TNF Inhibitors Prove Effective
Hidradenitis Suppurativa Systemic Therapy Options
MauiDerm 2015 - Hidradenitis suppurativa (HS) is a debilitating chronic inflammatory disease that has historically been very challenging to treat, with truly effective therapeutic modalities few and far between. Recent research with TNF inhibitors has shown promise for the treatment and management of HS, offering effective systemic therapy for moderate to severe cases.
Also known as acne inversa, HS is characterized by the development of painful abscesses, nodules, and fistulas in apocrine gland-bearing skin such as in the inguinal, sub-mammary, and axillary regions. Keloids, contractures, and immobility commonly develop in the affected areas. In severe cases, HS can be associated with a number of co-morbidities including metabolic syndrome, follicular occlusion disorders, spondylarthropathy, inflammatory bowel diseases such as Crohn’s disease, and others. HS and its co-morbidities can have a significant negative impact on patients’ quality of life, begging the need for effective therapies that can address this notoriously difficult-to-treat disease.
“It is very important to remember that HS is an inflammatory disease akin to psoriasis, psoriatic arthritis, and Crohn’s disease. As such, evolving agents such as the TNF inhibitors that can reduce the inflammation in the patient could be an ideal treatment option for HS patients, particularly those with moderate to severe disease or in refractory cases,” said Bruce E. Strober, M.D., Ph.D., associate professor and vice chair, department of dermatology, University of Connecticut School of Medicine, Farmington, Conn.
According to Dr. Strober, several different TNF inhibiting agents have been tried and researched in clinical trials for the treatment and improvement of the symptoms of HS including etanercept (Enbrel, Amgen), infliximab (Remicade, Janssen), and most recently adalimumab (Humira, AbbVie).
AbbVie recently announced phase 3 data of the PIONEER I study, a 36-week, multicenter, randomized, double-blinded, two-period clinical trial that evaluated the efficacy and safety of adalimumab in 307 patients with moderate to severe HS1. In the first 12-week study period (Period A), patients were randomized to receive adalimumab 160mg at week 0, 80mg at week 2 and 40mg once weekly (n=153) starting at week 4, or placebo (n=154). Following Period A, eligible patients were re-randomized in a 24-week treatment period (Period B) in which they received adalimumab 40mg weekly, 40mg every other week, or placebo. The results of Period B have not yet been released. Using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure, investigators assessed treatment response, which was defined as at least 50% reduction from baseline in total abscess and inflammatory nodule count at week 12 with no increase for either abscess or draining fistula count.