Table 3. Overview of TEAEs Through Week 16 in Modified Safety Population.
| Variable | No. (%) | |
|---|---|---|
| PBO + TCS (N = 66) | LEB + TCS (N = 145) | |
| Any TEAE | 23 (34.8) | 63 (43.4) |
| Mild | 12 (18.2) | 32 (22.1) |
| Moderate | 10 (15.2) | 28 (19.3) |
| Severe | 1 (1.5) | 3 (2.1) |
| Serious AE | 1 (1.5) | 2 (1.4) |
| Death | 0 | 0 |
| AEs leading to treatment discontinuation | 0 | 3 (2.1) |
| TEAEs reported in ≥2% of LEB + TCS group | ||
| Conjunctivitisa | 0 | 7 (4.8) |
| Headache | 1 (1.5) | 7 (4.8) |
| Hypertension | 1 (1.5) | 4 (2.8) |
| Nasopharyngitis | 4 (6.1) | 3 (2.1) |
| Atopic Dermatitis | 3 (4.5) | 3 (2.1) |
| Dry eye | 0 | 3 (2.1) |
| TEAEs of clinical interest | ||
| Infectionsb | 9 (13.6) | 24 (16.6) |
| Potential opportunistic infectionsc,d | 0 | 3 (2.1) |
| Skin infections | 1 (1.5) | 2 (1.4) |
| Herpes infectione | 1 (1.5) | 5 (3.4) |
| Eosinophilia | 0 | 1 (0.7) |
| Eosinophil-related disorders | 0 | 0 |
| Injection site reactionsf | 1 (1.5) | 4 (2.8) |
Abbreviations: AE, adverse event; LEB, lebrikizumab; MedDRA, Medical Dictionary for Regulatory Activities; PBO, placebo; TCS, topical corticosteroid; TEAEs, treatment-emergent AEs.
a
Conjunctivitis single preferred term only.
b
Infections are defined using the MedDRA preferred terms from the Infections and Infestations System Organ Class.
c
Potential opportunistic infections, based on Winthrop et al.26
d
A blinded medical review was completed prior to database lock and all potential opportunistic infections were assessed as not opportunistic based on the Winthrop et al criteria.26
e
Herpes infections was defined using the MedDRA HLT herpes viral infection.
f
Injection site reaction was defined as MedDRA HLT injection site reactions.