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

Adalimumab is a powerful drug used to treat psoriasis, that has been specially designed to mimic normal human molecules, and for this reason it is classed as a ‘biological’ drug. It reduces inflammation by inhibiting the activity of a chemical ‘cytokine’ in the body called ‘tumour necrosis factor alpha’ (TNF-alpha). The aim of this study, from the USA, was to assess long-term safety for patients with psoriasis receiving adalimumab. The authors looked at data from 3727 patients receiving the drug as part of 18 different clinical trials in which adverse events (AEs, meaning unwanted side effects while on the drug) were recorded. Overall, there were 16,536 AEs during 5429.7 patient years (304.6 AEs for every 100 patient years). Patient years (PYs) means the number of patients, multiplied by the amount of time they were included in the study. Most common AEs were nasopharyngitis (a common throat complaint), upper respiratory infection, and headache (23.7, 12.9, and 7.9 AEs per 100 PYs, respectively). Incidence rates for serious infections, tuberculosis, and opportunistic infections were 1.8, 0.3, and 0.02 AEs per 100 PYs, respectively. Incidence of malignancy (cancer) excluding non-melanoma skin cancer (NMSC) was 0.8 AEs per 100 PYs. Incidences of NMSC and melanoma were 0.6 and 0.2 AEs per 100 PYs, respectively. The authors conclude that AE rates remained stable in this analysis of patients with psoriasis receiving adalimumab; no new safety signals (such as increased AEs) were identified compared with earlier studies.