The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM). JAK inhibitors represent a breakthrough in addressing inflammatory conditions like AD, providing a targeted approach that enhances treatment efficacy and safety, while promising new therapeutic options for diverse patient populations, says GlobalData, a leading data and analytics company.

Incyte Dermatology’s Opzelura (ruxolitinib) is a topical JAK 1/2 inhibitor that has been approved for AD in the US. Its role in AD treatment has been explored, with completed clinical trials for Opzelura in AD involving diverse AD patient populations; the Phase III TRuE AD1 (NCT03745638) and TRuE AD2 (NCT03745651) studies were aimed at adolescents and adults, and the TRuE AD3 (NCT04921969) study was aimed at children.

An additional Phase III study (NCT05456529) has also been completed for adolescents. Opzelura’s safety profile in AD is consistent with its known effects in other conditions, with careful monitoring required for potential blood count changes and infections.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “With both Phase III trials for Opzelura meeting the key primary and secondary endpoints and exhibiting clinically meaningful reduction in itch, with no serious adverse events (AEs), its introduction to the market across 7MM may be promising, as new treatments are needed in the field of AD.”

Among the marketed JAK 1/2 inhibitors, a direct competitor of Opzelura is Eli Lilly’s Olumiant (baricitinib), which has been approved in the five major European markets (5EU: France, Germany, Italy, Spain, and the UK) and Japan for moderate to severe atopic dermatitis in adult and pediatric patients ages two years and older.

Olumiant is a dual JAK1/2 inhibitor that is functionally similar to Opzelura and has exhibited significant reduction in patients with moderate-to-severe AD as seen in previous clinical trials. Additionally, Olumiant significantly reduced inflammation and pruritus, as well as improved quality of life and skin pain. Olumiant aims at patients with moderate-to-severe AD whereas Opzelura has been approved for mild-to-moderate cases of AD.

Maniatis adds: “In recent years, other JAK inhibitors, including AbbVie’s oral JAK 1 inhibitor Rinvoq (upadatacitinib), have been approved across the 7MM for moderate-to-severe AD patients and LEO Pharma’s topical JAK 1/2/3 inhibitor Corectim (delgocitinib) in Japan for AD patients. These approvals enrich the current standard of care and highlight the opportunity in the market.”

Additionally, the late-stage pipeline is also filled with other JAK inhibitors including Reistone Biopharma’s JAK 1 inhibitor ivarmacitinib, Aclaris Therapeutics’ JAK 1 inhibitor lepzacitinib, and the pan-JAK/spleen tyrosine kinase (SYK) inhibitors from Zelgen (jaktinib hydrochloride) and Asana Bioscience (gusacitinib). The AD field has received increased popularity with regards to JAK inhibitors.

Maniatis concludes: “The late-stage pipeline in AD looks exciting for the future of JAK inhibitors. The key opinion leaders (KOLs) interviewed by GlobalData revealed that JAK inhibitors—specifically oral JAK inhibitors—have been crucial in the fight against AD in moderate-to-severe patients. This further highlights the opportunity in the market however, the need for comparative studies to show the differences in efficacy and safety between topical JAK therapies and between oral JAK therapies is also of high importance.”

7MM: The US, France, Germany, Italy, Spain, the UK, and Japan.