ObjectivesTo describe the baseline characteristics of SLE patients requiring biologic therapy in the UK and to explore short term efficacy and infection rates associated with rituximab (RTX) use.MethodsPatients commencing biologic therapy for refractory SLE and who consented to join BILAG-BR were analysed. Baseline characteristics, disease activity (BILAG 2004/SLEDAI-2K) and rates of infection over follow-up were analysed. Response was defined as loss of all A and B BILAG scores to ⩽ 1 B score with no new A/B scores in other organ systems at 6 months.ResultsTwo hundred and seventy SLE patients commenced biologic therapy from September 2010 to September 2015, most commonly RTX (n = 261). Two hundred and fifty (93%) patients were taking glucocorticoids at baseline at a median [interquartile range (IQR)] oral dose of 10 mg (5–20 mg) daily. Response rates at 6 months were available for 68% of patients. The median (IQR) BILAG score was 15 (10–23) at baseline and 3 (2–12) at 6 months (P < 0.0001). The median (IQR) SLEDAI-2K reduced from 8 (5–12) to 4 (0–7) (P < 0.001). Response was achieved in 49% of patients. There was also a reduction in glucocorticoid use to a median (IQR) dose of 7.5 mg (5–12 mg) at 6 months (P < 0.001). Serious infections occurred in 26 (10%) patients, being more frequent in the first 3 months post-RTX therapy. A higher proportion of early infections were non-respiratory (odds ratio = 1.98, 95% CI: 0.99, 3.9; P = 0.049).ConclusionRTX is safe and is associated with improvement in disease activity in refractory SLE patients with concomitant reductions in glucocorticoid use. Early vigilance for infection post-infusion is important to further improve treatment risks and benefits.
Running Title Belimumab use in Refractory SLEKey Words Systemic Lupus Erythematosus, Biologic Therapy, Rituximab, Belimumab, Register. We sought to investigate the number of patients and the clinical characteristics of patients treated with a biologic in the BILAG-BR who would potentially have been eligible for belimumab using this guidance [5] Of the 270 patients registered for biologic use to Nov 2015, 82 (33%) had evidence of both low complement and elevated anti-dsDNA antibodies at enrolment. Of these, 46 (56.1%) patients had a BILAG A in the renal (n=29) or neuropsychiatric system (n=17) making them ineligible for therapy. An additional 4 (4.9%) had a SLEDAI score < 10. Thus from 2010-2015 32 patients (13%) enrolled in the BILAG-BR would have been eligible for belimumab.Amongst these 32 patients the BILAG mucocutaneous (MUC) and musculoskeletal (MSK) systems had the most frequent A (MSK=7, MUC=6) and B scores (MSK=11 ,MUC=8) ( Figure 1). 17 (53%) patients had a history of renal disease. The median (IQR) baseline SLEDAI was 12.5 (12 -15.75).Regarding medication use 28 (87.5%) and 27 (84.4%) patients were on an anti-malarial or oral prednisolone respectively. The median (IQR) baseline prednisolone dose was 15mg (10mg-20mg). The median (IQR) number of prior standard immunosupressant agents was 2 (1-3). Mycophenolate mofetil was the most frequently prescribed therapy (n=23) followed by azathioprine (n=15) and cyclophosphamide (n=11).When we assessed response to RTX in this cohort who would now be eligible for belimumab, the median (IQR) SLEDAI improved from 12.5 (12-15.75) at baseline to 4 (0-8) at 6 months (p < 0.0001). The total number of BILAG A scores reduced from 16 to 2 and B scores from 33 to 9. A corresponding reduction in corticosteroid dose was also noted from 15mg (10mg-20mg) to 6mg (5mg-10mg) at 6 months (p < 0.001).Improved access to biologic therapies will enhance physician's ability to control disease activity whilst facilitating corticosteroid tapering and preventing damage [6]. Given the response rate to most biologic therapies in SLE is approximately 50%, the addition of belimumab to UK physicians' armamentarium is to be welcomed, especially for those patients who have not responded to conventional therapy. Our data will help inform clinicians and planners about the expected rates of usage and the clinical characteristics of patients requiring belimumab in the UK. Mucocutaneous and musculoskeletal were the systems most likely to have active disease requiring belimumab. A history of renal involvement was however noted in approximately 50% of cases, emphasising that previous renal involvement does not exclude patients from belimumab, indeed both the BLISS-52 and 76 trials included patients with active renal disease and a post hoc analysis suggested favourable renal outcomes in this population [7]. Our data also suggests that RTX remains a realistic therapeutic option for patients who fail to respond to belimumab.In summary, between 2010 and 2015 13% of patients who commenced biologic therapy f...
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