Inpharma 1473 - 5 Feb 2005 Etanercept no additional benefit in Wegener’s granulomatosis Patient’s with Wegener’s granulomatosis gain no additional benefit from treatment with etanercept in combination with standard therapy in terms of maintenance of remission, according to US-based researchers. In the multicentre WGET * study, 181 such patients were randomised to receive SC etanercept 25mg twice weekly (n = 89) or placebo, in addition to standard treatment for Wegener’s granulomatosis; the median durations of treatment were 25 and 19 months for the etanercept and placebo groups, respectively. Among the 174 evaluable patients, there was no significant difference between the etanercept and placebo groups with regard to the proportion of patients who achieved a sustained remission, defined as a remission lasting for ≥ 6 months (69.7% vs 75.3%); sustained remission was maintained in only 86 (49.4%) patients for the duration of the trial. 118 and 134 disease flares were observed in the etanercept and placebo groups, respectively. An increase in the mean Vasculitis Damage Index score from baseline to the end of the trial was observed in both groups. Both etanercept and placebo recipients experienced an improvement in quality of life as determined by the SF-36. ** There were no significant between-group differences with regard to the incidences of severe or life- threatening adverse events and death. * Wegener’s Granulomatosis Etanercept Trial ** Medical Outcomes Study 36-Item Short Form General Health Survey Wegener’s Granulomatosis Etanercept Trial (WGET) Research Group. Etanercept plus standard therapy for Wegener’s granulomatosis. New England Journal of Medicine 352: 351-361, No. 4, 27 Jan 2005 800996150 1 Inpharma 5 Feb 2005 No. 1473 1173-8324/10/1473-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Etanercept no additional benefit in Wegener's granulomatosis

Download PDF Report

View
215
Download
2

Embed Size (px)

Citation preview

Inpharma 1473 - 5 Feb 2005

Etanercept no additional benefit inWegener’s granulomatosis

Patient’s with Wegener’s granulomatosis gain noadditional benefit from treatment with etanercept incombination with standard therapy in terms ofmaintenance of remission, according to US-basedresearchers.

In the multicentre WGET* study, 181 such patientswere randomised to receive SC etanercept 25mg twiceweekly (n = 89) or placebo, in addition to standardtreatment for Wegener’s granulomatosis; the mediandurations of treatment were 25 and 19 months for theetanercept and placebo groups, respectively.

Among the 174 evaluable patients, there was nosignificant difference between the etanercept andplacebo groups with regard to the proportion of patientswho achieved a sustained remission, defined as aremission lasting for ≥ 6 months (69.7% vs 75.3%);sustained remission was maintained in only 86 (49.4%)patients for the duration of the trial. 118 and 134 diseaseflares were observed in the etanercept and placebogroups, respectively.

An increase in the mean Vasculitis Damage Indexscore from baseline to the end of the trial was observedin both groups. Both etanercept and placebo recipientsexperienced an improvement in quality of life asdetermined by the SF-36.**

There were no significant between-group differenceswith regard to the incidences of severe or life-threatening adverse events and death.* Wegener’s Granulomatosis Etanercept Trial** Medical Outcomes Study 36-Item Short Form General HealthSurvey

Wegener’s Granulomatosis Etanercept Trial (WGET) Research Group. Etanerceptplus standard therapy for Wegener’s granulomatosis. New England Journal ofMedicine 352: 351-361, No. 4, 27 Jan 2005 800996150