Adalimumab provides significant efficacy for patients with hidradenitis suppurativa (HS) as demonstrated by at least 50% of patients achieving HS clinical response by week 12 that is maintained through week 168 in the PIONEER trials.To identify whether there are biomarkers that could predict adalimumab response as well as markers that differentially responded to adalimumab in HS patients.Baseline and week 12 plasma samples from the PIONEER studies were used to assess the levels of circulating proteins by multiplex assays and enzyme-linked immunosorbent assays.These analyses revealed significantly higher high sensitivity C-reactive protein (hs-CRP) and CCL16 (HCC-4) levels in non-responders at baseline and identified a multivariate response signature of calprotectin, fractalkine and HCC-4 reaching an 86% predictive accuracy rate for adalimumab response. Additionally, post-treatment reduction of plasma CXCL9, CXCL8 (IL-8) and CCL19 (MIP-3β) were greater in adalimumab super-responders compared to non-responders (p = 0.026, 0.044 and 0.026, respectively). These cytokines are involved in recruitment of innate and adaptive inflammatory cells and/or stimulation of certain inflammatory responses, suggesting that these pathways could be disease drivers in adalimumab non-responders.These initial results suggest HCC-4, calprotectin and fractalkine as potential predictive biomarkers of adalimumab response in HS and identified possible TNF-independent disease pathways.
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Authors: Y Cao, F Hong, D M Conlon, L Sidur, K M Smith, Y Fang, C A Cuff, Z Kaymakcalan, M C Ruzek