Open-label study reports 80 percent response in hidradenitis suppurativa on tirzepatide

A new proof-of-concept study reports that 16 of 20 adults with moderate-to-severe hidradenitis suppurativa (HS) responded to 24 weeks of once-weekly tirzepatide, an 80 percent response rate that researchers called statistically significant ^[1]. The study, published in the Journal of Drugs in Dermatology, was open-label and had no placebo or control group, meaning every participant knew they were getting the drug and there was no comparison arm to rule out other explanations for the improvement ^[1].

The trial enrolled adults with a Physician's Global Assessment score of 3 or higher, a marker of at least moderate disease, and a body mass index of 27 or above ^[1]. Participants received tirzepatide titrated up to the highest dose they could tolerate for 24 weeks, then were followed through an 8-week period off the drug ^[1]. The main measure of success was HiSCR, the Hidradenitis Suppurativa Clinical Response, a standard scale used across HS research ^[1]. At week 24, 80.0 percent of participants (16 of 20) met that bar, with a reported P value below 0.00001 ^[1].

Beyond the main HiSCR result, researchers tracked quality of life using the Dermatology Life Quality Index, pain using a visual analog scale, and disease severity using the Physician's Global Assessment ^[1]. All three showed improvement, and some of those gains held through week 32, eight weeks after participants stopped the drug ^[1]. The study authors also reported that treatment was well tolerated with high adherence and what they described as favorable metabolic effects, though the paper does not spell out specific side effect rates in the material reviewed here ^[1]. The trial is registered on ClinicalTrials.gov as NCT06301256 ^[2].

HS is a chronic inflammatory skin condition that causes painful, recurring lumps and abscesses, most often in the armpits, groin, and other skin-fold areas. The study authors note that HS is closely tied to obesity and metabolic dysfunction, and current treatments such as adalimumab, secukinumab, bimekizumab, and antibiotics do not target that metabolic and inflammatory burden directly ^[1]. One of the study's co-authors is affiliated with Eli Lilly and Company, which makes tirzepatide under the brand names Mounjaro and Zepbound ^[1].

Why it matters for patients

HS is difficult to treat, and existing options do not work well for everyone. A high response rate in this small study may be encouraging news for patients and dermatologists looking for more tools, especially for people who also carry excess weight and are already candidates for a GLP-1 medication for other reasons. But the design of this study limits what can be concluded. Without a placebo group, it is not possible to separate the drug's specific effect on HS from natural fluctuation in a disease that often waxes and wanes, from the effects of weight loss itself, or from the attention and structure of being in a clinical study. The open-label design also means participants and researchers both knew who was getting treatment, which can influence how symptoms are reported. The authors themselves flagged the single-center design, lack of blinding, and modest sample size of 20 people as limitations ^[1].

Tirzepatide is not currently approved by the FDA for hidradenitis suppurativa. Patients using or considering Mounjaro or Zepbound for approved uses such as type 2 diabetes or weight management should not read this study as evidence the drug is a proven HS treatment.

What happens next

The study authors call for larger, randomized trials to confirm whether the effect seen here holds up against a control group and whether the benefits last beyond the 32-week window tracked in this study ^[1]. No timeline for such a follow-up trial is given in the available material, and it is not yet known whether the FDA will consider an HS indication for tirzepatide based on this or future data.