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 adult patients with moderate to severe hidradenitis suppurativa.
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 how to identify and treat moderate to severe hidradenitis suppurativa, or HS, and how to differentiate it from other skin conditions. We’ll also take a look at some common, but non-FDA-approved, treatment options.
To begin, it’s important to understand that HS is a dynamic, progressive disease that varies considerably from patient to patient. That can make it challenging to figure out how to help patients navigate their therapeutic options.
So, what does HS look like? Some of the typical morphological features of HS include: inflamed nodules, as seen here, abscesses, sinus tracts, and hypertrophic fibrous, or “bridged,” scarring like this. Because several other skin conditions manifest in a similar fashion, it can be difficult to distinguish HS, especially in cases where only a single nodule appears. Because of this, diagnosis of HS is sometimes delayed for as long as 7 to 8 years.
A differential diagnosis of HS is extensive and includes these skin conditions: boils, acne, anogenital cutaneous Crohn’s disease, epidermoid or dermoid cyst, furuncle—which is caused by a staphylococcal infection, and carbuncle—a cluster of furuncles, pilonidal cyst, erysipelas, and sexually transmitted infections, including granuloma inguinale, lymphogranuloma venereum, and noduloulcerative syphilis.
As HS progresses, the diagnosis becomes more apparent, especially in cases where a patient is presenting with frequent recurrences, scarring, fistulas, sinus tracts, and incomplete healing. But by then, the damage may be permanent. Which is why it’s so important to diagnose moderate to severe HS early. Because HS is a progressive condition, severity increases over time and the therapeutic needs at each stage continue to change.
To determine HS severity, dermatologists rely on the Hurley Staging System, a widely used classification system. The system classifies patients into 3 groups based largely on the presence and extent of scarring and sinus tracts. Let’s take a closer look at the 3 stages. Stage I typically presents as single or multiple abscesses, without the presence of sinus tracts or scarring. By Stage II the disease typically presents as single or multiple, widely separated, recurrent abscesses with sinus tract formation and scarring. And finally, Stage III. At this point, the disease typically presents as diffuse or near-diffuse involvement with multiple interconnected sinus tracts and abscesses across the entire area.
Now, let’s take a look at some common treatment approaches to HS. In my clinical experience, when I started my own practice and began to see patients with HS return, I realized that the inflammatory lesions under the arms, breasts, and groin were part of a bigger inflammatory disease state. After I understood the chronic, recurrent, progressive nature of HS, I became more aggressive in my management of the disease, but there wasn’t much data regarding the type of efficacy I could expect for my patients with the available treatment options.
Many therapies have been used to manage symptoms, though none of these have been approved for HS treatment by the FDA. Although literature about specific HS treatment guidelines is limited, systemic antibiotics are frequently recommended as a first-line therapy. While the role of bacteria in HS is unclear, antibiotics, administered topically or systemically, are used to treat and prevent secondary infection in existing lesions. Corticosteroids are also used, both intralesionally and orally. Oral contraceptive agents that contain a high estrogen to progesterone ratio are used to address the possible hormonal etiology of HS. Another approach is incision and drainage. This helps by providing short-term relief for early, limited disease. And finally, surgery. When patients with HS progress beyond mild, surgery is used to excise the lesions, sinus tracts, or scarring.
While many of these treatments manage symptoms, they do not target one of the key sources that contribute to inflammation.
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.