EMA: Treat Hidradenitis Suppurativa With Adalimumab

The European Medicines Agency (EMA) has recommended extending the use of adalimumab to include treatment of adults with active moderate to severe hidradenitis suppurativa (HS) who have failed to respond to conventional systemic treatments. Under this proposal, Humira would be the first medicine approved for the treatment of this disease in the European Union.

Humira is currently approved for the treatment of rheumatoid arthritis as well as other inflammatory autoimmune conditions in adults and children, including juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Chrohn’s disease, and ulcerative colitis.

According to the manufacturers, the active substance in adalimumab is a monoclonal antibody that is designed to attach to tumor necrosis factor-alpha (TNF). TNF is involved in causing inflammation and is found in high levels in patients with autoimmune diseases. Adalimumab works by blocking TNF-alpha to reduce inflammation and other symptoms of the diseases.

There are no approved medicines for the treatment of HS in the European Union. Treatments for HS include mostly the use of antibiotics to treat infection and surgery, and/or laser treatments in severe cases.

In 2 studies of 633 people with moderate to severe HS, participants were randomly assigned to receive Humira or a placebo in addition to daily use of a topical antiseptic. Both studies showed that patients using Humira had greater reduction in the number of abscesses and inflammatory nodules than placebo.

Adverse events are similar to other uses of Humira and include the risk of infection and malignancy.

Reference:

Humira (adalimumab) approved by European Commision for moderate to severe hidradenitis suppurativa [press release]. Abbvie. July 30, 2015. http://abbvie.mediaroom.com/2015-07-30-HUMIRA-Adalimumab-Approved-by-European-Commission-for-Moderate-to-Severe-Hidradenitis-Suppurativa-HS. Accessed August 25, 2015.