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.