ABSTRACT
BackgroundBelimumab (BLM) is a monoclonal antibody that inhibits B-lymphocyte stimulating factor (BlyS) approved as a specific treatment for systemic lupus erythematosus (SLE) in 2011. We present the experience with BLM in a Spanish cohort with more than 460 patients.ObjectivesTo describe demographic characteristics, efficacy and safety of BLM in patients with SLE in Spanish population since its approval.MethodsDescriptive, 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, laboratory variables, SLEDAI, renal involvement, steroid dose, administration routes and safety were assessed. To see whether a trend in BLM prescription had changed or not over time, two periods of time were analyzed: 2011-2016 (period1) and 2017-2022 (period2).ResultsBaseline 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). Significant decreases in prednisone dose, SLEDAI and anti-DNA antibodies were observed from baseline until the last visit, whereas complement C3 and C4 values raised (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 frequently reported. After BLM, 73.3% of these patients improved (median proteinuria of 0.2 g/day (0.1-0.7).In period1, 100 patients started BLM compared to 362 in period2. The median time from SLE diagnosis to BLM begin was 7.1 (4.0-13.7) and 6.2 (2.1 -14.4) years in period1 and period2, respectively (p=0.454). We found a trend to use more csDMARD before BLM treatment in period1: 2.5 (2-3) vs. 2 (2-3) (p=0.088).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, mostly mild;2 patients died, 16 had COVID-19 and 4 patients developed tumors requiring discontinuation of the drug.ConclusionIn our cohort of SLE patients in a real-world setting, BLM has been effective, safe and seems to be a good choice to treat renal involvement.References[1]Navarra SV, Guzmán RM, Gallacher AE, et al. Lancet. 2011;377(9767):721-31.[2]Stohl W, Hiepe;rt al. Arthritis Rheum. 2012;64(7):2328-37.[3]Furie R, Rovin BH, Houssiau F, et al. N Engl J Med. 2020;383(12):1117-1128.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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Background: The novel coronavirus emerged in 2019 in Wuhan has caused a global pandemic of coronavirus disease (COVID-19). Immune-mediated diseases (IMID), as inflammatory arthritis or inflammatory bowel disease (IBD), have some special implications due to their pathogenesis and treatments. Some treatments employed in IMID are now being used in the treatment of severe COVID-19. There still exists controversy about IMID behavior and its complications. 1, 2 Objectives: To assess COVID-19 severity in IMID patients and its prognosis predictors. Methods: An observational retrospective multicenter study was performed in two Spanish Hospitals (Clinical University Hospital in Santiago De Compostela and Gregorio Marañón Hospital). Patients were selected if they were diagnosed of an IMID (rheumatoid arthritis, psoriatic arthritis, espondyloarthritis, ulcerative colitis and Crohn's disease) and had COVID-19 infection between February and April 2020. Demographic, clinical, analytical and treatment data were collected. Logistic regression was used to evaluate potential predictors. Stata 15.1 was used to perform statistical analysis. Results: 91 patients were recruited. 55 suffered from a rheumatic disease and 36 suffer IBD. Baseline characteristics are shown in Table 1. Univariable analysis reached age, comorbidity, female gender, flu vaccine, arthropathy, basal classical synthetic anti-rheumatic drugs (csDMARD), pneumonia and basal C-reactive protein (CRP) as potential predictors of non-severe (absence of death, respiratory insufficiency, intensive care unit admission or sepsis) COVID-19 disease (p < 0.2). After multivariable analysis, only female gender (OR 4.60 [CI95% 1.00, 21.2] p=0.050), lower age (OR 0.94 [CI95% 0.88, 1.00] p=0.042) and lower basal levels of CRP (OR 0.87 [CI95% 0.77, 0.97] p=0.010) were predictors for non-severe disease (p < 0.005). Mean time of healing (symptoms solved in outpatient and hospital discharge in admitted) from COVID-19 was 13.8 days (SD 16.3). Univariable analysis showed arthropathy, COVID-19 symptomatic and basal glucocorticoids (GC) dose as potential predictors of higher time-to-healing from COVID-19 disease (p < 0.2). After multivariable analysis, only lower GC basal dose predicts higher time-tohealing (OR -1.83 [CI95% -2.81, -0.84] p=0.001). 11 patients deceased because of COVID-19. Univariable analysis reached age, basal csDMARD, pneumonia and basal CRP as potential predictors of COVID-19 mortality (p < 0.2). After multivariable analysis, only higher age was a predictor for mortality (OR 1.14 [CI95% 1.04,1.25] p=0.006). Conclusion: IMID patients showed similar predictors of mortality than general population involving COVID-19. Immune-modulating agents did not seem to overshadow the prognosis of COVID-19 infection. Female gender, lower age and lower basal CRP could select a cohort of “good” prognosis patients with mild COVID-19 disease as well higher age points out the worst prognosis. Even that, each case should be individiualized.
