Accrual of organ damage in Behçet’s syndrome: trajectory, associated factors, and impact on patients’ quality of life over a 2-year prospective follow-up study

Study design and outcomes

The present study included and followed up for 2 years the patients enrolled in the BODI validation study, a multicenter cohort of BS patients recruited according to the following inclusion criteria: (a) diagnosis of BS fulfilling the International Study Group (ISG) criteria [6] or the International Criteria for Behçet’s Disease (ICBD) [7], (b) disease duration ≥12 months, (c) age at enrollment ≥18 years and (d) ability to provide informed consent.

Active and cumulative clinical manifestations, previous and ongoing medications, and overall disease activity assessed by the Behçet’s Disease Current Activity Form (BDCAF) [8], the Physician Global Assessment (PGA) [9], and the Patient Global Assessment (PtGA) [9] were recorded during follow-up. Furthermore, disease relapses, defined by any treatment escalation due to disease activity during follow-up, were recorded. The HR-QoL and the extent and type of organ damage were recorded at baseline and 2-year follow-up visits.

The HR-QoL was assessed by the SF-36 questionnaire, which consists of a multipurpose, generic (no disease-specific) short-form health survey with only 36 questions. It yields an eight-scale profile of scores as well as physical and mental health summary measures (higher scores correspond to higher HR-QoL) [10]. In this study, all eight domains of the SF-36 questionnaire were assessed: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), mental health (MH), vitality (VT), social functioning (SF), and role emotional (RE). The results were then summarized in the Physical Component Summary (PCS), measuring the physical domains of QoL (PF, RP, BP, GH), and in the Mental Component Summary (MCS), measuring the emotional domains of QoL (SF, VT, RE, MH) [10].

The extent and type of damage were assessed by the BODI, consisting of 34 items and 12 subitems, categorized into 9 organ/system domains: mucocutaneous, musculoskeletal, ocular, vascular, cardiovascular, neuropsychiatric, gastrointestinal, reproductive system and miscellaneous. Each item and subitem score 1 point, with the total score ranging from 0-46. In the present study, damage accrual was defined as a ∆-BODI ≥1, calculated by subtracting the baseline BODI score from the score recorded at the 2-year follow-up visit. Furthermore, to evaluate the effect of glucocorticoids (GCs) on damage accrual, the individual BODI items were a priori classified into the following categories: definitely related to glucocorticoid (GC) therapy (i.e. diabetes, cataract, osteoporotic fractures or vertebral collapse, avascular necrosis, diabetes), possibly related to GCs (i.e. muscle atrophy, ischaemic heart disease), and independent of GCs (e.g. pulmonary aneurysms, myelopathy), taking into account underlying adverse effects [11, 12].

Statistical analysis

Categorical variables were expressed as absolute values and frequencies (%). Normally and nonnormally distributed continuous variables are reported as the mean ± standard deviation (SD) and median and interquartile range (IQR), respectively.

The chi-squared test or Mann–Whitney U-test was used in univariate analysis to identify potential risk factors for damage accrual. Then, a multivariate model for stepwise logistic regression included factors with a p-value < 0.1 in univariate analysis. Odds ratios (ORs) with 95% confidence intervals (95% CIs) were calculated. Multiple linear regression models were built to assess the relationship between organ damage accrual and HR-QoL, including the individual and composite SF-36 domains as dependent variables and ∆-BODI ≥1 as independent variables. The models included age, sex, disease activity, fibromyalgia, glucocorticoid duration, and major organ involvement as potential confounding factors. The results were reported as a beta (B) coefficient. Statistical significance was set at p-value < 0.05.

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