EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Olumiant is already approved in the European Union to treat moderate to severe active rheumatoid arthritis, a disease causing inflammation of the joints.

Atopic dermatitis (also known as eczema, an itchy red rash of the skin) is a chronic inflammatory skin disease that occurs most frequently in children but also in adults. While in children most cases clear up spontaneously, the disease can persist or start in adulthood. In Europe, it is estimated that up to 7% of adults have atopic dermatitis and the proportion of adults with the moderate to severe form of the disease is approximately 30%. One in four adults with the disease report its onset in adulthood.

Atopic dermatitis causes skin lesions, itchy skin, skin pain, sleep disturbance and is commonly associated with the occurrence of other atopic conditions such as asthma and allergic rhinitis (hay fever). It may lead to difficult-to-control scratching, skin inflammation and infections, functional impairment and mental distress, and feelings of anxiety and depression.

Patients with mild forms of the disease are generally treated with emollients (moisturisers) and topical corticosteroids (creams used to reduce swelling and redness during flare-ups), and/or topical calcineurin inhibitors. However, patients with moderate to severe atopic dermatitis require additional therapies to control their skin inflammation and alleviate the most bothersome symptoms. Systemic treatment options are limited and there is still a need for new treatment options.

Olumiant works by blocking the action of enzymes known as Janus kinases (JAKs) that mediate the pathways involved in the inflammatory process in atopic dermatitis. It is the first JAK inhibitor to treat moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy in the EU and offers a different mode of action to the currently available treatment options. It is the first medicine for moderate as well as severe atopic dermatitis that patients can take orally.

The opinion by EMA’s human medicines committee (CHMP) is based mainly on data from three 16-week phase 3 randomised double blind, placebo-controlled studies where Olumiant was used as monotherapy or in combination with topical treatments in adults with moderate to severe atopic dermatitis for whom available topical treatments were insufficient or not tolerated. In all three studies Olumiant was shown to be more effective than placebo in reaching ‘IGA 0 or 1’ at week 16. IGA, or Investigator Global Assessment, is a commonly used scale in clinical studies for atopic dermatitis, and a score of 0 or 1 equates to skin that is ‘clear’ or ‘almost clear’ of signs of the disease.

The most common side effects with Olumiant in clinical trials include increased LDL cholesterol (‘bad’ cholesterol), upper respiratory tract infections and headache. Infections reported with Olumiant treatment include herpes simplex (a viral infection that causes cold sores). This is generally in line with what is already known from treatment with the medicine in rheumatoid arthritis.

The opinion adopted by the CHMP at its September 2020 meeting is an intermediary step on Olumiant’s path to patient access in this new indication. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.

Posted on the EMA website on 18 September 2020