Therapy Areas: Autoimmune
Janssen announces primary endpoint from Phase 2 study of STELARA (ustekinumab) in lupus patients
8 November 2017 -

Healthcare company Janssen Research & Development, LLC said on Tuesday that it has received encouraging results from a randomised, placebo-controlled Phase 2 study of the anti-interleukin (IL)-12/23 monoclonal antibody STELARA (ustekinumab) in the treatment of active systemic lupus erythematosus (SLE or lupus).

Lupus is a chronic, inflammatory autoimmune disease that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain. SLE can range from mild to severe and is characterised by inflammation of any organ system including kidneys, nervous system and brain.

The company added that the Phase 2 study study met the primary endpoint, with a significantly higher proportion of patients in the ustekinumab group showing improvements in lupus disease activity as measured by the SLE Responder Index (SRI)-4 response at week 24, compared with patients receiving placebo. About 60% of patients receiving ustekinumab showed significant reductions in lupus disease activity versus 31% of patients receiving placebo.

Under the Phase 2 study study, the patients were randomised (3:2) to receive intravenous (IV) ustekinumab 6 mg/kg or placebo (PBO) at week 0, followed by subcutaneous (SC) injections of ustekinumab 90 mg or placebo every eight weeks, both in addition to standard of care therapy for 24 weeks.

A pre-specified exploratory endpoint demonstrated that the risk of a new BILAG flare (at least one new BILAG A or at least two new BILAG B) was nominally significantly lower in the ustekinumab group compared with the placebo group. It plans to advance ustekinumab into Phase 3 development program based on Phase 2 results

In conjunction, the company is presenting the data as a late-breaking oral presentation at the 2017 ACR/ARHP Annual Meeting in San Diego.

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