Kviatkovsky Milla Johanna, Ramiro Sofia, Landewé Robert, Dougados Maxime, Tubach Florence, Bellamy Nicholas, Hochberg Marc, Ravaud Philippe, Martin-Mola Emilio, Awada Hassane, Bombardier Claire, Felson David, Hajjaj-Hassouni Najia, Logeart Isabelle, Matucci-Cerinic Marco, van de Laar Mart, van der Heijde Désirée
From the Department of Rheumatology, Leiden University Medical Center, Leiden; Department of Clinical Immunology and Rheumatology, Amsterdam Rheumatology Center, Amsterdam; Arthritis Center Twente, Medisch Spectrum Twente, University Twente, Enschede, the Netherlands; Department of Rheumatology B, Paris-Descartes University, Paris, France; Université Paris Diderot, Sorbonne Paris Cité, UMR 1123; INSERM, UMR 1123, CIC-EC 1425; APHP, Hôpital Bichat, Département d'Epidémiologie et Recherche Clinique; INSERM, U738; AP-HP, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique; Université Paris Descartes; Pfizer SAS, Paris, France; School of Medicine, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia; Departments of Medicine and Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland; Boston University School of Medicine, Boston, Massachusetts, USA; Rheumatology Department, Hospital Universitario La Paz, Universidad Autónoma Madrid, Madrid, Spain; Hotel-Dieu de France Hospital, Saint Joseph University, Rheumatology Department, Beirut, Lebanon; Division of Rheumatology, Department of Health Policy, Management, and Evaluation, University of Toronto; Division of Clinical Decision Making and Health Care, Toronto General Research Institute, University Health Network; Institute for Work and Health; Mount Sinai Hospital, Toronto, Ontario, Canada; Mohammed Vth University, LIRPOS URAC30, Rheumatology and Physical Rehabilitation Department, El Ayachi Hospital, Salé, Morocco; Department of Experimental and Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Florence, Italy.M.J. Kviatkovsky, DO, MPH, Department of Rheumatology, Leiden University Medical Center; S. Ramiro, MD, MSc, PhD, Department of Rheumatology, Leiden University Medical Center; R. Landewé, MD, PhD, Department of Clinical Immunology and Rheumatology, Amsterdam Rheumatology Center; M. Dougados, MD, Department of Rh
J Rheumatol. 2016 Sep;43(9):1680-6. doi: 10.3899/jrheum.151244. Epub 2016 Jun 15.
To establish cutoffs for the minimum clinically important improvement (MCII) and the patient-acceptable symptom state (PASS) for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with ankylosing spondylitis (AS).
Patients with AS who started nonsteroidal antiinflammatory drugs were included. After 4 weeks, the PASS and the MCII were defined using external anchor questions (for the PASS, patients considering their condition of AS over the prior 48 h as "acceptable" forever; and for the MCII, those reporting moderate or slightly important improvement). Consistency of the MCII and PASS were tested according to HLA-B27 status, presence/absence of SpA extraarticular manifestations, age, sex, disease duration, and baseline BASDAI/BASFI score. The 75th percentile of the cumulative distribution was used to determine the MCII and PASS.
In total, 283 patients from a multinational cohort were included. Overall cutoffs for the PASS were 4.1 in the BASDAI and 3.8 in the BASFI. Cutoffs for the MCII were 0.7 and 0.4 for the BASDAI and BASFI, respectively. Subgroup analyses revealed that disease duration and baseline BASDAI/BASFI were significantly associated with the PASS and MCII. In a subanalysis limited to patients with active disease (baseline BASDAI ≥ 4), the MCII was 1.1 for the BASDAI and 0.6 for the BASFI.
The conceptual viability of the PASS for the BASDAI is questionable because levels approach those required for the start of biological therapy. Because the MCII is less variable than the PASS, we propose its exclusive use, with cutoffs of 1.1/0.6 for the BASDAI/BASFI in patients with active disease. Because these values are based on a subset of the study population, we recommend confirmation in larger studies focused on patients with baseline BASDAI ≥ 4.
确定强直性脊柱炎（AS）患者中，巴斯强直性脊柱炎疾病活动指数（BASDAI）和巴斯强直性脊柱炎功能指数（BASFI）的最小临床重要改善（MCII）及患者可接受症状状态（PASS）的界值。
纳入开始使用非甾体抗炎药的AS患者。4周后，通过外部锚定问题定义PASS和MCII（对于PASS，患者将其过去48小时内的AS病情视为“永远可接受”；对于MCII，患者报告有中度或轻度重要改善）。根据HLA - B27状态、SpA关节外表现的有无、年龄、性别、病程以及基线BASDAI/BASFI评分，对MCII和PASS的一致性进行检验。使用累积分布的第75百分位数来确定MCII和PASS。
总共纳入了来自多国队列的283例患者。PASS在BASDAI中的总体界值为4.1，在BASFI中为3.8。BASDAI和BASFI的MCII界值分别为0.7和0.4。亚组分析显示，病程和基线BASDAI/BASFI与PASS和MCII显著相关。在一项仅限于活动性疾病患者（基线BASDAI≥4）的亚分析中，BASDAI的MCII为1.1，BASFI为0.6。
BASDAI的PASS的概念可行性存在疑问，因为其水平接近开始生物治疗所需的水平。由于MCII比PASS的变异性小，我们建议仅使用MCII，对于活动性疾病患者，BASDAI/BASFI的界值为1.1/0.6。由于这些值基于研究人群的一个子集，我们建议在针对基线BASDAI≥4患者的更大规模研究中进行验证。
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