Results of two analyses from a Phase 2 study of Stelara® (ustekinumab) in lupus showed the drug’s effectiveness over one year. Both highlight the benefit of ustekinumab on disease activity and the rate of severe flares.
Ustekinumab reduced the rate of severe flares four times as much as placebo by week 24. The rate of flares went down further in weeks 24-48. The drug’s safety compared with that seen in other studies.
The second study looked at the same ustekinumab Phase 2 study using biomarker data. This could help explain how the drug works in lupus. Researchers collected the data over 24 weeks from patients who responded to ustekinumab and those who did not, as well as from those patients who received placebo. The analysis saw a link from response to treatment to novel biomarkers.
Stelara is sold by The Janssen Pharmaceutical Companies of Johnson & Johnson. It is approved by the FDA as a treatment for psoriasis, psoriatic arthritis, and Crohn’s disease. A Phase 3 worldwide lupus trial is underway. It is being tested through the Lupus Research Alliance Lupus Clinical Investigators Network (LuCIN) in sites across North America.
The Lupus Research Alliance is particularly excited about this study. Our analysis first saw the potential of Stelara® for lupus, and we asked Janssen to test its use in people with lupus.