Should you treat Lupus patients with Anifrolumab?

Описание: Why is there controversy over the phase III trials?

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The FDA recently approved the drug anifrolumab for use in people with systemic lupus erythematosus, also called SLE, or lupus for short. Anifrolumab is the first type 1 interferon receptor antagonist that can be used in lupus and one of the only new treatments approved to treat lupus in the last decade.

Anifrolumab’s phase II clinical trial showed patients with moderate to severe lupus had a notable decrease in arthritis and rash compared to the placebo group. But the phase III trial, called TULIP-1, failed to meet the study’s primary endpoint: the number of patients who achieved an SLE responder index of 4 after 52 weeks.

Researchers decided to change the primary endpoint of an almost-identical trial that was running in parallel to TULIP-1 and called it TULIP-2. The new primary endpoint would be patients who met BICLA after 52 weeks, making SRI-4 a secondary endpoint. The results of TULIP-2 suggest anifrolumab was effective at treating lupus, according to both metrics.

While it may be reasonable to assume BICLA might be better than SRI-4 at capturing partial responses to a drug or that SRI-4 puts more weight on arthritis than skin symptoms, this is probably not the case, since both TULIP-1 and TULIP-2 were almost identical studies. The likely explanation is simply that lupus is a hard disease to study, with many different types of the disease, some of which may or may not respond well to certain drugs.

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https://www.nejm.org/doi/10.1056/NEJM...
https://www.nature.com/articles/s4159...
https://www.ncbi.nlm.nih.gov/pmc/arti...
https://ard.bmj.com/content/73/1/183....

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