Clinical trials and drug discovery
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
Andrea Doria , 1 Ronald F van Vollenhoven , 2 Eric F Morand , 3 Marta Mosca, 4 Jonatan Nåtman, 5 Miina Waratani, 6 Jacob Knagenhjelm, 5 Catharina Lindholm, 5 Danuta Kielar 6
To cite: Doria A, van Vollenhoven RF, Morand EF, et al . 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 2026; 13 :e001891. doi:10.1136/ lupus-2025-001891 ► Additional supplemental material is published online only. To view, please visit the journal online (https://doi.org/10.1136/ lupus-2025-001891).
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.
organ damage even at early disease stages, and this damage is cumulative. 1 2 Prompt initi- ation of treatments aimed at achieving remis- sion is recommended for patients receiving an SLE diagnosis. 3 Antimalarials such as hydroxychloroquine (HCQ), glucocorticoids WHAT IS ALREADY KNOWN ON THIS TOPIC ⇒ The efficacy and safety of anifrolumab have been demonstrated in a broad population of patients with moderate-to-severe systemic lupus erythemato- sus (SLE) who were receiving standard therapy in TULIP-1, TULIP-2 and the TULIP long-term extension study. ⇒ Recently updated treatment recommendations for SLE allow for the use of biologic therapies such as anifrolumab earlier in the treatment paradigm, be- fore use of immunosuppressants (IS), in patients with inadequate response to antimalarials (such as hydroxychloroquine) alone or in combination with glucocorticoids (GCs) or for patients who are unable to reduce GCs below doses acceptable for chronic use. ⇒ However, data on the efficacy of biologic therapies in patients with SLE based on prior IS use are limited. WHAT THIS STUDY ADDS ⇒ Results from this post hoc analysis of pooled TULIP-1/TULIP-2 data demonstrate that anifrolumab improves outcomes both for IS-experienced patients with moderate-to-severe SLE and for those with no reported IS use. HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY ⇒ These results suggest that anifrolumab may be ben- eficial alongside standard therapy in patients with SLE regardless of previous IS use.
Received 13 November 2025 Accepted 12 March 2026
For numbered affiliations see end of article. permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. © Author(s) (or their employer(s)) 2026. Re-use
Correspondence to Dr Catharina Lindholm; Catharina.Lindholm@ astrazeneca.com
INTRODUCTION Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can cause
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Doria A, et al . Lupus Science & Medicine 2026; 13 :e001891. doi:10.1136/lupus-2025-001891
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