Seven Sengul, Pedersen Susanne Juhl, Østergaard Mikkel, Felbo Sara Kamp, Sørensen Inge Juul, Døhn Uffe Møller, Terslev Lene
Copenhagen Center for Arthritis Research and Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Front Med (Lausanne). 2020 Jul 15;7:341. doi: 10.3389/fmed.2020.00341. eCollection 2020.
To investigate the anatomical distribution, morphological abnormalities and response to adalimumab therapy of ultrasound(US)-detected peripheral enthesitis in patients with axial spondyloarthritis (SpA). In a randomized, placebo-controlled, double-blinded, investigator-initiated trial (NCT01029847), patients with axial SpA according to the Assessment of Spondyloarthritis International Society criteria were randomized to subcutaneous adalimumab 40 mg every other week or placebo from baseline to week 6. From week 6 to 24, all patients received adalimumab 40 mg every other week. Of 49 patients enrolled, 21 patients participated in our observational US sub-study. US assessment applying the OMERACT US definitions for enthesitis of 10 peripheral entheseal regions of the upper and lower extremities and clinical examination were performed at baseline, weeks 6 and 24. US was performed by one experienced investigator. Hypo-echogenicity, increased thickness and Doppler activity of the enthesis were considered signs of active inflammation, whereas insertional bone erosions, intratendinous calcifications, and enthesophytes were regarded as signs of structural lesions. Enthesitis on US was mostly present in the lower limbs, especially in the Achilles tendon (81%), the quadriceps tendon (62%), and the greater femoral trochanter (52%). Structural lesions were predominant (38 vs. 12% of examined entheses with inflammatory changes), particularly in the entheses of the lower limbs, and exhibited no change during treatment. US-detected structural lesions were common while inflammatory lesions were relatively rare in patients initiating adalimumab due to axial SpA. Structural lesions did not appear to change during 24 weeks follow-up, suggesting that these lesions may not be helpful outcome measures in short-term clinical trials.
研究轴性脊柱关节炎(SpA)患者中超声(US)检测到的外周附着点炎的解剖分布、形态学异常及对阿达木单抗治疗的反应。在一项由研究者发起的随机、安慰剂对照、双盲试验(NCT01029847)中,根据国际脊柱关节炎评估协会标准诊断为轴性SpA的患者从基线至第6周被随机分为皮下注射阿达木单抗40mg,每两周一次或安慰剂组。从第6周至24周,所有患者均接受皮下注射阿达木单抗40mg,每两周一次。在49名入组患者中,21名患者参与了我们的超声观察亚研究。在基线、第6周和第24周,采用OMERACT超声定义对上下肢10个外周附着点区域进行超声评估及临床检查。超声检查由一名经验丰富的研究者进行。低回声、附着点厚度增加及多普勒活动被视为活动性炎症的征象,而附着点处骨质侵蚀、肌腱内钙化及附着点骨赘则被视为结构损伤的征象。超声检查发现附着点炎多位于下肢,尤其是跟腱(81%)、股四头肌肌腱(62%)和股骨大转子(52%)。结构损伤为主(38%对比12%有炎症改变的检查附着点),尤其在下肢附着点,且在治疗期间无变化。在因轴性SpA开始使用阿达木单抗治疗的患者中,超声检测到的结构损伤常见而炎性损伤相对少见。在24周的随访期间,结构损伤似乎没有变化,提示这些损伤在短期临床试验中可能不是有用的疗效指标。