Safety data show ruxolitinib cream well tolerated in atopic dermatitis, vitiligo at 1 year

Key takeaways:

• Four of 589 adverse events were serious and included skin cancer, pericarditis and thrombocytopenia.
• None of the adverse events indicated in the warning for Janus kinase inhibitors occurred.

Safety data for ruxolitinib cream, a Janus kinase inhibitor, in the first year after its approval has shown that the drug is generally well tolerated for the treatment of atopic dermatitis or vitiligo, according to a postmarketing review.

A postmarketing study with oral tofacitinib triggered a class warning for Janus kinase (JAK) inhibitors that treat certain inflammatory diseases. Although a topical solution, ruxolitinib cream (Opzelura, Incyte) is subject to these same warnings as it is indicated for two inflammatory skin diseases — mild to moderate AD and nonsegmental vitiligo.

To evaluate the safety of ruxolitinib cream, Wilson Hu, MD, MBA, associate vice president of global risk management and safety surveillance at Incyte, and colleagues analyzed approximately 13,833 patient-years of postmarketing safety data from the first year following the drug’s market approval. All data of adverse events reported with ruxolitinib cream was retrieved from the Incyte global safety database and U.S. FDA Adverse Event Reporting System.

The researchers found 294 postmarketing individual case safety reports containing 589 events, four of which were serious adverse events. No deaths were reported.

The most common adverse events, comprising more than 2% of all events, were application site pain (n = 16), AD (n = 15), skin irritation (n = 15), itch (n = 14) and aggravated condition (n = 13). The four serious adverse events were skin cancer, which occurred twice, pericarditis and thrombocytopenia.

“Insufficient information was available to assess any potential associations between ruxolitinib cream and the serious [adverse events] of skin cancer, pericarditis or thrombocytopenia,” the authors said. “Indeed, based on the rate of these events in the general population and the increased risk of nonmelanoma skin cancer in patients with AD, the rate of these events likely reflects the background rates in the target population.”

None of the serious adverse events associated with the class warnings for JAK inhibitors were reported. The authors hypothesized that the absence of adverse events indicated in the warning may be due to the low systemic bioavailability of ruxolitinib cream.

“This review of safety data available for ruxolitinib cream in the first year after its approval suggests that ruxolitinib cream is generally well tolerated for the treatment of AD or vitiligo,” the authors concluded.