Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S19 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) A G, Basel, Switzerland I ntroduction: Obesity is a frequent comorbidity in patients with psoriasis. In the CLEAR study, secukinumab, a fully human monoclonal antibody targeting IL-17A, demonstrated superior PASI90, PASI75, PASI100, and IGA mod 2011 responses at 16 weeks ( wk) when compared to ustekinumab. Here, we present an analysis of these responses in the subgroup of patients with a body weight >100 kg. Methods: Randomized, double-blind, 52-wk clinical trial which compared secukinumab 300mg with ustekinumab 45 or 90mg (45mg in patients ≤100 kg and 90mg in patients >100kg) in 676 patients with moderate-to-severe plaque psoriasis. The randomization was stratified by body weight (≤100 or >100kg). The response variables PASI90 (primary endpoint), PASI75, PASI100, and IGA mod2011 (IGA) were analyzed in the first 16 wk of the study in the >100kg subgroup. The missing values were assigned as "no responders" for all patients, including this pre-planned per protocol analysis. Results: In all patients at Week 16, PASI90, PASI75, PASI100, and IGA 0/1 responses were achieved by 79.0, 93.1, 44.3, and 82.9 percent of patients receiving secukinumab 300mg, respectively, and by 57.6, 82.7, 28.4, and 67.5 percent of patients receiving ustekinumab 45 or 90mg, respectively. Overall, secukinumab 300mg was superior to ustekinumab 45 or 90mg in PASI90 response at Week 16 (p<0.0001), and that response was 37.1 percent higher for secukinumab. Secukinumab also showed a statistically significant higher response for all response variables at Week 4 (p<0.0001 for PASI90, PASI75, and IGA; p=0.014 for PASI100). In this analysis in patients with a body weight >100kg at baseline (n=78 for secukinumab and n =83 for ustekinumab), PASI90, PASI75, PASI100, and IGA responses at Week 16 were 64.1, 84.6, 30.8, and 73.1 percent with secukinumab and 48.2, 80.7, 14.5, and 60.2 percent with ustekinumab 90mg, respectively. In this subgroup, secukinumab 300mg demonstrated a significantly higher PASI90 response at Week 16 compared with ustekinumab 90mg (p=0.042). Secukinumab also demonstrated a statistically significant higher PASI75 and IGA response at Week 4 (p=0.021 and p=0.003) and PASI100 at Week 16 (p=0.013). PASI90 response at Week 16 was 33 percent higher with secukinumab. Conclusion: Secukinumab 300mg demonstrated a clinically and statistically significant higher efficacy (PASI90 at Week 16) than ustekinumab 90mg in patients with a body weight over 100kg. Secukinumab 300mg is more efficacious than ustekinumab 90mg. Financial diclosures/funding: This research was sponsored by Novartis Pharma AG, Basel, Switzerland. These results were originally presented at the 25th Annual Congress of the European Academy of Dermatology and Venereology, Austria, Vienna, September 28–October 2, 2016. Secukinumab Improves Signs and Symptoms of Psoriatic Arthritis: 52-week Results of Phase 3 FUTURE 2 Study Stratified by Concomitant Methotrexate Use Presenters: Gottlieb AB, 1 Mclnnes IB, 2 Mease PJ, 3 Bhosekar V, 4 Mpofu S 5 Affiliations: 1 New York Medical College, Valhalla, New York,; 2 University of Glasgow, Institute of Infection, Immunity and Inflammation, Glasgow, UK; 3 Swedish Medical Centre and University of Washington, School of Medicine, Seattle, Washington; 4 N ovartis Healthcare Pvt Ltd, H yderabad, India; 5 N ovartis Pharma AG, Basel, Switzerland Introduction: Concomitant use of methotrexate (MTX) with biologics is common in patients (pts) with psoriatic arthritis (PsA). Secukinumab, a fully human anti–IL-17A monoclonal a ntibody, improved the signs and symptoms of PsA at Week 24 in the FUTURE 2 study (NCT01752634) in both the concomitant MTX and without MTX subgroups. 1 Here, we report the 52-week results of this sub-group analysis. Methods: 397 pts with PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75mg or placebo at baseline, Weeks 1, 2, 3, and 4 and every four weeks thereafter. Concomitant MTX at a stable dose (≤25mg/wk) was permitted. Primary endpoint was ACR20 response at Week 24. Week 52 analyses included ACR20/50, PASI75/90, HAQ-DI, SF-36 PCS, DAS28-CRP, and resolution of dactylitis and enthesitis. The analyses used non-responder imputation for binary variables and mixed effect model repeated measure for continuous variables. Results: Baseline demographics and disease characteristics were similar across the groups, regardless of MTX status. Of the 397 pts, 47.9 percent (n=190) received concomitant MTX with a mean dose range of 15.9– 18.0mg/wk. Improvements achieved in ACR20/50 at Week 24 (secukinumab 300mg with MTX [n=45]: 53.3%/37.8%; and secukinumab 300mg without MTX [n=55]: 54.5%/32.7%; secukinumab 150mg with MTX [n=46]: 50.0%/34.8%; and secukinumab 150mg without MTX [n=54]: 51.9%/35.2%) were sustained through Week 52 (secukinumab 300mg with MTX: 60.0%/42.2%; and secukinumab 300mg without MTX:

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