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Bermekimab Successfully Treats Hidradenitis Suppurativa, Including Significant Reduction in Pain
The present study enrolled 42 patients, each receiving 400mg subcutaneous weekly doses of bermekimab in a 12-week treatment regimen. There were two treatment groups of subjects: those who had failed prior anti-TNF therapy (n=24); and those with no prior anti-TNF treatment history (n=18). The study was conducted at eleven different dermatology research centers across the U.S.
Bermekimab was well-tolerated with no safety concerns. Statistically significant improvement was seen for efficacy endpoints in both anti-TNF and anti-TNF naïve groups, including the Hidradenitis Suppurativa Clinical Response Score (HiSCR); Dermatology Life Quality Index (DLQI); Physician’s Global Assessment (
Assessing the percentage of patients who achieve a HiSCR response is a key measure to determine treatment effectiveness1. The HiSCR response is achieved during the treatment period if a patient has at least 50% reduction in the number of inflammatory lesions (abscesses + inflammatory nodules), and has no increase in the number of abscesses or draining fistulas. Abscesses, inflammatory nodules, and draining fistulas are the painful and disfiguring lesions associated with HS. For subjects who received bermekimab with no prior anti-TNF therapy, 61% (11/18) of patients achieved HiSCR. For patients who received bermekimab after failure of prior anti-TNF therapy (ie, adalimumab), 58% (14/24) of patients still achieved HiSCR by week 12.
The Chair of the present study, Dr.
Another major finding in the study was a significant treatment-related reduction of pain in the HS patients. Pain is widely recognized among experts as a key objective for HS treatment, but this symptom has been largely unaddressed by available approved therapies. Pain was assessed with a patient questionnaire using a numerical rating scale from 0 to 10. A 30% and ≥1-unit reduction in pain score is considered a clinically important relief from pain. Remarkably, 67% and 72% of patients who had prior or no prior anti-TNF therapy achieved this endpoint at week 12, respectively. No approved monotherapy for HS has shown a significant effect on pain2.
Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses3,. Pain is a paramount condition in patients suffering from HS, as this chronic inflammation and accompanying pain account for the fact that HS is ranked first among skin disorders in terms of adversely affecting quality of life5. The global prevalence for HS is estimated at up to 4% of the population4.
Results from an investigator-sponsored phase 2 study evaluating MABp1 (bermekimab) for the treatment of hidradenitis suppurativa were published in the
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1 HiSCR has been accepted as a primary measure of treatment efficacy by the
2 Only 34 of 122 (28%) of patients treated weekly with adalimumab achieved this endpoint at week 12 in the PIONEER I monotherapy study.
3 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
4 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.
5 Canoui-Poitrine F, Revuz JE, Wolkenstein P, Viallette C, Gabison G, Pouget F, et al. Clinical characteristics of a series of 302 French patients with hidradenitis suppurativa, with an analysis of factors associated with disease severity. J Am Acad Dermatol 2009; 61: 51-57.
6 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2017