AMBISPECTIVE, MULTICENTER REGISTRY OF TREATMENT WITH ANIFROLUMAB IN REAL LIFE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS FROM SPANISH RHEUMATOLOGY DEPARTMENTS (ANIFRO-REU): BASELINE CHARACTERISTICS

Background: Anifrolumab is a biological treatment with recent approval for systemic lupus erythematosus (SLE), supported by its efficacy in clinical trials. However, data from real clinical practice are lacking. Objectives: To describe the patient’s baseline clinical characteristics at the time of anifrolumab initiation and reasons for its prescription in patients with SLE under follow-up in Spanish Rheumatology Departments. Methods: Observational, uncontrolled, ambispective and multicenter study with medication of a cohort of patients with SLE (according to the 2019 EULAR/ACR criteria), treated in 19 Rheumatology departments. All patients who received at least one dose of anifrolumab and signed the informed consent were included. Sociodemographic, clinical, blood test variables and treatments, were collected. In addition, indexes or scales of activity (SLEDAI-2k, SFI, SLE-DAS, CLASI), damage (SLICC/ACR/DI), fatigue (FACIT), neuro-cognitive dysfunction (MoCA) and disease impact (LIT) of the baseline visit were calculated. A descriptive analysis of the sample was performed. Ethics Committee code: 2023/10814. Results: A total of 56 SLE patients were included. Table 1 shows the demographic, clinical characteristics and treatments of the patients. Graph 1 shows the main clinical manifestations that motivated the initiation of treatment with anifrolumab. Table 1. Demographic and clinic characteristics of the patients DEMOGRAPHIC Age at anifrolumab initiation 45.5 ± 12.9 Years from SLE diagnosis to anifrolumab initiation 14.2 ± 8.9 Age at SLE diagnosis 30.8 ± 13.6 Sex (women) 49 (87.5%) Ethnicity  Caucasian 46 (82.1%)  Hispanic 6 (10.7%)  Asian 2 (3.6%)  Arab 2 (3.6%) Active workers 27 (48.2%) SLEDAI Recent onset seizure 2 (3.6%) Psychosis 2 (3.6%) Organic brain syndrome 1 (1.8%) Visual disturbance 1 (1.8%) New onset sensory or motor neuropathy involving cranial nerves 1 (1.8%) Lupus headache 1 (1.8%) New onset stroke 1 (1.8%) Vasculitis 5 (8.9%) Arthritis 31 (55.4%) Myositis 1 (1.8%) Heme-granular or RBC urinary casts 1 (1.8%) Hematuria 1 (1.8%) Proteinuria 2 (3.6%) Pyuria 5 (8.9%) Inflammatory-type rash 34 (60.7%) Alopecia 22 (39.3%) Oral or nasal mucosal ulcers 22 (39.3%) Pleuritis 2 (3.6%) Pericarditis 2 (3.6%) Low complement CH50, C3, or C4 21 (37.5%) High DNA binding 20 (35.7%) Temp >38°C 3 (5.4%) Platelets <100 x 10 /L 4 (7.1%) WBC <3 x 10 /L 14 (25%) OTHER MANIFESTATIONS (NOT SLEDAI ) Diffuse interstitial lung disease 2 (3.6%) Hands tremor 1 (1.8%) Intense asthenia 5 (8.9%) Raynaud 2 (3.6%) SCALES AND ACTIVITY Flares 47 (83.9%) Severe flare 12 (21.4%) MoCA test 24.2 ± 6 LIT 49.3 ± 31.9 FACIT 24.4 ± 13.4 SLE-DAS 9.7 ± 6.4 SLICC/ACR DI 0.82 ± 1.1 SLEDAI 8.9 ± 7.1 PGA 2.4 ± 2.3 CLASI ACTIVITY 9.6 ± 9.5 CLASI DAMAGE 2.3 ± 3.9 TREATMENTS Hydroxychloroquine 46 (82.1%) Hydroxychloroquine dose 204.6 ± 102.2 Corticosteroids dose 48 (85.7%) Median ± SD dose of corticosteroids 9.5 ± 8.5 1 DMARDs at anifrolumab initiation 52 (92.9%) 2 DMARDs at anifrolumab initiation 16 (28.6%) 3 DMARDs at anifrolumab initiation 5 (8.9%) Type of previous DMARD  Methotrexate 28 (50%)  Leflunomide 7 (12.5%)  Azathioprine 6 (10.7%)  Mycophenolate 17 (30.3%)  Chloroquine sulfate 3 (5.4%)  Mepacrine 5 (8.9%)  Other 5 (8.9%) Previous biologic treatment 51 (91.1%) Type of previous biologic  Rituximab 13 (23.2%)  Belimumab 34 (60.7%)  Anti-TNFα 3 (5.4%)  Other 1 (1.8%) Graph 1. Main cause of anifrolumab initiation Conclusion: To date, in this registry, anifrolumab was initiated in a real-life setting in patients with a long disease evolution and refractory to several synthetic and biological treatments. Even though patients presented with a whole array of clinical manifestations, there was a clear predominance of the mucocutaneous ones. It remains to be elucidated, through systematic follow-up and the analysis of prospective data, if anifrolumab is just as effective when used in real-life clinical practice as compared to clinical trials. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: None declared. DOI: 10.1136/annrheumdis-2024-eular.2914 Keywords: Observational studies/ registry, Biological DMARD, Descriptive Studies Citation: , volume 83, supplement 1, year 2024, page 985Session: Systemic lupus erythematosus (Poster View)

Observational studies/ registry, Biological DMARD, Descriptive Studies