AB1068 REGISTRY OF ANIFROLUMAB USE IN SYSTEMIC LUPUS ERYTHEMATOSUS IN THE VALENCIAN COMMUNITY
Authors: M. Garijo Bufort, M. Aguilar Zamora, K. Arévalo Ruales, C. Valera-Ribera, J. Rosas Gómez de Salazar, I. De la Morena Barrio, L. C. Charca Benavente, M. Fernandez Matilla, M. D. García Armario, G. Albert Espí
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Anifrolumab is a recently approved human monoclonal antibody of the immunoglobulin G1 kappa type for the treatment of SLE (Systemic Lupus Erythematosus). There is limited real-world data available. <h3>Objectives:</h3> To describe the demographic characteristics, efficacy, and safety of Anifrolumab in patients with SLE in real-world setting. <h3>Methods:</h3> Descriptive, retrospective, multicenter study analyzing patients with SLE treated with Anifrolumab. Demographic and clinical variables were collected at baseline, at 3 months, and at 6 months of follow-up. Additionally, infusion reactions and reasons for treatment discontinuation were recorded. Statistical analysis was conducted using RStudio 4.3.2. <h3>Results:</h3> A total of 14 patients were included, with one patient excluded from subsequent analysis due to a lack of follow-up data. The majority were females (85.71%) with a mean age of 49.71±12.52 years. Serologically, 5 patients were positive for anti-double-stranded DNA antibodies (AP Ab+), of which 2 developed anti-phospholipid syndrome (APS). 71.43% had positive anti-nuclear antibodies with different specificities. Clinically, 92.86% had mucocutaneous involvement, and 50% had hematological involvement. Three patients had renal involvement, with 2 confirmed by biopsy (class III and IV, respectively). All patients had prior disease-modifying antirheumatic drugs (DMARDs) therapy, with an average of 3.21±0.97 (13 hydroxychloroquine, 7 MTX, 10 azathioprine, 7 mycophenolate, 4 tacrolimus, 2 leflunomide, 1 cyclosporine, 1 chloroquine). The mean number of prior biologics before starting Anifrolumab was 1.36±0.63 (11 belimumab, 7 rituximab, 1 tocilizumab). Only 21.43% required corticosteroid boluses, and none required cyclophosphamide. Anifrolumab was concomitantly prescribed with hydroxychloroquine in 57.14% of patients, mycophenolate in 28.57%, methotrexate in 14.29%, azathioprine in 14.29%, tacrolimus in 7.14%, and mepacrine in 7.14%. At 3 months of Anifrolumab treatment, 61.54% of patients had a reduction in prednisone dose (95% CI 32.28-84.87). The mean reduction in prednisone dose at 3 months was -4.23 (SD 4.13, p=0.0031). The percentage of patients who reduced their CRP levels at 3 months of treatment was 15.38% (95% CI 2.71-46.34) with a mean reduction of 9.06 (SD 13.56, p=0.033). The proportion of patients who decreased SLEDAI scores was 83.33% (95% CI 50.88-97.06). The mean reduction in SLEDAI at 3 months compared to baseline was -4.08 (SD 2.75, p=0.001). The proportion of patients without skin involvement increased from 38.46% to 86.62% at 3 months (p=0.0438). Changes in analytical and clinical variables are recorded in Tables 1, 2, and 3. Remarkably no patient experienced infusion reactions or had to discontinue treatment. <h3>Conclusion:</h3> From the third month of Anifrolumab treatment, a significant reduction in prednisone dose and a decrease in CRP levels, as well as SLEDAI scores, were observed. The domains showing the greatest improvement were hematological, joint, and mucocutaneous, with statistical significance observed for cutaneous involvement. Therefore, Anifrolumab appears to be a safe and effective treatment for this profile of patients. Limited data is available to assess long-term efficacy and safety. <b>Table 1.</b> Analytical and Clinical Variables with Anifrolumab at Baseline, 3 Months, and 6 Months of Follow-Up. <b>Table 2.</b> Difference Between the Values of Prednisone, ESR, CRP, DNA, and SLEDAI at t_0 (baseline) and at 3 Months. <b>Table 3.</b> Percentage of patients transitioning from indicating "Yes" in their respective variables to indicating "No." <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>