Hidradentitis Suppurativa

Hidradenitis suppurativa is a chronic debilitating systemic skin disease which results in painful inflammation of the hair follicles, most notably in the armpit, groin and genitalia regions. The clinical hallmarks of this disease include very painful inflammatory nodules, boils or abscesses that typically open and release odorous inflammatory fluids. In the more chronic form of the disease, patients experience draining fistulas, also referred to as sinus tracts, which ultimately lead to scarring and related functional disability in certain areas. Hidradenitis suppurativa patients suffer primarily from pain and significant discomfort resulting from the constant formation of pus, often requiring the use of bandages and diapers, resulting in social isolation. Not surprisingly, hidradenitis suppurativa severely and adversely affects patients' quality of life.

Hidradenitis suppurativa typically presents in the second and third decade of a patient's life and often develops into a life-long debilitating chronic disease. The disease has orphan designation in the United States, and in the Seven Major Markets there were approximately 785,000 diagnosed cases in 2018 according to Decisions Resources Group.

In warmer climates, the number of affected patients is believed to be greater, with higher prevalence and incidence of HS. The diagnosis and treatment is in most countries handled by dermatologists even though patients often first present with early symptoms to primary care physicians or even to emergency departments in order to seek surgical relief of formed abscesses.

 

 

The general standard of care for hidradenitis suppurativa patients includes topical, oral or intravenous antibiotic treatment which often provide only temporary symptomatic relief. In some cases, patients also undergo different types of surgery. Hidradenitis suppurativa is recognised as a systemic autoimmune disease, for which there are numerous suggested etiological factors, including genetics. Neutrophils are believed to play a potential disease-promoting role as well as certain cytokines and mediators commonly found in autoimmune diseases such as TNF-α, IL-17, IL-1 andothers. This rationale is supported by the 2015 approval in the US and Europe of adalimumab, an anti-TNF-α monoclonal antibody, for the treatment of patients with moderate to severe and Hurley stage 2 and 3 hidradenitis suppurativa. The Hurley system is a classification system used to characterise the disease from early and easier-to-treat forms of hidradenitis suppurativa in Hurley stage 1 to the chronic and difficult to treat forms in Hurley stages 2 and 3. The system has been used as the basis for clinical trials. Combined results from the two pivotal adalimumab (Humira®) trials, which enrolled a total of 633 patients, showed that approximately 50% of the 316 patients who were treated with adalimumab achieved a response in the HiSCR, while approximately 27% of the 317 patients who received placebo achieved a HiSCR response, in each case at the end of a 12-week treatment period. Patients are considered to be HiSCR responders when they achieve a 50% or higher reduction of the combined abscess and nodule count from baseline, but no increase of the abscess or draining fistula count from baseline. The HiSCR is the primary endpoint that was used to support regulatory approval by the FDA and EMA of adalimumab for the treatment of hidradenitis suppurativa patients.

Currently, the only approved drug available for the treatment of moderate and severe hidradenitis suppurativa is the injectable TNF-α inhibitor Humira® (adalimumab) which was approved in 2015. There are no treatments approved for mild hidradenitis suppurativa. Adjunctive therapies, off-label, include non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, corticosteroids, oral retinoids, topical resorcinol, and hormone therapy.

 


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