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Background  Treatment with apremilast has recently demonstrated clinically meaningful improvement in moderate hidradenitis suppurativa ( HS ).    Objective  To evaluate the change in expression of inflammatory markers in lesional skin of  HS  patients receiving apremilast 30 mg twice daily ( n  = 15) for 16 weeks compared with placebo ( n  = 5).    Methods  At baseline, 5‐mm punch biopsies were obtained from an index lesion ( HSL ) and non‐lesional ( HSN ) skin in the same anatomical area. Subsequent  HSL  samples were taken as close as possible to the previously biopsied site at week 4 and week 16. After sampling, biopsies were split; one half was processed for  in vivo   mRNA  analysis using real‐time quantitative  PCR ; the other half was cultured for  ex vivo  protein analysis using a proximity extension assay (Olink). Linear mixed effects models were calculated to compare the levels of inflammatory markers in  HSL  skin between apremilast and placebo over time.    Results  At baseline, 17 proteins with a fold change >2 in  HSL  vs.  HSN  skin were identified in 20 patients. The top five were  IL ‐17A (5), S100A12,  CST 5,  IL ‐12/23p40, CD6 (1) with fold changes ranging from 6.6 to 1638, respectively (FDR <0.044). Linear mixed effects models for 75 assays were calculated. Protein levels of S100A12 decreased during treatment in the apremilast group compared with the placebo group ( p  = 0.014,  FDR  = 0.186). None of the 14 genes exhibited significant changes in expression over time. However, an evident downward trend in relative  mRNA  expression of  IL ‐17A and  IL ‐17F was demonstrated in patients receiving apremilast.    Conclusion  We did not detect statistically significant changes in inflammatory markers in  HSL  skin of  HS  patients receiving apremilast compared with placebo, despite clinical improvement in the apremilast group. Nonetheless, S100A12 and  IL ‐17A were significantly elevated in  HSL  skin and showed a decrease in response to apremilast. The translational model in clinical trials involving  HS  clearly needs further improvement.

Apremilast for moderate hidradenitis suppurativa: no significant change in lesional skin inflammatory biomarkers