MedWire News: Pooled results from four studies show that etanercept is an effective treatment for psoriasis for up to 4 years, with low rates of serious adverse events.
Previous research has shown etanercept is well-tolerated and effective for up to 2.5 years in patients with moderate to severe plaque psoriasis, but not beyond.
Kim Papp (Probity Medical Research, Waterloo, Ontario, Canada) and colleagues analyzed data for a total of 506 participants of two trials and two open-label extension studies who received etanercept 25 mg twice weekly, 50 mg weekly, or 50 mg twice weekly for between 12 and 24 months.
The mean age of participants was 46 years at study entry, and 67% were men. Effectiveness of treatment was based on changes from baseline in the static Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), and safety was measured as exposure-adjusted rates of adverse events including infections, malignancies, and cardiovascular events.
A total of 449, 398, 144, and 108 patients received at least 12, 24, 36, and 48 months of treatment.
At baseline, the median DLQI and PGA scores were 11.1 (where 30=maximal impairment) and 3.2 (where 0="clear" for psoriasis), and by month 3 of follow-up 74.3% and 45.3% of participants classed as DLQI responders (based on a 5-point improvement or a score of 0) were "clear" or "almost clear" on the PGA, respectively.
By month 48 of follow-up, these figures were 75.9% and 27.8%, respectively.
The exposure-adjusted rates for all adverse events and serious adverse events were 243.5 and 7.8 per 100 patient-years of treatment taken, and Papp et al report a decrease in all adverse events for every additional year of etanercept treatment.
No serious adverse events (such as myocardial infarction and basal cell carcinoma) occurred at a rate greater than 1.0 per 100 patient-years of exposure, remarks the team in the Journal of the American Academy of Dermatology.
Overall, 12 serious infections occurred in nine patients, and 19 malignancies were reported including 7 nonskin malignancies and 12 nonmelanoma skin cancers. All cardiovascular and serious cardiovascular events occurred at a rate of 2.8 and 1.7 events per 10 patient-years.
"In general, etanercept therapy was well tolerated over the 48-month period, with no evidence of cumulative toxicity," conclude the researchers.
"There was no increase in adverse events, serious adverse events, infectious adverse events, or serious infections, malignancies, and cardiovascular events over time," they add.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
Free abstract
