Clinical trials and drug discovery
Figure 3 Mean (A) daily GC use over 52 weeks in the overall patient group and (B) the percentage of patients with baseline GC dosage ≥10mg/day who achieved GC taper to ≤7.5mg/day by week 40 and maintained GC ≤7.5mg/day from study Weeks 40 to 52. In (A), observed data are presented without any non-responder imputation for patients with premature anifrolumab discontinuation. In (B), maintained GC reduction was defined as all the following: reduction of GC dosage from a baseline dosage of ≥10mg/day to ≤7.5mg/day by week 40, maintained GC dosage ≤7.5mg/day from week 40 to week 52, no study treatment discontinuation, and no use of restricted medications beyond the protocol-allowed threshold before assessment. Response rates, difference in estimates and associated 95% CIs and nominal p values are calculated using a stratified Cochran–Mantel–Haenszel approach, with stratification factors SLEDAI-2K score, type I IFNGS test result at screening and study (TULIP-1 vs TULIP-2). The differences between the IS subgroups are descriptive only. GC doses are prednisone or equivalent. GC, glucocorticoid; IFNGS, type I interferon gene signature; IS, immunosuppressant; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.
between elevated serum IFN- α levels and SLE flares over 1 year in patients in remission. 17 There were some notable differences between the IS subgroups at baseline that may have confounded the
results. Fewer IS-inexperienced patients had BILAG severe scores, organ damage and anti-double-stranded DNA positivity at baseline compared with IS-experienced patients, suggesting that they may have had less severe
9
Doria A, et al . Lupus Science & Medicine 2026; 13 :e001891. doi:10.1136/lupus-2025-001891
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