PO:16:236 | Achieving a low disease activity state with a corticosteroid dose of 5 mg or less: observational study with anifrolumab in patients with systemic lupus erythematosus in Italy

Alessandra Bortoluzzi¹, Fulvia Ceccarelli², Fabio Leo³, Paola Roccatagliata³, Chiara Tani⁴, Margherita Zen⁵ | ¹Azienda Ospedaliera Universitaria Sant' Anna di Cona, Università di Ferrara Italy; ²Unità di Reumatologia, Università Sapienza Roma Italy; ³AstraZeneca S.p.a. Milano Italy; ⁴Università di Pisa e Azienda Ospedaliero Universitaria Pisana, Pisa Italy; ⁵Dipartimento di Medicina DIMED , Divisione di Reumatologia, Università di Padova, Italy

Background. Despite recent improvements in the management of systemic lupus erythematosus (SLE), patients still face a high risk of morbidity and mortality. Sustained remission is the goal of SLE management, although it is rarely achieved in clinical practice. When remission cannot be reached, the Lupus Low Disease Activity State (LLDAS) represents an alternative Treat-to-Target objective. In Italy, real-world data are lacking on the achievement and maintenance of LLDAS, remission, and corticosteroid tapering in patients treated with anifrolumab. Therefore, a study was designed with the primary objective of describing the proportion and characteristics of patients who achieve LLDAS5 and remission during treatment with anifrolumab in Italian clinical practice, and with the secondary objective of defining a glucocorticoid tapering scheme to inform clinical practice.

Materials and Methods. DAHLIA is an Italian, multicenter, prospective, observational cohort study conducted in accordance with Good Clinical Practice (GCP). The study population will include 245 Italian adult patients of both sexes with SLE, according to EULAR/ACR criteria, who are prescribed initiation of anifrolumab therapy for the first time in the context of routine Italian clinical practice, in line with the approved and reimbursed label. The primary objective is to describe the proportion and characteristics of patients who achieve LLDAS with a corticosteroid (prednisone) dose equal to or less than 5 mg (LLDAS5) at week 52. Secondary objectives include assessment of the estimated cumulative probability of achieving LLDAS5 over the course of the study; the percentage of flares following glucocorticoid reduction to a dose equal to or less than 5 mg/day; the cumulative probability of achieving DORIS remission; the persistence of DORIS remission; and the description of a glucocorticoid tapering scheme used in routine clinical practice. The sample size was estimated based on results from analyses of LLDAS achievement in the TULIP trials, the number of participating centers, and the potential study dropout rate. The study period for each participant will last 104 ± 1 weeks from treatment initiation or until discontinuation of anifrolumab, loss to follow-up, or death. Participating patients, who do not attend the visit after the first infusion, will be included only in the safety analysis. Data will be collected starting from the first day of anifrolumab treatment, as part of routine clinical practice.

Conclusions. The multicenter observational DAHLIA study will collect real-world evidence from Italian clinical practice, identifying the characteristics of patients treated with anifrolumab who achieve the LLDAS5 target and DORIS remission. In addition, it will help to identify a glucocorticoid tapering scheme in patients with SLE treated with anifrolumab.