Background First multicenter study in clinical practice in SLE patients treated with BLM in Spain.
Methods Descriptive, retrospective, multicenter study in patients diagnosed with SLE according to EULAR/ACR 2019, SLICC and/or ACR 1997 diagnostic criteria. Data regarding SLE patients treated with BLM were collected from medical records (2011–2022). Demographic features, efficacy, analytical variables, SLEDAI, renal involvement, steroid dose, administration routes and safety were assessed.
Results Baseline characteristics of patients are summarized in table 1.
A total of 462 patients (36 hospitals) were included, 50.9% were on intravenous (IV), 34% on subcutaneous (SC) and 15.1% switched from IV to SC route. The median number of pre-BLM csDMARD use was 2.0 (2.0–3.0), being hydroxychloroquine (HCQ) the most frequently used (94.5%). Fifty-two patients were treated with IV cyclophosphamide with a median of 6 bolus received. At the time of BLM start, 443 patients were on prednisone with a median dose of 6.2 mg (5.0–10.0). A statistically significant decrease in prednisone dose, SLEDAI and DNA was observed from baseline until the last visit, whereas complement C3 and C4 values raised (p<0.001) (figure 1). A total of 118 patients (27.4%) had renal involvement with a median proteinuria of 1.0 g/day (0.5–2.4). Renal biopsy was done in 102 out of 118 patients, being class IV (33%), class III (21%) and class V (16%) the most reported. After BLM, 73.3% of these patients improved (median proteinuria of 0.2 g/day (0.1–0.7)). A total of 143 (30.5%) patients discontinued treatment mostly due to inefficacy (55.9%) and infections (11.9%). In fact, 116 patients developed infections, most of them mild; 2 patients died, 16 had COVID and 4 patients developed tumors requiring discontinuation of the drug.
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