Posters Show Ruxolitinib Cream to Be Both Effective and Safe for Treating AD

No systemic adverse events (AEs) were reported when patients with atopic dermatitis (AD) used the effective ruxolitinib cream for their AD, according to findings from a poster presented at Revolutionizing Atopic Dermatitis (RAD) 2023.¹ Another poster found that ruxolitinib 1.5% cream was effective when used for moderate to severe chronic hand dermatitis.²

In September 2021, ruxolitinib cream became the first Janus kinase (JAK) inhibitor approved in the United States for the treatment of mild to moderate AD. Almost 10 months later, the cream was also approved to treat nonsegmental vitiligo. The 2 posters presented at RAD 2023 aimed to assess the safety and efficacy of the cream in different areas.

To test the safety of the cream, the researchers of the first poster assessed databases of safety reports during the first year of market approval. The researchers used the Incyte global safety database and the FDA Adverse Event Reporting System to find any reports about AEs that were received between September 21, 2021, and September 20, 2022.

The researchers found 294 postmarketing individual case safety reports (ICSRs) that contained 585 nonserious AEs and 4 serious AEs; there were no AEs that led to death. A total of 220 ICSRs were received from spontaneous sources and 74 were received from noninterventional/solicited sources. A health care professional was able to medically confirm an AE in 73 of the 221 ICSRs that were reported by consumers. Female patients were involved in 176 of the 257 ICSRs that reported gender. In the 64 ICSRs that reported age, there was a median age of 39 years.

Application site pain (16 events), dermatitis atopic, skin irritation (15 events each), scratch (14 events), and condition aggravated (13 events) were AEs reported with a frequency of more than 2%. Cream texture was the source of the initial issue of application site pain, skin irritation, and scratch, and was addressed quickly. Skin cancer (2 events), pericarditis, and thrombocytopenia (1 event each) made up the 4 serious AEs. However, none of these had sufficient evidence of its being related to ruxolitinib cream. The safety data did not indicate any of the serious AEs that have been seen with the use of oral JAK inhibitors.

Reports containing minimal clinical information, underreporting, reporting bias, and challenges in determining causal association between an AE and a specific drug were some of the limitations of this research.

These researchers concluded that ruxolitinib cream does not carry significant systemic AEs, had a low incidence of application site reactions, and was well tolerated.

A second poster presented during the conference tested the efficacy of ruxolitinib 1.5% cream in patients with chronic hand dermatitis (CHD), which has been found to have a negative effect on patients’ quality of life. There is no current medication for CHD that has been approved by the FDA, which led the researchers to test the FDA-approved topical ruxolitinib for treatment. The interim results of an open-label, single-site study (NCT05293717) were presented during a late-breaking research session.

All participants were required to undergo a washout period before enrolling in the study. All patients applied ruxolitinib cream twice per day to the entire hand. Moisturizers were only allowed if the patient had previously used moisturizers before the study. Patients were excluded if they had a positive patch test and could not avoid the antigen or if they had prolonged contact with water.

There were 14 participants who completed the first 4 weeks of treatment and had previously failed topical treatments; some had also failed systemic treatments. All patients had a baseline Investigator Global Assessment (IGA) score of 2 or more and had a moderate to severe hand eczema severity index (HECSI) score. Average itch at baseline was deemed moderate (mean [SD] numeric rating scale score, 5.5 [3.39]).

A total of 79% of patients had a reduction of 2 points or more in IGA after 4 weeks of treatment; 100% of patients reached a HECSI-50 (indicating a 50% reduction in HECSI score) and 64% reached a HECSI-75, with a mean reduction in HECSI of 44. A total of 71% of patients had a reduction of 2 points or more and 57% of patients had a 4 point or more improvement in average itch; 75% of patients had a reduction in worst daily itch of 2 points or more within the first week.

“The interim analysis suggests that ruxolitinib [cream] may be an effective, well tolerated treatment for moderate to severe chronic hand dermatitis, with significant improvement on quality of life and itch,” coauthor Hannah Smith, BA, said when presenting the findings at the RAD meeting. “The trial is ongoing to evaluate these outcomes at 12 weeks. We have our last participant finishing treatment at the end of May.”

References

1. Hu W, Thornton M, Livingston RA. Real-world use of ruxolitinib cream: safety analysis at 1 year. Presented at: Revolutionizing Atopic Dermatitis 2023; April 29-May 1, 2023; Washington, DC. Abstract 377.
2. Smith HD, Moy A, De Benedetto A. Ruxolitinib 1.5% cream efficacy data for moderate-to-severe chronic hand dermatitis: open label trial 4-weeks interim analysis. Presented at: Revolutionizing Atopic Dermatitis 2023; April 29-May 1, 2023; Washington, DC. Abstract 384.