Objective We investigated DORIS (Definition of Remission in SLE) attainment in patients with SLE in the placebo-controlled phase 3 TULIP long-term extension (LTE) trial of anifrolumab. DORIS attainment includes a requirement for a clinical SLEDAI-2K (cSLEDAI-2K) score of 0. Initial analyses of DORIS in the TULIP-LTE excluded all laboratory parameters in the calculation of cSLEDAI-2K,¹ consistent with the cSLEDAI-2K definition in the TULIP protocols. Here, we updated our analysis to align with the published DORIS definition by excluding only the serologic laboratory parameters from cSLEDAI-2K. Including both clinical laboratory parameters and manifestations provides a more complete understanding of patients’ status.

Methods Patients with moderate to severe SLE despite standard therapy could reconsent after the 52-week TULIP-1/-2 trials to participate in the randomized, double-blind, 3-year LTE (NCT02794285). We analyzed patients randomized to intravenous anifrolumab 300 mg or placebo for the 4-year TULIP-LTE. In this new analysis, DORIS attainment was defined as total cSLEDAI-2K score (sum of all SLEDAI-2K items except increased DNA binding and low complement) =0, physician global assessment <0.5, prednisone/equivalent dosage ≤5 mg/day, stable maintenance immunosuppressant doses, no restricted medication use (TULIP-1/-2 only), and no premature investigational product discontinuation. DORIS attainment was calculated using a stratified Cochran-Mantel-Haenszel approach.

Results We analyzed 369 patients (anifrolumab, n=257; placebo, n=112) who continued treatment in the LTE. Using the new analysis described above, 19.7% of anifrolumab-treated patients attained DORIS at the first LTE visit (Week 64) compared with 9.9% of the placebo group (treatment difference, ∆ [95% CI]=9.8% [0.6–19.1], nominal P=0.037); DORIS attainment rates increased from baseline throughout the trial (figure 1). Trends favoring anifrolumab versus placebo were observed up to Week 208 (30.3% vs 18.3%; ∆=12.0% [−0.6–24.6], nominal P=0.062).

• Download figure
• Open in new tab
• Download powerpoint

Abstract LBO1 Figure 1

DORIS attainment in patients with SLE during the 4-year TULIP-LTE study periods

Conclusion Remission is an important SLE treatment goal that protects from flares and organ damage. Anifrolumab treatment was associated with higher DORIS remission rates compared with placebo during the 4-year trial.

Acknowledgments Sponsor: AstraZeneca. Writing assistance: Rosie Butler, PhD, of JK Associates Inc. (Avalere Health).

Reference

1. van Vollenhoven, Morand, Furie, et al. Remission in patients with SLE treated with anifrolumab compared with placebo over a 4-year period [abstract]. Arthritis Rheumatol. 2023;75[supp 9].