CLINICAL TRIAL DATA
HUMIRA was studied in the first and only completed Phase III clinical trials (PIONEER I and PIONEER II) of adult 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
(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.
(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:
reduction in total abscess and
increase in abscess count
increase in draining
*HiSCR=Hidradenitis Suppurativa Clinical Response.
Dr. Cather discussesHUMIRA CLINICAL TRIAL DATA: MODERATE TO SEVERE HS
HUMIRA CLINICAL TRIAL DATA: MODERATE TO SEVERE HS
Dermatologist Dr. Cather discusses HUMIRA safety and efficacy. HUMIRA is a biologic that targets TNF-α, and the first and only FDA-approved treatment for moderate to severe hidradenitis suppurativa. See safety data for this HS treatment.
DR CATHER: I’m Dr. Jennifer Cather. Today I’d like to talk to you about HUMIRA, the first and only FDA-approved treatment for moderate to severe hidradenitis suppurativa, or HS. HUMIRA is a subcutaneous injectable biologic that targets TNF-α, a key cytokine and source of inflammation in many immune-mediated diseases, including HS. The relationship between these pharmacodynamic activities and the mechanism or mechanisms by which HUMIRA exerts its clinical effect is unknown.
The safety and efficacy of HUMIRA was studied in PIONEER I and PIONEER II, the first and only completed Phase 3, randomized, placebo-controlled trials in HS. These were 36-week, double-blind trials with 2 treatment periods: A and B. The patient population was 633 adult patients with lesions, 1 of which was Hurley stage II or Hurley stage III. The Hurley staging system is a widely used classification. The total abscess and inflammatory nodule count was at least 3 at the baseline visit.
In Period A, which was baseline to Week 12, patients in both studies received HUMIRA or control by subcutaneous injection. Concomitant oral antibiotic use was allowed in PIONEER II. During the trial, at Week 0 dosing started at 160 mg, then 80 mg at Week 2, and finally a maintenance dose at Week 4 of 40 mg every week through Week 11. The primary endpoint was the proportion of patients achieving HiSCR, which was the measure of clinical response in these trials, at Week 12. HiSCR stands for Hidradenitis Suppurativa Clinical Response.
Clinical response required: At least a 50% reduction in total abscess and inflammatory nodule count relative to baseline, with no increase in abscess count AND no increase in draining fistula count. Period B explored the safety and efficacy of different maintenance regimens over 24 weeks. Patients were instructed to discontinue from Period B and enter the open-label extension—or OLE—study if they achieved HiSCR in Period A and subsequently had loss of response, or if they did not achieve HiSCR and experienced worsening or absence of improvement on or after Week 16.
170 and 116 patients completed Period B in PIONEER I and PIONEER II, respectively. 79% of patients entered the OLE. In PIONEER I, a significantly greater proportion of HUMIRA-treated patients achieved clinical response vs control patients at Week 12: 42% of HUMIRA-treated patients vs 26% of control patients. In PIONEER II, more than twice as many patients treated with HUMIRA achieved clinical response vs control patients at Week 12: 59% of HUMIRA-treated patients vs 28% of control patients.
Here you can see what clinically meaningful improvement may look like for your patients with moderate to severe HS. And in my experience using various HS treatments, moderate patients who start on therapy before their disease becomes severe do better. The safety profile of HUMIRA in patients with HS was consistent with the known safety profile of HUMIRA.
Here you can see the treatment-emergent adverse events in PIONEER I during Period A. And here are the treatment-emergent adverse events in PIONEER II during Periods A and B.
Adverse reaction rates observed in clinical trials may not predict the rates observed in a broader patient population in clinical practice. This is because clinical trials are conducted under controlled conditions.
So to sum up: HUMIRA studies PIONEER I and II are the first and only completed Phase 3 clinical trials in HS, a disease that in moderate to severe stages can be progressive and debilitating. In these trials, many patients taking HUMIRA achieved clinically meaningful improvement, or HiSCR, with a safety profile that was consistent with the known safety profile of HUMIRA.
HUMIRA for moderate to severe HS is a weekly subcutaneous injectable. The way that HUMIRA treats HS is different. It targets a key source of inflammation and is the first and only FDA-approved treatment for HS. Primary care physicians and OB/Gyns have been referring patients to specialists for management of immune-mediated diseases for many years. Though HS is seen less frequently than some other immune-mediated diseases, there are dermatologists who have become specialists in treating it and have a high comfort level with HS treatment options. So when you see patients with moderate to severe HS, I would recommend partnering with a dermatologist.
Significantly more adult patients achieved clinically meaningful improvement at week 12.1,2
†HiSCR=Hidradenitis Suppurativa Clinical Response.
||Control=placebo ± antibiotic.
WHAT CLINICALLY MEANINGFUL IMPROVEMENT MAY LOOK LIKE FOR YOUR ADULT 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 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!”
– Insight from actual HS female patient
CONSISTENT WITH THE KNOWN
SAFETY PROFILE OF HUMIRA1
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.
Overview of treatment-emergent adverse events per 100 patient-years (PYs) in adults during Period A4
Only Period A safety shown as control patients were re-randomized to HUMIRA in Period B.
Overview of treatment-emergent adverse events per 100 patient-years (PYs) in adults 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.
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.
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.
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.”
– Insight from an OB/GYN
HUMIRA HAS A LEGACY OF
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.