Serious Infections: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Malignancies: Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.
Other Serious Adverse Reactions: Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.
Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Hi, I’m Dr. Jennifer Cather and I’d like to talk to you about hidradenitis suppurativa, or HS. The goal of this video is to help you understand the chronic, progressive, immune-mediated nature of HS; learn more about the people who have it; and highlight the importance of diagnosing and treating it early.
So, what exactly is HS? HS is a chronic, inflammatory skin disease that affects skin containing apocrine glands. It’s characterized by nodules, abscesses and draining fistulas. HS can have a devastating effect on patients. As it progresses, nodules and abscesses can become more difficult to manage, increasing the impact HS has on a person’s life.
The exact cause of HS is unknown. But what we do know is, elevated levels of cytokines like IL-1ß, IL-10 and TNF-α play a key role in fueling HS inflammation. One study showed that HS lesions expressed five times more TNF-α than normal skin.
In HS patients, hair follicles become plugged and rupture, and an inflammatory response fueled by an overproduction of proinflammatory cytokines follows, causing an inflammatory nodule or abscess to form. Then, these lesions may heal, but the process becomes chronic. This can lead to sinus tracts and scarring. These wounds may become infected, but it’s important to note, HS is not a primary skin infection.
Let’s take a look at who the HS patient is. Approximately 200,000 people in the US suffer from moderate to severe HS, affecting more women than men. The age of onset is typically between a patient’s early 20s to 50s. Studies suggest tobacco use and obesity could potentially exacerbate HS. For women, the most commonly affected areas are under the breasts and in the groin. Men, however, are more commonly affected on the buttocks and in the perianal area.
So, as you can see, HS affects areas that are difficult to examine, and patients can find it embarrassing to show and discuss all aspects of the disease. Because of this, they often minimize the impact their disease has on their lives; it’s hard for them to ask for help. Sometimes it’s necessary for the physician to ask.
As HS progresses it causes the destruction of cutaneous architecture making it more challenging to treat. This could result in a number of debilitating medical and psychosocial sequelae. First, lesions can spontaneously rupture or coalesce to form painful abscesses. These often exude a purulent discharge.
Patients may also experience limited limb mobility or even loss of limb function, caused by excessive scarring and fibrosis produced by the lesions. And, patients may develop draining sinuses that may produce a foul discharge.
Between the drainage, the odor that comes from it, and the scarring, there’s a significant amount of burden for patients that accompanies HS. Especially with the odor. I’ve seen so many patients who always think they smell. Many of them have resorted to taping maxi pads underneath their arms to stop the dripping. I’ve heard patients say they’re embarrassed when friends and coworkers notice the nodules and abscesses in their armpits. I’ve also heard patients sat that even sitting down is uncomfortable when they have numerous lesions around their inner thighs and buttocks.
Hearing from patients what they go through and what they’ve missed out on is heartbreaking. When physicians understand the impact that moderate to severe HS can have on a patient, they would prioritize this disease. It is crucial to treat patients’ symptoms and manage the underlying inflammation as soon as possible.
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
For full Prescribing Information, visit rxabbvie.com/pdf/humira.pdf
Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.