Hidradenitis suppurativa (HS)
HUMIRA is the first and only originator biologic* indicated in the treatment of HS†
HUMIRA is indicated for the treatment of active moderate to severe HS in adult and adolescent patients (12 to 17 years of age weighing ≥30 kg), who have not responded to conventional therapy (including systemic antibiotics).
* Also known as a reference biologic.
† Comparative clinical significance has not been established.
HUMIRA DEMONSTRATED CLINICAL RESPONSE (HiSCR) AT WEEK 12
PIONEER II: Significantly more adult HUMIRA patients achieved HiSCR at Week 12 vs. placebo.1
2X (58.9% vs. 27.6%) as many adult HUMIRA patients achieved HiSCR at Week 12 vs. placebo.
* p<0.001 vs. placebo
Adapted from the HUMIRA Product Monograph1
PIONEER I: Significantly more HUMIRA patients achieved clinical response HiSCR at Week 12
vs. placebo.1
41.8% vs. 26.0% (p=0.003; n=153 vs. n=154)
HISCR definition
Evaluating clinical efficacy in HS with HiSCR
HiSCR is defined as:1
a ≥50% reduction in total AN count*
no increase in abscesses or draining fistulas*
Two hypothetical examples to illustrate the difference between a HiSCR responder vs.
non-responder:†
HiSCR=hidradenitis suppurativa clinical response; AN count=total abscess and inflammatory nodule count
* Relative to baseline
† May not be representative of all HS patients.
PIONEER I/II: Two randomized, double-blind, placebo-controlled, 2-period studies of 307 patients (PIONEER I) and 326 patients (PIONEER II) with moderate to severe HS who were intolerant, had a contraindication or an inadequate response to systemic antibiotic therapy. Both studies consisted of an initial 12-week double-blind treatment period (Period A), and a subsequent 24-week double-blind treatment period (Period B). In Period A, patients received placebo or HUMIRA at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11. After 12 weeks, patients who had received HUMIRA in Period A were re-randomized in Period B to 1 of 3 treatment groups (HUMIRA 40 mg every week, HUMIRA 40 mg every other week, or placebo from Week 12 to Week 35). Patients who had been randomized to placebo in Period A were assigned to receive HUMIRA 40 mg every week (in PIONEER I) or placebo (in PIONEER II).
HUMIRA DEMONSTRATED CLINICAL RESPONSE (HISCR) AT WEEKS 24 AND 36
Clinical response during Period B of PIONEER I and PIONEER II in adult
patients who had at least a partial response to HUMIRA 40 mg weekly at
Week 12 (secondary endpoint).1,2
>50% of adult patients on HUMIRA 40 mg weekly maintained HiSCR at Weeks 24 and 36.
EOW=every other week; ns=not significant
* p=0.004 vs. placebo
†p=0.001 vs. placebo
‡p=0.027 vs. placebo
Adapted from the HUMIRA Product Monograph and Data on file1,2
Patients who had received HUMIRA in Period A (baseline to Week 12) were re-randomized in Period B
(from Week 12 to Week 36) to 1 of 3 treatment groups.
§ HUMIRA 40 mg EOW is NOT A RECOMMENDED DOSE.
Observed lesions in some patients with moderate to severe HS before and after 24 or 36 weeks of HUMIRA treatment
Images may not be reflective of all patients.
Patients with at least a partial response included:
HiSCR responders at Week 12
Partial responders, defined as HiSCR non-responders who
achieved a ≥25% improvement in total AN count at Week 12
AN count=total abscess and inflammatory nodule count; HiSCR=hidradenitis suppurativa clinical response
PIONEER I/II: Two randomized, double-blind, placebo-controlled, 2-period studies of 307 patients (PIONEER I) and 326 patients (PIONEER II) with moderate to severe HS who were intolerant, had a contraindication or an inadequate response to systemic antibiotic therapy. Both studies consisted of an initial 12-week double-blind treatment period (Period A), and a subsequent 24-week double-blind treatment period (Period B). In Period A, patients received placebo or HUMIRA at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11. After 12 weeks, patients who had received HUMIRA in Period A were re-randomized in Period B to 1 of 3 treatment groups (HUMIRA 40 mg every week, HUMIRA 40 mg every other week, or placebo from Week 12 to Week 35). Patients who had been randomized to placebo in Period A were assigned to receive HUMIRA 40 mg every week (in PIONEER I) or placebo (in PIONEER II).
