PO:14:195 | Real-world effectiveness of anifrolumab in achieving treatment targets and reducing systemic lupus erythematosus disease burden: 6-month interim analysis of the REVEAL study

Chiara Cardelli^1|2, Chiara Tani¹, Luca Moroni³, Filippo Vesentini⁴, Francesca Bottazzi⁵, Micaela Fredi⁶, Ettore Silvagni⁷, Matteo Piga⁸, Flavia Riccio⁹, Fulvia Ceccarelli¹⁰, Ginevra De Marchi¹¹, Edoardo Biancalana¹², Gianluca Moroncini¹³, Rita Mulè¹⁴, Mariele Gatto¹⁵, Laura Coladonato¹⁶, Paola Conigliaro¹⁷, Maria Gerosa¹⁸, Andrea Picchianti Diamanti¹⁹, Benedetta Bianchi²⁰, Federica Maiolini²⁰, Michela Gasparotto²⁰, Serena Guiducci²⁰, Maria Ilenia De Andres²⁰, Alberto Lo Gullo²⁰, Silvia Noviello²⁰, On Behalf Of The Reveal Investigators²⁰, Marta Mosca¹. | ¹Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa; ²Department of Medical Biotechnologies, University of Siena, Siena; ³Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Hospital, Milano; ⁴Rheumatology Unit, Department of Medicine, University of Padua, Padova; ⁵Department of Internal Medicine and Therapeutics, University of Pavia, Pavia; ⁶Rheumatology and Clinical Immunology, Department of Clinical and Experimental Sciences, University of Brescia, Brescia; ⁷Section of Rheumatology, Department of Medical Sciences, University of Ferrara; AOU Sant'Anna, Ferrara; ⁸Rheumatology Unit, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari;  ⁹Department of Precision Medicine, University of Campania Luigi Vanvitelli, Napoli; ¹⁰Rheumatology Unit, Dept. of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Roma; ¹¹Division of Rheumatology, Department of Medicine, Azienda Sanitaria Universitaria del Friuli Centrale, Udine; ¹²Internal Interdisciplinary Medicine Unit, Department of Experimental and Clinical Medicine, University of Florence, Firenze; ¹³Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona; ¹⁴Azienda Ospedaliero-Universitaria di Bologna, Internal Medicine and Rheumatology, IRCCS S. Orsola Malpighi, Bologna; ¹⁵Academic Rheumatology Centre, Department of Clinical and Biological Sciences, University of Turin; AO Mauriziano, Torino; ¹⁶Rheumatology Unit, Department of Precision and Regenerative Medicine and Ionian Area, University of Bari, Bari; ¹⁷Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, Tor Vergata University of Rome, Roma; ¹⁸Clinical Rheumatology, ASST Gaetano Pini CTO; Department of Clinical Sciences and Community Health, University of Milano, Milano; ¹⁹Department of Clinical and Molecular Medicine, Sapienza University of Rome; AOU Sant'Andrea, Roma, Italy; ²⁰Italian REVEAL Study Group Italy, Italy

Background. Following the recent approval of anifrolumab (ANI) for the treatment of moderate-to-severe Systemic Lupus Erythematosus (SLE), real-world data remain limited beyond those from clinical trials. Real-world eVidencE of Anifrolumab in systemic Lupus erythematosus (REVEAL) is a 5-years, multicenter, prospective, observational study designed to collect real-life data on ANI use, which are currently scarce especially from the patient’s perspective. This analysis evaluates the effectiveness of ANI in routine clinical practice and its impact on disease burden and patients’ quality of life (QoL).

Materials and Methods. Adult SLE patients (2019 EULAR/ACR criteria) were enrolled at ANI prescription across referral Italian centers. Data on demographics, clinical history, prior treatments and organ damage (SLICC-DI) were retrospectively collected from medical charts at enrolment. Patients were evaluated at baseline and after 1, 3 and 6 months of ANI treatment, assessing disease activity (SLEDAI-2K, SLE-DAS, Physician Global Assessment (PhGA), CLASI, joint count), concomitant therapies, and QoL through Patient Reported Outcomes (PROs, including Patient Global Assessment (PtGA), Lupus Impact Tracker (LIT) and FACIT-F). Achievement of remission (DORIS criteria) or low disease activity state (LLDAS5, modified from Franklin) at 3 and 6 months was assessed.

Results. We included 236 patients (92.8% female, 92.4% Caucasian) from 25 centers. ANI was most frequently prescribed for mucocutaneous (66.5%) and articular involvement (49.2%), followed by haematological manifestations (22.5%, mainly leukopenia (36/236, 15.3%) and thrombocytopenia (25/236, 10.6%)). Thirteen patients (5.5%) had fever attributable to SLE per SLEDAI-2K. Table1 depicts detailed baseline characteristics of the cohort. Notably, in 100 patients (42.4%) ANI was the first biologic and 20 (8.5%) were naïve to immunosuppressants; 38 patients (16.1%) started ANI within 2 yrs of SLE diagnosis. In 18 cases (7.6%) ANI was added to antimalarial monotherapy and 2 patients (0.8%) received ANI alone. As shown in Table2, all disease activity measures progressively improved, alongside a significant reduction in GCs daily dose. PROs also improved significantly, with changes detectable as early as week 4 and sustained over time (Table2, Figure1). At baseline, a significant correlation was observed between PtGA and SLEDAI-2K, SLE-DAS, PhGA and CLASI-activity (rs>=0.259, p<=0.001), between LIT and PhGA, CLASI-activity and tender joints (rs>=0.204, p<=0.03), and between FACIT-F and tender joints (rs=-0.256, p=0.036). As for treatment outcomes, at 3 months, 30/176 patients (17.0%) achieved remission and 85/176 (48.3%) were in LLDAS5; at 6 months, 37/140 (26.4%) were in remission and 80/140 (57.1%) reached LLDAS5.

Conclusions. In this real-world Italian cohort, ANI showed early and sustained effectiveness, with a substantial proportion of patients achieving remission or LLDAS5 by 6 months. The treatment was also associated with improved QoL and reduced GC exposure. These findings support ANI use in routine clinical settings and highlight the value of incorporating patient’s perspective in monitoring SLE outcomes.