Journal of Clinical and Aesthetic Dermatology

Plaque-type Psoriasis Supplement 2016

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

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S8 SUPPLEMENT TO THE JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY [JUNE 2016 • VOLUME 9 • NUMBER 6 • SUPPLEMENT 1] g reater. At the beginning of the study, 738 patients with plaque psoriasis were initially randomly assigned to one of three arms: secukinumab 300mg (administered once weekly for 5 weeks, then every 4 weeks), secukinumab 150mg, or placebo. A cross the study groups, the patients' demographic and baseline clinical characteristics were balanced. In the ERASURE study, the average age of participants were 45 years, 69 percent being male, and 79 percent being Caucasian. The average weight was between 87kg to 90kg, and the body mass index (BMI) averaged 30. Patients had 17 years duration of plaque psoriasis. Among the three study groups, the baseline average PASI score is between 21.4 to 22.5, and the BSA is between 29.7 to 33.3 percent. Approximately two- thirds of patients had a score of 3 (moderate disease) on modified IGA, and one-third had a score of 4 (severe disease) on modified IGA. Between 19 to 27 percent of patients have psoriatic arthritis. Approximately 30 percent of patients were on a previous biologic agent. More patients in the secukinumab groups were previously on a conventional agent (51–52%) compared to placebo group (44%). Outcomes: Coprimary endpoints and key secondary endpoints. Overall, secukinumab was found to be superior to placebo in all of the coprimary and key secondary endpoints. In addition, the 300mg secukinumab achieved numerically superior response rates with respect to efficacy endpoints compared to the 150mg dose. Specifically, at the end of 12 weeks, the investigators found that the proportion of patients achieving PASI 75 was 81.6 percent in the secukinumab 300mg arm, 71.6 percent in secukinumab 150mg arm, and 4.5 percent in the placebo arm (P<0.001 for each secukinumab dose vs. placebo). The proportion of patients achieving IGA 0 or 1 was 65.3 percent with secukinumab 300mg, 51.2 percent with secukinumab 150mg, and 2.4 percent with placebo (P<0.001 for each secukinumab dose vs. placebo). The key secondary endpoints that were assessed were PASI 90, patient-reported psoriasis-related itching, pain, and scaling on the Psoriasis Symptom Diary at Week 12, maintenance of PASI 75 and IGA 0 or 1 from Week 12 through Week 52. The investigators found that the PASI 90 responses at Week 12 were 59 percent, 39 percent, and one percent in patients randomized to secukinumab 300mg, 150mg, and placebo, respectively. The PASI 100 responses at Week 12 were 29 percent, 13 percent, and one percent in patients randomized to secukinumab 300mg, 150mg, and placebo, respectively. Compared to placebo, both doses of secukinumab also had significantly greater response on patient-reported psoriasis-related itching, pain, and scaling on the Psoriasis Symptom Diary (P<0.001). The proportion of patients achieving Dermatology Life Quality Index (DLQI) 0 or 1 was significantly higher in both doses of secukinumab groups compared to placebo (P<0.001). Both doses of secukinumab were also superior to placebo in patient- reported psoriasis-related itching, pain, and scaling. Finally, with regard to maintenance (Figure 1), the peak response rate appears to be achieved at around Week 16, a fter which the response has stabilized. Safety. Overall, the rates of adverse events were similar between the secukinumab groups and the placebo during the induction period. However, higher proportions of patients with infections were seen in the secukinumab group (29% in t he 300mg group and 27% in the 150mg group) compared to placebo (16%). Throughout the study, the most common adverse effects were nasopharyngitis, upper respiratory track infection, and headache. Secukinumab versus Etanercept and versus Placebo: the FIXTURE Study Primary objective. Similar to the ERASURE study, the primary objective of the 52-week FIXTURE study was to evaluate Week 12 superiority of secukinumab over placebo as measured by two coprimary endpoints: 1) proportion of patients achieving PASI 75, and 2) proportion of patients achieving 0 (clear) or 1 (almost clear) on the modified IGA. The key difference between the ERASURE and the FIXTURE study is that, in the FIXTURE study, etanercept was used as one of the comparator arms. This study design is to reflect the different key secondary objectives in the FIXTURE study to compare secukinumab versus etanercept. Study design and study population. The FIXTURE study is also a randomized Phase 3, double-blind, 52-week clinical trial that took place between June 2011 through June 2013 at 231 sites worldwide. This study had a screening period of 1 to 4 weeks, an induction period of 12 weeks, a maintenance period of 40 weeks, and a follow-up period of eight weeks. The inclusion criteria and exclusion criteria for the FIXTURE study are similar to those of the ERASURE study except that patients who had used etanercept at anytime before screening were excluded. In the FIXTURE study, 1,306 patients with plaque psoriasis were initially randomly assigned to one of the four arms: secukinumab 300mg (administered once weekly for 5 weeks, then every 4 weeks), secukinumab 150mg, etanercept 50mg (administered twice weekly for 12 weeks and then once weekly), or placebo. Among the comparison arms in the FIXTURE study, the patients' demographic and baseline clinical characteristics were similar. Among the groups, the average age of participants ranged between 44 to 45 years; male patients comprised between 69 to 73 percent of the patients; Caucasian patients comprised more than two-thirds of the study population. The average weight of participants ranged between 83 to 85kg, and the BMI averaged 28. The average baseline PASI score was 24, and the average baseline BSA was between 34 and 35 percent. Approximately 60 percent of patients had a score of 3 (moderate disease) on modified IGA, and 40 percent had a score of 4 (severe disease) on modified IGA. With regards to psoriatic arthritis, 13.5 percent of patients randomized to

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