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

Morand, EF; van Vollenhoven, R; Furie, RA; Kalunian, KC; Manzi, S; Abreu, G; Tummala, R; Duncan, EA; Al-Mossawi, H; Lindholm, C

doi:10.1016/j.ard.2025.01.016

Lupus low disease activity state (LLDAS) and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials

Ann Rheum DisPublished 30 Jan 2025Post hoc analysis of the TULIP-1/TULIP-2 randomised controlled trials and long-term extension

Primary result · In LLDASResultOdds ratio 2.7 95% CI 1.3–5.5

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Authors' conclusion

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.

Study context

Population: Patients with moderate to severe systemic lupus erythematosus (SLE) in TULIP-1/TULIP-2 who continued the same treatment in the 3-year long-term extension
Participants: 369 patients

Comparison: Intravenous anifrolumab 300 mg vs placebo once every 4 weeks
Anifrolumabn = 257
Placebon = 112reference
Primary endpoint: LLDAS attainment
Follow-up: Week 208

Methodological detailsphase 3, 52-week trials plus 3-year long-term extension, nominal P values

Phase 3
52-week trials plus 3-year long-term extension
Nominal P values

Primary result

In LLDAS · Week 208 (4 years)

Odds ratio

2.7

95% CI 1.3–5.5

P = 0.0081

By group

Anifrolumab36.9%

Placebo17.1%

Anifrolumabvs Placebo

OR 2.7 (95% CI 1.3–5.5); P = 0.0081

As reported in the abstract

Further findings

Outcome	Anifrolumab	Placebo	← Lower with anifrolumab ←→ Higher with anifrolumab →	Estimate	P value
DORIS remission · Week 208Nominal P · post hoc analysis	30.3%	18.3%	0.20.5125	OR for being in DORIS remission 1.9 (95% CI 1.0–3.9)	P = 0.0663
Time to first LLDASNominal P			0.20.5125	HR for first LLDAS attainment 1.56 (95% CI 1.18–2.09)	P = 0.0024
Time to first DORIS remissionNominal P			0.20.5125	HR for first DORIS attainment 1.50 (95% CI 1.04–2.22)	P = 0.0373
			0.20.5125Ratio (log scale)

Cumulative time in LLDAS and DORIS

Cumulative time in LLDAS greater with anifrolumab than placebo: P = 0.0004
Cumulative time in DORIS greater with anifrolumab than placebo: P = 0.0032

Nominal P values

Original publication

LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Ann Rheum Dis. Published 30 January 2025. doi:10.1016/j.ard.2025.01.016

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