AbbVie Presents Phase II Data Evaluating the Efficacy of HUMIRA® (adalimumab) in Patients with Hidradenitis Suppurativa (HS), a

AbbVie Presents Phase II Data Evaluating the Efficacy of HUMIRA® (adalimumab)
 in Patients with Hidradenitis Suppurativa (HS), a Chronic Inflammatory Skin
                                   Disease

  PR Newswire

  NORTH CHICAGO, Illinois, Oct. 3, 2013

-- The post-hoc analysis applies a new measurement tool created by AbbVie to
assess the efficacy of HS therapy

-- HUMIRA is the first therapy to enter Phase III studies in patients with
moderate-to-severe HS

NORTH CHICAGO, Illinois, Oct. 3, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV)
today announced results from a post-hoc analysis of an investigational Phase
II study, which evaluated HUMIRA ^® (adalimumab) in the treatment of patients
with moderate-to-severe hidradenitis suppurativa (HS) after 16 weeks of
therapy.(1) Efficacy results were reported using a novel Hi dradenitis S
uppurativa C linical R esponse (HiSCR) endpoint that was developed in
consultation with regulatory health authorities. These data, which analyze the
reduction of total abscess and inflammatory nodule (AN) count from baseline,
were presented at the 22 ^nd Congress of the European Dermatology and
Venereology (EADV) meeting in Istanbul, Turkey.(1) HUMIRA is not approved by
health authorities for the treatment of HS.

The post-hoc analysis found that HUMIRA induced a significant response rate in
adult patients with moderate-to-severe HS at week 16 versus placebo (pbo) for
the two dosing regimens assessed. The efficacy of HUMIRA was re-assessed in
this analysis by using the HiSCR measure, which is an endpoint defined as at
least a 50 percent reduction from baseline in total AN count, with no increase
in counts for abscesses and draining fistulas. Specifically, HiSCR response
rates for HS patients given pbo, HUMIRA every other week (eow) or HUMIRA
weekly (ew) were 25.6 percent (11/43), 33.3 percent (15/45) and 54.5 percent
(24/44), respectively.(1) In addition, this analysis provides initial evidence
that HiSCR is a more responsive method to determine improvement in patients
than HS-physician-global assessment (PGA) based on clinical response and
demonstrate that HiSCR may be a useful new tool to assess the efficacy of HS
therapy in clinical practice and research trials.

"Although hidradenitis suppurativa affects a significant number of people,
there is no approved treatment option for this underserved patient group,"
said Gregor Jemec, M.D., Department of Dermatology, University of Copenhagen,
Roskilde Hospital. "These Phase II study results suggest HUMIRA could be a
promising therapeutic option in patients with moderate-to-severe HS and will
be further evaluated in Phase III trials."

Hidradenitis suppurativa is a chronic, often painful, immune-mediated disease
characterized by inflamed areas, typically located around the armpits and
groin.(2),(3) Mild cases of HS can resemble small bumps or blackheads, while
patients with more severe forms can have multiple interconnected sinus tracts
and abscesses, which sometimes release fluid. Progression of the disease can
lead to significant pain and discomfort and may result in scarring.(2),(3),(4)
Currently, there is no cure or approved treatment for HS by any regulatory
health authorities, which is estimated to affect one percent of the general
adult population.(3)

"AbbVie developed the HiSCR endpoint to help advance hidradenitis suppurativa
research and address the need for a reliable and relatively simple measure of
clinical response in HS," said John Medich, Ph.D., vice president, Clinical
Development, Immunology, AbbVie. "We are excited that HiSCR has the potential
to be a useful method to assess the efficacy of HS therapies in research and
in clinical practice."

Two fully-enrolled Phase III clinical trials (PIONEER I and PIONEER II) are
underway to evaluate the safety and efficacy of HUMIRA in approximately 600
adult patients with moderate-to-severe HS. Results of these Phase III trials
are expected in 2014. More information on these trials is available at
www.clinicaltrials.gov (NCT01468207 and NCT01468233).

About the Study

In the Phase II trial, the HS-PGA, one of the current methods for measuring HS
severity, was used to evaluate the clinical response of HUMIRA at 16
weeks.(1),(5) These study findings correlate with the HS-PGA data published
previously, which was the primary efficacy variable of the study. At week 16,
3.9 percent (2/51), 9.6 percent (5/52) and 17.6 percent (9/51) of patients in
the pbo, eow and ew groups, respectively, achieved an HS-PGA of clear,
minimal, or mild, with at least a 2-grade improvement relative to baseline
(P<0.05 for ew compared to pbo).

