Background/Purpose: In 2 phase 3 trials, TULIP-1 and TULIP-2, anifrolumab, a type I IFN receptor mAb, improved disease activity in patients with SLE.^1,2 Here, we compared the efficacy of anifrolumab in patients with recent onset vs established SLE disease (defined by time since diagnosis), using pooled data from the TULIP trials.

Methods: TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) were randomized, placebo-controlled, 52-week trials of intravenous anifrolumab 300 mg every 4 weeks for 48 weeks in eligible patients who fulfilled the ACR 1997 criteria for SLE and had moderate to severe SLE despite standard therapy.^1,2 Baseline characteristics and BILAG–based Composite Lupus Assessment (BICLA)³ response rates at Week 52 for anifrolumab 300 mg vs placebo were compared between patients who at the time of their baseline study visits were within 2 years of their SLE diagnosis (recent onset) and patients who were diagnosed beyond 2 years (established). Efficacy was analyzed with a stratified Cochran–Mantel–Haenszel approach controlling for randomization stratifications factors and study.

Results: Of the 726 patients included from TULIP-1 and TULIP-2 (anifrolumab, n=360; placebo, n=366), 594 had established disease (anifrolumab, n=301; placebo, n=293), and 132 had recent onset disease (anifrolumab, n=59; placebo, n=73) at baseline. In contrast to patients with recent onset disease, patients with established disease had a higher median age (43 vs 37 years), were more likely to be female (94.1% vs 87.1%), and less likely to be black (12.1% vs 16.7%). At baseline, patients with established disease were more likely to be IFN gene signature high (83.5% vs 78.8%), anti-dsDNA antibody-positive (45.6% vs 38.6%), have ≥1 BILAG-2004 A item (49.7% vs 43.9%), have a higher mean global SDI score (0.7 vs 0.1), and be receiving oral glucocorticoids (83.2% vs 76.5%), and immunosuppressants (49.8% vs 40.9%), but not anti-malarials (69.5% vs 78.0%) (Table). The numbers of BILAG-2004 A or B items across organ domains at baseline were comparable in patients with established or recent onset disease, excluding the renal domain, where a higher proportion of patients with established disease had more severe scores (A or B items; 8.9% vs 3.0%) (Figure). Treatment benefit of anifrolumab vs placebo, assessed by BICLA response at Week 52, was observed in patients with established (difference [95% CI] 17.1% [9.3–24.8], nominal P<0.001) and recent onset disease (difference [95% confidence intervals (CI)] 14.4% [−2.2–31.1], nominal P=0.090).

Conclusion: Data from the TULIP trials support the efficacy of anifrolumab in patients with SLE who have either established or recent onset disease.

1. Furie RA. Lancet Rheumatol. 2019;1:e208–19.

2. Morand EF. N Engl J Med. 2020;382:211–21.

3. Wallace DJ. Ann Rheum Dis. 2014;73:183–90.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/anifrolumab-results-in-favorable-responses-regardless-of-sle-disease-duration-post-hoc-analysis-of-data-from-2-phase-3-trials/