No New Safety Signals in Broad Ruxolitinib Dataset, Including AD, Vitiligo, and AA
KEY TAKEAWAYS
New data based on 2,000 person-years of exposure to ruxolitinib cream shows low incidence of serious adverse events.
Systemic drug levels remained below thresholds linked to JAK-associated toxicities.
No new safety concerns emerged in adult or pediatric patients with AD, vitiligo, or other inflammatory skin diseases.
A new safety analysis presented at the 2026 Winter Clinical Dermatology Conference in Maui supporting the long-term tolerability of ruxolitinib cream (Opzelura®, Incyte) in a range of inflammatory skin conditions.
The integrated data, published in a poster, were pooled from 20 clinical trials including 2,493 patients and more than 2,000 person-years (PY) of exposure. Study authors assessed adverse event incidence associated with JAK inhibitor class warnings (including serious infections, major adverse cardiovascular events (MACE), thromboembolic events, and malignancies). The analysis included pediatric and adult patients with AD, as well as adults with vitiligo, alopecia areata (AA), hidradenitis suppurativa (HS), lichen planus (LP), and lichen sclerosus (LS).
Among patients with AD aged ≥18 years, the number of patients experiencing an adverse event per 100 PY were 1.18 for serious infections, 0.24 for MACE, 0.47 for thromboembolic events, and 0.47 for nonmelanoma skin cancer (NMSC). In the pediatric AD cohort (ages 2 to 17), no events of MACE, thromboembolism, or malignancy were reported. In patients with vitiligo, all events were ≤ 0.35 per 100 PY. No patients with HS experienced any events in these categories. Mean plasma ruxolitinib concentrations stayed below the 281 nM threshold associated with JAK-mediated myelosuppression in vitro.
“These findings may be attributable to low systemic exposure owing to topical administration of ruxolitinib cream,” the authors wrote. “No new safety signals were identified across the studies”.
Source: Bunick C, Ezzedine K, Eichenfield L, et al. Integrated Safety Analysis of Ruxolitinib Cream: Data From 20 Clinical Studies in Inflammatory Dermatologic Conditions. Presented at: 2026 Winter Clinical Hawaii, January 16-21, Maui.