Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis

Ruxolitinib cream 1.5% (OPZELURA™) is a topical formulation of ruxolitinib, a potent, selective inhibitor of Janus kinase (JAK)1 and JAK2. The targeting of these kinases is associated with therapeutic benefits in patients with atopic dermatitis (AD). In two identically designed, multinational, phase III studies in patients aged ≥ 12 years with mild to moderate AD, ruxolitinib cream 1.5% improved measures of disease severity, pruritus and sleep disturbance relative to vehicle cream when applied twice daily for 8 weeks. Disease severity was controlled for the next 44 weeks when applied as needed to active lesions. Ruxolitinib cream 1.5% was well tolerated in this patient population; its safety profile was similar to that of vehicle cream over the short term, with the types of treatment-emergent adverse events typical of those seen in the vehicle-controlled period over the longer term. Moreover, application site treatment-emergent adverse events indicative of skin tolerability issues (e.g. stinging/burning sensation) were infrequent and no safety findings suggestive of systemic JAK inhibition were identified. Although further longer-term data would be of use, ruxolitinib cream 1.5% provides an alternative to established topical agents (e.g. corticosteroids and calcineurin inhibitors) for the treatment of mild to moderate AD in adults and adolescents.Atopic dermatitis (AD; also known as atopic eczema) is a chronic, relapsing, inflammatory skin disease that most commonly occurs in children but may also affect adults. Ruxolitinib cream 1.5% (OPZELURA™) is a topical therapy that inhibits Janus kinase (JAK)1 and JAK2, which are enzymes that can modify the inflammatory pathways involved in AD. It is approved in the USA for short-term and non-continuous longer-term treatment of mild to moderate AD in non-immunocompromised patients aged ≥ 12 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Patients experienced clearer skin and a reduction in itch and disturbed sleep when treated with ruxolitinib cream 1.5% twice daily compared with a non-medicated cream for 8 weeks. Moreover, clearer skin was maintained for a further 44 weeks when using the treatment as needed. The safety profile of ruxolitinib cream 1.5% was similar to that of the non-medicated cream, and stinging/burning sensations following application were infrequent. Thus, ruxolitinib cream 1.5% offers an alternative to established topical agents (e.g. corticosteroids and calcineurin inhibitors) for the treatment of adults and adolescents with mild to moderate AD.