Recognizing
HS
For the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older
HUMIRA IS THE FIRST
FDA-APPROVED TREATMENT FOR HS
Not an actual HS patient
Looking to
treat with
HUMIRA?
The Role of HUMIRA in HS
The overexpression of proinflammatory cytokines, such as TNF-α, is believed to play a key role in fueling HS inflammation that may cause abscesses, inflammatory nodules, and draining tunnels. HUMIRA, the first FDA-approved treatment for moderate to severe HS (≥12 years of age), is a subcutaneous injectable biologic that helps address inflammation by targeting and blocking TNF-α.1-4*
*The relationship between these pharmacodynamic activities and the mechanism(s) by which HUMIRA exerts its clinical effect is unknown.1
Clinically Meaningful Improvement
Primary endpoint in PIONEER I and II trials:
42% (PIONEER I) and 59% (PIONEER II) of HUMIRA-treated adult patients achieved
HiSCR† at Week 12, vs 26% and 28% on placebo, respectively.1,5†
HiSCR Requires the Following Relative to Baseline1,5
HiSCR requires counting abscesses, inflammatory nodules, and draining tunnels before and after an intervention.5
†HiSCR=Hidradenitis Suppurativa Clinical Response.
Results your patients can see: visualizing HiSCR
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Martin Miehe. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Andreas Pinter. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Severe/Stage III:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
Severe/Stage III:
BEFORE
AFTER
BEFORE
| Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. At baseline, patients had AN counts ≥3 and lesions in ≥2 anatomic areas, 1 of which was at least Hurley Stage II. |
AFTER
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 count and draining tunnel count.1,5
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 control1,5
PIONEER I
42%of HUMIRA patients achieved HiSCR
P=0.003 vs control
vs
26%of control patients achieved HiSCR
PIONEER II
59%of HUMIRA patients achieved HiSCR
P<0.001 vs control
vs
28%of control patients 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)
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 count and draining tunnel count.1,5
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation
Flare incidence through 3 months
Lower occurrence of flare in the short term vs control18
Pre-specified other secondary endpoint
Integrated analysis of PIONEER I and PIONEER II through 12 weeks.
Flare: ≥25% increase in AN count and an absolute increase of ≥2 relative to baseline1,18
DATA LIMITATIONS
Flare and Days on Flare were pre-specified other secondary endpoints in Period A and not controlled for multiplicity. This data cannot be regarded as statistically or clinically significant, and therefore, no conclusions can be drawn.5,8
PIONEER I control=placebo
PIONEER II control=placebo +/- antibiotic
AN=abscess and inflammatory nodules
DMARDs=disease-modifying antirheumatic drugs
EOW=every other week
EW=every week
22% (of 100) patients who were withdrawn from HUMIRA after 12 weeks experienced flare.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 count and draining tunnel count.1,5
Higher proportion of patients did not experience lesion spread in a post hoc analysis vs control19
HUMIRA’s lesion spread data is an integrated exploratory post hoc analysis of PIONEER I and II. In the analysis, lesion spread was assessed through 36 weeks in patients randomized to HUMIRA 40 mg weekly or placebo in Period A and B. PIONEER I and II are the only completed Phase 3 trials in HS.
Lesion spread: lesions (abscesses, inflammatory nodules or draining tunnels) in any anatomic region not seen at baseline
DATA LIMITATIONS
- Lesion spread was not a pre-specified endpoint and was not controlled for multiplicity. This data cannot be regarded as statistically or clinically significant, and therefore, no conclusions can be drawn.
- Placebo comparator only includes data from PIONEER II, so differences should be interpreted with caution.
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 count and draining tunnel count.5
Well-Studied Safety Profile of HUMIRA
HUMIRA has clinical trial experience across 11 immune-mediated diseases. HUMIRA has been studied in adults with HS in 3 controlled studies and an open-label extension study, and the safety profile for adult patients with HS treated with weekly dosing was consistent with the known safety profile of HUMIRA.1,10
8,000+ patients
treated in clinical studies1
25+ years
of clinical trial experience beginning with rheumatoid arthritis in 199711
3 years
Up to 3 years of safety data in HS,
including open-label extension6
Anticipated safety in adolescents
Safety of the recommended HUMIRA dose in the adolescent HS population is anticipated to be consistent with the known safety profile of HUMIRA based on a cross-indication safety profile of HUMIRA in both adults and pediatric patients at similar or higher exposure determined through pharmacokinetic modeling.1
Patients prescribed HUMIRA worldwide in immune-mediated disease12
Source: Information derived from Symphony Health (PatientSource) and IQVIA (NPA, NSP) using proprietary methodology (January 2010-July 2020)
11 Indications
including 5 pediatric indications and the first FDA-approved treatment for moderate to severe HS1,4
Experience in Dermatology
10+ years
of clinical experience in dermatology14
50,000+ patients
have been prescribed HUMIRA for HS since its FDA approval in 201515§
§Information derived from PatientSource data provided by Symphony Health and IQVIA (NSP) for HS (Sep 2015) through Mar 2020
Partner with a dermatologist
Dermatologists have experience with advanced treatment options, such as biologics.16,17
A 50% improvement… I
almost can’t picture it. Oh, the
shirts I would wear!
– Insight from actual HS female patient
Watch “Navigating the Unknown”
Reflections on HS from HS-treating dermatologists, a pediatrician, and actual patients.
Members of the HS care team, including HS-treating dermatologists and a pediatrician, discuss the importance of timely identification and appropriate treatment of HS. Actual HS patients discuss the impact HUMIRA has had on their journey with HS.
