AbbVie announced results from a phase 3 pivotal study demonstrating that Humira (adalimumab) is effective in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules. These data were presented at the 44th Annual European Society for Dermatological Research (ESDR) Meeting in Copenhagen, Denmark.

HS, sometimes referred to as "acne inversa" by dermatologists, is a chronic skin disease characterised by inflamed areas typically located around the armpits, groin, on the buttocks and under the breasts. A number of physical symptoms are associated with HS namely, nodules and/or abscesses, sinus tracts and scarring. These symptoms make it a painful disease and impact the lives of patients with HS. HS is estimated to affect 1 percent of the general adult population. However, HS can be challenging to diagnose and many patients experience a lengthy delay in diagnosis and treatment. There is currently no cure for HS and there are no approved medications for the treatment of the disease. Humira is not currently approved by regulatory authorities for the treatment of HS.

"The clinical signs of HS include nodules or abscesses. These can cause severe pain and foul-smelling discharge that can be upsetting for patients," said Alexa Kimball, M.D., M.P.H., PIONEER I Study Investigator, medical director at Massachusetts General Physicians Organization and Professor of Dermatology at Harvard Medical School. "Results of this study expand on previous work demonstrating that adalimumab can reduce the nodules and abscesses in patients with moderate-to-severe HS."

Results from the PIONEER I study show that moderate-to-severe HS patients treated with Humira 40 mg weekly achieved a significantly greater response versus those on placebo at week 12 (41.8 per cent versus 26 per cent, p = 0.003).3 Response was defined as an improvement of HS related abscesses and inflammatory nodules at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure. This is defined as at least 50 per cent reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.

Results from a second phase 3 clinical trial, PIONEER II, also evaluating the safety and efficacy of Humira in patients with moderate-to-severe HS, will be presented at an upcoming medical congress.

"This trial adds to our more than 17 years of clinical trial experience with Humira and demonstrates our ongoing commitment to addressing the unmet needs of patients with difficult-to-treat diseases like HS," said John Medich, Ph.D., vice president, Clinical Development, Immunology, AbbVie. "We are encouraged by the results of PIONEER I and look forward to sharing results from our second phase 3 trial, PIONEER II."

In addition, AbbVie will be presenting other abstracts at ESDR today that include information about treatment satisfaction and health-related quality of life (abstracts #177 and #197).

PIONEER I is a phase 3, 36-week, multicentre, randomised, double-blind, two-period study in moderate-to-severe HS patients (n=307). In the first 12-week study period (known as Period A), patients were randomised to receive Humira 160 mg at week 0, 80 mg at week 2 and 40 mg once weekly (n = 153) starting at week 4, or placebo (n = 154). Following Period A, patients were eligible to enroll in a 24-week treatment period (known as Period B). In Period B, patients originally randomised to Humira were re-randomisd to receive Humira 40 mg weekly, 40 mg every other week, or placebo. Patients randomised to placebo were assigned to receive Humira weekly. The primary endpoint was the percentage of patients achieving a clinical response in improvement of HS severity at 12 weeks using the HiSCR measure. The results for Period B have not been presented.

The most common adverse events (AEs) (>5 per cent of subjects in any treatment group) observed in PIONEER I with Humira versus placebo were exacerbation of HS (9.2 per cent vs. 13.2 per cent), nasopharyngitis (5.9 per cent vs. 10.5 per cent) and headache (9.2 per cent vs. 9.9 per cent). Serious AEs were observed in 2 per cent of Humira patients and 3.3 per cent of placebo patients.

Hidradenitis suppurativa (HS), sometimes referred to as "acne inversa" by dermatologists, is a chronic, often painful, immune-mediated disease characterized by inflamed areas typically located around the armpits and groin. These inflamed areas often include lesions, nodules, boils and abscesses, and usually occur where many oil and sweat glands are located, as well as under the breasts, on the buttocks and in the inner thighs, where skin rubs together. The reason why patients develop HS is unclear; however, it is thought that an abnormal response in the body's own immune system plays a role.

While not all cases of HS are progressive (meaning that the disease can increase in severity over time), some cases of HS can grow more severe. As a result, diagnosing and properly managing HS as early as possible is important. Diagnosis can be difficult, but dermatologists are trained to recognize the difference between HS and other skin diseases. Patients who have symptoms of HS may wish to consult a dermatologist.

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Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. Humira can be used alone, with methotrexate, or with certain other medicines.Psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines. Humira may prevent further damage to bones and joints and may help the ability to perform daily activities.


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To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.