Clinical trials and drug discovery
Figure 2 Over 52 weeks, (A) BICLA response attainment in the overall patient group, and (B) CLASI-50 response attainment among patients with baseline CLASI-Activity score ≥10. A CLASI-50 response was defined as ≥50% reduction in CLASI Activity score from baseline. Patients treated with restricted medication beyond the protocol allowed threshold and those who discontinued study treatment were considered non-responders. Responder/non-responder rates, the difference in estimates and associated 95% CIs, and nominal p v alues were calculated using a stratified Cochran–Mantel–Haenszel approach, with stratification factors SLEDAI-2K score at screening, Day 1 GC dose, type I IFNGS test result at screening and study (TULIP-1 vs TULIP-2). Nominal p values for anifrolumab 300 mg vs placebo in IS-inexperienced: *p < 0.05; **p < 0.01; ***p < 0.001. Nominal p -values for anifrolumab 300 mg vs placebo in IS-experienced patients: ˆp < 0.05; ˆˆp < 0.01; ˆˆˆp < 0.001. BICLA, British Isles Lupus Assessment Group-based Composite Lupus Assessment; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; GC, glucocorticoid; IFNGS, type I interferon gene signature; IS, immunosuppressant; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.
at Week 52, regardless of IS experience (IS-inexperienced, 46.5% (59/127) vs 32.4% (42/130), p=0.0187; IS-expe- rienced, 48.1% (112/233) vs 30.0% (70/236), p < 0.0001) (figure 2A). Among patients with baseline CLASI Activity score ≥ 10, CLASI-50 response rates at week 52 favoured anifrolumab versus placebo in IS-experienced patients (68.6% (50/73) vs 46.1% (26/57), p=0.0091); a similar trend was seen in IS-inexperienced patients, though results did not reach nominal significance (52.7% (18/34) vs 44.1% (16/37), p=0.4678) (figure 2B). Thus, CLASI-50
response rates were lower with anifrolumab in IS-inexpe- rienced versus IS-experienced patients (52.7% (18/34) vs 68.6% (50/73)). Though nominal significance was reached only for IS-experienced patients, SRI(4) response rates at Week 52 were higher in anifrolumab- versus placebo-treated patients in both IS subgroups (IS-inexperienced, 54.4% (69/127) vs 46.4% (60/130), p=0.1988; IS-experienced, 51.1% (119/233) vs 37.1% (87/236), p=0.0020) (online supplemental figure 1).
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Doria A, et al . Lupus Science & Medicine 2026; 13 :e001891. doi:10.1136/lupus-2025-001891
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