LUPUS LOW DISEASE ACTIVITY STATE ATTAINMENT AND REDUCED GLUCOCORTICOID USE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS IN THE TULIP LONG-TERM EXTENSION TRIAL OF ANIFROLUMAB

PV269 / #125 Poster Topic: AS24 - SLE-Treatment Background/Purpose Attainment of Lupus Low Disease Activity State (LLDAS) is associated with reductions in disease flares, damage accrual, oral glucocorticoid (GC) use, and mortality in patients with systemic lupus erythematosus (SLE). In a post hoc analysis of pooled data from the 52-week phase 3 TULIP-1/-2 trials, patients with SLE treated with anifrolumab were more likely to attain LLDAS compared with placebo.[1] Although criteria for attainment of LLDAS requires a GC dosage of ≤ 7.5 mg/day, the European Alliance of Associations for Rheumatology 2023 guidelines recommend ≤ 5 mg/day GC for patients with SLE.[2] In the present analysis, the long-term impact of anifrolumab treatment on LLDAS attainment together with GC reduction to ≤ 5 mg/day during the 3-year TULIP long-term extension (LTE) study was evaluated. Methods In the TULIP-LTE study ( NCT02794285 ), patients with moderate to severe SLE despite standard therapy received anifrolumab 300 mg or placebo as an extension of their assigned treatment in the 52-week TULIP-1/-2 trials.[3] Patients were followed from baseline (of TULIP-1/-2) through the LTE (Week 208). Response was defined as LLDAS attainment together with GC dose reduction to ≤ 5 mg/day (LLDAS+GC ≤ 5) at the same visit; response rates were analyzed using a stratified Cochran–Mantel–Haenszel method. Responses were also analyzed by disease onset (established [SLE diagnosis > 2 years prerandomization] vs recent onset [SLE diagnosis ≤ 2 years prerandomization]). LLDAS attainment was defined as (all): SLE Disease Activity Index 2000 ≤ 4 without major organ activity, no new disease activity, Physician’s Global Assessment (0-3) ≤ 1, prednisone/equivalent ≤ 7.5 mg/day, standard immunosuppressant dosing, no restricted medications (TULIP-1/-2 period only), and no investigational product discontinuation. Results LLDAS+GC ≤ 5 response rates were higher with anifrolumab treatment vs placebo overall throughout TULIP-LTE (Figure 1A; anifrolumab vs placebo, Week 52: 33.1% [81/254] vs 23.2% [25/108]; Week 208: 31.1% [58/194] vs 17.1% [11/65]). LLDAS+GC ≤ 5 response rates were higher through Week 208 with anifrolumab vs placebo in patients with established disease (Figure 1B; 29.1% [46/162] vs 13.7% [7/53]); treatment differences between groups were not consistent through Week 208 among patients with recent onset disease, given the small sample size. Figure 1. LLDAS+GC ≤ 5 in patients in the overall population (A) and by disease onset (B) treated with anifrolumab compared with placebo over the 3-year LTE period Conclusions Anifrolumab treatment was associated with higher rates of LLDAS attainment together with GC reduction to ≤ 5 mg/day vs placebo, overall and in patients with established disease. Thus, LLDAS attainment and GC reduction are treatment goals that can be achieved with anifrolumab. References: [1.] Morand EF. Ann Rheum Dis 2023;82:639-45. [2.] Fanouriakis A. Ann Rheum Dis 2024;83:15-29. [3.] Kalunian KC. Arthritis Rheumatol 2023;75:253-65. Acknowledgments: This study was sponsored by AstraZeneca. Writing assistance was provided by Tamara Fink, PhD, of JK Associates Inc., part of Avalere Health, and funded by AstraZeneca. Presented at EULAR 2024 and reused with permission of Morand E. Ann Rheum Dis 2024;83:958.

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