Risk of flare and damage accrual after tapering glucocorticoids in modified serologically active clinically quiescent patients with systemic lupus erythematosus: a multinational observational cohort study

Author:

Katsumata YasuhiroORCID,Inoue Eisuke,Harigai MasayoshiORCID,Cho JiacaiORCID,Louthrenoo Worawit,Hoi AlbertaORCID,Golder Vera,Lau Chak Sing,Lateef Aisha,Chen Yi-Hsing,Luo Shue-Fen,Wu Yeong-Jian Jan,Hamijoyo LaniyatiORCID,Li Zhanguo,Sockalingam Sargunan,Navarra Sandra,Zamora Leonid,Hao YanjieORCID,Zhang ZhuoliORCID,Chan Madelynn,Oon Shereen,Ng Kristine,Kikuchi JunORCID,Takeuchi TsutomuORCID,Goldblatt Fiona,O’Neill Sean,Tugnet Nicola,Law Annie Hui NeeORCID,Bae Sang-CheolORCID,Tanaka YoshiyaORCID,Ohkubo Naoaki,Kumar Sunil,Kandane-Rathnayake RangiORCID,Nikpour Mandana,Morand Eric FORCID

Abstract

Objectives To assess the risk of flare and damage accrual after tapering glucocorticoids (GCs) in modified serologically active clinically quiescent (mSACQ) patients with systemic lupus erythematosus (SLE). Methods Data from a 12-country longitudinal SLE cohort, collected prospectively between 2013 and 2020, were analysed. SLE patients with mSACQ defined as the state with serological activity (increased anti-dsDNA and/or hypocomplementemia) but without clinical activity, treated with ≤7.5 mg/day of prednisolone-equivalent GCs and not-considering duration, were studied. The risk of subsequent flare or damage accrual per 1 mg decrease of prednisolone was assessed using Cox proportional hazard models while adjusting for confounders. Observation periods were 2 years and censored if each event occurred. Results Data from 1850 mSACQ patients were analysed: 742, 271 and 180 patients experienced overall flare, severe flare and damage accrual, respectively. Tapering GCs by 1 mg/day of prednisolone was not associated with increased risk of overall or severe flare: adjusted HRs 1.02 (95% CI, 0.99 to 1.05) and 0.98 (95% CI, 0.96 to 1.004), respectively. Antimalarial use was associated with decreased flare risk. Tapering GCs was associated with decreased risk of damage accrual (adjusted HR 0.96, 95% CI, 0.93 to 0.99) in the patients whose initial prednisolone dosages were >5 mg/day. Conclusions In mSACQ patients, tapering GCs was not associated with increased flare risk. Antimalarial use was associated with decreased flare risk. Tapering GCs protected mSACQ patients treated with >5 mg/day of prednisolone against damage accrual. These findings suggest that cautious GC tapering is feasible and can reduce GC use in mSACQ patients.

Funder

Bristol-Myers Squibb

National Research Foundation of Korea

Janssen Pharmaceutica

Merck Serono

Japanese MEXT (the Ministry of Education, Culture, Sports, Science and Technology) KAKENHI

Eli Lilly and Company

AstraZeneca

GlaxoSmithKline Australia

UCB

Publisher

BMJ

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