Ab0526 evaluation of satisfaction and efficacy of switching from intravenous to subcutaneous belimumab in patients with systemic lupus erythematosus in daily clinical practice

Background In 2017, Belimumab (BEL) was approved in subcutaneous (SC) version [1]. The effectiveness after switching from intravenous (IV) to SC and patient satisfaction in daily clinical practice has not been studied. During the pandemic, patient follow-up and treatment were significantly affected, including the administration of IV biologic therapies. In some patients, a change from IV to SC, including BEL therapy, was required [2]. Objectives Our aim was to evaluate in daily clinical practice satisfaction to BEL SC therapy in patients previously treated IV BEL. We hypothesized that SC BEL in SLE patients previously treated with IV BEL was similar in effectiveness and conferred higher satisfaction. Methods Observational, multicenter study, conducted in 7 reference centres in Catalonia (Spain). Inclusion criteria: Stable SLE patients (EULAR/ACR 2019) on treatment with BEL SC and previous use of BEL IV (at least 3 months of treatment with BEL IV before switching). Since there are no well-validated tools for SC BEL treatment satisfaction, we used RASQ-SC, validated in patients with lymphoma who switched from Rituximab IV to SC treatment [3], modified for BEL treatment. Results Twenty-seven patients were included. Demographic and general characteristics are summarized in Table 1. The mean time from treatment with BEL IV before switch to SC was 26 (SD 21) months. 84% of patients reported confidence in BEL SC. 80% felt that treatment with BEL SC was convenient or very convenient. 85% felt they had gained time with the change. 89% would recommend the SC injection to other patients (Figure 1a,b,c,d). Disease activity (mean SLEDAI) and remission rates remain stable after switching. Patients did not require higher doses of glucocorticoids after the switch (Table 1). No major new side effects were reported. TABLE 1. Clinical and demographic characteristics DEMOGRAPHIC Age at inclusion (years), n (%) 45,9 (12,5) Female, n (%) 23 (85,2) Ethnicity, n (%) Caucasian 22 (81,5) Mestizo 4 (14,8) Maghrebi 1 (3,7) Current smoker, n (%) 10 (37) DISEASE CHARACTERISTIC Age at diagnosis (years), mean (sd) 28,8 (13,4) SLICC at the time of inclusion, mean (sd) 0,67 (0,88) Cumulative manifestations, n (% ) Fever 10 (37) Skin manifestation Malar rash 17 (63) Discoid lupus 4 (14,8) Lupus tumidus 1 (3,7) Acute cutaneous lupus 11 (40,7) Ulcers 17 (63,0) Alopecia 6 (22,2) Articular Arthralgias 27 (100) Arthritis 26 (96,3) Renal Proteinuria 3 (11,1) Serositis Pericarditis 4 (14,8) Pleuritis 11 (40,7) Neurological Myelitis 1 (3,7) Acute confusional state 1 (3,7) Hematological Leukopenia 18 (66,7) Lymphopenia 15 (55,6) Thrombocytopenia 2 (7,4) INMUNOLOGICAL ANA 27 (100) Anti-dsDNA 25 (92,6) Anti-Sm 10 (37) Lupus anticoagulant 5 (18,5) aCL 4 (14,8) Anti-B2GP1 4 (14,8) Low C3 21 (77,8) Low C4 20 (74,1) CHARACTERISTICS AT THE MOMENT OF LAST BELIMUMAB IV ADMINISTRATION Disease duration at the moment of initiation of BEL IV (months), mean (Sd) 153,4 (114,6) SLEDAI, mean (sd) 2,96 (2,4) Glucocorticoid treatment, n (%) 19 (70,4) Prednisone equivalent mg/d, mean (sd) 4,8 (6,3) Clinical remission, n (%) 19 (70,4) Serological remission, n (%) 10 (37) Complete remission, n (%) 8 (29,6) Mean time from treatment with BEL IV before switch to SC (months), mean (sd) 26,35 (21,3) LAST VISIT WITH BELIMUMAB SC Time since change (months), mean (sd) 30,9 (7,8) SLEDAI, mean (sd) 1,82 (2,02) Glucocorticoid treatment, n (%) 17 (63) Prednisone equivalent mg/d, mean (sd) 3,57 (2,34) Clinical remission BEL SC, n (%) 20 (74,1) Serological remission BEL SC, n (%) 14 (51,9) Complete remission BEL SC, n (%) 12 (44,4) Figure 1. RASQ-SC modified Conclusion Overall satisfaction, satisfaction with via of administration and satisfaction with the time taken to receive BEL were higher for SC BEL treatment. A switching SC strategy is a reasonable alternative for BEL patients. References [1]Stohl W, et al. Arthritis Rheum. 2017;69(5):1016–1027. [2]Mucke J, et al. Patient Prefer Adherence. 2019;13:1889-1894 [3]Theodore-Oklota C, et al. Patient Prefer Adherence. 2016;10:1767-1776 Acknowledgements: NIL. Disclosure of Interests None Declared.