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Clinical Trial
. 2025 May;84(5):777-788.
doi: 10.1016/j.ard.2025.01.016. Epub 2025 Jan 30.

LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials

Eric F Morand  1 , Ronald van Vollenhoven  2 , Richard A Furie  3 , Kenneth C Kalunian  4 , Susan Manzi  5 , Gabriel Abreu  6 , Raj Tummala  7 , Elizabeth A Duncan  7 , Hussein Al-Mossawi  8 , Catharina Lindholm  9
Affiliations
Free article
Clinical Trial

LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials

Eric F Morand et al. Ann Rheum Dis. 2025 May.
Free article

Abstract

Objectives: To investigate the long-term impact of anifrolumab versus placebo on lupus low disease activity state (LLDAS) and definition of remission in systemic lupus erythematosus (DORIS) attainment in patients with systemic lupus erythematosus (SLE).

Methods: This post hoc analysis included patients with moderate to severe SLE who were randomly assigned to receive intravenous anifrolumab 300 mg or placebo (once every 4 weeks) in the 52-week, phase 3 TULIP-1/TULIP-2 trials and continued with the same treatment in the 3-year long-term extension. LLDAS/DORIS rates over time were analysed using a stratified Cochran-Mantel-Haenszel approach and logistic regression. Time to first LLDAS/DORIS was estimated using Cox regression. Cumulative time and percentage of time in LLDAS/DORIS were assessed using an analysis of covariance. All P values are nominal.

Results: This analysis included 369 patients (anifrolumab n = 257, placebo n = 112). After 4 years of treatment (at Week 208), 36.9% of anifrolumab-treated patients versus 17.1% of placebo-treated patients were in LLDAS (odds ratio [OR], 2.7; 95% CI, 1.3-5.5; P = .0081); 30.3% versus 18.3% were in DORIS (OR, 1.9; 95% CI, 1.0-3.9; P = .0663). Time to first LLDAS and DORIS favoured anifrolumab versus placebo (LLDAS: hazard ratio, 1.56; 95% CI, 1.18-2.09; P = .0024; DORIS: hazard ratio, 1.50; 95% CI, 1.04-2.22; P = .0373). Cumulative time in LLDAS and DORIS was greater with anifrolumab than that with placebo (P = .0004 and P = .0032, respectively).

Conclusions: LLDAS and DORIS remission, which are associated with favourable outcomes such as reduced damage and mortality in patients with SLE, are attainable and sustainable treatment targets with long-term anifrolumab treatment.

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Conflict of interest statement

Competing interests EFM received research grants to his institution from AbbVie, Amgen, AstraZeneca, Biogen, BMS, EMD Serono, Eli Lilly, Janssen, GSK, Genentech, Novartis, Takeda, and UCB; received consulting fees from AbbVie, AstraZeneca, Biogen, BMS, EMD Serono, GSK, Gilead, and Novartis; received honoraria from AstraZeneca, EMD Serono, and Roche; received support for attending meetings and/or travel from EMD Serono and Roche; has WO2022074123A1, WO2021184080A1, WO2023044530A1, WO2021094378A1, and WO2023057369A2 patents planned, issued, or pending; has participated in advisory boards for EMD Serono, Janssen, BMS, Takeda, Biogen, GSK, and DragonFly; held/holds the Board Director position in Rare Voices Australia and Exosome Biosciences; and owns stock or stock options of Dragonfly Tx. RvV received grant support to his institution from Bristol Myers Squibb; received support for educational programmes to his institution from AstraZeneca, Galapagos, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB; received consultancy fees (institutional and/or personal honoraria) from AbbVie, AstraZeneca, Biogen, Bristol Myers Squibb, Galapagos, GSK, Janssen, Pfizer, RemeGen, and UCB; and received speaking fees (institutional and/or personal honoraria) from AbbVie, AstraZeneca, Bristol Myers Squibb, Galapagos, GSK, Janssen, Pfizer, and UCB. RAF received consulting fees, payment or honoraria, and support for attending meetings and/or travel from AstraZeneca and participated in Data Safety Monitoring or Advisory Boards for AstraZeneca. KCK has received consulting fees from AstraZeneca. SM received research grants from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Cartesian, and HGS/GSK; served as consultant for AstraZeneca, Eli Lilly, Exagen Diagnostics Inc, GSK, and UCB Advisory Boards; served as advisory consultant for Cartesian; has patents planned, issued or pending for Exagen Diagnostics, Inc (assignees: Allegheny Singer Research Institute, University of Pittsburgh); held/holds royalties for Exagen Diagnostics Inc; participated in a Data Safety Monitoring Board for NIAID; and served as Board Chair of the Lupus Foundation of America. GA is an employee of AstraZeneca. RT is a former employee of AstraZeneca. CL is an employee of AstraZeneca. EAD is a former employee and owns stocks of AstraZeneca. HA-M is a former employee of AstraZeneca; holds leadership or fiduciary roles in Immunocore; and owns stock or stock options in AstraZeneca and Immunocore.

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