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Objectives In patients with SLE treated with ANI in clinical practice in Spain, our aim was to assess a) the profile of patients receiving ANI b) effectiveness and c) safety.Methods Observational multicenter study of patients diagnosed with SLE (EULAR/ACR 2019 classification criteria) treated with ANI. Demographic, clinical, laboratory, and pathologic variables were evaluated, along with previous and concomitant therapies, disease activity indices (SLE-DAS, SLEDAI-2K, PGA), organ damage index (SDI), and safety were evaluated.Results 206 patients (183 females/23 males), mean age 44.6 ± 12.6 years (range 15-90 years) (54 hospitals) were included. Baseline characteristics of patients and prior treatment before starting ANI are summarized in table 1.The main reason for starting ANI was clinical activity: cutaneous (61.7%), articular (48.5%), hematological (27.2%), corticosteroid dependence (5.4%), renal (4%), serositis (3%), serious adverse events with other immunosuppressants (1.9%), neurological (1%), and Kikuchi disease (0.5%).The mean number of immunosuppressants received prior to ANI was 2.5±1.6 (range 0-8). All patients received 300 mg/4 weeks of ANI except two patients with renal involvement who received a loading dose. In addition to corticosteroids and antimalarials, ANI was administered in many cases concomitantly with other immunomodulator drug (table 1).A rapid (from the 1st month) and maintained significant improvement was observed in: a) disease activity (SLE-DAS, SLEDAI-2K, PGA) (figure 1) b) immunologic markers (decrease in anti-dsDNA antibody titers and normalization of C3 and C4 levels) (figure 1) and c) prednisone dose (figure 2). The organ damage index remained stable.After a mean follow-up of 7.5 ± 5.3 months, a reduction in the number of relapses was observed (median [IQR] of 2 [1-6] prior ANI to 0 [0-0] after ANI (p<0.001). The most relevant adverse events were: herpes zoster (n=5), headache (n=3), upper respiratory tract infection (n=3) and pneumonia (n=3). 20 patients discontinued treatment due to primary failure (n=8), secondary failure (n=3), severe infections (n=6), hypotension (n=1), acute anterior uveitis (n=1), and pregnancy desire (n=1).Abstract PO:11:301 Figures and TableConclusions A rapid and maintained effectiveness was observed even in severe and refractory patients. The safety profile was acceptable with the limitation of short follow-up.