Black box warnings for JAK inhibitors arise from rheumatoidarthritis studies, leading one expert to question the risk-benefit relevance to dermatologic diseases, particularly in younger patients. DermTwitter AAD2023
Ted BosworthNEW ORLEANS — All but one Janus kinase inhibitor with dermatologic indications carries a black box warning that lists multiple risks for drugs in this class, including the risk of major adverse cardiac events , even though the basis for all the risks is a rheumatoid arthritis study, according to a critical review at the American Academy of Dermatology 2023 Annual Meeting.
In fact, despite a study enriched for a higher risk of many events tracked, most adverse events were only slightly elevated, King pointed out. For example, the incidence of MACE over the 4 years of follow-up was 3.4% among those taking any dose of tofacitinib versus 2.5% of those randomized to TNF inhibitor. Rates of cancer were 4.2% versus 2.9%, respectively.
For the RA diseases, upadacitinib was associated with a greater risk than comparators for several outcomes, including serious infections. But in AD, there was a smaller increased risk of adverse outcomes for the JAK inhibitor relative to comparators. "Is a 30-year-old patient with a dermatologic disorder possibly at the same risk as the patients in the study from which we got the boxed warning? The answer is simply no," he said.
"We need to think carefully about the risk-to-benefit ratio in older patients or patients with risk factors, such as obesity and diabetes," he said. But the safety profile of JAK inhibitors"is almost certainly better" than the profile suggested in black box warnings applied to JAK inhibitors for dermatologic indications, he advised.This position was supported by numerous other experts when asked for their perspectives.
George Z. Han, MD, PhD, an associate professor of dermatology, Zucker School of Medicine at Hofstra, Northwell Medical Center, New Hyde Park, New York, also agreed but added some caveats.
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