HS-RELATED SKIN PAIN
PIONEER II: Significantly more adult HUMIRA patients achieved at least a
30% decrease in HS-related skin pain (NRS30) at Week 12 vs. placebo
(secondary endpoint).1,2
2X (45.7% vs. 20.7%) as many adult HUMIRA patients achieved a decrease of ≥30% in HS-related skin pain by Week 12 vs. placebo.
* p<0.001 vs. placebo
Adapted from the HUMIRA Product Monograph and Data on file1,2
PIONEER I: At Week 12, there was no statistically significant difference in the percentage of adult
patients achieving at least a 30% decrease in HS-related skin pain (NRS30) between the HUMIRA and
the placebo groups.1
NRS30=reduction of ≥30% in skin pain based on the Numeric Rating Scale
PIONEER I/II: Two randomized, double-blind, placebo-controlled, 2-period studies of 307 patients (PIONEER I) and 326 patients (PIONEER II) with moderate to severe HS who were intolerant, had a contraindication or an inadequate response to systemic antibiotic therapy. Both studies consisted of an initial 12-week double-blind treatment period (Period A), and a subsequent 24-week double-blind treatment period (Period B). In Period A, patients received placebo or HUMIRA at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11. After 12 weeks, patients who had received HUMIRA in Period A were re-randomized in Period B to 1 of 3 treatment groups (HUMIRA 40 mg every week, HUMIRA 40 mg every other week, or placebo from Week 12 to Week 35). Patients who had been randomized to placebo in Period A were assigned to receive HUMIRA 40 mg every week (in PIONEER I) or placebo (in PIONEER II).
HUMIRA DEMONSTRATED LOWER INCIDENCE OF FLARES
PIONEER II: Significantly fewer adult HUMIRA patients had flares during the
initial 12 weeks of treatment vs. placebo (secondary endpoint).1,3
3X fewer (11% vs. 35%) adult HUMIRA patients experienced flares during 12 weeks of treatment vs. placebo.
* p<0.001 vs. placebo
Adapted from the HUMIRA Product Monograph and Kimball, et al.1,3
Flare defined as ≥25% increase in AN count with a minimum increase of 2 relative to baseline.
PIONEER I: Significantly fewer HUMIRA patients had flares during the initial 12 weeks of treatment vs. placebo (secondary endpoint).1,3
14% vs. 36% (p<0.001; n=153 vs. n=154)
PIONEER I/II: Two randomized, double-blind, placebo-controlled, 2-period studies of 307 patients (PIONEER I) and 326 patients (PIONEER II) with moderate to severe HS who were intolerant, had a contraindication or an inadequate response to systemic antibiotic therapy. Both studies consisted of an initial 12-week double-blind treatment period (Period A), and a subsequent 24-week double-blind treatment period (Period B). In Period A, patients received placebo or HUMIRA at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11. After 12 weeks, patients who had received HUMIRA in Period A were re-randomized in Period B to 1 of 3 treatment groups (HUMIRA 40 mg every week, HUMIRA 40 mg every other week, or placebo from Week 12 to Week 35). Patients who had been randomized to placebo in Period A were assigned to receive HUMIRA 40 mg every week (in PIONEER I) or placebo (in PIONEER II).
Safety information
Click here for additional information and for a link to the Product Monograph discussing:
• Contraindications in patients with severe infections such as sepsis, tuberculosis (TB) and opportunistic infections, and moderate to severe heart failure (NYHA class III/IV).
• The most serious warnings and precautions regarding hepatosplenic T-cell lymphoma, serious infections and pediatric malignancy.
• Other relevant warnings and precautions regarding concurrent administration with other biologic disease-modifying antirheumatic drugs (DMARDs) or other tumour necrosis factor (TNF) antagonists not recommended, switching between biological DMARDs, surgery, patients with congestive heart failure, hematologic events, hypersensitivity reactions, autoimmunity, immunosuppression, immunizations, infections including TB, opportunistic infections and hepatitis B virus reactivation, malignancies including malignancies in pediatric patients and young adults, lymphoma and non-lymphoma malignancy, neurologic events, uveitis and central demyelinating disorders, pregnant or nursing women, and geriatrics.
• Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions.
The Product Monograph is also available by calling us at 1-866-8HUMIRA (1-866-848-6472).
References:
1. HUMIRA Product Monograph. AbbVie Corporation.
2. AbbVie Corporation. Data on File.
3. Kimball AB, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med 2016;375:422-34.