Skip to main content

Table 2 Safety assessment

From: Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

  Current study (OLE) CHRONOS (52 weeks)
300 mg qw [N = 2677] Placebo + TCS [n = 315] 300 mg qw + TCS [n = 315]
Events Pts with ≥ 1 event, [n (%)] nE/100 PY nP/100 PY Events Pts with ≥ 1 event [n (%)] nE/100 PY nP/100 PY Events Pts with ≥ 1 event, [n (%)] nE/100 PY nP/100 PY
TEAEs 13,826 2264 (84.6) 270.1 173.7 1520 268 (85.1) 531.9 325.1 1,500 263 (83.5) 504.5 322.43
Serious TEAEs 354 256 (9.6) 6.92 5.28 24 16 (5.1) 8.40 5.75 11 10 (3.2) 3.70 3.40
Severe TEAEs 355 246 (9.2) 6.94 5.08 46 28 (8.9) 16.10 10.31 24 17 (5.4) 8.07 5.88
TEAEs leading to study drug discontinuation 116 95 (3.5) 2.27 1.87 29 25 (7.9) 10.15 9.14 10 9 (2.9) 3.36 3.06
Serious TEAEs related to treatment 36 31 (1.2) 0.70 0.61 3 3 (1.0) 1.05 1.06 2 2 (0.6) 0.67 0.68
Deatha 2 2 (< 0.1) 0.04 0.04 0 0 0 0 1 1 (0.3) 0.34 0.34
Most common TEAEs by PT (≥ 5% of patients in the OLE)
 Nasopharyngitis 1543 752 (28.1) 30.14 19.16 90 62 (19.7) 31.49 24.93 86 62 (19.7) 28.92 24.16
 Atopic dermatitis 736 438 (16.4) 14.38 9.61 243 147 (46.7) 85.03 74.32 91 55 (17.5) 30.60 20.71
 Upper respiratory tract infection 532 350 (13.1) 10.39 7.56 48 32 (10.2) 16.80 12.03 65 43 (13.7) 21.86 15.85
 Headache 408 216 (8.1) 7.97 4.54 31 19 (6.0) 10.85 6.98 48 25 (7.9) 16.14 8.97
Conjunctivitisb 826 521 (19.5) 16.14 11.96 29 25 (7.9) 10.15 9.24 91 61 (19.4) 30.60 23.37
Injection-site reactions (HLT) 855 260 (9.7) 16.70 5.58 105 25 (7.9) 36.74 9.39 232 63 (20.0) 78.02 25.46
Herpes viral infections (HLT) 715 333 (12.4) 13.97 7.21 32 25 (7.9) 11.20 9.17 43 22 (7.0) 14.46 7.72
Skin infections 291 231 (8.6) 5.69 4.81 NA 57 (18.1) NA 20.21 NA 26 (8.3) NA 7.87
Eczema herpeticum (PT) 14 12 (0.4) 0.27 0.24 6 6 (1.9) 2.10 2.13 0 0 0 0
Most common serious TEAEs by PT (≥ 0.2% of patients in the OLE)
 Squamous cell carcinoma of skin 14 8 (0.3) 0.27 0.16 0 0 0 0 1 1 (0.3) 0.34 0.34
 Osteoarthritis 10 9 (0.3) 0.20 0.18 0 0 0 0 1 1 (0.3) 0.34 0.34
 Dermatitis atopic 7 6 (0.2) 0.14 0.12 1 1 (0.3) 0.35 0.35 2 1 (0.3) 0.67 0.34
 Syncope 6 5 (0.2) 0.12 0.10 0 0 0 0 0 0 0 0
 Inguinal hernia 5 5 (0.2) 0.10 0.10 0 0 0 0 0 0 0 0
 Appendicitis 5 5 (0.2) 0.10 0.10 0 0 0 0 0 0 0 0
  1. HLT MedDRA High Level Term, MedDRA Medical Dictionary for Regulatory Activities, NA not available, nE number of events, nP number of patients, OLE open-label extension, PT MedDRA Preferred Term, pts patients, PY patient-year, qw weekly, TCS topical corticosteroid, TEAE treatment-emergent adverse event
  2. aOne death in the OLE due to natural causes in an 88-year-old female and one due to unknown causes in a 60-year-old female approximately 5 months after the final dose of study drug; death in CHRONOS previously reported [10]
  3. bIncludes PT: conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial, conjunctivitis viral, and atopic keratoconjunctivitis