The results of AstraZeneca's Phase II trial of its drug anifrolumab appeared promising. Anifrolumab is a drug used to treat moderate to severe cases of systemic lupus erythematosus (SLE or lupus).
Its mid-stage trial revealed anifrolumab is more effective than another lupus drug they are currently testing, sifalimumab. The Phase III stage of the trial has started with a 30 mg dose of anifrolumab in July.
In the past 60 years, the only lupus drug introduced was Benlysta by GlaxoSmithKline. Lupus is a disease wherein the immune system attacks the organs and the joints. Unlike Benlysta, AstraZeneca's anifrolumab targets an inflammation-related protein called type 1 interferon (IFN) receptor, which plays a central role in lupus.
Findings showed that a 300 mg of anifrolumab produced results in 34.4 of patients after 169 days. After a year, the over 50 percent of patients responded to the drug. The researchers also found that need for oral corticosteroids had lowered among patients involved in the study. The results were presented at the 2015 annual meeting of the American College of Rheumatology in San Francisco, California on Nov. 6 to 11.
"These results provide very compelling evidence that blocking the type 1 interferon system with an inhibitor of the type I interferon receptor is a promising strategy for the treatment of SLE and support the progression of anifrolumab into Phase III," said Dr. Richard A. Furie from the North Shore-LIJ HEALTH System. Furie added that the lupus medical community had been waiting for clinical results of this magnitude for a long time.
While the results of the Phase II study showed promising results for lupus treatments, there were increased occurrences of influenza and shingles among patients involved in the study. The research team stressed that the incidents were promptly remedied with antiviral medications.
There are other pharmaceutical companies such as ImmuPharma and Anthera Pharmaceuticals currently testing their lupus drugs. In July, UCB's lupus drug epratuzumab failed to meet efficacy goals in their Phase III testing.
According to the Lupus Foundation of America, there are approximately 1.5 million Americans suffering from the illness, with over 16,000 new cases reported every year nationwide.