An early study for a new injectable treatment shows improvement in Hidradenitis Suppurativa (HS) activity and pain scores while demonstrating safety. Dr. Alice Gottlieb of Icahn School of Medicine at Mount Sinai, New York led the research investigating the results of bermekimab use in 42 patients with Hidradenitis Suppurativa. The results were recently published in the Journal of Investigative Dermatology.

Interleukin-1 as target for HS Treatment

High amounts of interleukin-1 (or IL-1) were found in the drainage from severe HS lesions. So, drugs that block IL-1 might help treat HS. Drugs that block IL-1 were tried in small studies and showed some promise. This study was done to try a new drug, called bermekimab, in a bigger group of people with HS. The main goal was to make sure the drug was safe. The researchers also measured how well it worked to decrease symptoms and activity of HS.

Twelve Weeks of Bermekimab Treatment

There were 24 people with HS who did not have enough improvement with anti-TNFa treatment and 18 people with HS who never had anti-TNFa treatment in the study. All of them got a subcutaneous shot of bermekimab every week for 12 weeks. There was no placebo comparison – this is good because everyone got the drug, but we don’t know how much the drug helps people compared to nothing or another treatment.

Early study demonstrates safety and efficacy

The most common safety issues were redness, swelling, and soreness at the injection site and nausea. For the group of people who had prior anti-TNF treatment: 63% of people achieved HiSCR and as a group their pain scores decreased by 64% after 12 weeks of treatment. For the group of people who never had anti-TNF treatment: 61% of people achieved HiSCR and as a group their pain scores decreased by 54% after 12 weeks of treatment.

Bigger Studies Needed

The immune system is a big part of what causes HS. Treatments that target the high levels of immune chemicals (like interleukins and cytokines) are hoping to make a big difference. Interleukin-1 is emerging as an important treatment target and bermekimab may be a good treatment, but bigger studies are needed.

Cytokines: Chemicals made by cells that make things happen in the immune system and the body. Cytokines can cause more activity from the immune system, more cells, more swelling, more pain – or can decrease the immune system
HiSCR: The HiSCR (Hidradenitis Suppurativa Clinical Response) is used in clinical trials to how well a drug works for HS. HiSCR is either achieved or not. In order to achieve HiSCR, a person must have at least a 50% of the abscesses and inflammatory nodules on their body go away – and the number of abscesses and draining tunnels (or fistulas) can’t go up compared to the beginning of the study.
Interleukin: a type of cytokine that causes changes in the immune system or the body. The interleukins are numbered to help keep them separate from each other.
Placebo: This is when people are given a shot, pill, or treatment in a study that closely matches the real drug, but doesn’t have the actual ingredient.
Subcutaneous: Refers to putting something under the skin. Like a subcutaneous injection, this means a needle puts liquid under the skin, but not any deeper. From this place, it gets moved out and around the body.
TNF-a: TNF-a or Tumor Necrosis Factor-alpha is a cytokine. Its name is a bit confusing because it is found in lots of things, not just tumors or cancers. It is found at higher levels in the skin lesions of HS.