Phase 2 Clinical Trial of Bermekimab Shows Potential New Standard of Care for Treatment of Hidradenitis Suppurativa, Including Significant Pain Reduction without Antibiotics
- Significant therapeutic benefit achieved whether or not patients had previously failed treatment with existing
- 61-63% of patients achieved a positive HiSCR (the accepted measure of disease severity in HS).
- 67-72% of patients achieved a clinically meaningful reduction in pain.
Dr. Gottlieb showed that by week 12 of treatment, 63% of patients who have previously failed anti-TNF therapy achieved a positive HiSCR (the accepted measure of disease severity in HS); similarly, 61% of patients with no prior anti-TNF therapy achieved positive HiSCR1. These results translated into a 46% (p<0.001) and 60% (p=0.005) reduction in the number of abscesses and inflammatory nodules, respectively, for the two groups. A breakthrough finding was that 67% and 72% of patients achieved a clinically meaningful reduction in pain by week 122.The existing
XBiotech’s President & CEO,
The study enrolled 42 patients, each receiving 400mg subcutaneous weekly doses of bermekimab in a 12-week treatment regimen. There were two treatment groups: 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.
An intravenous infusion formulation of bermekimab was previously used in a randomized, double-blind, placebo controlled Phase 2 study for patients with HS, where bermekimab treated patients had a significantly higher rate of HiSCR compared to placebo. However, this was the first study of bermekimab in HS using a new subcutaneous formulation that is administered from pre-filled syringes.
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 abscesses4,5. 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 life6. The global prevalence of HS is estimated at up to 4% of the population5.
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1 HiSCR response rates at week 12 were 42% and 59% in the so called PIONEER I and PIONEER II Phase III studies with the
3 Kimball et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016
4 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
5 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.
6 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.