3种附着点炎指数在阿达木单抗治疗外周型脊柱关节炎患者中的表现
Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab.
作者信息
Mease Philip J, Van den Bosch Filip, Sieper Joachim, Xia Yinglin, Pangan Aileen L, Song In-Ho
机构信息
From Rheumatology Research, Swedish Medical Center, and University of Washington School of Medicine, Seattle, Washington; Department of Medicine, University of Illinois at Chicago; Immunology Clinical Development, AbbVie Inc., Chicago, Illinois, USA; Department of Rheumatology, Ghent University Hospital, Ghent, Belgium; Department of Medicine I, Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany.
P.J. Mease has received research grants and consulting fees from Amgen, Lilly, Novartis, and Pfizer. F. Van den Bosch has received consultancy and/or speaker fees from Janssen, Novartis, and UCB.
出版信息
J Rheumatol. 2017 May;44(5):599-608. doi: 10.3899/jrheum.160387. Epub 2017 Mar 15.
OBJECTIVE
To evaluate the validity of enthesitis indices in patients with peripheral spondyloarthritis (pSpA).
METHODS
The ABILITY-2 study evaluated the efficacy of adalimumab (ADA) versus placebo (PBO) in patients with active pSpA over 12 weeks. Patients received open-label ADA for an additional 144 weeks. Twenty-nine enthesitis sites used in 3 enthesitis scoring systems [Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index, Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)] were assessed; discriminatory capacity and treatment response at Week 12 were calculated by standardized mean difference (SMD) and Guyatt's effect size (ES). Sites showing resolution or new-onset enthesitis from baseline to Week 12 were analyzed.
RESULTS
Overall, 165 patients (ADA, n = 84; PBO, n = 81) were randomized; 143 had ≥ 1 enthesitis site at baseline. The LEI (SMD -0.73, ES -1.07) and SPARCC (SMD -0.56, ES -0.99) enthesitis indices showed higher discriminatory ability and treatment response than MASES (SMD -0.32, ES -0.81). At Week 12, among sites that were positive at baseline, significantly more (p < 0.05) showed resolution among patients treated with ADA versus PBO in the Achilles tendon (60.4% and 36.5%, respectively), medial epicondyle (73.2%, 48.7%), lateral epicondyle (80.6%, 52.8%), and iliac crest (73.5%, 47.2%). Among negative sites at baseline, significantly less (p < 0.05) new-onset enthesitis was observed with ADA versus PBO for Achilles tendon (3.6% and 10.9%, respectively), greater trochanter (3.4%, 14.4%), lateral epicondyle humerus (4.7%, 15.1%), medial femoral condyle (1.6%, 9.2%), and quadriceps insertion superior patella (1.5%, 7.0%).
CONCLUSION
The LEI and SPARCC enthesitis indices showed better discriminatory capacity and treatment response in patients with pSpA versus MASES, likely because these indices contain more peripheral sites.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov NCT01064856.
目的
评估附着点炎指数在周围型脊柱关节炎（pSpA）患者中的有效性。
方法
ABILITY-2研究评估了阿达木单抗（ADA）与安慰剂（PBO）在活动性pSpA患者中治疗12周的疗效。患者随后接受了144周的开放标签ADA治疗。对3种附着点炎评分系统[利兹附着点炎指数（LEI）、加拿大脊柱关节炎研究联盟（SPARCC）附着点炎指数、马斯特里赫特强直性脊柱炎附着点炎评分（MASES）]中使用的29个附着点部位进行了评估；通过标准化平均差（SMD）和盖亚特效应量（ES）计算第12周时的鉴别能力和治疗反应。分析了从基线到第12周出现附着点炎消退或新发附着点炎的部位。
结果
总体而言，165例患者（ADA组84例，PBO组81例）被随机分组；143例患者在基线时有≥1个附着点部位。LEI（SMD -0.73，ES -1.07）和SPARCC（SMD -0.56，ES -0.99）附着点炎指数显示出比MASES（SMD -0.32，ES -0.81）更高的鉴别能力和治疗反应。在第12周时，在基线时呈阳性的部位中，接受ADA治疗的患者与接受PBO治疗的患者相比，跟腱（分别为60.4%和36.5%）、内上髁（73.2%，48.7%）、外上髁（80.6%，52.8%）和髂嵴（73.5%，47.2%）处出现消退的患者显著更多（p < 0.05）。在基线时为阴性的部位中，与PBO相比，ADA治疗的患者在跟腱（分别为3.6%和10.9%）、大转子（3.4%，14.4%）、肱骨外上髁（4.7%，15.1%）、股骨内侧髁（1.6%，9.2%）和股四头肌髌骨上附着点（1.5%，7.0%）处出现新发附着点炎的情况显著更少（p < 0.05）。
结论
与MASES相比，LEI和SPARCC附着点炎指数在pSpA患者中显示出更好的鉴别能力和治疗反应，可能是因为这些指数包含更多的外周部位。
试验注册号
ClinicalTrials.gov NCT01064856。
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