Ustekinumab Safe and Effective After Two Years in People with Active Lupus

In an extension of a phase II clinical drug trial, ustekinumab (Stelara®) was found to be a safe and effective treatment for lupus over two years of use. Researchers assessed multiple measures of disease improvement and found the medication was linked to clinical improvements in both overall and organ-specific disease activity measures.

Of the original 102 people enrolled in the initial phase II trial, 46 completed the long-term extension study: 24 people received ustekinumab since the very beginning of the trial (the “ustekinumab group”) while 14 started as part of the placebo group (a group receiving an inactive drug that has no treatment value) and then crossed over to ustekinumab treatment at week 24 (the “crossover group”).

Both groups benefitted from maintaining their treatment long-term:

• Both groups had at least a 4-point improvement from their baseline disease activity scores.
• 79% of the ustekinumab group and 93% of the crossover group had at least a 30% improvement in their physician global assessment score from baseline – a measure of overall disease activity based on a clinician’s evaluation.
• 86% of the ustekinumab group and 91% of the crossover group saw at least a 50% improvement in their joint pain and inflammation.
• 79% of the ustekinumab group and 100% of the crossover group benefitted from at least a 50% improvement in their skin disease activity scores.
• The drug did not cause any safety concerns after prolonged use.

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