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\n <\/figure>\n\u201cWe chose to study the subcutaneous administration of Saphnelo because we wanted to see if we could help even more patients achieve the benefits of DORIS-defined remission and lower disease activity in a more flexible and convenient way,\u201d she added.<\/p>\n
The multinational, phase 3, double-blind, placebo-controlled TULIP-SC trial assessed subcutaneous anifrolumab for efficacy and safety in adults with moderate to severe SLE. Eligible participants had received standard SLE therapy.<\/p>\n
\u201cPatients with SLE have a higher risk for early death and an estimated 50% have irreversible organ damage within 5 years of diagnosis due to disease activity and chronic oral corticosteroid use,\u201d Manzi said. <\/p>\n
The interim analysis included 109 adults with SLE assigned anifrolumab 120 mg and 111 adults with SLE assigned placebo on the same schedule for 52 weeks. Treatment difference in BILAG-based Composite Lupus Assessment (BICLA) response at 52 weeks served as the primary endpoint for the interim data set. Meanwhile, the full analysis assessed key secondary and other endpoints.<\/p>\n
Results at the interim timepoint showed that anifrolumab bested placebo as assessed by the primary outcome measure, 59.4% vs. 43.9% (BICLA response difference =15.5%; P<\/i> = .0211), according to the researchers.<\/p>\n
The full analysis included 184 patients assigned anifrolumab and 183 assigned placebo. <\/p>\n
According to the results of that assessment, 56.2% of participants in the anifrolumab group, and 34% participants in the placebo group, achieved BICLA response while patients maintained low or reduced doses of oral glucocorticoids through 52 weeks (P<\/i> < .0001). Moreover, time to sustained BICLA response was reduced in the anifrolumab group, compared with placebo (HR = 2.2; P<\/i> < .0001). <\/p>\n
Further assessment at 52 weeks showed that anifrolumab bested placebo in terms of both DORIS remission (treatment difference = 14.2%; P<\/i> = .0012) and Low Lupus Disease Activity State (treatment difference = 14.1%; P<\/i> = .0038). <\/p>\n
Serious adverse events occurred in 11.9% of patients assigned active therapy, and in 10.4% of those assigned placebo. Herpes zoster was reported in 3.8% of participants in the anifrolumab group and 1.1% of those in the placebo group.<\/p>\n
\u201cThe TULIP-SC results are clinically meaningful and provide confidence that the efficacy and DORIS-defined remission rates that we have seen with Saphnelo IV can be achieved in a new subcutaneous administration,\u201d Manzi said. \u201cThis self-administration of Saphnelo offers the potential for even more patients to achieve the clinically meaningful benefits of the treatment with greater flexibility and convenience.\u201d<\/p>\n
For more information:<\/h2>\n
Susan Manzi, MD, MPH,<\/b> can be reached at Sonali.Ranasoma@edelman.com. <\/p>\n\n
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