Ustekinumab in hidradenitis suppurativa: clinical results and a search for potential biomarkers in serum

Background Treatment of hidradenitis suppurativa (HS) is difficult and the search for effective therapies continues. Objectives To evaluate the efficacy of ustekinumab and to discover a potential biomarker for HS. Methods Seventeen patients were included in this open-label study and treated with 45 or 90 mg ustekinumab at weeks 0, 4, 16 and 28. Proteomic technology and enzyme-linked assay analysis was applied to sera. Results Twelve patients completed the protocol. Moderate-to-marked improvement of the modified Sartorius score was achieved in 82% of patients at week 40 and the Hidradenitis Suppurativa Clinical Response 50 in 47%. With regard to the expression of 54 serum proteins, at baseline, a significant difference was observed between patients and healthy controls. Involved pathways were related to inflammation, immune cell signalling and tissue morphology/development. Good responders had milder disease and lower expression of leukotriene A4-hydrolase (LTA4H). Interleukin (IL)-2R, tumour necrosis factor-alpha, IL-17A and IL-17F were not elevated and did not change during treatment. Conclusions The majority of patients improved with ustekinumab. Although no biomarker was discovered, low LTA4H concentrations with mild disease severity may be predictive of the effectiveness of ustekinumab.