赛妥珠单抗聚乙二醇化制剂治疗中轴型脊柱关节炎的持续疗效、安全性及患者报告结局：RAPID-axSpA研究的4年结果
Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA.
作者信息
van der Heijde Désirée, Dougados Maxime, Landewé Robert, Sieper Joachim, Maksymowych Walter P, Rudwaleit Martin, Van den Bosch Filip, Braun Jürgen, Mease Philip J, Kivitz Alan J, Walsh Jessica, Davies Owen, Bauer Lars, Hoepken Bengt, Peterson Luke, Deodhar Atul
机构信息
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
Department of Rheumatology, Cochin Hospital, Paris, France.
出版信息
Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.
OBJECTIVE
The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA.
METHODS
RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported.
RESULTS
Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received certolizumab pegol from week 0. Of these, 65% remained in the study at week 204 (AS: 67%; nr-axSpA: 63%). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1% (non-responder imputation); 83.7% (observed case, OC); ASAS40: 44.0% (non-responder imputation); 68.1% (OC); ASDAS inactive disease: 32.1% (last observation carried forward); 31.4% (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported.
CONCLUSION
In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals.
TRIAL REGISTRATION
ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.
目的
旨在评估聚乙二醇化赛妥珠单抗在中轴型脊柱关节炎（axSpA，包括强直性脊柱炎（AS）和非放射学中轴型脊柱关节炎（nr-axSpA））患者中连续治疗4年的长期安全性和疗效。
方法
RAPID-axSpA是一项3期随机试验，双盲，安慰剂对照至第24周，剂量盲法至第48周，开放标签至第204周。患者有axSpA的临床诊断，符合国际脊柱关节炎协会（ASAS）标准，且患有活动性疾病。评估的结果包括ASAS20、ASAS40、强直性脊柱炎疾病活动度评分（ASDAS）、巴斯强直性脊柱炎疾病活动指数（BASDAI）、巴斯强直性脊柱炎功能指数（BASFI）和巴斯强直性脊柱炎测量指数（BASMI）评分，以及选定的缓解指标。还报告了更多患者报告的结果、外周关节炎、附着点炎、葡萄膜炎和生活质量指标。
结果
325例随机分组的患者中，218例（AS：121例；nr-axSpA：97例）从第0周开始接受聚乙二醇化赛妥珠单抗治疗。其中，65%在第204周仍留在研究中（AS：67%；nr-axSpA：63%）。在所有结果中，对于AS和nr-axSpA，至第204周均观察到持续改善[第204周总体axSpA：ASAS20：54.1%（非应答者推算）；83.7%（观察病例，OC）；ASAS40：44.0%（非应答者推算）；68.1%（OC）；ASDAS非活动疾病：32.1%（末次观察结转）；31.4%（OC）]。在安全性数据集（n = 315）中，每100患者年有292.8次不良事件和10.4次严重不良事件。未报告死亡病例。
结论
在第一项评估抗TNF药物对两个axSpA亚组疗效的研究中，24周和96周时临床和患者报告结果的改善在4年治疗期间持续存在，且无新的安全信号。
试验注册
ClinicalTrials.gov，http://clinicaltrials.gov，NCT01087762 。
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