LBO1 DORIS remission in patients with SLE treated with anifrolumab or placebo during the 4-year TULIP-LTE trial: post hoc analysis

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). 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 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].