Abstract

BackgroundSystemic glucocorticoid (GC) therapy remains a necessity for a significant subset of patients with SLE. Chronic corticosteroid use is associated with the accrual of irreversible organ damage over time, with the highest risk being among those exposed to a mean prednisone dose of ≥20 mg/day. That is why, CG toxicity assessment should be an important part of routine clinical care as well.ObjectivesThe aim of this study is to describe for the first time individual patient GC toxicity in SLE patients using the Glucocorticoid Toxicity Index (GTI)MethodsA total of 37 patients SLE (30 (81%) women and 7 (19%) men) were enrolled in this study. The mean age was 36± 11,9 years and the median disease duration was 36 [12; 128] months. At the first visit, all patients were assessed for SLE activity by the SLEDAI 2K index, irreversible organ damage by SLICC Damage Index (DAI), GTI *, and current treatment.ResultsThe mean disease activity index SLEDAI 2K was 11,3±6,2, DAI SLICC ≥1 was in 20 (54%), 17 (46 %) patients had not any irreversible organ damage DAI SLICC = 0. During the period of illness the maximum GC dose was 33,7 mg ± 19,9 mg, the median of cumulative dose of GC administered intravenously was 1563 mg [293; 6478] mg, median duration of GC treatment was 22 months [8; 112]. 30 (81%) of patients had GTI with median 33 [19; 48] points. 2 (5%) patients had zero GTI, but there were severe organsʼ injuries from the GTI Specific List (1 patient had cataract and 1 patient had cataract and avascular necrosis). 5 (14%) patients had zero GTI with no severe organs’ injuries from the TGI Specific List. In 3 out of 5 patients, the duration of GC treatment did not exceed 6 months, in 2 out of 5 patients, the maximum dose of GC during the period of the disease did not exceed 5 mg/day. In 1 out of 5 patients, the duration of GC treatment was 13 months, and the maximum dose of GC was 15 mg during the period of treatment.The most frequent changes occurred in 5 of 9 main domains: an increase in body mass index was detected in 10 (27%) patients, an increase in blood pressure was detected in 15 (41%) patients, hyperlipidemia was detected in 9 (24%) patients, a decrease bone mineral density was detected in 6 (16%) patients and the development of infectious complications in 5 (14%) patients;The less frequent changes occurred in 5 of 9 main domains: 3 (8%) patients had impaired glucose tolerance, 2 (5%) patients had steroid myopathy; neuropsychiatric intoxication was detected in 2 (5%) patients.Severe organs’ injuries were identified, included in a Special list and not scored in points: cataracts were detected in 7 (19%) patients, avascular necrosis was detected in 3 (8%) patients, osteoporotic fractures - in 2 (5%) patients.GTI correlated with disease duration (r = 0.33); the maximum dose of GC per os (r = 0.43); duration of GC therapy (r = 0.37); DAI SLICC (r-0.39), p<0.05 in all cases.ConclusionGTI was detected in a significant number of patients with SLE (81%). ITG correlates with the duration of the disease, the maximum dose of GC during the period of illness, the duration of GC therapy, and the SLICC DAI. GTI should be used to evaluate the safety of GC therapy in patients with SLE who receive GC therapy for more than 6 months, together with the SLICC DAI.*The GTI includes Composite Index and Specific List. Composite Index, consists of 9 domains and 31 elements, each of which is assigned a certain number of points. It contains information on the most common complications of GC therapy: BMI, glucose tolerance, BP, lipids, myopathy, bone mineral density, skin lesions, neuropsychiatric lesions, infections.Severe organ damages, which is less common but contributes significantly to GC toxicity, are included in a special list. The specific list includes 11 domains (9 of which are also used in the Composite index) and 23 elements (avascular necrosis, osteoporotic fractures, cataracts, etc.).Disclosure of InterestsNone declared

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