This post-hoc analysis evaluated HS patients with a baseline AN count of > 3
and draining fistula count of < 20 in the three study arms: pbo (n=43), HUMIRA
40 mg eow after an initial loading dose (n=45) or HUMIRA 40 mg ew after
initial loading doses (n=44).(1),(5) Patients were assessed based on several
retrospective evaluations including achieving HS-PGA-based clinical response;
HiSCR; 50 percent, 75 percent, 100 percent reduction in total AN count (AN50,
AN75, AN100) relative to baseline and percent change from baseline in AN
count.

The safety findings observed in the randomized study population (n=154) were
consistent with those seen in previous HUMIRA studies.(5) The most common
adverse events (AEs) ( > 10 percent of subjects in any treatment group)
observed in the HUMIRA eow arm at week 16 of the study versus placebo were
headache (13.5 percent vs. 3.9 percent), nasopharyngitis (13.5 percent vs.
11.8 percent) and hidradenitis (13.5 percent vs. 11.8 percent). The most
common AEs observed in the HUMIRA ew arm of the study versus placebo were
headache (15.7 percent vs. 3.9 percent), nasopharyngitis (11.8 percent vs.
11.8 percent) and hidradenitis (7.8 percent vs. 11.8 percent).

The findings from this analysis supplement the initial presentation at the
2013 American Academy of Dermatology (AAD) Annual Meeting.

About Hidradenitis Suppurativa

Hidradenitis suppurativa, sometimes referred to as "acne inversa" by
dermatologists, is an inflammatory disorder that can occur at any age, but the
condition most commonly develops in adults in their early 20s, with declining
rates after the age of 50 to 55(2),(3). ^ Women are more likely to develop HS
than men.(2),(3) ^ The condition is characterized by inflamed areas typically
located around the armpits and groin. These inflamed areas often include
lesions, nodules and boils, 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 severity of the disease varies
considerably, and patients often report diminished quality of life as symptoms
progress.(2),(3),(4)

U.S. Product Information for HUMIRA ^® (adalimumab) (6) 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 your bones and joints and may
         help your 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 your
         bones and joints and may help your 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.
  *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 is a TNF blocker medicine that affects the immune system and can lower
the ability 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 at risk of TB may be treated with medicine for TB. Treatment
with HUMIRA should not be started in a person with an active infection, unless
approved by a doctor. HUMIRA should be stopped if a person develops a serious
infection. People should tell their doctor if they live in or have been to a
region where certain fungal infections are common, have had TB, hepatitis B,
are prone to infections, or have symptoms such as fever, fatigue, cough, or
sores.

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. This type of cancer 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 problems, blood
problems, certain immune reactions, including a lupus-like syndrome, liver
problems, and new or worsening heart failure or psoriasis. The use of HUMIRA
with anakinra or abatacept is not recommended. 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.

In the E.U. SmPC, HUMIRA is contraindicated in people who are allergic to
adalimumab or any other ingredients of HUMIRA, those who have a severe
infection including active TB, or those who have moderate to severe heart
failure. ^ (7)

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. 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. In 2013, AbbVie employs approximately 21,000 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.

References

1.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 22 ^nd Congress of
    the European Dermatology and Venereology (EADV) Meeting, Istanbul, Turkey.
2.Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
3.Mayo Health Clinic. Hidradenitis Suppurativa. Available at
    http://www.mayoclinic.com/health/hidradenitis-suppurativa/DS00818 .
    Updated April 9, 2013. Accessed September 22, 2013.
4.Collier F., Smith R., Morton C. Diagnosis and Management of Hidradenitis
    Suppurativa. BMJ. 2013; 346:f2121.
5.Kimball AB, Kerdel F, Adams D, et al. Adalimumab for the Treatment of
    Moderate to Severe Hidradenitis Suppurativa. Ann Intern Med. 2012;
    157:846-855.
6.HUMIRA injection [package insert]. North Chicago, IL: AbbVie.
7.HUMIRA [Summary of Product Characteristics], Maidenhead, United Kingdom;
    AbbVie.

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