Deodhar Atul, Braun Jürgen, Inman Robert D, van der Heijde Désirée, Zhou Yiying, Xu Stephen, Han Chenglong, Hsu Benjamin
Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.
Department of Rheumatology, Rheumazentrum Ruhrgebiet, Herne, Germany.
Ann Rheum Dis. 2015 Apr;74(4):757-61. doi: 10.1136/annrheumdis-2014-205862. Epub 2014 Nov 11.
Assess golimumab efficacy/safety through 5 years in patients with active ankylosing spondylitis (AS).
356 patients with AS were randomly assigned to placebo, golimumab 50 mg or 100 mg every 4 weeks. At week 16, patients with inadequate response early escaped with blinded dose adjustments (placebo to 50 mg, 50 mg to 100 mg). At week 24, all patients receiving placebo crossed over to 50 mg. Blinded active therapy continued through week 104; from week 104 to week 252, the golimumab dose could be adjusted. Intent-to-treat and observed efficacy data were assessed by randomised treatment groups.
At week 256, and with >4.5 years of golimumab, overall intent-to-treat Assessment in SpondyloArthritis international Society criteria for 20% improvement (ASAS20) and ASAS40 response rates were 66.0% (235/356) and 57.0% (203/356), respectively; Bath AS Disease Activity Index 50% improvement response was 55.9% (199/356). Observed response rates among the 255 (72%) patients who continued golimumab through week 252 were consistent, albeit somewhat higher. Among patients who increased golimumab from 50 to 100 mg, 60.6% (20/33) and 44.7% (17/38) achieved ASAS20/ASAS40 responses, respectively, following ≥2 consecutive doses of golimumab 100 mg. Golimumab safety through week 268 was similar to that through week 24 regardless of dose.
Clinical improvements observed in patients treated with golimumab through week 24 were sustained through week 256 (5 years). Long-term golimumab safety is consistent with that of other established tumour-necrosis-factor-antagonists.
ClinicalTrials.gov: NCT00265083.
评估戈利木单抗治疗活动性强直性脊柱炎（AS）患者5年的疗效和安全性。
356例AS患者被随机分配至安慰剂组、每4周注射50mg戈利木单抗组或每4周注射100mg戈利木单抗组。在第16周时，早期反应不佳的患者通过盲法调整剂量（安慰剂组调整为50mg，50mg组调整为100mg）。在第24周时，所有接受安慰剂治疗的患者交叉至50mg组。盲法积极治疗持续至第104周；从第104周到第252周，戈利木单抗剂量可进行调整。意向性治疗和观察到的疗效数据通过随机治疗组进行评估。
在第256周时，使用戈利木单抗超过4.5年，总体意向性治疗中，根据国际脊柱关节炎协会标准达到20%改善（ASAS20）和ASAS40反应率分别为66.0%（235/356）和57.0%（203/356）；巴斯强直性脊柱炎疾病活动指数改善50%的反应率为55.9%（199/356）。在第252周继续使用戈利木单抗的255例（72%）患者中观察到的反应率是一致的，尽管略高。在将戈利木单抗从50mg增加至100mg的患者中，在连续≥2剂100mg戈利木单抗治疗后，分别有60.6%（20/33）和44.7%（17/38）达到ASAS20/ASAS40反应。至第268周，戈利木单抗的安全性与至第24周时相似，与剂量无关。
在第24周接受戈利木单抗治疗的患者中观察到的临床改善持续至第256周（5年）。戈利木单抗的长期安全性与其他已确立的肿瘤坏死因子拮抗剂一致。
ClinicalTrials.gov：NCT00265083。
