Comprehensive long-term safety of adalimumab from 18 clinical trials in adult patients with moderate-to-severe plaque psoriasis

The British Journal of Dermatology
Craig LeonardiW C Valdecantos

Abstract

Adalimumab (Humira® , AbbVie Inc., North Chicago, IL, U.S.A.) is a fully human monoclonal antibody specific for tumour necrosis factor-α that is approved to treat adults with moderate-to-severe chronic plaque psoriasis. To assess long-term safety for patients with psoriasis receiving adalimumab in clinical studies. Adalimumab safety data from adults with psoriasis who received at least one 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 the last dose or cut-off date (31 December 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. Cumulative exposure was 5429·7 PYs in 3727 patients. Overall, there were 16 536 AEs (304·6 E/100 PYs). The 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 ma...Continue Reading

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Citations

Jan 4, 2019·The British Journal of Dermatology·C Ryan
Dec 25, 2019·Expert Opinion on Drug Safety·Lluís Puig
Oct 1, 2019·Journal of the European Academy of Dermatology and Venereology : JEADV·A Svedbom, M Ståhle
Apr 14, 2020·Expert Review of Clinical Immunology·Nikolai Dyrberg LoftLone Skov
Apr 17, 2021·American Journal of Clinical Dermatology·Akshitha ThatiparthiJashin J Wu
Aug 17, 2021·Journal of Cutaneous Medicine and Surgery·Amy Semaka, Thomas G Salopek

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