超短效糖皮质激素与托珠单抗治疗巨细胞动脉炎：TOPAZIO研究扩展阶段的结果
Treatment of giant cell arteritis with ultra-short glucocorticoids and tocilizumab: results from the extension of the TOPAZIO study.
作者信息
Muratore Francesco, Marvisi Chiara, Cassone Giulia, Ricordi Caterina, Boiardi Luigi, Mancuso Pamela, Besutti Giulia, Spaggiari Lucia, Casali Massimiliano, Croci Stefania, Durmo Rexhep, Versari Annibale, Di Tommaso Gabriella, Catanoso Mariagrazia, Giorgi Rossi Paolo, Salvarani Carlo
机构信息
Rheumatology Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
University of Modena and Reggio Emilia, Modena, Italy.
出版信息
Rheumatology (Oxford). 2025 May 1;64(5):3057-3062. doi: 10.1093/rheumatology/keae400.
OBJECTIVES
To assess the maintenance of efficacy of one year of tocilizumab (TCZ) monotherapy after its discontinuation in large vessel-GCA (LV-GCA).
METHODS
17 patients with active LV-GCA were previously treated with 3 boluses of intravenous methylprednisone and weekly subcutaneous TCZ in monotherapy for 52 weeks. Patients in relapse-free clinical remission at week 52 discontinued TCZ and entered part two, which was a 26-week observational follow-up period. PET/CT was performed in all patients at the end of the 26-week observational period (week 78). End points were the variation in PET vascular activity score (PETVAS) at week 78 compared with baseline and with week 52, and the proportion of patients with relapse-free clinical remission at week 78 and at the end of the follow-up.
RESULTS
Compared with baseline, a significant reduction in PETVAS was observed at week 78, mean (95% CI) change -6.6 (-9.5 to -3.7). However, compared with week 52, PETVAS significantly increase 6 months after TCZ discontinuation (week 78), mean (95% CI) change 4.6 (0.7-8.5). The proportion of patients with relapse-free clinical remission at weeks 78 and at the end of the follow-up (median time from TCZ discontinuation 148 weeks) was 11/17 (65%, 95% CI 38-86) and 8/17 (47%, 95% CI 23-72), respectively. Age and sex-adjusted HR (95% CI) for each unit increase of PETVAS indicating subsequent relapse was 1.36 (0.92-2.00).
CONCLUSIONS
One year of TCZ monotherapy was effective in maintaining drug-free clinical remission in LV-GCA. Changes in PETVAS early after TCZ discontinuation may predict subsequent relapses.
TRIAL REGISTRATION
ClinicalTrials.gov, http://clinicaltrials.gov, NCT05394909.
目的
评估托珠单抗（TCZ）单药治疗1年后停药在大血管巨细胞动脉炎（LV-GCA）中的疗效维持情况。
方法
17例活动性LV-GCA患者先前接受了3次静脉注射甲泼尼龙和每周皮下注射TCZ单药治疗52周。在第52周临床无复发缓解的患者停用TCZ并进入第二阶段，即26周的观察随访期。在26周观察期结束时（第78周）对所有患者进行PET/CT检查。终点指标为第78周时PET血管活性评分（PETVAS）与基线及第52周时的变化，以及第78周和随访结束时临床无复发缓解患者的比例。
结果
与基线相比，第78周时PETVAS显著降低，平均（95%CI）变化为-6.6（-9.5至-3.7）。然而，与第52周相比，停用TCZ 6个月后（第78周）PETVAS显著增加，平均（95%CI）变化为4.6（0.7 - 8.5）。第78周和随访结束时（从停用TCZ起的中位时间为148周）临床无复发缓解患者的比例分别为11/17（65%，95%CI 38 - 86）和8/17（47%，95%CI 23 - 72）。PETVAS每增加一个单位表明随后复发的年龄和性别调整后的HR（95%CI）为1.36（0.92 - 2.00）。
结论
TCZ单药治疗1年对维持LV-GCA患者停药后的临床缓解有效。停用TCZ后早期PETVAS的变化可能预测随后的复发。
试验注册
ClinicalTrials.gov，http://clinicaltrials.gov，NCT05394909
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