Official HUMIRA (adalimumab) Site
Hidradenitis suppurativa patient image with a 50% reduction in HS abscesses and nodules

HUMIRA: THE FIRST AND ONLY
FDA-APPROVED TREATMENT
FOR MODERATE TO SEVERE HS

Helps provide clinically
meaningful improvement1
Not an actual HS patient.
Computerized illustration of 50% reduction in abscesses and nodules.
HUMIRA is the first & only FDA-approved treatment for moderate to severe hidradenitis suppuritiva

CLINICAL TRIAL DATA

HUMIRA was studied in the first and only completed Phase III clinical trials (PIONEER I and PIONEER II) of patients with moderate to severe HS.1,2

Study design: Randomized, double-blind studies with 2 treatment periods (A and B) compared the safety and efficacy of HUMIRA once weekly with control in 633 adult patients with:

Hurley Stage II and III disease AND

At least 3 abscesses or inflammatory nodules in 2 areas of the body3

PERIOD A
(WEEK 0 THROUGH WEEK 12):

Patients in both studies received HUMIRA or control; concomitant oral antibiotic use was allowed in PIONEER II. The route of administration was subcutaneous injection. Dosing for week 0 was 160 mg; week 2 was 80 mg; for week 4 through week 11, there was a maintenance dose of 40 mg every week.

PERIOD B
(WEEK 12 THROUGH WEEK 35):

Explored the safety and efficacy of different maintenance regimens (continuation of HUMIRA every week, reduction to HUMIRA every other week, or treatment withdrawal) over 24 weeks.

Primary endpoint: The proportion of
patients achieving
HiSCR* at week 12.
Clinical response required1:

≥50%
reduction in total abscess and
inflammatory nodule
count relative
to baseline
NO
increase in abscess count
NO
increase in draining
fistula count

*HiSCR=Hidradenitis Suppurativa Clinical Response.

THE RESULTS:

Significantly more patients achieved clinically meaningful improvement at week 12.1,2

PIONEER I1,2

42% of HUMIRA-treated patients achieved HiSCR in PIONEER 1 clinical trial

*P=0.003 vs control.

Significantly greater proportion of HUMIRA patients achieved clinically meaningful improvement vs control patients
PIONEER l: HUMIRA (n=64/153), control (n=40/154)

HiSCR=Hidradenitis Suppurativa Clinical Response.

Control=placebo.

PIONEER II1,2

59% of HUMIRA-treated patients achieved HiSCR in PIONEER 2 clinical trial

§P<0.001 vs control.

>2x as many HUMIRA patients achieved clinically meaningful improvement vs control|| patients
PIONEER II: HUMIRA (n=96/163), control (n=45/163)

||Control=placebo ± antibiotic.

Flare in patients withdrawn from HUMIRA1
22% of patients who were withdrawn from HUMIRA experienced flare of HS during Period B
following the primary efficacy time point in both studies. Flare was defined as ≥25% increase from baseline in abscesses and inflammatory nodule counts and with a minimum of 2 additional lesions.

Patients who were withdrawn from therapy received HUMIRA in Period A and were re-randomized to control in Period B (PIONEER I: n=49, PIONEER II: n=51).

WHAT CLINICALLY MEANINGFUL IMPROVEMENT MAY LOOK LIKE FOR YOUR PATIENTS WITH MODERATE TO SEVERE HS

Move the slider to see the difference in clinically meaningful improvement between baseline and Week 12 in the clinical trials.

Baseline prior
to treatment
HiSCR achieved
at Week 12

Move slider to see baseline and Week 12

Baseline prior
to treatment
HiSCR achieved
at Week 12

Move slider to see baseline and Week 12

Baseline photo is not from an individual patient but made from a composite of actual patients. The after photo was then modified to represent 50% reduction in abscesses and nodules. For illustrative purposes only. Individual results may vary.

“A 50% improvement… I almost can’t picture it. Oh, the shirts I would wear!”

CONSISTENT WITH THE KNOWN
SAFETY PROFILE OF HUMIRA1

HUMIRA has been studied for HS in 3 controlled studies and 1 open-label extension study, and the safety profile for patients with HS treated with weekly dosing was consistent with the known safety profile of HUMIRA.

SAFETY PROFILE AND ADVERSE EVENTS

PIONEER I:

Overview of treatment-emergent adverse events per 100 patient-years (PYs) during Period A4

Control=placebo.

Only Period A safety shown as control patients were re-randomized to HUMIRA in Period B.

PIONEER II:

Overview of treatment-emergent adverse events per 100 patient-years (PYs) during Periods A and B4

Control=placebo +/- antibiotic.

Treatment-emergent adverse event is defined as any adverse event with an onset date on or after the first dose of study drug in Period A and prior to the first dose of Period B or up to 70 days after last dose of study drug if the patient discontinued prematurely from Period A.

AEs=adverse events; E/100PY=events per 100 patient-years; EW=every week; HSTCL=hepatosplenic T-cell lymphoma; NMSC=non-melanoma skin cancer.

aAs assessed by investigator.

bAccording to AE analysis conventions, AEs that occurred for patients who were on HUMIRA in Period A and withdrawn to control in Period B are counted up to 70 days from the last EW dose.

FIND A DERMATOLOGIST
FOR A REFERRAL

“I’m confident with oral antibiotics, but if that doesn’t help, I refer my moderate to severe patients to a dermatologist for treating this inflammatory disease.”

HUMIRA HAS A LEGACY OF
TREATMENT EXPERIENCE

A subcutaneous biologic with nearly 2 decades of clinical trial experience beginning with rheumatoid arthritis5*

Data from >100 global clinical trials in efficacy and safety including 10 US-approved indications6

Over 1 million patients currently treated worldwide7†

>50,400,000 pens/syringes dispensed in the US since 2003

US FDA-approved to treat 10 immune-mediated diseases in dermatology, rheumatology, ophthalmology, and gastroenterology, including 2 pediatric indications1

*Beginning with rheumatoid arthritis, first patient dosed in April 1997.

As of June 2016.

Based on IMS National Prescription Audit™ cumulative data, January 2003 to December 2015, across all indications.

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Terms and Conditions

AbbVie is providing this service to help patients find dermatologists in their area who have experience with HUMIRA.

No fees have been received by or paid to dermatologists for inclusion in this specialist locator directory. Inclusion of a physician in this directory does not represent an endorsement by or a recommendation from AbbVie Inc., nor does it imply that the dermatologists on the list will determine if HUMIRA is right for you.

The selection of a physician is an important decision that should not be based solely on the inclusion in this dermatologist locator tool.

AbbVie Inc. is a maker and marketer of HUMIRA (adalimumab).