Department of Rheumatology, Immunology and Allergology, University Hospital, Bern, Switzerland.
Institute for Social and Preventive Medicine, Bern, Switzerland.
Rheumatology (Oxford). 2018 Jun 1;57(6):982-986. doi: 10.1093/rheumatology/key015.
To analyse magnetic resonance angiographic (MRA) vessel wall signals from a randomized controlled trial of tocilizumab (TCZ) to treat GCA.
Participants were assigned in a 2:1 ratio to receive either TCZ + glucocorticoids (GCs) or placebo + GC infusions at 4-week intervals for 52 weeks. GCs were started at 1 mg/kg/day, then tapered to 0.1 mg/kg/day at week 12 and thereafter down to zero. Patients with initial positive MRA findings underwent control MRA at weeks 12 and 52. Vessel wall signals were scored from 0 (normal) to 3 (intense late enhancement). Outcomes were the number of patients with complete MRA remission at weeks 12 and 52, and changes in vasculitis score, vessel anatomy and atherosclerosis.
Of the 30 randomized participants, nine TCZ and two placebo patients had no vessel wall enhancement on initial MRA. At week 12, MRAs were performed in nine TCZ and four placebo patients (nine and three in clinical remission, respectively). Three (33%) TCZ patients showed normalization of vessel wall signals compared with one (25%) placebo patient. At week 52, there was additional MRA improvement in some TCZ patients, but one-third showed persistent or increased late vessel wall enhancement. There was no formation of aneurysms or stenosis and no increase in atherosclerosis.
Although TCZ resulted in complete clinical and laboratory remission of GCA over 52 weeks, MRA signals in vessel walls normalized in only one-third of patients. Whether these signals are of prognostic importance remains to be determined.
分析托珠单抗(TCZ)治疗巨细胞动脉炎(GCA)的随机对照试验中的磁共振血管造影(MRA)血管壁信号。
将参与者按 2:1 的比例随机分配,分别接受 TCZ+糖皮质激素(GCs)或安慰剂+GC 输注,每 4 周一次,共 52 周。GCs 起始剂量为 1mg/kg/天,第 12 周时减至 0.1mg/kg/天,此后逐渐减至零。初始 MRA 阳性发现的患者在第 12 周和第 52 周进行对照 MRA。血管壁信号评分从 0(正常)到 3(强烈延迟增强)。结局为第 12 周和第 52 周完全 MRA 缓解的患者数量,以及血管炎评分、血管解剖和动脉粥样硬化的变化。
30 名随机参与者中,9 名 TCZ 和 2 名安慰剂患者在初始 MRA 时无血管壁增强。第 12 周时,9 名 TCZ 和 4 名安慰剂患者进行了 MRA(分别有 9 名和 3 名处于临床缓解)。与 1 名安慰剂患者(25%)相比,3 名(33%)TCZ 患者的血管壁信号正常化。第 52 周时,部分 TCZ 患者的 MRA 进一步改善,但三分之一患者的血管壁延迟增强持续或增加。未形成动脉瘤或狭窄,也未发生动脉粥样硬化增加。
尽管 TCZ 在 52 周内导致 GCA 的临床和实验室完全缓解,但只有三分之一的患者的血管壁 MRA 信号正常化。这些信号是否具有预后意义仍有待确定。