OBJECTIVE: To assess the safety and efficacy of etanercept 50 mg administered twice weekly versus 25 mg administered twice weekly as monotherapy in patients with tumor necrosis factor-alpha (TNF-alpha) blocker-naäve active rheumatoid arthritis (RA). METHODS:Seventy-seven patients with RA were randomized in an unequal allocation (2:1) in a blinded fashion to receive either 50 mg (51 patients) or 25 mg (26 patients) of etanercept twice a week for 24 weeks. RESULTS: The primary outcome measure, the ACR-N AUC at 24 weeks, showed no difference between the 2 dose groups. In addition, there was no difference in ACR 20, 50, and 70 responses or in EULAR response criteria by Week 24. There were no statistically significant differences between the 2 groups in the proportion of patients with any non-infectious adverse event. The proportion of patients with upper respiratory tract infections was significantly higher in patients receiving 50 mg etanercept compared with those receiving 25 mg (26% vs 4%, p = 0.027). CONCLUSION:Etanercept as a monotherapy at 50 mg twice weekly does not provide increased efficacy when compared to the standard dose of 25 mg twice weekly in TNF-alpha blocker-naäve patients.
RCT Entities:
OBJECTIVE: To assess the safety and efficacy of etanercept 50 mg administered twice weekly versus 25 mg administered twice weekly as monotherapy in patients with tumor necrosis factor-alpha (TNF-alpha) blocker-naäve active rheumatoid arthritis (RA). METHODS: Seventy-seven patients with RA were randomized in an unequal allocation (2:1) in a blinded fashion to receive either 50 mg (51 patients) or 25 mg (26 patients) of etanercept twice a week for 24 weeks. RESULTS: The primary outcome measure, the ACR-N AUC at 24 weeks, showed no difference between the 2 dose groups. In addition, there was no difference in ACR 20, 50, and 70 responses or in EULAR response criteria by Week 24. There were no statistically significant differences between the 2 groups in the proportion of patients with any non-infectious adverse event. The proportion of patients with upper respiratory tract infections was significantly higher in patients receiving 50 mg etanercept compared with those receiving 25 mg (26% vs 4%, p = 0.027). CONCLUSION: Etanercept as a monotherapy at 50 mg twice weekly does not provide increased efficacy when compared to the standard dose of 25 mg twice weekly in TNF-alpha blocker-naäve patients.
Authors: D E Furst; F C Breedveld; J R Kalden; J S Smolen; G R Burmester; J Sieper; P Emery; E C Keystone; M H Schiff; P Mease; P L C M van Riel; R Fleischmann; M H Weisman; M E Weinblatt Journal: Ann Rheum Dis Date: 2007-11 Impact factor: 19.103
Authors: K A Kimmerling; B D Furman; D S Mangiapani; M A Moverman; S M Sinclair; J L Huebner; A Chilkoti; V B Kraus; L A Setton; F Guilak; S A Olson Journal: Eur Cell Mater Date: 2015-01-31 Impact factor: 3.942
Authors: Jasvinder A Singh; Alomgir Hossain; Amy S Mudano; Elizabeth Tanjong Ghogomu; Maria E Suarez-Almazor; Rachelle Buchbinder; Lara J Maxwell; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2017-05-08
Authors: Jasvinder A Singh; Alomgir Hossain; Elizabeth Tanjong Ghogomu; Ahmed Kotb; Robin Christensen; Amy S Mudano; Lara J Maxwell; Nipam P Shah; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2016-05-13
Authors: Jasvinder A Singh; George A Wells; Robin Christensen; Elizabeth Tanjong Ghogomu; Lara Maxwell; John K Macdonald; Graziella Filippini; Nicole Skoetz; Damian Francis; Luciane C Lopes; Gordon H Guyatt; Jochen Schmitt; Loredana La Mantia; Tobias Weberschock; Juliana F Roos; Hendrik Siebert; Sarah Hershan; Michael Pt Lunn; Peter Tugwell; Rachelle Buchbinder Journal: Cochrane Database Syst Rev Date: 2011-02-16
Authors: Jasvinder A Singh; Alomgir Hossain; Elizabeth Tanjong Ghogomu; Amy S Mudano; Lara J Maxwell; Rachelle Buchbinder; Maria Angeles Lopez-Olivo; Maria E Suarez-Almazor; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2017-03-10