AstraZeneca Succeeds in Treating Lupus in Late-Stage Study

By Reuters Staff

November 12, 2019

(Reuters) - AstraZeneca Plc said on Monday its experimental treatment anifrolumab significantly reduced disease activity in patients with systemic lupus erythematosus (SLE) in its late-stage study TULIP-2 study.

The results pit anifrolumab against GlaxoSmithKline Plc's Benlysta (belimumab) - the only new drug approved for lupus in the last 60 years.

Benlysta recorded 473 million pounds of global sales in 2018, up 26% from a year earlier.

In the trial of 365 patients on standard therapy for moderate-to-severe SLE, 47.8% of those who received anifrolumab experienced improvement in disease activity after 52 weeks of treatment, compared with 31.5% of patients on placebo, based on the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA).

In addition, more than half the patients on the intravenous treatment, administered every four weeks, were able to reduce their use of oral corticosteroids, compared with 30.2% of patients on placebo, the company said.

And 49% of patients receiving anifrolumab with moderate to severe skin disease experienced improved skin manifestations at week 12, the pre-specified timepoint, compared with 25% of patients receiving placebo

"(The) results demonstrated that, by targeting the type I interferon receptor, anifrolumab reduces overall disease activity, reduces corticosteroid use and improves skin manifestations," Eric Morand, principal investigator on the trial, said in a statement.

Data from TULIP-2 will be presented November 12 at the American College of Rheumatology (ACR) Annual Meeting in Atlanta. Data from TULIP-1 were presented today and published simultaneously in The Lancet Rheumatology. (http://bit.ly/2ND7IjG)

As previously disclosed, TULIP-1 did not meet its primary endpoint based on the SLE Responder Index 4 (SRI4) composite measure. However, analyses of secondary endpoints show efficacy consistent with TULIP 2 on BICLA response, reduction in oral steroid use, and improvement in skin disease activity.

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