MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study.

Patients with moderate to severe hidradenitis suppurativa (HS) failing adalimumab therapy, or those ineligible to receive it, remain a population with an unmet need.20 patients not eligible for adalimumab were randomized to receive 12 weeks blind treatment with placebo or MABp1, a true human antibody targeting interleukin (IL)-1alpha. HS clinical response score at week 12 was the primary endpoint.The primary endpoint was met in 10% and 60% of placebo- and MABp1-treated patients respectively (odds ratio 13.50, 95% confidence intervals 1.19-152.51). Clinical efficacy was maintained at 24 weeks in nil and 40%. Improvement in the visual analogue scale was reported by 20% and 85.7% of patients failing previous anti-TNF treatment. Ultrasound showed decreased neovascularization and lesion skin depth in the MABp1 group. MABp1 treatment was associated with decrease of circulating IL-8 and of stimulated production of IL-8 by whole blood. Whole blood production for human β-defensin (hBD)-2 was negatively associated with ultrasound changes in the placebo group but not in the MABp1 group.MABp1 is a promising treatment for HS not eligible for adalimumab. Inhibition of neovascularization and modulation of the production of IL-8 and hBD-2 are suggested mechanisms of action.