For the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older

Clinically meaningful improvement at week 12

Offer your moderate to severe HS patients a chance at achieving HiSCR1,2


HUMIRA is the first & only FDA approved treatment for hidradenitis suppurativa

STUDY DESIGN INTRODUCTIONS

PIONEER I (N=307) and II (N=326) were 2 similarly designed clinical trials in adult patients with 2 double-blind, placebo-controlled periods. In Period A, patients were assigned to either HUMIRA 40mg weekly (after initial doses) or placebo for 12 weeks. In period B, patients were reassigned to HUMIRA weekly or EOW, or placebo for 24 weeks. Primary endpoint was HiSCR at week 12, defined as at least a 50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining-fistula counts.2

View full study design and baseline characteristics

Week 12 data

Significantly more adult patients achieved clinically meaningful improvement at week 12 with HUMIRA vs control1,2

PIONEER I1,2   P=0.003

42%

vs

26%

ACHIEVED HiSCR

PIONEER II1,2   P<0.001

59%

vs

28%

ACHIEVED HiSCR

HUMIRA 40 mg EW (PIONEER I, n=64/153, control=placebo; PIONEER II, n=96/163, control=placebo +/- antibiotic)

Control (PIONEER I, n=40/154, control=placebo; PIONEER II, n=45/163, control=placebo+/- antibiotic)

Assess disease severity in your patients

Efficacy in adolescents extrapolated from adult data

Efficacy in adolescents extrapolated from adult data

HUMIRA efficacy in adolescent HS patients is extrapolated from the adult HS patient data based on the likelihood that the disease course and drug effects are similar to that of adults at the same exposure levels determined through pharmacokinetic modeling.1


EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation

Visualizing HiSCR

BASELINE PRIOR TO TREATMENT

HiSCR ACHIEVED AT WEEK 12

DRAG TO VIEW

BASELINE PRIOR TO TREATMENT

HiSCR ACHIEVED AT WEEK 12

DRAG TO VIEW

BASELINE PRIOR TO TREATMENT

HiSCR ACHIEVED AT WEEK 12

DRAG TO VIEW

BASELINE PRIOR TO TREATMENT

HiSCR ACHIEVED AT WEEK 12

DRAG TO VIEW

Computerized illustrations of HiSCR criteria. Individual results may vary.


EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation; LOCF=last observation carried forward

Open-label extension

HiSCR response up to OLE Week 1683

Adult patients receiving continuous weekly treatment, up to week 168, in PIONEER I, II, and OLE

percentage of HUMIRA patients achieving HISCR response in clinical trials through week 168
Path to OLE

HUMIRA EW Population: Graph represents HUMIRA EW population of 88 patients who received continuous 40 mg weekly HUMIRA in Periods A and B of PIONEER I or II and in the OLE.

HiSCR: (Hidradenitis Suppurativa Clinical Response) was defined as ≥ 50% reduction in AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.

Limitations associated with an open-label extension analysis apply, such as uncontrolled nature of the data and enrichment of responder population.


EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation; LOCF=last observation carried forward