De Stefano Renato, Frati Elena, De Quattro Davide, Menza Luana, Manganelli Stefania
Unit of Rheumatology, Azienda Ospedaliera Universitaria Senese, Siena, Italy,
Clin Rheumatol. 2014 May;33(5):707-11. doi: 10.1007/s10067-013-2372-6. Epub 2013 Sep 6.
We wanted to do a prospective open-label study to evaluate if ankylosing spondylitis (AS) patients in clinical remission with twice weekly etanercept (ETN) 25 mg therapy could be changed to weekly regimen or even to every other week regimen without increased dose for injection. Thirty-eight AS patients self-administered 25 mg of ETN (Wyett) subcutaneously. According to the protocol, patients who were in clinical partial remission with twice weekly ETN 25 mg at week 12 and 16 changed to a weekly regimen without a change of the dose. If clinical remission, despite the reduction of the dose, persists at week 24 and 28, patients changed to an every-other-week regimen, continuing with this administration schedule for the entire duration of the study if at week 36 and 46 clinical remission was maintained. At the end of the study, 18 patients (47 %) were still in remission, 4 (10 %) with a weekly regimen, and 14 (37 %) with an every-other-weekly regimen. Our study indicates that a consistent percentage of subjects with AS, treated with ETN 25 mg twice weekly, achieved clinical remission within the first 3 months of therapy, and also, a substantial percentage of these patients maintains the partial remission with an every other week regimen.
我们希望开展一项前瞻性开放标签研究,以评估临床缓解的强直性脊柱炎(AS)患者,在接受每周两次、每次25毫克依那西普(ETN)治疗时,能否在不增加注射剂量的情况下改为每周给药方案,甚至改为每两周给药方案。38例AS患者自行皮下注射25毫克ETN(惠氏公司生产)。根据方案,在第12周和第16周接受每周两次、每次25毫克ETN治疗且处于临床部分缓解的患者,改为每周给药方案,剂量不变。如果在第24周和第28周尽管剂量减少但仍保持临床缓解,患者改为每两周给药方案,若在第36周和第46周仍维持临床缓解,则在研究的整个期间继续采用该给药方案。研究结束时,18例患者(47%)仍处于缓解状态,其中4例(10%)采用每周给药方案,14例(37%)采用每两周给药方案。我们的研究表明,相当比例接受每周两次25毫克ETN治疗的AS患者在治疗的前3个月内实现了临床缓解,而且这些患者中有很大一部分通过每两周给药方案维持了部分缓解状态。