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AstraZeneca reports successful monoclonal antibody studies in RA, SLE

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Two investigational monoclonal antibodies met primary endpoints in phase 2 studies involving patients with rheumatoid arthritis and systemic lupus erythematosus, AstraZeneca announced.

“Compelling phase 2 data from our two molecules — mavrilimumab for rheumatoid arthritis [RA] and sifalimumab for systemic lupus erythematosus [SLE] — further confirm our commitment to bringing new medicines to patients as quickly as possible,” Bahija Jallal, PhD, executive vice president of MedImmune, the global biologics research and development arm of AstraZeneca, said in a news release.

In a phase 2b study, 326 patients with moderate to severe RA were treated for 6 months with low, medium or high doses of mavrilimumab, a human monoclonal antibody that targets the alpha receptor for the cytokine granulocyte-macrophage colony-stimulating factor, or placebo, along with standard methotrexate. All doses of mavrilimumab met co-primary endpoints of American College of Rheumatology 20 response rate (ACR20) and Disease Activity Score 28 (DAS28).

The most effective dose was the highest, with an ACR20 response rate of 73.4% at week 24 compared with 24.7% for placebo and a reduction of mean DAS28 score of –1.9 vs. –0.68 for placebo at day 85 (P<.001, all).

Headache, nasopharyngitis, hypertension, bronchitis and RA worsening were commonly reported (>3%) adverse events, the release said.

In another phase 2 study, three doses of sifalimumab, a human monoclonal antibody targeting interferon-alpha, were compared against placebo when added to standard of care therapy in patients with moderate to severe SLE. Primary endpoint of the percentage of patients who responded by the SLE Responder Index at 1 year was met. While there was a “numerical increase” in herpes zoster reactivations, sifalimumab had an overall acceptable safety profile, the release said.

“Patients with lupus have severely limited options for control of their symptoms, as only one new treatment has been approved in more than 50 years,” Bing Yao, PhD, head of MedImmune’s Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit, said in the release. “There is clearly a sense of urgency to deliver new treatments for patients suffering from this debilitating, chronic disease, and we are hopeful that we will be able to offer a new option.”