MedWire News: The risk of serious adverse events (SAEs) for psoriasis patients taking tumour necrosis factor (TNF)-α inhibitors is relatively rare and comparable to people’s risk of dying in a car accident, researchers report.
Steven Feldman (Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA) and colleagues analysed published data to determine the number needed to treat and the number needed to harm for TNF-α therapy.
To make the statistics more meaningful, they compared the risk of SAEs with TNF-α therapy with that of death from driving a car.
The efficacy analysis was based on phase III, multi-centre, randomised, double-blind clinical trials that involved patients with moderate-to-severe psoriasis receiving treatment for 24 weeks.
The team calculated that only one to two patients with moderate-to-severe psoriasis would need to receive TNF-α inhibitors to see at least a 75% improvement in Psoriasis Area and Severity Index scores.
To calculate the number needed to harm, Feldman et al focused on the reported incidences of SAEs in Food and Drug Administration-approved prescribing information and from review articles describing integrated clinical trial databases. They also limited the adverse events to tuberculosis, lymphoma and demyelinating disease.
The researchers report in the British Journal of Dermatology that the number needed to harm with TNF-α therapy ranged from 380 to 360,000 patients.
They note that in the USA in 2005 there were 21 fatalities per 100,000 licensed drivers, giving a number needed to harm for driving of 4700 drivers.
“Patients are about as likely to die in a car accident as to have a serious adverse event from treatment with a TNF-α inhibitor,” Feldman and co-workers deduce.
Our study “offers a clinically relevant tool to allow physicians and their patients to effectively conceptualize and evaluate the benefits and risks of TNF-α inhibitors and to decide for themselves whether these drugs are the right choice for their psoriasis treatment strategy”, they conclude.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009
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