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Ruxolitinib cream may lead to a reduction in itch and an increase in quality of life (QoL) in patients with atopic dermatitis (AD), according to study results published in the Journal of the American Academy of Dermatology. Researchers reported that itch reduction had a direct correlation with lowered QoL burden as confirmed by Skindex-16 improvements after the application of ruxolitinib cream.
Researchers in this phase 2 study evaluated patients18 to 70 years of age with AD (N=307) who had an Eczema Area and Severity Index score of ≤7 and those with a score >7, assigning them to randomized, double-blind treatments using a combination of vehicle control cream, 0.1% triamcinolone acetonide, or ruxolitinib cream 0.15% to 1.5% once daily together with 1.5% twice daily. During a 4-week period, participants were allowed to apply antihistamines and bland emollients while receiving the 1.5% ruxolitinib cream twice daily.
Participants were required to have an Investigator’s Global Assessment score of 2 or 3 and a body surface area involvement within the range of 3% to 20%. Patients were responsible for recording their itch numerical rating scale (NRS) scores in an electronic diary and reporting itch severity on a scale of 0 to 10 in 24-hour increments. They were assessed for “clinically relevant improvement in itch NRS,” which was defined as a ≥4-point reduction versus baseline.” This differs from the minimal clinically important difference (MCID) in itch NRS, a 2- to 3-point reduction compared with the baseline. Participants also rated questions regarding AD symptom burden on a scale of 0 to 6. Measures for itch and QoL relied on descriptive statistics to collect aggregate incident plots of the first itch response in each treatment group.
Participants were randomly assigned double-blind treatment of either vehicle (N=52), triamcinolone (N=51), 0.15% ruxolitinib once daily (N=51), 0.5% ruxolitinib once daily (N=51), 1.5% ruxolitinib once daily (N=52), or 1.5% ruxolitinib twice daily (N=50), in which the mean NRS score was recorded as 6.0±2.1.
Exactly 36 hours after initial administration of 1.5% ruxolitinib cream twice daily, significant reductions were observed in itch NRS scores (-1.8 vs -0.2; P <.0001). The response rate of “1.5% ruxolitinib cream [twice daily] at week 2 were also significantly higher compared with triamcinolone (19.4%, P <.05),” it was noted. The same is true for alleviation in itch observed at week 4, as the mean difference was -64.6% for 1.5% twice daily and -54.0% for 1.5% once daily, both higher than -50.3% for triamcinolone.
The first clinically relevant improvement response incidence rates were notably higher in every ruxolitinib group compared with the vehicle (log-rank P <.001). Participants (N=272) who were eligible to take the MCID test had higher rates detected on Day 2 after using 1.5% ruxolitinib cream once daily (37.2%; P <.05) in addition to twice daily (42.5%; P <.01). Patients who were randomly assigned into the 1.5% ruxolitinib cream twice daily group and continued in the open-label treatment period (N=43) sustained a mean improvement in itch of 76.1% since the week 12 baseline. Those who transitioned from other treatment groups exhibited a significant reduction in itch NRS scores.
According to the QoL outcomes, the number of visible AD lesions declined after 4 weeks of treatment with ruxolitinib cream, as seen through clinical images. The overall Skindex-16 scores for patients using the 1.5% ruxolitinib cream twice daily improved from the baseline by 73.7% after week 4 (P =.02), higher than triamcinolone at only 59.7%.
Limitations of this study include the inability to apply ruxolitinib cream to facial AD lesions due to the safety restrictions assigned to triamcinolone cream. Despite the frequent occurrence of AD in children, they were excluded from the study as all participants were required to be older than 18 years of age. A future large-scale study will incorporate children into the phase 3 development of ruxolitinib cream, the investigators indicated.
All ruxolitinib cream regimens showed a clinically meaningful decrease in itch NRS scores along with a notable reduction in QoL burden when compared with the vehicle group, the researchers concluded. They wrote that “reduction in itch was positively associated with decreased QoL burden (Pearson correlation, 0.67; P <.001)” and that ruxolitinib cream is more efficacious than standard topical treatments such as corticosteroids against AD inflammation.
Disclosure: This clinical was supported by Incyte Corporation. Several authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Reference
Kim BS, Sun K, Papp K, Venturanza M, Nasir A, Kuligowski ME. Effects of ruxolitinib cream on pruritus and quality of life in atopic dermatitis: results from a phase 2, randomized, dose-ranging, vehicle- and active-controlled study [published online February 11, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.02.009
