Long-Term Safety and Efficacy of Trial Lupus Drug Stelara

In an extension of a phase 2 clinical drug trial, the treatment Stelara showed long-term favorable results for people with active lupus after taking the medication for two years. Both overall disease activity and organ-specific involvement improved in those receiving the treatment.

Stelara, a drug administered as an intravenous (IV) infusion or injection under the skin, is already approved as a treatment for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Earlier results of the phase 2 study showed that the therapy safely and effectively reduced lupus disease activity in study participants after 24 weeks. In the latest drug trial extension, 46 of the original participants agreed to continue the treatment long-term. After 112 weeks (a little over two years), the vast majority of people (34 participants) saw improvements in their overall disease activity, as well as improvements in joint pain and inflammation and skin disease.

No new or unexpected safety concerns arose after long-term treatment. After 120 weeks, 17 of the participants treated with Stelara experienced a serious health event, such as a serious infection. Most serious health complications occurred within roughly the first year of treatment, and researchers determined that the major health complications – two heart-related events – were not caused by the treatment.

For the latest breaking news on Stelara and other lupus drug developments, continue to follow the Lupus Foundation of America. Learn more about medications used to treat lupus.

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