A ustralasian College of Dermatologists Abstracts Presented at the 48th Annual Scientific Meeting 16–19 M ay 2015 A delaide, S outh A ustralia

Abstract

Introduction and objectives: PIONEER II evaluated the safety and efficacy of adalimumab (ADA) vs placebo (PBO) in patients (pts) with moderate to severe hidradenitis suppurativa (HS). Methods and results from the first 12 weeks (wks) are reported. Materials and methods: This multicenter study included a 12‐wk double‐blind PBO‐controlled period (Per A). Pts were randomized 1:1 to blinded ADA 40 mg weekly starting at Wk4 (following 160 mg at Wk0; 80 mg at Wk2) or matching PBO. At baseline, pts had a diagnosis of HS for at least 1 year, a total abscess and inflammatory nodule (AN) count of >3, HS lesions in >2 body areas (1 at Hurley Stage II or III) and had no prior TNF‐alpha‐inhibitor treatment, including ADA. Efficacy in Per A was analyzed for all randomized pts (intent‐to‐treat [ITT‐A Population]); safety was analyzed for pts in the ITT‐A Population who received at least 1 dose of study drug. The primary endpoint was HiSCR (HS Clinical Response; >50% reduction from baseline in AN count and no increase in abscess or in draining fistula counts) at Wk12. Missing assessments were handled by nonresponder imputation (categorical variables) and lastobservation‐ carried‐forward (continuous variables). Results: Of the 326 in the ITT‐A Population, 67.8% were women; 83.7% were white; mean age was 35.5 (SD 11.13) years; mean HS duration was 11.5 (SD 9.03) years. Baseline characteristics were similar between groups. 93.9% completed Per A. HiSCR rate at Wk12 was significantly higher for pts randomized to ADA (96/163, 58.9%) vs PBO (45/163, 27.6%; p < 0.001). Statistically significant treatment differences were observed for all 3 ranked secondary endpoints (Wk12, ITT‐A Population) as follows: 1) among pts with Hurley Stage II, a significantly higher proportion of ADA pts achieved AN count of 0, 1 or 2 (ADA [44/85, 51.8%] vs PBO [28/87, 32.2%; p = 0.010]); 2) a significantly higher proportion of ADA pts achieved at least a 30% reduction and at least 1 unit reduction from baseline in Patients' Global Assessment of Skin Pain numerical rating scale(NRS) based on 24‐hour recall of worst pain (ADA [48/105, 45.7%] vs PBO [23/111, 20.7%; p < 0.001]), among pts with baseline NRS > 3; 3) ADA pts achieved a significantly greater mean reduction from baseline in modified Sartorius Score (ADA [n = 163, ‐28.9] vs PBO [n = 162, ‐9.5; p < 0.001]). 57.7% (ADA) and 66.9% (PBO) reported at least 1 treatmentemergent adverse event (TEAE). TEAEs in >10% of pts in any treatment arm were headache (12.9% ADA; 12.9% PBO) and exacerbation of HS (4.3% ADA; 12.9% PBO). 1.8% (ADA) and 3.7% (PBO) had serious TEAEs. There were no deaths. Conclusions: Significantly more HS pts treated with adalimumab achieved clinically relevant reduction in objective disease activity and pain compared to placebo. The safety profile for pts in both treatment groups was comparable.