PO:16:235 | Anifrolumab in systemic lupus erythematosus: real-life experience of a single-center cohort

Filippo Vesentini¹, Luca Iaccarino¹, Federico Arru², Greta Hulej¹, Anna Giorgia Osele¹, Noemi Merra¹, Davide Ragno¹, Andrea Doria¹, Margherita Zen¹ | ¹UOC Reumatologia, Dipartimento di Medicina DIMED, Università degli Studi di Padova; ²UO Medicina, ASL 3 Nuoro, Italy

Background. Anifrolumab (ANI) is a monoclonal antibody directed against type 1 interferon receptor. Its use in the treatment of patients with systemic lupus erythematosus (SLE) is becoming more frequent in clinical practice. The aim of this study is to evaluate the efficacy of ANI in SLE without active renal involvement.

Methods. Data were prospectively collected from SLE patients (according to the ACR, SLICC, or EULAR/ACR classification criteria) undergoing treatment with ANI. Specifically, SLEDAI-2K, SLE Disease Activity Score (SLEDAS), painful/swollen joint count (SJT/TJC), and CLASI (Cutaneous LE Disease Area and Severity Index) were acquired before the start of therapy and subsequently every 3 months for the first year of therapy. Platelet count (PC) and lymphocyte count (LC), complement levels, anti-dsDNA antibody titers, and daily prednisone dose (PDN) were also collected at the same frequency. The SDI (SLICC/ACR damage index) was assessed at baseline and after 6 months. Finally, rates of remission (SLEDAI-2K=0 with PDN ≤5 mg/day), clinical remission (clinical SLEDAI-2K=0 with PDN ≤5 mg/day) and modified lupus low disease activity state (SLEDAI-2K ≤4 without major organ involvement and no new manifestations, with PDN≤7.5 mg/day) were obtained. The T-test and Wilcoxon test for paired data were used to compare the various timepoints.

Results. Since September 2023, 22 patients with SLE have been treated with ANI: of these, 11 (50%) for skin involvement, 10 (45%) for joint involvement, while hematological and serosal involvement were present in 4 (18%) and 2 (9%) patients, respectively. In 8 patients (36%), ANI was administered before conventional immunosuppressants (IS). Reductions in the mean SLEDAI-2K (p = 0.016 at 6 months and p = 0.007 at 9 months), SLEDAS (p < 0.001 at 6 months), CLASI (p = 0.008 at 6 months and p = 0.043 at 9 months), TCJ (p = 0.009 at 6 months and p = 0.033 at 9 months), SJC (p = 0.023 at 6 months) and LC (p = 0.021 at 6 months and p = 0.007 at 9 months) were encountered. No changes were found in PC, hypocomplementemia rates, elevated anti-dsDNA antibody titers or SDI at 6 months (Figure 1). A trend toward reduced prednisone use was observed. Rates of remission, clinical remission, and modified lupus low disease activity state are shown in Figure 2. Treatment was discontinued in 3 patients (2 due to ineffectiveness and 1 due to sepsis). There were no cases of herpes zoster.

Conclusions. ANI has been shown to reduce disease activity, with major impact in the cutaneous and articular domains. Further data are needed to evaluate its effect on hematological and serositis manifestations.