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

CLINICALLY MEANINGFUL IMPROVEMENT AT WEEK 12

HUMIRA is the only FDA approved treatment for hidradenitis suppurativa.

Also see:

VISUALIZING HiSCR: RESULTS YOUR PATIENTS CAN SEE

HUMIRA is the only FDA approved treatment for hidradenitis suppurativa.

Also see:

Primary endpoint in PIONEER I and II trials: Many adults with moderate to severe HS achieved HiSCR at Week 12, defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining tunnel counts.2

Results your patients can see: visualizing HiSCR

STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at Week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining tunnel counts.1,2


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

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

PIONEER I

42% of HUMIRA patients achieved HiSCR in PIONEER I

42%of HUMIRA patients achieved HiSCR

P=0.003 vs control

vs

26% of control patients achieved HiSCR in PIONEER I

26%of control patients achieved HiSCR

PIONEER II

59% of HUMIRA patients achieved HiSCR in PIONEER II

59%of HUMIRA patients achieved HiSCR

P<0.001 vs control

vs

28% of control patients achieved HiSCR in PIONEER II.

28%of control patients achieved HiSCR

  • HUMIRA 40 mg EW (PIONEER I, n=64/153, control=placebo; PIONEER II, n=96/163)
  • Control (PIONEER I, n=40/154, control=placebo; PIONEER II, n=45/163, control=placebo+/- antibiotic)

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


STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining tunnel counts.2


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

HiSCR response up to OLE Week 1683

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

 

Proportion of HiSCR achievers in HUMIRA every week population through OLE

LOCF Analysis (n=88)

Percentage of HUMIRA patients achieving HiSCR response in clinical trials through week 168.

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 tunnel 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.

STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining tunnel counts.2


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

Video thumbnail of Navigating the Unknown.

Watch "Navigating the Unknown"

Listen to actual HUMIRA-treated patients describe the impact of HS, and watch HS-treating dermatologists discuss why they choose HUMIRA for moderate to severe HS.

2019 North American HS Clinical Guidelines, level 1 Evidence, Humira received strongest recommendation.

*Strength of Recommendation based on: A – Consistent and good-quality patient-oriented evidence; B – Inconsistent or limited-quality patient-oriented evidence; C – Consensus, opinion, case studies or disease-oriented evidence.

Evidence Grading Level: Level I – Good-quality patient-oriented evidence; Level II – Limited-quality patient-oriented evidence; Level III – Other evidence, including consensus guidelines, opinion, case studies, or disease-oriented evidence.

NOTE: These guidelines reflect the best available efficacy evidence at the time of preparation, but did not include safety considerations and should not be interpreted as setting the standard of care.

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