Why carry out this study?
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Adult patients with moderate-to-severe plaque psoriasis who have failed to respond to systemic therapies or phototherapies may respond to brodalumab, a treatment option that has been shown to be efficacious in this patient population. |
Because psoriasis is a chronic disease that requires long-term treatment, it is important to assess long-term data regarding common adverse events and events of special interest in a real-world setting, including suicidal ideation and behavior (which occurred in patients treated with brodalumab during pivotal trials, although no causal association was established). |
Focusing on the most common adverse events listed in the brodalumab package insert and adverse events of special interest, this analysis summarizes brodalumab pharmacovigilance data reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017, through August 14, 2019, to provide a clear safety profile of brodalumab. |
What was learned from the study?
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The most commonly reported adverse event was arthralgia, there were 46 serious infections and no serious fungal infections, and there were 13 reports of malignancies that occurred in 10 patients (none of which were deemed related to brodalumab); notably, there were no reports of suicide attempts or completed suicides. |
This 2-year US pharmacovigilance report supports the safety profile of brodalumab previously reported in long-term analyses of clinical trials and 1-year pharmacovigilance data and may assist healthcare providers when choosing the best treatment option for patients with psoriasis. |
Digital Features
Introduction
Methods
Results
Real-World Occurrence of AEs Listed in Prescribing Information
AE | Patients experiencing event, n (r)a | Event related to brodalumab, nb | Brodalumab discontinued, n (%)c | Brodalumab maintained, n (%)c | Action unknown or NA, n (%)c |
---|---|---|---|---|---|
Arthralgia | 73 (0.04) | 1 | 20 (27) | 30 (41) | 23 (32) |
Fatigue | 23 (0.01) | 1 | 4 (17) | 14 (61) | 5 (22) |
Diarrhea | 24 (0.01) | 0 | 4 (17) | 14 (58) | 6 (25) |
Injection-site reaction | 25 (0.02) | 0 | 1 (4) | 15 (60) | 9 (36) |
Headache | 28 (0.02) | 0 | 5 (18) | 18 (64)d | 5 (18) |
Myalgia | 21 (0.01) | 0 | 7 (33) | 10 (48) | 4 (19) |
Nausea | 19 (0.01) | 0 | 3 (16) | 13 (68) | 3 (16) |
Oropharyngeal pain | 14 (0.01) | 0 | 1 (7) | 8 (57)e | 5 (36) |
Influenza | 13 (0.01) | 0 | 4 (31) | 5 (38) | 4 (31) |
Neutropenia | 0 | 0 | – | – | – |
Tinea infection | 0 | 0 | – | – | – |