Abstract
PV279 / #686
Poster Topic: AS24 - SLE-Treatment
Background/Purpose Anifrolumab (ANI), an anti-type 1 interferon-alpha receptor antibody, has recently been approved for SLE treatment, following the positive results in 2 phase III randomized controlled trials. The purpose of this work is assessing the efficacy of Anifrolumab in active non-renal SLE, focusing on cutaneous and musculoskeletal manifestations.
Methods Data of SLE (ACR/SLICC or EULAR/ACR classification criteria) patients (pts) treated with ANI were prospectively collected. Disease activity measures, including SLE Disease Activity Index 2000 (SLEDAI-2K), SLE Disease Activity Score (SLE-DAS), swollen joint count (SJT), tender joint count (TJC) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) were assessed at baseline and every 3 months thereafter. Platelet count (PC), lymphocyte count (LC), complement levels, anti-dsDNA titers, and prednisone dose were also assessed at same timepoints. SLICC/ACR Damage Index (SDI) was collected at baseline and after 6 months of treatment. T-test and Wilcoxon test for paired data were used to assess differences across different timepoints.
Results Since September 2023, 22 SLE pts have been treated with ANI. ANI was prescribed for active cutaneous involvement in 11/22 (50%), joint involvement in 10/22 (45%), hematological involvement in 4/22 (18%), and serosal involvement in 2/22 (9%). In 8/22 pts (36%), ANI was administered prior to any conventional immunosuppressants (IS) (including 2 pts in which it was administered after belimumab only). At 6 months, significant reductions from baseline of mean SLEDAI-2K (p=0,016), SLE-DAS (p<0.001), CLASI (p=0,008), TCJ (p=0,009), SJC (p=0,023), and LC (p=0,021) were observed (Image 1 and Image 2). At 9 months, improvements were confirmed in all previous endpoints (Image 1 and Image 2). Efficacy was similar between conventional IS experienced vs. naïve pts. Of note, a trend toward reduced prednisone use was observed. At 6 and 9 months, no significant changes in PC, rates of hypocomplementemia and proportion of patients with positive anti-dsDNA antibodies were detected. SDI did not vary after 6 months of follow-up. Treatment was discontinued for inefficacy in 2 pts (1 joint and 1 hematological involvement) and for safety reasons in 1 pt (sepsis).
Conclusions In our cohort, ANI showed promising results, reducing overall and organ-specific disease activity, confirming its efficacy in cutaneous and joint manifestations. Further data are needed to evaluate its steroid-sparing effect and its impact on hematological manifestations.
- Copyright © 2025 by the Journal of Rheumatology
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