Table 2.
Overview of AEs through Week 52 in the safety population. Data are presented as n (%)
| Safety events | LEB 250 mg Q2W (N = 206) n (%) |
|---|---|
| TEAEs | 134 (65.0) |
| Mild | 69 (33.5) |
| Moderate | 61 (29.6) |
| Severe | 4 (1.9) |
| SAEs | 5 (2.4) |
| Atopic dermatitis | 1 (0.5) |
| Bile duct stone | 1 (0.5) |
| Cardiac arresta | 1 (0.5) |
| Conjunctivitis allergicb | 1 (0.5) |
| Multiple injuriesc | 1 (0.5) |
| Testicular torsiond | 1 (1.0) |
| Deatha | 1 (0.5) |
| AEs leading to treatment discontinuation | 5 (2.4) |
| Cardiac arresta | 1 (0.5) |
| Conjunctivitis allergicb | 1 (0.5) |
| Cutaneous T-cell lymphoma | 1 (0.5) |
| Hemolytic anemia | 1 (0.5) |
| Injection site pain | 1 (0.5) |
| TEAEs reported in ≥ 2% of patientse | |
| Atopic dermatitis | 27 (13.1) |
| Nasopharyngitis | 20 (9.7) |
| COVID-19 | 18 (8.7) |
| Upper respiratory tract infection | 13 (6.3) |
| Headache | 12 (5.8) |
| Oral herpes | 11 (5.3) |
| Conjunctivitis | 10 (4.9) |
| Eosinophilia | 8 (3.9) |
| Acne | 7 (3.4) |
| Cough | 7 (3.4) |
| Diarrhea | 6 (2.9) |
| Urticaria | 6 (2.9) |
| Herpes dermatitis | 5 (2.4) |
| Pruritus | 5 (2.4) |
| Nausea | 5 (2.4) |
| AEs of clinical interest | |
| Conjunctivitis clusterf | 14 (6.8) |
| Conjunctivitis | 10 (4.9) |
| Conjunctivitis allergic | 4 (1.9) |
| Conjunctivitis bacterial | 1 (0.5) |
| Keratitis clusterg | 1 (0.5) |
| Atopic keratoconjunctivitis | 1 (0.5) |
| Injection site reactionsh | 5 (2.4) |
| Overall infections | 74 (35.9) |
| Skin infections | 5 (2.4) |
| Herpes infectioni | 15 (7.3) |
| Zoster infections | 0 (0) |
| Parasitic infections | 0 (0) |
| Potential opportunistic infectionsj | 4 (1.9) |
| Confirmed opportunistic infections | 0 (0) |
| Eosinophiliak | 8 (3.9) |
| Eosinophil-related disorders | 0 (0) |
| Anaphylaxis | 0 (0) |
| Malignancyl | 1 (0.5) |
| NMSC | 0 (0) |
| Non-NMSC | 1 (0.5) |
Abbreviations: AE adverse event, LEB lebrikizumab, MedDRA Medical Dictionary for Regulatory Activities, N number of patients in the analysis population, n number of patients in the specified category, NMCS non-melanoma skin cancer, PT preferred term, Q2W every 2 weeks, SAE serious adverse event, TEAE treatment-emergent adverse event
aSAEs and AEs leading to treatment discontinuation are inclusive of death. Death was a single patient with cardiac arrest that was fatal, serious, and led to discontinuation. Hospital records noted cardiac arrest and COVID-19 as cause of death, and the death was assessed by investigator as related to COVID-19 and not to the study drug
bConjunctivitis allergic event led to treatment discontinuation
cMultiple injuries after falling from a bicycle
dDenominator-adjusted because of gender-specific event for males: N = 98
eTEAEs are defined using the MedDRA preferred terms
fConjunctivitis cluster includes the following preferred terms: conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial, conjunctivitis viral, and giant papillary conjunctivitis
gKeratitis cluster includes the following preferred terms: keratitis, atopic keratoconjunctivitis, allergic keratitis, ulcerative keratitis, and vernal keratoconjunctivitis
hInjection site reactions were defined as MedDRA based on high level term Injection Site Reactions
iHerpes infections were defined using MedDRA high-level term Herpes Viral Infections. No herpes zoster was reported
jAll infections were non-serious and all potential opportunistic infections were medically reviewed prior to database lock and were assessed as not opportunistic based on the Winthrop criteria [20]
kEosinophilia was reported as an AE by the investigator
lMalignancy event was a suspected case of cutaneous T-cell lymphoma