| Autor: |
Leonardi, C, Papp, K, Strober, B, Thaçi, D, Warren, R B, Tyring, S, Arikan, D, Karunaratne, M, Valdecantos, W C |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Zdroj: |
Leonardi, C, Papp, K, Strober, B, Thaçi, D, Warren, R B, Tyring, S, Arikan, D, Karunaratne, M & Valdecantos, W C 2019, ' Comprehensive Long-Term Safety of Adalimumab from Eighteen Clinical Trials in Adult Patients With Moderate to Severe Plaque Psoriasis ', The British journal of dermatology, vol. 180, no. 1, pp. 76-85 . https://doi.org/10.1111/bjd.17084 |
| Popis: |
BACKGROUND: Adalimumab (Humira® ; AbbVie Inc., USA) is a fully human monoclonal antibody specific for tumour necrosis factor-α approved to treat adults with moderate-to-severe chronic plaque psoriasis.OBJECTIVE: To assess long-term safety for patients with psoriasis receiving adalimumab in clinical studies METHODS: Adalimumab safety data from adults with psoriasis who received ≥1 adalimumab dose in 18 clinical trials were evaluated. Adalimumab was delivered subcutaneously in all treatment regimens. Treatment-emergent adverse events (AEs) were collected from the first dose to 70 days after last dose or cutoff date (December 31, 2015). AE incidence rates were expressed as events per 100 patient-years (E/100 PYs) of adalimumab exposure. Standardized incidence ratios (SIRs) for malignancies and standardized mortality ratios (SMRs) were calculated.RESULTS: Cumulative exposure was 5429.7 PYs in 3727 patients. Overall, there were 16,536 AEs (304.6 E/100 PYs). Most common AEs were nasopharyngitis, upper respiratory infection, and headache (23.7, 12.9, and 7.9 E/100 PYs, respectively). Incidence rates for serious infections, tuberculosis, and opportunistic infections were 1.8, 0.3, and 0.02 E/100 PYs, respectively. Incidence of malignancy excluding non-melanoma skin cancer (NMSC) was 0.8 E/100 PYs (SIR=0.86; 95% CI, 0.58-1.23). Incidences of NMSC and melanoma were 0.6 and 0.2 E/100 PYs, respectively. SIR was 1.55 (95% CI, 1.10-2.13) for NMSC and 3.04 (95% CI, 1.11-6.62) for melanoma. SMR was 0.34 (95% CI, 0.16-0.65).CONCLUSIONS: AE rates remained stable in this analysis of patients with psoriasis receiving adalimumab; no new safety signals were identified compared with earlier analyses. This article is protected by copyright. All rights reserved. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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