1. Real-world effectiveness of intravenous belimumab in adults with systemic lupus erythematosus: results of the observational OBSErve study in the Russian Federation.
- Author
-
Lila AM, Aseeva EA, Zagrebneva AI, Vinogradova IB, Samigullina RR, Khamashta M, Elfishawy T, Teichman L, Dos Santos D, Queiroz J, Kniazeva LA, and Noibi S
- Abstract
Background: The real-world effectiveness of intravenous (IV) belimumab in treating systemic lupus erythematosus (SLE) has been demonstrated in various countries through the OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) program. Here we describe the clinical effectiveness of IV belimumab for treating SLE in real-world clinical practice in the Russian Federation., Methods: In the retrospective, observational OBSErve Russia study (GSK Study 215349), eligible physicians enrolled adults with SLE receiving IV belimumab as part of their standard care. De-identified data were collected from patient medical records from September 2021 to March 2022. The primary outcome was the physician-assessed overall clinical response at 6 months post-index versus index (belimumab initiation) among patients receiving belimumab for ≥6 months. Other endpoints included change in Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score and glucocorticoid use., Results: Overall, 59 patients initiated IV belimumab, mainly due to the previous regimen not being effective and to decrease glucocorticoid use (76.3% each); 15.3% of patients started belimumab within the first year of SLE diagnosis. Only 13.6% of patients discontinued belimumab within the first 6 months, mainly due to loss to follow-up and loss of insurance/reimbursement. At 6 months post-index, among patients who completed ≥6 months of belimumab therapy (full analysis set, n = 53), 90.6% and 60.4% had an overall clinical improvement of ≥20% and ≥50%, respectively. Mean (standard deviation, SD) change in SELENA-SLEDAI score from index to 6 months post-index was -5.9 (4.3). Mean (SD) glucocorticoid dose decreased from 12.2 (7.3) mg/day at index to 8.6 (5.1) mg/day at 6 months post-index (n = 50)., Conclusions: Patients with SLE receiving IV belimumab for 6 months in real-world settings in the Russian Federation experienced overall clinical improvements and reductions in glucocorticoid use, which is an important long-term strategy of SLE treatment., Competing Interests: Declarations. Ethics approval and consent to participate: This study was conducted in accordance with the Guidelines for Good Pharmacoepidemiology Practices and the Declaration of Helsinki 2008 and approved by the Ethics Committee at the City Clinical Hospital No 52 of the Department of Healthcare of Moscow for the Moscow Rheumatology Centre site, the Ethics Committee at the North-West State Medical University named after I.I. Mechnikov of the Ministry of Health of the Russian Federation for the North-western State Medical University named after I.I. Mechnikov site, the Ethics Committee at the Ulyanovsk Regional Clinical Hospital for the Ulyanovsk Regional Clinical Hospital site, and the Ethics Committee at the Research Institute of Rheumatology named after V.A. Nasonova for the Research Institute of Rheumatology site. The requirement for patient informed consent was waived by the corresponding Ethics Committees listed above for each involved center as the study was non-interventional, and patient data were de-identified. Consent for publication: Not applicable. Competing interests: AML, EAA, AIZ, IBV, and RRS have received grants from GSK during the conduct of the study. MK, LT, JQ, and SN are employees of GSK. DdS and TE were employees of GSK at the time of the study. MK, TE, and SN hold financial equities in GSK. LAK is a former employee of GSK and a current employee of No. 1 Medical Center, Department of Rheumatology, Kursk, Russian Federation., (© 2025. The Author(s).)
- Published
- 2025
- Full Text
- View/download PDF