利妥昔单抗与硫唑嘌呤用于抗中性粒细胞胞浆抗体相关性血管炎维持治疗的比较：对整体残疾状况及健康相关生活质量的影响
Rituximab versus azathioprine for ANCA-associated vasculitis maintenance therapy: impact on global disability and health-related quality of life.
作者信息
Pugnet Grégory, Pagnoux Christian, Terrier Benjamin, Perrodeau Elodie, Puéchal Xavier, Karras Alexandre, Khouatra Chahéra, Aumaître Olivier, Cohen Pascal, Maurier Francois, Decaux Olivier, Ninet Jacques, Gobert Pierre, Quemeneur Thomas, Blanchard-Delaunay Claire, Godmer Pascal, Carron Pierre-Louis, Hatron Pierre-Yves, Limal Nicolas, Hamidou Mohamed, Ducret Maïzé, Daugas Eric, Papo Thomas, Bonnotte Bernard, Mahr Alfred, Ravaud Philippe, Mouthon Luc, Guillevin Loic
机构信息
National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris; and Toulouse University Hospital, Internal Medicine Department, Toulouse, France.
Department of Rheumatology, Mount Sinai Hospital, University of Toronto, Canada.
出版信息
Clin Exp Rheumatol. 2016 May-Jun;34(3 Suppl 97):S54-9. Epub 2016 Mar 25.
OBJECTIVES
To investigate the effects on health-related quality of life (HRQOL) and functional capability of rituximab vs azathioprine for ANCA-associated vasculitis (AAV) maintenance therapy.
METHODS
In a 24-month phase III randomised-controlled trial, 115 patients over time received rituximab or azathioprine for AAV maintenance therapy. Mean changes of 36-item Short-form Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) scores from baseline were analysed.
RESULTS
Mean improvements of HAQ scores, from baseline to month 24 were significantly better for the rituximab (0.16 points lower) than the azathioprine group (p=0.038). As demonstrated by SF-36, study patients' baseline HRQOL was significantly impaired compared with age- and sex-matched US norms. At month 24, mean changes from baseline of SF-36 physical component score tended to be better for the rituximab group (+3.95 points, p=0.067) whereas mean changes from baseline of the SF-36 mental component score were significantly better for the azathioprine group (+4.23 points, p=0.041).
CONCLUSIONS
Azathioprine-treated patients' for AAV maintenance therapy showed a decline in physical abilities when compared to RTX at M24 in the MAINRITSAN trial.
TRIAL REGISTRATION
ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00748644.
目的
研究利妥昔单抗与硫唑嘌呤用于抗中性粒细胞胞浆抗体相关性血管炎（AAV）维持治疗时对健康相关生活质量（HRQOL）和功能能力的影响。
方法
在一项为期24个月的III期随机对照试验中，115例患者随时间接受利妥昔单抗或硫唑嘌呤进行AAV维持治疗。分析了36项简短健康调查（SF-36）和健康评估问卷（HAQ）评分相对于基线的平均变化。
结果
从基线到第24个月，利妥昔单抗组的HAQ评分平均改善情况（降低0.16分）显著优于硫唑嘌呤组（p=0.038）。如SF-36所示，与年龄和性别匹配的美国标准相比，研究患者的基线HRQOL显著受损。在第24个月时，利妥昔单抗组SF-36身体成分评分相对于基线的平均变化趋于更好（+3.95分，p=0.067），而硫唑嘌呤组SF-36精神成分评分相对于基线的平均变化显著更好（+4.23分，p=0.041）。
结论
在MAINRITSAN试验中，与利妥昔单抗相比，接受硫唑嘌呤进行AAV维持治疗的患者在第24个月时身体能力有所下降。
试验注册
ClinicalTrials.gov，http://clinicaltrials.gov/，NCT00748644。
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