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Background: Chloroquine (CQ) and hydroxychloroquine (HCQ) have been employed in a huge range of indications, from autoimmune diseases (such as rheumatoid arthritis [RA], cutaneous lupus or systemic erythematosus lupus [SLE]) to infectious ones (as malaria or helminthiasis).1 A newer purpose came upon the new coronavirus disease 2019 (COVID-19), where they seem to be effective modulating immune response. Controversial results have been published from clinical and observational data concerning its effectiveness.2 Ocular toxicity have been described as a serious adverse event of these antimalarial drugs and screening protocols have been displayed for its prevention.3 Objectives: To evaluate CQ/HCQ ocular toxicity and to identify potential predictors of appearance. Also to asses screening protocols compliance. Methods: Demographic, diagnostic and treatment data were collected from patients under CQ or HCQ treatment in the Clinical University Hospital in Santiago De Compostela (Spain) during the first wave of the COVID-19 pandemic (January to April 2020). Univariable logistic regression was performed to identify potential predictors of maculopathy. Variables with p<0.20 were selected for multivariable testing. Stata 15.1 was used to perform statistical analysis. Results: 503 patients taking CQ/HCQ were identified. 495 were women. Most frequent diagnosis were SLE (48.28%), cutaneous lupus (22.85%) and rheumatoid arthritis (RA, 12.54%). Mean age at diagnosis was 44.99 years (SD 17,88). 93.33% of patients were under treatment with HCQ. Mean age at beginning of CQ/HCQ treatment was 48.10 years (SD 17.79) and mean time between diagnosis and CQ/ HCQ onset was 2.03 years (SD 5.50). Mean maximum HCQ dosage per patient was 3.83 mg/kg (SD 1,59;252.57 mg per day, SD 89.98) and CQ was 3.24 mg/kg (SD 1,91;219.49 mg per day, SD 103.90). Mean time under CQ/HCQ treatment was 6.39 years (SD 5.63). 20 patients developed maculopathy. Mean time between CQ/HCQ onset and maculopathy appearance was 2.67 years (SD 3.10). Only 25 patients did not complete ophthalmologic exams for maculopathy screening. After univariable analysis, higher age at diagnosis and age at beginning of CQ/ HCQ treatment were identified as potential predictors of maculopathy (p<0.20). After multivariable analysis, both higher age at diagnosis and higher age at CQ/ HCQ onset were identified as predictors for suffering maculopathy under treatment with CQ/HCQ (OR 1.06 [CI95% 1.03-1.10] p=0.000 and OR 1.09 [CI95% 1.02-1.16] p=0.008, respectively). Conclusion: Ocular toxicity remains as one of the most harmful and disabling adverse events in patients under CQ/HCQ treatment. Higher age at diagnosis and higher age at beginning of treatment appear to be risk factors for maculopathy appearance. Screening protocols are well-assumed by patients and seemed to be helpful for preventing and early identifying events. CQ/HCQ usage in COVID-19 patients should be individualized, specially in older patients, and protocols involving ocular toxicity should be implemented in the follow-up of this population.