Disease-modifying effect and long-term safety of belimumab in patients with systemic lupus erythematosus: A single-center retrospective study.

Autor: Nakai T; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo, Japan., Fukui S; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo, Japan.; Center for Clinical Epidemiology, St Luke's International University, Tokyo, Japan.; Department of Emergency and General Medicine, Kyorin University School of Medicine, Tokyo, Japan.; Division of Rheumatology, Inflammation, and Immunity, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, MA, USA., Sawada H; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo, Japan.; Department of Medicine, John A. Burns School of Medicine, University of Hawaii, Honolulu, HI, USA., Ikada Y; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo, Japan., Tamaki H; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo, Japan., Kishimoto M; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo, Japan.; Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan., Okada M; Immuno-Rheumatology Center, St Luke's International Hospital, Tokyo, Japan.
Jazyk: angličtina
Zdroj: Lupus [Lupus] 2023 Nov; Vol. 32 (13), pp. 1518-1527. Date of Electronic Publication: 2023 Oct 19.
DOI: 10.1177/09612033231208845
Abstrakt: Background: Disease modification in systemic lupus erythematosus (SLE) is important for minimizing disease activity while limiting treatment-associated toxicities. Belimumab can be used as a remission-induction/maintenance systemic lupus erythematosus therapy; however, its disease-modifying effects are unclear. We aimed to determine these effects in patients with systemic lupus erythematosus.
Methods: This single-center retrospective cohort study included 92 patients with systemic lupus erythematosus treated with belimumab. We analyzed the changes in flare free rate/lupus low disease activity state (LLDAS) attainment rate/glucocorticoid dosage/Systemic Lupus International Collaborating Clinics and American College of Rheumatology damage index (SDI) score/drug retention rate after treatment initiation.
Results: Fifty-two weeks after initiating belimumab, the flare rate decreased from 82.6% to 14.1% ( p < .01). Until week 52 and 1000 days after initiating belimumab treatment, > 70% and ∼90% of the patients attained lupus low disease activity state, respectively. Belimumab treatment significantly reduced glucocorticoid demand (initiation day, 8.88 (6.00-15.00) mg/d; week 52, 5.00 (2.00-7.00) mg/d; final day of the study period, 3.00 (0.46-6.06) mg/d, initiation day vs. week 52: p < .01, initiation day vs. final day: p < .01); at the end of the study period, 68.5% of patients required ≤5 mg/d prednisolone, and 22.8% discontinued glucocorticoids. Most patients were SDI progression-free (week 52, ∼95%; day 1000, ∼90%), and belimumab showed a high drug retention rate (week 52, 90%; day 1000 > 80%).
Conclusion: Most patients experienced lupus low disease activity state, reduced flare rate and glucocorticoid demand, and a stable SDI trend after belimumab treatment initiation. Given its efficacy and retention rate, belimumab treatment may serve as a fundamental strategy in disease modification.
Competing Interests: Declaration of conflicting interestsHT received personal fees from Chugai pharmaceutical, AbbVie, Ono pharmaceutical, Kyowa-Kirin, Takeda Pharmaceutical, Astellas Pharma, Tanabe-Mitsubishi, and Ayumi outside the submitted work. MK received consulting fees and/or honoraria from AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma. MO received speaking fees and/or honoraria from Eli Lilly and Company, Santen Pharmaceutical, Mitsubishi Tanabe Pharma, Pfizer, and Abbott, Japan. The other authors have no conflicts of interest to declare.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje