Acta Dermato-Venereologica 98-10CompleteContent | Page 7

932 CLINICAL REPORT Achieving Hidradenitis Suppurativa Response Score is Associated with Significant Improvement in Clinical and Patient-reported Outcomes: Post Hoc Analysis of Pooled Data From PIONEER I and II Alexandra Boer KIMBALL 1 , Thrasivoulos TZELLOS 2,3 , Brian M. CALIMLIM 4 , Henrique D. TEIXEIRA 4 , Ziqian GENG 4 and Martin M. OKUN 5 Harvard Medical School and Beth Israel Deaconess Hospital, Boston, Massachusetts, USA, 2 Department of Dermatology, Faculty of Health Sciences, University Hospital of North Norway, 3 Institute of Clinical Medicine, Arctic University, Tromsø, Norway, 4 AbbVie Inc., North Chicago, Illinois, and 5 Fort HealthCare, Fort Atkinson, Wisconsin, USA 1 Hidradenitis Suppurativa Clinical Response (HiSCR), is a validated tool that has been used to assess the efficacy of adalimumab among patients with hidradenitis sup- purativa. We evaluated the clinical meaning of HiSCR by relating it to patient-reported outcomes to give further context to its achievement in a post hoc ana- lysis of integrated data from two phase 3 clinical trials (PIONEER I and II). Pooling placebo and active treat- ment arms, 39% of patients (245/629) achieved HiSCR at week 12. Irrespective of treatment, significantly (p < 0.05) more HiSCR responders than non-respon- ders experienced clinically meaningful improvement in Dermatology Life Quality Index (60.5% vs 30.4%), Pain Numeric Rating Scale (46.9% vs 19.9%), hidra- denitis suppurativa quality of life (49.4% vs 26.9%), work-related performance (52.6% vs 37.7%), and non-work-related performance (59.5% vs 33.3%). Clinically meaningful outcomes in hidradenitis suppu- rativa are more likely to be attained in patients achie- ving HiSCR level improvement. Key words: abscess; inflammatory nodule; DLQI; PIONEER I; PIONEER II; minimum clinically important difference. Accepted Jul 27, 2018; Epub ahed of print Aug 7, 2018 Acta Derm Venereol 2018; 98: 932–937 Corr: Brian M. Calimlim, DrPH, MS, Dept GMH1, AbbVie Inc., 1 N Waukegan Road, North Chicago, IL 60064, USA. E-mail: [email protected] H idradenitis suppurativa (HS), or acne inversa, is a chronic skin disease characterized by recur- rent inflammation and deep‐seated lesions in apocrine gland‐bearing, intertriginous areas of the body (1–3). The reported prevalence of HS varies widely from 0.03% to 8%, depending on the setting and methodology used (4), but may be underreported, as the average time from first symptoms to diagnosis is 7 years (5). HS can cause scar- ring and disability (6, 7) and substantially affects patient health-related quality of life (HRQL) outcomes (8–11). Available clinical measures for assessing HS disease severity include Hurley stage, modified Sartorius score, and the HS Physician’s Global Assessment (12–15); however, none of these measures have been validated in depth regarding clinical and patient relevance and impact. HS clinical response (HiSCR) (16) is a validated tool that has been used to assess treatment efficacy in clinical doi: 10.2340/00015555-3012 Acta Derm Venereol 2018; 98: 932–937 SIGNIFICANCE Hidradenitis suppurativa is a chronic skin disease cha- racterized by inflammation and deep-seated lesions. The hidradenitis suppurativa clinical response (called HiSCR) is a straightforward and well-validated tool designed to as- sess treatment response. It is based on the counts of easily recognizable clinical signs of hidradenitis suppurativa, in- cluding inflammatory nodules, abscesses, and draining fis- tulas. This study verifies that the HiSCR is a reliable tool for assessing clinically meaningful improvements in inflamma- tory signs and symptoms of hidradenitis suppurativa and improving health outcomes from the patient’s perspective. Given these characteristics, the HiSCR is appropriate for use in clinical trials and clinical care. trials. HiSCR is designed to be a practical measure and is based on counts of easily recognizable clinical signs, including inflammatory nodules, abscesses, and draining fistulas. The HiSCR was designed based on data from a phase 2 clinical trial in patients with HS and retrospec- tively tested in that data set (16, 17). Phase 3 clinical trials (PIONEER I and II) (18) assessing the effect of adalimumab (ADA) on HS subsequently used HiSCR as a measure of treatment response and ultimately led to approval by the US Food and Drug Administration (FDA) for the treatment of moderate to severe HS in adult patients, and by the European Medicines Agency (EMA) for the treatment of active moderate to severe HS in adult patients who have failed to respond to con- ventional systemic therapies. A recent systematic review (19) of HS outcome mea- sures concluded that good-quality validation evidence is available for the HiSCR instrument, making HiSCR an appropriate tool to use to assess anti-inflammatory treatment effect in HS. The Ingram review (19) noted that evidence of association between HiSCR and mini- mum clinically important difference (MCID) in various outcomes was lacking. Therefore, the objective of this post hoc analysis was to further validate and assess the association of HiSCR with manifestations of HS commonly seen in the clinical setting and measures of HRQL, irrespective of treatment in combined data from two phase 3 randomized, controlled, double-blind trials This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2018 Acta Dermato-Venereologica.