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Background: 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.
Objectives: To describe the demographic characteristics, efficacy, and safety of Anifrolumab in patients with SLE in real-world setting.
Methods: Descriptive, retrospective, multicenter study analyzing patients with SLE treated with Anifrolumab. Demographic and clinical variables were collected at baseline, at 3 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.
Results: A total of 30 patients were included. The majority were females (93,3%) with a mean age of 47.6±11.91 years. Serologically, 9 patients were positive for anti-double-stranded DNA antibodies (AP Ab+), of which 5 developed anti-phospholipid syndrome(APS). 86,67% had positive anti-nuclear antibodies with different specificities. Clinically, 90% had mucocutaneous involvement, and 53,3% had hematological involvement. 6 patients had renal involvement, with 4 confirmed by biopsy (1 class 1V, 2 class IV and 1 class III). Only 1 patient was treated with anifrolumab without prior disease-modifying antirheumatic drugs (DMARDs) therapy, with an average of 2.6±1.25 previous DMARDs (23 hydroxychloroquine, 13 MTX, 15 azathioprine, 10 mycophenolate, 5 tacrolimus, 5 leflunomide, 1 cyclosporine, 1 chloroquine, 1 dapsone). The mean number of prior biologics before starting Anifrolumab was 1.29±0.78 (15 belimumab, 13 rituximab, 1 tocilizumab, 1 abatacept, 2 antiTNF, 1 cenerimod). Only 33.33% required corticosteroid boluses, and one required cyclophosphamide. Anifrolumab was concomitantly prescribed with hydroxychloroquine in 53.33% of patients, mycophenolate in 13.33%, methotrexate in 20% and azathioprine, tacrolimus and mepacrine in 6.66%. At 3 months of Anifrolumab treatment, 55% of patients had a reduction in prednisone dose (95% CI 32.2-76.8) maintained until sixth month of treatment(55,5% CI 25,12-83,93%). The mean reduction in prednisone dose at 3 months was -4.25(SD 4.74, p=0.020). The proportion of patients who decreased SLEDAI scores at 3 month was 83.24%(CI 72,92-103,55). The mean reduction in SLEDAI at 3 months compared to baseline was -5.18(SD4,02, p=0.001). The proportion of patients without skin involvement increased from 50% to 85.71% at 3 months(p=0.0449). Changes in analytical and clinical variables are recorded in Tables 1–3. Remarkably no patient experienced infusion reactions or had to discontinue treatment.
Conclusion: From the third month of Anifrolumab treatment, a significant reduction in prednisone dose mantained until 6th month, 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.
Analytical and Clinical Variables with Anifrolumab at Baseline, 3 Months, and 6 Months of Follow-Up.
| Basal | 3 months | 6 months | |
|---|---|---|---|
| Prednisone (mg) | 13,42±14,89 | 5,75±7.39 | 7.34±8.55 |
| ESR (mm/h) | 24,54±25,76 | 23,10±25,66 | 18.29±21.82 |
| CRP (mg/L) | 8,53±17,38 | 9,17±17,72 | 13.81±24.24 |
| DNA | n=11
| n=4
| n=6
|
| C3, C4 | n=7
| n=5
| n=1
|
| SLEDAI | 7.96±6.20 | 2.12±2.55 | 3.29±2.98 |
| Cytopenia |
n=14
|
n=4
| n=1
|
| Proteinuria | n=2
| n=2
| n=1
|
| Arthritis |
n=18
|
n=7
| n=6
|
| Cutaneous |
n=15
|
n=3
| n=3
|
| Alopecia |
n=7
| n=0 | n=0 |
| Aphthous ulcers |
n=10
|
n=3
| n=3
|
| Neuropsychiatricmanifestations |
n=3
|
n=1
| n=0 |
Difference Between the Values of Prednisone, ESR, CRP, DNA, and SLEDAI at t_0 (baseline) and at 3 Months.
| Proportion of patients with prednisone reduction at 3 months: | 55.00% (CI 32,2-76.8%) | Mean reduction in prednisone at 3 months: | -4,25 (SD 4,74, p=0,020 ) |
| Proportion of patients with SLEDAI reduction at 3 months: | 83,24% (CI 72.92-103.55) | Mean reduction in SLEDAI at 3 months: | -5.18 (SD 4.02, p=0,001 ) |
Difference Between the Values of Prednisone, ESR, CRP, DNA, and SLEDAI at t_0 (baseline) and at 6 Months.
| Proportion of patients with prednisone reduction at 6 months: | 55.55% (CI 25.12-83.97%) | Mean reduction in prednisone at 6 months: | -4.93 (SD 5.99, p=0,021 ) |
| Proportion of patients with SLEDAI reduction at 6 months: | 85.71% (CI 59.49-111.64%) | Mean reduction in SLEDAI at 6 months: | -4.29 (SD 5.22, p=0,0728 ) |
Percentage of patients transitioning from indicating “Yes” in their respective variables to indicating “No.”
| Proportion of patients without cytopenias at baseline and at 3 months | 53.33%, 80.95% ( p=0,2025 ) | Proportion of patients without cytopenias at baseline and at 6 months | 53.33%, 90.91%( p=0.6128 ) |
| Proportion of patients without joint involvement at baseline and at 3 months. | 40%, 66.67% ( p=0,4272 ) | Proportion of patients without joint involvement at baseline and at 6 months. | 40%, 45.45% ( p=0.4848 ) |
| Proportion of patients without cutaneous involvement at baseline and at 3 months. | 50%, 85.71% ( p=0,0449 ) | Proportion of patients without cutaneous involvement at baseline and at 6 months.
| 50%, 72.73% ( p=0.4165 ) |
| Proportion of patients without alopecia at baseline and at 3 months. | 76.67%, 100% ( p=0,103 ) | Proportion of patients without alopecia at baseline and at 6 months. | 76.67%, 100% ( p=0.6128 ) |
| Proportion of patients without mouth ulcers at baseline and at 3 months | 66.67%, 85.71% ( p=0,223 ) | Proportion of patients without mouth ulcers at baseline and at 6 months | 66.67%, 75%( p=0.957 ) |
REFERENCES: NIL.
Acknowledgements: NIL.
Disclosure of Interests: None declared.
© The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (