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Cutaneous damage caused by hidradenitis suppurativa (HS) is an important contributor to disease burden, independent of active lesions. Outcome measures used to specifically assess damage are becoming commonplace in the assessment of inflammatory diseases. However, no standardized method for assessing HS damage currently exists. The purpose of this study was to review outcome measures in HS that include constructs of both active disease and damage, review damage-specific instruments used in other inflammatory and destructive diseases, and review instruments used to assess scars of various aetiologies. This ultimately provides insight into how attributes of different tools can be applied to develop an outcome measure specific to HS damage. What is already known about this topic? Hidradenitis suppurativa (HS) is a chronic, relapsing, inflammatory skin condition, which causes consequent cutaneous damage and scarring. Damage caused by HS is highly prevalent and an important contributor to its morbidity. Damage is an important component of inflammatory diseases that has proven its utility in a number of outcome measures; however, no standardized method for assessing HS damage currently exists. What does this study add? This narrative review assesses outcome measures used to measure damage in other inflammatory and destructive diseases. Instruments used to assess damage in other diseases can provide a starting point for the development of a damage outcome measure for HS., (© 2022 British Association of Dermatologists.)

Background: Weekly adalimumab (Humira ® ) is approved for the treatment of hidradenitis suppurativa (HS) based on the 12-week placebo-controlled periods of the two phase III PIONEER trials., Objectives: Using PIONEER integrated trial results, we aimed to evaluate the optimal medium-term adalimumab maintenance dosing strategy for moderate-to-severe HS., Methods: Each trial had two double-blind periods; 12-week Period A and 24-week Period B. Patients randomized to adalimumab 40 mg every week (ADAew) (Period A), were rerandomized in Period B to ADAew (ADAew/ew), ADA every other week (ADAew/eow), or placebo (ADAew/pbo). Placebo-randomized patients were reassigned in Period B to ADAew (PIONEER I) or placebo (PIONEER II). The primary outcome was HS Clinical Response (HiSCR). Patients who lost response during Period B were discontinued from the study and offered an option to enter the open-label extension (OLE) to receive ADAew. Results are reported across the two study periods, and data were combined from the two study periods and the OLE., Results: For week-12 HiSCR achievers, the HiSCR week-36 rate was 48·1% (ADAew/ew) vs. 46·2% (ADAew/eow) and 32·1% (ADAew/pbo). Combining (post hoc) these patients with week-12 partial responders further differentiated outcomes in Period B (ADAew/ew 55·7% vs. ADAew/eow 40·0% and ADAew/pbo 30·1%). Period-B adverse-event rates were ADAew/ew 59·6% vs. ADAew/eow 57·4% and ADAew/pbo 65·0%. One patient (ADAew/ew) reported a serious infection., Conclusions: Weekly adalimumab treatment, effective throughout 36 weeks, was the optimal maintenance medium-term dosing regimen for this population. At least partial response after 12 weeks with continued weekly dosing had better outcomes than dose reduction or interruption. Patients who do not show at least a partial response to weekly adalimumab by week 12 are unlikely to benefit from continued therapy. No new safety risks were identified. What's already known about this topic? Hidradenitis suppurativa (HS) is a chronic inflammatory disease, commonly misinterpreted as an infection and treated with long-term antibiotic regimens or surgical incisions. Based on the chronicity of HS and the lack of evidence for efficacious and safe long-term HS treatments, it is important to evaluate medium- to long-term therapies for HS. Weekly adalimumab (Humira ® ) is approved for the treatment of moderate-to-severe HS based on the two phase III PIONEER trials. What does this study add? This study pooled data from the two PIONEER trials, providing a more robust assessment of outcomes. After at least partial treatment success with weekly adalimumab short-term therapy (12 weeks), continuing weekly dosing during the subsequent 24 weeks had better outcomes than dose reduction or treatment interruption. Patients who do not show at least a partial response to weekly adalimumab by week 12 are unlikely to benefit from continued therapy., (© 2019 The Authors British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)