PO:16:231 | Differential clinical features of systemic lupus erythematosus patients on biological therapies: insights from a monocentric cohort

Pietro Francesco Pilo, Elisa Bellis, Claudia Garulli, Claudio Cruciani, Marta Saracco, Claudia Lomater, Elena Marucco, Gloria Crepaldi, Valeria Data, Annamaria Iagnocco, Mariele Gatto. | Academic Rheumatology Centre, Department of Clinical and Biological Sciences, University of Turin, AO Mauriziano, Torino, Italy.

Background. to compare the clinical profile of patients prescribed with either BEL or ANI and assess preliminary efficacy of ANI in a monocentric cohort of systemic lupus erythematosus (SLE) patients.

Methods. we performed an observational study on consecutive patients with active SLE prescribed with a biological drug at our clinic between July 2023 to July 2024, with a follow-up of at least 6 months from baseline (start of biologic). Clinical, demographic and serological data were collected at baseline, at 3 and 6 months. Disease activity was measured through the SLE-disease activity index 2000 (SLEDAI-2K) and the SLE-disease activity score (SLEDAS) including assessment of active serology. For skin involvement, ANI patients had their CLASIa (Cutaneous LE Disease Area and Severity Index) calculated. Comparisons between continuous and categorical variables were carried out using parametric or non parametric tests as appropriate. We used Friedman’s test to repeat measures and compare paired samples. Categorical variables were expressed as n (%) and continuous variables as mean±standard deviation (SD).

Results. we included 15 SLE patients (Table 1) with a mean follow-up of 8.90 (6.10) months since start of biologic, receiving either BEL (7, 46.6%) or ANI (8, 53.4%). The main organ involvement encompassed skin rash and arthritis in the ANI group (both 62.5%), and skin rash (41%) and arthritis (71%) in the BEL group. BEL and ANI group did not differ in terms of baseline disease activity; more patients were serologically active (positive anti-dsDNA and/or low complement) in the BEL group while not reaching statistical significance. Organ damage was significantly lower at baseline in the BEL group. Out of 8 patients on ANI, 3 (37.5%) had to stop the drug after a mean time of 3.50±2.78 months due to inefficacy (1 case) or adverse events (2 cases: recurrent vaginal bleeding and pneumonia requiring ICU admission). No withdrawals were seen in the BEL group within the follow-up. Both SLEDAI-2K and SLEDAS decreased significantly in both ANI and BEL groups (Table 2). ANI patients further displayed a significant decrease in CLASIa as well between baseline and T6 (10.71±10.57 vs. 3.14±5.39, p=0.023), indicating improvement of skin involvement. Prednisone daily dosage was quickly tapered in the BEL group Relative to ANI group, patients prescribed with BEL had received a significantly lower number of traditional immunosuppressants before the initiation of the biological drug (p<0.001, Table 1); no patients on BEL had received any other biologic before.

Conclusions. in our consecutive cohort of SLE patients receiving biologics in the last 18 months, both drugs showed similar efficacy in decreasing disease activity. BEL was prescribed earlier than ANI in disease history and confirmed a steroid-sparing potential, underscoring the importance of early treatment in active SLE.