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. 2021 Jul 31;4:67–69. doi: 10.1016/j.jdin.2021.06.001

Table I.

Reported adverse events and dupilumab discontinuation based on follow-up time

Variable Follow-up periods
0-16 weeks (N = 145) 16-52 weeks (N = 143) 52-104 weeks (N = 139)
One or more adverse event, n (%) 64 (44) 48 (34) 31 (22)
Reported adverse events, n (%)
 Ocular surface disease 45 (31) 36 (25) 18 (13)
 Infections 8 (6) 3 (2) 4 (3)
 Oral herpes 6 (4) 1 (1) 2 (1)
 Cellulitis 2 (1) 1 (1) 1 (1)
 Cystitis 1 (1) 1 (1) 0
 Flu-like symptoms 1 (1) 2 (1) 0
 Upper respiratory tract infection 0 0 1 (1)
 Skin disorders
 Injection site reaction 6 (4) 2 (1) 2 (1)
 Head and neck eczema flare or redness 2 (1) 4 (3) 7 (5)
 Urticaria 1 (1) 2 (1) 2 (1)
 Asthma flare 1 (1) 0 0
 Musculoskeletal
 Fatigue 1 (1) 0 0
 Arthralgia 2 (1) 3 (2) 0
 Headache 0 0 0
 Gastrointestinal symptoms 4 (3) 2 (1) 0
 Generalized nonspecific symptoms 4 (3) 2 (1) 0
Dupilumab discontinuation, n (%) 5 (3) 20 (14) 9 (6)
 Secondary to adverse event 4 (3) 6 (4) 4 (3)
 Due to lack of efficacy 1 (1) 12 (8) 1 (1)
 Non–drug-related reason 0 2 (1) 4 (3)

n, Number of subjects meeting criteria.

Nonspecific symptoms include episodes of dizziness, lightheadedness, blurred vision, and/or sweating.

Patients who discontinued dupilumab due to an adverse event or lack of efficacy were carried forward and included as Investigator Global Assessment nonresponders for each timepoint. Discontinuation due to non–drug-related reasons was excluded from Investigator Global Assessment analysis.

Non–drug-related reasons include pregnancy, travel, and loss of insurance drug coverage.