New Drug Trial Finds Ustekinumab May Not Be Effective for Treatment of Lupus

Though earlier clinical trials have suggested ustekinumab (Stelara®) may be an effective therapy for the treatment of systemic lupus erythematosus, the latest research findings call the drug’s efficacy into question.

In a phase III clinical trial, researchers analyzed data from 289 people with active lupus. Participants were randomly assigned to receive treatment with ustekinumab or a placebo (an inactive pill, liquid or powder with no treatment value) every eight weeks for 48 weeks. At the end of the trial period, researchers found that ustekinumab did not result in significantly different outcomes compared to the placebo:

• Of those receiving ustekinumab, 44% saw overall benefits in disease activity compared to 56% of those who received the placebo.
• There were comparable rates of disease flares in both groups: 28% in ustekinumab group and 32% of the placebo group.
• On average, the first flares occurred around roughly the same time after treatment initiation, with those in the ustekinumab group having their first flare after at after about 204 days and those in the placebo group having their first flare after roughly 200 days.
• By the end of the trial, 70% of the ustekinumab group and 75% of the placebo group had at least one adverse event, such as an infection.

While the earlier phase II trial found that a significantly greater portion of people treated with ustekinumab saw clinical improvements compared to the placebo group, the new phase III study did not find sufficient evidence to support the continued use of this therapy for the treatment of lupus.

However, many more medications are currently being investigated for the advancement of lupus treatment and the future of lupus drug development is bright. Continue to follow the Lupus Foundation of America for breaking drug research news.

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