Efficacy and safety of anifrolumab in patients with systemic lupus erythematosus without prior immunosuppressant use: post hoc analysis of phase 3 TULIP-1 and TULIP-2 trials

Clinical Snapshot

Key Findings

• P Value: DORIS: p=0.0242 (IS-inexperienced), p=0.0304 (IS-experienced); LLDAS: p=0.1718 (IS-inexperienced), p=0.0038 (IS-experienced)

• Effect Size: Absolute risk reduction of 10.2% in IS-inexperienced and 7.3% in IS-experienced patients for DORIS remission

• Primary Outcome: DORIS remission at Week 52: IS-inexperienced 16.2% vs 6.0% (p=0.0242); IS-experienced 14.6% vs 7.3% (p=0.0304)

• Nnt Or Sensitivity: NNT approximately 10 for DORIS remission in IS-inexperienced patients, 14 in IS-experienced patients

• Confidence Interval: Not reported

Clinical Application

Requires IV infusion facilities and monitoring for type I interferon-related adverse effects Relevant to Australian practice given TGA approval of anifrolumab; aligns with evolving RACGP and specialist rheumatology guidelines supporting early biologic intervention in appropriate SLE patients Adults with moderate-to-severe SLE, particularly those without prior immunosuppressant exposure

Abstract

OBJECTIVE: Although current treatment recommendations for systemic lupus erythematosus (SLE) provide the option for biologic agents without prior failure of immunosuppressants (IS), data on this treatment approach are limited. This study evaluates the efficacy and safety of anifrolumab by IS exposure. METHODS: Pooled data from the Phase 3 TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) trials were analysed post hoc to compare patients with moderate-to-severe SLE treated with intravenous anifrolumab 300 mg or placebo alongside standard therapy by reported IS use. Efficacy outcomes by IS use included Definition of Remission in SLE (DORIS) remission and Lupus Low Disease Activity State (LLDAS) attainment, analysed using a stratified Cochran-Mantel-Haenszel approach; all p values are nominal. Safety was summarised descriptively. RESULTS: In this analysis, 257 patients had no reported IS use (IS-inexperienced; anifrolumab 300 mg, n=127; placebo, n=130), and 469 were IS-experienced (anifrolumab 300 mg, n=233; placebo, n=236). At Week 52, DORIS remission and LLDAS attainment rates were higher with anifrolumab versus placebo in both IS subgroups (DORIS, IS-inexperienced, 16.2% vs 6.0%, p=0.0242; IS-experienced, 14.6% vs 7.3%, p=0.0304; LLDAS, IS-inexperienced, 34.0% vs 26.2%, p=0.1718; IS-experienced, 27.7% vs 16.2%, p=0.0038). Anifrolumab was well tolerated, regardless of reported IS history; safety was more favourable among IS-inexperienced versus IS-experienced patients. CONCLUSIONS: This post hoc analysis of pooled TULIP-1/TULIP-2 data supports the efficacy and tolerability of anifrolumab in patients with moderate-to-severe SLE regardless of IS treatment history.

References

1. 1.Doria, A., van Vollenhoven, R. F., Morand, E. F., Mosca, M., Nåtman, J., Waratani, M., Knagenhjelm, J., Lindholm, C., & Kielar, D. (2026). Efficacy and safety of anifrolumab in patients with systemic lupus erythematosus without prior immunosuppressant use: post hoc analysis of phase 3 TULIP-1 and TULIP-2 trials. Lupus Science & Medicine, Article lupus-2025-001891. https://doi.org/10.1136/lupus-2025-001891