AbbVie Announces Pivotal Phase 3 Data Evaluating Efficacy of HUMIRA® (adalimumab) in Patients with Hidradenitis Suppurativa (HS), a Chronic Inflammatory Skin Disease

COPENHAGEN, Denmark, Sept. 11, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) today 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 44^th Annual European Society for Dermatological Research (ESDR) Meeting in Copenhagen, Denmark.³

HS, sometimes referred to as "acne inversa" by dermatologists, is a chronic skin disease characterized 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.^1,2,4 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.^1,2 There is currently no cure for HS and there are no approved medications for the treatment of the disease.¹ 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."

Study Results
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% versus 26%, 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% reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.⁶

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).^7,8

About the Study
PIONEER I is a Phase 3, 36-week, multicenter, randomized, 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 randomized 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 randomized to HUMIRA were re-randomized to receive HUMIRA 40 mg weekly, 40 mg every other week, or placebo. Patients randomized 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.³

The most common adverse events (AEs) (>5 percent of subjects in any treatment group) observed in PIONEER I with HUMIRA versus placebo were exacerbation of HS (9.2% vs. 13.2%), nasopharyngitis (5.9% vs. 10.5%) and headache (9.2% vs. 9.9%). Serious AEs were observed in 2% of HUMIRA patients and 3.3% of placebo patients.³ 

More information on PIONEER I and PIONEER II is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233, respectively).

About Hidradenitis Suppurativa
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.^1,2 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.^2,9

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.¹⁰

Uses
HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
  • 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.
  • Ankylosing spondylitis (AS) in adults.
  • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• 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.

Important Safety Information
HUMIRA can lower the ability of the immune system to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People should tell their doctor if they've been to areas where certain fungal infections are common and if they've had TB or hepatitis B, are prone to infections, or have flu like symptoms or sores. People should not take HUMIRA if they have or develop an infection.

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma, which often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus, allergic reactions, nervous system and blood problems, certain immune reactions including a lupus-like syndrome, liver problems, and new or worsening heart failure or psoriasis. People should not use HUMIRA with anakinra or abatacept. People using HUMIRA should not receive live vaccines.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

This is not a complete list of the Important Safety Information for HUMIRA.

For additional important safety information, please click here for the Full Prescribing Information and Medication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.
AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1. Dufour DN, Emtestam L, Jemec GB. Hidradenitis Suppurativa: A Common and Burdensome, Yet Under-Recognised, Inflammatory Skin Disease. Postgrad Med J. 2014; 90 (1062):216-21.
2. Jemec G.  Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
3. Safety and Efficacy of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from First 12 Weeks of PIONEER I, a Phase 3, Randomized, Placebo-Controlled Trial. Abstract #210 44th Annual Meeting of the European Society for Dermatological Research (ESDR), Copenhagen, Denmark 2014. http://www.nature.com/jid/journal/v134/n2s/full/jid2014340a.html
4. Mayo Health Clinic. Hidradenitis Suppurativa. Available at: http://www.mayoclinic.com/health/hidradenitis-suppurativa/DS00818. Published April 9, 2013. Accessed September 10, 2013.
5. Zouboulis CC, Tsatsou F (2012) Disorders of the Apocrine Sweat Glands. In: Goldsmith LA, Katz SI, Gilchrest BA, Paller AS, Leffell DJ, Wolff K (eds) Fitzpatrick's Dermatology in General Medicine. 8th ed, McGraw Hill, New York Chicago, pp 947-959.
6. Efficacy Results Using a Novel Hidradenitis Suppurativa Endpoint, HiSCR (Hidradenitis Suppurativa Clinical Response), From the Placebo-Controlled Phase of a Phase 2 Adalimumab Study. Abstract #FC03.5 22nd Congress of the European Dermatology and Venereology (EADV) Meeting, Istanbul, Turkey. 2013.
7. Adalimumab Improves Treatment Satisfaction with Medication (TS-M) in Patients with Moderate to Severe Hidradenitis Suppurativa (HS) in a 12-week Randomised Controlled Trial (PIONEER I). Abstract #177. 44th Annual Meeting of the European Society for Dermatological Research (ESDR), Copenhagen, Denmark. http://www.nature.com/jid/journal/v134/n2s/full/jid2014340a.html. 2014.
8. HUMIRA Improves Health-Related Quality of Life (HRQoL) in Patients with Moderate to Severe Hidradenitis Suppurativa (HS): Results from the First 12 Weeks of PIONEER I. Abstract #197. 44th Annual Meeting of the European Society for Dermatological Research (ESDR), Copenhagen, Denmark. http://www.nature.com/jid/journal/v134/n2s/full/jid2014340a.html. 2014.
9. Collier F., Smith R., Morton C. Diagnosis and Management of Hidradenitis Suppurativa. BMJ. 2013; 346:f2121. 
10. American Academy of Dermatology. Hidradenitis suppurativa. Available at: http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/e---h/hidradenitis-suppurativa. Accessed August 28, 2014.

SOURCE AbbVie

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