 9 (5.4) |
| Nonherpetic skin infectionsg | 8 (9.8) | 5 (6.0) | 1 (1.1) | 4 (2.4) |
| Injection-site reactionsh | 7 (8.5) | 6 (7.1) | 6 (6.9) | 18 (10.8) |
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; PT, MedDRA preferred term; SAE, serious adverse event; TEAE, treatment-emergent adverse event.
Two patients discontinued participation in the study because of atopic dermatitis and 1 patient because of acquired dacryostenosis.
One patient discontinued participation in the study because of glioblastoma, disorientation, and brain edema and 1 patient because of atopic dermatitis.
One death occurred during the 36-week treatment period (on study day 187) in a 21-year-old man in the dupilumab every 4 weeks group because of a gunshot wound (homicide). The event was considered by the investigator to be not related to study drug use.
The only SAE (MedDRA PT and system organ class) with incidence of 2% or greater in a treatment group was basal cell carcinoma, which occurred in 2 patients in the dupilumab every 8 weeks group and no other treatment groups.
Herpes simplex cutaneous infections with nonoral locations.
Includes any PTs that included the term conjunctivitis: conjunctivitis, conjunctivitis bacterial, conjunctivitis viral, conjunctivitis allergic, and atopic keratoconjunctivitis (for all conjunctivitis MedDRA PTs, see eTable 10 in Supplement 2).
Adjudicated; includes the following MedDRA PTs: tinea versicolor, folliculitis, impetigo, skin bacterial infection, skin infection, abscess limb, localized infection, staphylococcal skin infection, subcutaneous abscess, and tinea cruris (eTable 8 in Supplement 2).
MedDRA high-level terms (see eTable 7 in Supplement 2 for MedDRA PTs).