DR. KIRBY:
Hidradenitis suppurativa was once described to me by a patient as a roller coaster. They said, “I can’t be the mother I want to be because of my HS.” She has a two-year-old toddler and, on the days that her HS is really active under her arms and on her breasts, she can’t even pick up her own daughter.
DIRECTOR:
So what fire did that light in you?
DR. KIRBY:
A righteous one…HS is a disease of the immune system that shows up in the skin.
DR. LEDNICKY:
Patients usually present to us as undiagnosed. So we see them at their worst.
DR. DREW:
HS patients are often frustrated by what they think are a lack of options.
DR. KIRBY:
We’ve learned a lot about HS over the years, and while the exact cause is still not fully understood, systemic inflammation can play a role in HS.
NARRATOR:
Dermatologists can help patients improve their HS with treatment options including HUMIRA. HUMIRA is an FDA-approved treatment for moderate to severe HS.
ADAH:
I started noticing symptoms of HS around the time when I was a teenager. These areas were oozing pus and blood. They were very painful. They would eventually go under my stomach area into my thighs.
KARA:
I didn’t know what it was. I didn’t know what was going on. I felt nasty. I thought that it may have been due to my hygiene, it was my weight—because other girls my age haven’t heard of anything like that.
DR. KIRBY:
When a patient comes into my office with scarring or tunneling on the skin, that’s when I know that their HS is moderate to severe. So, I need to get them on a biologic like HUMIRA sooner rather than later.
DR. DREW:
The symptoms of HS can really be debilitating. Patients suffer the embarrassment of lesions that can be nodules or abscesses or draining sores that can happen on any part of the body.
DR. KIRBY:
It’s so crucial to get to adolescents early. But that is also the goal in adults.
NARRATOR:
Moderate to severe HS can present in a variety of ways. Typical signs and symptoms include painful lesions and nodules, abscesses, double comedones, draining fistulas, and hypertrophic scarring. HS may be challenging to diagnose and typically occurs in many patients’ most sensitive areas. Patients tend to get these symptoms, repeatedly, in the same or different areas over the course of 6 or more months. HS is a chronic, immune-mediated skin disease that can be progressive and debilitating.
DR. KIRBY:
If you see a patient two or more times for ingrown hairs, folliculitis, or acne in a fold of the body like under the arm, the groin, the buttock, under the breast, think of HS.
KARA:
The first time I had to see a doctor was in an emergency room. A nodule had gotten super red and I was in a lot of pain, and they said that they needed to do an incision and drainage. This would happen so frequently. I just knew something wasn’t right, but I couldn’t get answers from anybody or anywhere.
DR. LEDNICKY:
It’s important for us as physicians to start the conversation with patients. We have to bring it out into the light, ask the appropriate screening questions, and give them a thorough skin examination so that we can diagnose the condition.
ADAH:
About 12 years ago, I had 13 areas that were red and swelling, they smelled horrible. They were oozing. They were coming through on my clothes. When the doctors would ask me, “How’s it going today?” I could have 10 abscesses going and been in pain, bleeding and everything. I would not say a word because I just didn’t want to be humiliated or questioned. What this doctor did differently was he just didn’t take my word for it, he wanted to see it. He also said, “How long have you been having this?” I said, “Well, since I was a teenager.” That’s when he said to me, “Well, you have HS.” I looked at him, astonished that he was giving me the answer to my lifelong question of what I had. And he said, “Well, we’re gonna get you some help.” It took me over 30 years to get diagnosed with HS. I finally had an answer to all of the unanswered questions.
DR. DREW:
When people don’t know what they have and we diagnose them with HS, you can see the weight of the world off their shoulders.
DR. KIRBY:
That name means that it exists, that there are others, maybe in the world and in the country, in our town, that have it too...and our struggle, it's not ours alone. I like to set people’s expectations at the beginning of starting a treatment. So I let them know about the benefits and risks associated with a biologic, especially a biologic like HUMIRA, which has a risk for serious infections and malignancy. HUMIRA works by targeting and blocking TNF-alpha, which contributes to the inflammation that causes abscesses, inflammatory nodules, and draining tunnels in HS.
NARRATOR:
Let’s look closely at the efficacy results from the PIONEER I and PIONEER II clinical trials. HiSCR at Week 12 was the primary endpoint and measure of clinical response in both trials.
DR. KIRBY:
Achieving a 50% or more reduction in abscesses and nodules on HUMIRA, without an increase in abscesses and draining fistulas, is meaningful to my HS patients. At Week 12 in both PIONEER trials, significantly more people who were treated with HUMIRA achieved HiSCR compared to people in the control group.
NARRATOR:
In PIONEER I, 42% of adult HUMIRA-treated patients achieved HiSCR versus 26% of control patients. In PIONEER II, 59% of adult HUMIRA-treated patients achieved HiSCR versus 28% of control patients.
DR. KIRBY:
You can see at least a 50% reduction, just for this body site, in the number of inflammatory nodules and abscesses. Compared to the after photo, there is a reduction in the number of open areas.
NARRATOR:
The safety profile of HS was consistent with the safety profile of HUMIRA overall. Click each icon to view additional HUMIRA data on Lesion Spread, Flare, and HiSCR response rates at 3 years of treatment—or let the video play to continue watching.
