A New Study Finds That Ruxolitinib Cream 1.5% Is Effective for Most Patients With HS

Ruxolitinib cream 1.5% (Opzelura; Incyte ) can significantly reduce inflammation associated with Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa (HS), according to the results of a recent phase 2 trial which were presented at the American Academy of Dermatology (AAD) Annual meeting from March 8 to 12 in San Diego, California.

Findings from the phase 2 trial show that ruxolitinib cream was generally well-tolerated and significantly reduced disease severity compared to the control. In addition, most patients in the treatment arm experienced a clinical response.

“The results presented today reinforce the efficacy and safety profile of ruxolitinib cream, which shows great potential for people living with milder HS,” said Jim Lee, MD, PhD, group vice president, inflammation and autoImmunity, Incyte, in a press release.

Body care. Woman has dry skin on elbow. - Image credit: Dmytro Flisak | stock.adobe.com

Investigators decided to conduct a randomized, double-blind, vehicle-controlled phase 2 clinical trial to evaluate safety and efficacy of ruxolitinib cream 1.5% compared with a control. The study enrolled 69 adult patients with mild to moderate HS, and the primary end point was change from baseline in abscess and inflammatory nodule (AN) count at week 16.

The study met the primary endpoint with more patients in the treatment arm experiencing a reduction in AN count (average reduction of 3.61) compared with patients on the vehicle control (average reduction of 2.42).

Secondary end points included proportion of participants who experienced a reduced AN count from baseline, change in score on the skin pain numeric rating scale (NRS) from baseline, change in itch NRS score from baseline, proportion of participants who achieved hidradenitis suppurativa clinical response (HiSCR), change in the International Hidradenitis Suppurativa Severity Score System (IHS4) score from baseline, and number of treatment emergent adverse events (TEAEs).

In the ruxolitinib arm, 79.2% of patients achieved at least a 50% reduction in AN count (AN50), which is also the criteria for achieving an HiSCR. In addition, the treatment arm experienced a more significant reduction in disease severity, with their average IHS4 score dropping by 4.46points compared with 2.66 in the control group.

The most common TEAEs associated with treatment were COVID-19 (5.9%) and nasopharyngitis (5.9%), but no patients experienced serious TEAEs. For patients who experienced TEAEs, they occurred at a rate of 38.2% for patients on ruxolitinib cream compared with 42.9% of patients on the control.

HS is a chronic inflammatory skin condition that affects more than 150,000 people in the United States. HS causes painful nodules and abscesses, which can cause irreversible tissue destruction and scarring. The suggested cause of inflammation is an overactive JAK/STAT signaling pathway, which ruxolitinib cream 1.5% inhibits.

“Despite its daily impact on the lives of patients, there are currently no approved therapies for mild-to-moderate HS and the current standard of care is often inadequate,” said Lee in the press release.

There is no cure for HS, so patients with milder disease continue to require new and effective therapies, as controlling the disease can help with symptom management, according to Martina J Porter, MD, a dermatologist at the Beth Israel Deaconess Medical Center.

“Today’s data represent an important step in progressing research for HS with the goal of being able to provide patients with an effective option to better manage their condition,” said Lee in the press release.

REFERENCE

Incyte Announces New Data From Phase 2 Study Evaluating Ruxolitinib Cream (Opzelura®) In Patients With Mild-To-Moderate Hidradenitis Suppurativa. Incyte. News Release. March 10, 2024. Accessed on March 12, 2024. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-new-data-phase-2-study-evaluating-ruxolitinib