Yates Max, Hamilton Louise E, Elender Frances, Dean Loretta, Doll Helen, MacGregor Alex J, Thomas Joegi, Gaffney Karl
From the Department of Rheumatology, Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust; Norwich Medical School, University of East Anglia, Norwich; ICON Commercialisation and Outcomes, Oxford; James Paget University Hospital, Gorleston, UK.M. Yates, BSc(Hons), MBBS, MSc, MRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; L.E. Hamilton, BM BCh, MD, MRCP; F. Elender, BSc, PhD; L. Dean, PGDip, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust; H. Doll, MSc, DPhil, Norwich Medical School, University of East Anglia, and ICON Commercialisation and Outcomes; A.J. MacGregor, MBBS, MD, PhD, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust, and Norwich Medical School, University of East Anglia; J. Thomas, MBBS, MD, FRCP, James Paget University Hospital; K. Gaffney, MB ChB, BAO(Hons), FEGEMS, FRCPI, FRCP, Rheumatology, Norfolk and Norwich University Hospital NHS Foundation Trust.
J Rheumatol. 2015 Jul;42(7):1177-85. doi: 10.3899/jrheum.141335. Epub 2015 Jun 1.
To investigate, in a pilot randomized controlled trial, whether etanercept (ETN) 25 mg once weekly is effective at maintaining a clinical response in patients with ankylosing spondylitis (AS) who have responded to the standard 50 mg dose.
Adults with AS not responding to conventional therapies were prescribed ETN 50 mg once weekly for 6 months. Responders as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were randomly assigned to taper to 25 mg once weekly or continue on 50 mg and followed for a further 6 months. The primary outcome measure was maintenance of a 50% reduction in the BASDAI or fall in BASDAI by ≥ 2 units and a ≥ 2-unit reduction in BASDAI spinal pain as measured on a 10-point visual analog scale at 6 months postrandomization.
Of 89 patients assessed for eligibility, 59 were enrolled; 47 (80%) had sufficient clinical response and were eligible for randomization, 24 were assigned to continue receiving ETN 50 mg, and 23 to taper to 25 mg. After 6 months, 20 (83%) of the 50 mg arm maintained clinical response compared with 12 (52%) of the 25 mg arm (a difference of -31%, 95% CI -58% - -5%).
Although this pilot study demonstrates that treatment with ETN 25 mg was less effective at maintaining treatment response in the stepdown phase, 52% of participants maintained treatment response. Future research should address which patients are suitable for tapering.
在一项初步随机对照试验中，研究对于已对标准50mg剂量有反应的强直性脊柱炎（AS）患者，每周一次注射25mg依那西普（ETN）在维持临床反应方面是否有效。
对常规治疗无反应的成年AS患者，给予每周一次50mg ETN治疗，持续6个月。根据巴斯强直性脊柱炎疾病活动指数（BASDAI）定义的有反应者，被随机分配至逐渐减量至每周一次25mg或继续使用50mg，并随访6个月。主要结局指标为随机分组后6个月时，BASDAI降低50%或BASDAI下降≥2个单位，且在10分视觉模拟量表上测量的BASDAI脊柱疼痛降低≥2个单位。
在89例评估合格的患者中，59例入组；47例（80%）有足够的临床反应且符合随机分组条件，24例被分配继续接受50mg ETN治疗，23例逐渐减量至25mg。6个月后，50mg组20例（83%）维持临床反应，而25mg组为12例（52%）（差异为-31%，95%CI -58% - -5%）。
尽管这项初步研究表明，在减量阶段使用25mg ETN维持治疗反应的效果较差，但52%的参与者维持了治疗反应。未来的研究应探讨哪些患者适合减量。
