The European Commission has approved Humira ( Adalimumab ) for the treatment of active moderate to severe hidradenitis suppurativa ( acne inverse ) in adults with an inadequate response to conventional systemic hidradenitis suppurativa treatment.
Humira is now the first and only medication approved for hidradenitis suppurativa in the European Union.
Hidradenitis suppurativa, sometimes referred to as acne inversa by dermatologists, is a painful, chronic inflammatory skin disease. It is estimated to impact 1% of the adult population worldwide, but prevalence numbers vary across countries. It is characterized by recurrent, painful abscesses and nodules on the skin - typically around the armpits and groin, on the buttocks and under the breasts.
Hidradenitis suppurativa can have considerable impact on patients' daily lives, their work ability, physical activities and emotional state.
Hidradenitis suppurativa can be progressive in some people, and surgery may be considered to remove skin affected by the disease in advanced stages. Therefore, diagnosing and managing the disease early is important. This can be difficult, and many people with hidradenitis suppurativa experience a lengthy delay in diagnosis and treatment.
The marketing authorization is based on the results of two 36-week, two-period pivotal phase 3 studies in 633 people with moderate to severe hidradenitis suppurativa, PIONEER I and PIONEER II.
Patients in these studies were randomly assigned to receive either Adalimumab or placebo in addition to daily use of topical antiseptic.
Both studies showed that patients given Adalilamub had greater reductions in the numbers of abscesses and inflammatory nodules than patients given placebo.
No new safety signals were identified in these trials.
Additionally, at week 12, a significantly higher proportion of patients given Adalimumab in PIONEER II experienced a clinically relevant decrease in hidradenitis suppurativa-related skin pain compared to those given placebo.
Since first gaining approval 12 years ago, Humira has been approved in more than 87 countries. It is currently being used to treat more than 850,000 patients worldwide across 13 globally approved indications.
Humira is approved for use in adults with moderate to severe rheumatoid arthritis, severe active ankylosing spondylitis, severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's Disease, moderately to severely active ulcerative colitis and active moderate to severe hidradenitis suppurativa.
Humira is approved for use in paediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, severe active Crohn's disease, and active polyarticular juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy.
Humira is contraindicated in patients with active tuberculosis or other severe infections and in patients with moderate to severe heart failure. The use of Humira increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with a TNF-antagonist.
On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death.
A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded.
The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache, abdominal pain, nausea, rash and musculoskeletal pain. ( Xagena )
Source: Abbvie, 2015