Video
Safety Considerations for Vitiligo-Focused Drug Therapies
Safety considerations, particularly surrounding JAK inhibitors in vitiligo treatment, are emphasized by the panelists.
Jeffrey D. Dunn, PharmD, MBA: What role does the class black box warning play for you?
Brett King, MD, PhD: A very close look at the safety of JAK inhibitors shows that this is a safe class of medicines. It’s a relatively new class, with tofacitinib being approved for rheumatoid arthritis in late 2012, and now we have several more. But especially since early 2019, the new cycle has been dominated with safety of this class of medicines. Early this year, we saw the long-term postmarketing study of tofacitinib in the treatment of moderate-to-severe rheumatoid arthritis published in the New England Journal of Medicine. If one takes a very close look at that study and the patient demographics and risk factors, that was a study enriched in an at-risk population by design, and it wasn’t dangerous at all. The FDA doesn’t look at large data sets collected over years and say, “People are dying, but keep marketing this drug.” That study was enriched in patients who were at risk and didn’t show a particularly elevated risk.
When we think about JAK inhibitors in relatively healthy patients, such as our patients in dermatology with eczema, alopecia areata, and vitiligo, the risk-benefit proposition is balanced for the majority of the patients. That doesn’t mean that every provider isn’t going to have some risk mitigation strategy. Is an obese, inactive 65-year-old with uncontrolled cardiovascular disease a good candidate for an oral JAK inhibitor? We’re all going to agree that they aren’t. But most of our patients in dermatology probably are. Then when we think about a topical vs an oral, topical will be safe.
Transcript edited for clarity.
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