DR. DREW:
We like to start that therapy as quickly as a diagnosis is made and watch them begin the journey to improvement in HS.
ADAH:
I’ve been challenged every day with HS, but now I get to challenge myself in different ways that bring me joy.
DR. DREW:
If I were to summarize HUMIRA for HS patients, it is an opportunity, with the help of my doctor and this medicine, to make this disease a part of my life, not the definition of my life.
DR. KIRBY:
I think it’s crucial to build a long-term relationship with our HS patients. This is a chronic condition, it will come and go over the course of years.
DR. LEDNICKY:
When I see a patient that has a great response to it, I am as thrilled probably as they are, and it’s, it’s very fulfilling to have that kind of involvement and that effect on a person’s life, and it’s one of the reasons I love medicine.
POP-OUTS
Lesion Spread:
NARRATOR:
In an integrated exploratory post-hoc analysis of PIONEER I and II, lesion spread was assessed through 36 weeks in patients randomized to HUMIRA 40 mg weekly or placebo in Period A and Period B. Lesion spread is defined as abscesses, inflammatory nodules, or draining fistulas observed in any anatomic region not seen at baseline. 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 data are only available from PIONEER II, so differences should be interpreted with caution.
In this post-hoc analysis, 47% of HUMIRA-treated patients did not experience lesion spread at Week 36. 25% of patients in the control group did not experience lesion spread.
Flare:
Flare (3 Months):
NARRATOR:
In an integrated analysis of PIONEER I and PIONEER II, flare occurrence was examined through Week 12. Flare was defined as at least a 25% increase in abscess and nodule count, and an absolute increase of at least 2 abscesses and nodules relative to baseline. Flare was a pre-specified other secondary endpoint in Period A. Since PIONEER I did not reach statistical significance at the first key secondary endpoint, all endpoints in this integrated analysis cannot be regarded as statistically significant.
In Period A of PIONEER I and PIONEER II, 88% of patients on HUMIRA experienced no flares, compared to 65% of patients in the control group. For those who experienced flare, the mean days of flare were shorter for HUMIRA-treated patients versus control patients. HUMIRA-treated patients experienced flares of 19 days vs control-treated patients who experienced flares of 32 days.
Flare (3-9 Months):
NARRATOR:
In a post-hoc integrated analysis with a proportion of OLE patients, 80% of HUMIRA-treated patients did not experience flare from 3 through 9 months. Non-ranked endpoints were not controlled for multiplicity and thus required careful interpretation. A placebo comparator group was not available past week 12 due to study design allowing early escape to OLE. Period B flare results were analyzed post-hoc. Since PIONEER I did not reach statistical significance at the first key secondary endpoint, all endpoints in this integrated analysis cannot be regarded as statistically significant.
3-year response data:
NARRATOR:
In the open-label extension (OLE) for the PIONEER I and PIONEER II clinical trials, HUMIRA has HiSCR response rates out to 3 years of treatment. At Week 168, over 50% of patients taking HUMIRA weekly achieved HiSCR. In addition, among the PRR population, over 57% of HUMIRA-treated patients achieved HiSCR at Week 168.
HiSCR is defined by at least a 50% reduction in total abscess and inflammatory nodule count relative to baseline; with no increase in abscess count or draining-fistula count.
Limitations associated with an OLE analysis apply, such as the uncontrolled nature of the data and enrichment of the responder population.
Path of OLE Patient:
NARRATOR:
In the path to OLE for PIONEER I and PIONEER II clinical trials, 88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (Periods A and B) and throughout the OLE.
Path of PRR Patient:
NARRATOR:
The Partial Response Rate (PRR) population, which included 63 patients, was a post-hoc defined population of patients taking HUMIRA weekly, who had either achieved HiSCR or achieved at least a 25% reduction in AN count relative to baseline at Week 12.
Study Design:
NARRATOR:
The PIONEER I and PIONEER II clinical trials were 36-week randomized, placebo-controlled, double-blind studies with 2 treatment periods (A and B) evaluating the safety and efficacy of HUMIRA once weekly with control in 633 adult patients with:
Hurley Stage II or Stage III disease AND at least 3 abscesses or inflammatory nodules in at least 2 areas of the body at baseline. During Period A in both studies, patients received HUMIRA or control. Concomitant oral antibiotic use was allowed in PIONEER II. The treatment was administered through subcutaneous injection. At Week 0, patients were given 160 mg, and 80 mg at Week 2. For Week 4 through Week 11, patients were given a maintenance dose of 40 mg every week. The primary endpoint for both studies was the proportion of patients achieving HiSCR, or the measure of clinical response in these trials, at Week 12.
Clinical response required:
At least a 50% reduction in total abscess and inflammatory nodule count relative to baseline with NO increase in abscess count relative to baseline and NO increase in draining fistula count relative to baseline.
Period B (Week 12 through Week 36) explored the safety and efficacy of different maintenance regimens (for example, continuation of HUMIRA every week, reduction to HUMIRA every other week, or treatment withdrawal) over 24 weeks.
Important Safety Information:
NARRATOR 2:
Lesions=abscesses, inflammatory nodules, or draining tunnels.
