Is Humira good for treating hidradenitis suppurativa?

Humira (adalimumab) is approved by the FDA to treat moderate-to-severe hidradenitis suppurativa in people 12 years of age and older. In studies, results were seen in 12 weeks. Humira will not cure hidradenitis suppurativa but may help to reduce your number of nodules and abscesses, relieve your painful symptoms and control your disease worsening.

Humira is currently the only medicine approved by the FDA to treat hidradenitis suppurativa. Humira is a medicine that can suppress your immune system and increase your risk for infections. Other treatment options include surgery to remove skin affected by the disease and antibiotics to treat any infections. Your doctor might also use Humira in addition to surgery to help control inflammation.

Orphan drug designation provides Humira seven years of market exclusivity for hidradenitis suppurativa.

How effective is Humira in studies for hidradenitis suppurativa?

• Is Humira good for hidradenitis suppurativa? In the two Phase 3, PIONEER I and PIONEER II studies of 633 people with moderate to severe hidradenitis suppurativa, Humira reduced the total number of inflammatory nodules and abscesses by at least 50% in 12 weeks and was more effective than a placebo (an inactive treatment).
• There were no increases in the number of abscesses or draining wounds relative to when patients started the study.

The primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12, was defined as at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline.

Subjects used topical antiseptic wash daily and oral antibiotic use was allowed in Study 2 (occurred in 19.3% of patients). At week 12, the dose of Humira was 40 mg given by subcutaneous injection weekly.

In both studies, more patients who received Humira than placebo-treated subjects achieved the primary endpoint of HiSCR.

• Study 1: Humira (42%) vs. placebo (26%)
• Study 2: Humira (59%) vs. placebo (28%)

In a second phase, from Week 12 to Week 35, 100 patients were re-randomized from Humira treatment to placebo only. In 22% of patients who were withdrawn from Humira treatment following the primary efficacy timepoint in the two studies, a flare of hidradenitis suppurativa was documented. A flare is defined as ≥25% increase from baseline in abscesses and inflammatory nodule counts and with a minimum of 2 additional lesions.

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What is hidradenitis suppurativa?

Hidradenitis suppurativa is a chronic (long-lasting) and debilitating inflammatory skin disease. It is characterized by swollen, painful bumps (nodules) and abscesses typically located around the armpits, groin, and inner thighs, on the buttocks and under the breasts. It tends to start in young people after puberty, and can worsen and last for many years.

Risk factors that may increase your risk for hidradenitis suppurativa include:

• Age: Higher risk for people in their 20s and 30s
• Sex: Females over males are at greater risk
• Race: May be higher among Black people in the U.S.
• Family history: Can be inherited
• Being overweight or obese
• Smoking tobacco

The exact cause of hidradenitis suppurativa is unknown, but it is thought the immune system plays a role in the disease and symptoms. The body may produce too many proteins, like cytokines and Tumor Necrosis Factor (TNF) alpha, that lead to inflammation. Humira works by blocking TNF alpha, thought to contribute to the symptoms of hidradenitis suppurativa.

Learn more: Is Humira an immunosuppressant?

How is Humira given for hidradenitis suppurativa?

Humira is given as a subcutaneous (just under the skin) injection. You or a caregiver can be taught by your healthcare provider to give these injections at home. Do not inject Humira until you have received training from your healthcare team.

After initial dosing over the first fews weeks, Humira is administered either every week or every 2 weeks for hidradenitis suppurativa. Doses for adolescents 12 years of age and older are based on their weight.

Related: Humira dosing (in more detail)

This is not all the information you need to know about Humira (adalimumab) for safe and effective use and does not take the place of your doctor’s directions. Review the full Humira information and discuss this information and any questions you have with your doctor or other health care provider.