GHP November 2016

ghp November 2016 | 9 About the Phase 2 Guselkumab Psoriatic Arthritis Trial The Phase 2, randomised, double-blind, placebo– controlled, multicenter trial was designed to evaluate the efficacy and safety of guselkumab compared with placebo in adult patients with active psoriatic arthritis and a body surface area (BSA) of plaque psoriasis greater than or equal to three percent, despite current or previous treatment with standard- of-care therapies, including those previously exposed to anti-tumour necrosis factor (TNF)-alpha agents. Patients (n=149) were randomised in a two-to-one ratio to receive guselkumab 100 mg or placebo by subcutaneous injection at weeks 0, 4 and then every 8 weeks thereafter, followed by a 20-week active treatment period. At week 16, patients from either group with less than five percent improvement from baseline in both swollen and tender joint counts were eligible for early escape to open-label ustekinumab. At week 24, all remaining placebo patients crossed over to receive guselkumab 100 mg, which was administered again at week 28, and then every 8 weeks thereafter through week 44. In addition to meeting the primary endpoint of the study, all secondary endpoints achieved statistical significance in comparisons between the guselkumab and placebo groups. Secondary endpoints included ACR20 response at 16 weeks, ACR50 response at 24 weeks, the proportion of patients with 75% or greater improvement from baseline in psoriatic skin lesions as measured by the Psoriasis Area Severity Index (PASI 75) at 24 weeks, change from baseline in the health assessment questionnaire disability index (HAQ-DI) at 24 weeks, change in baseline measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36), percent change from baseline in Leeds Enthesitis Index (LEI) at 24 weeks, percent change from baseline in dactylitis score at 24 weeks, and proportion of patients achieving Minimal Disease Activity (MDA) at 24 weeks. • ACR20 response was achieved by 60%of patients receiving guselkumab compared with 16.3% of patients receiving placebo (P < 0.001) at week 16. • ACR50 response was achieved by 34% of patients receiving guselkumab compared with 10.2% of patients receiving placebo (P = 0.002) at week 24. • PASI 75 response was achieved by 78.6% of patients receiving guselkumab compared with 12.5% of patients receiving placebo (P < 0.001) at week 24. • Mean change from baseline in HAQ-DI scores were -0.42 for the guselkumab group compared with -0.06 for the placebo group (P < 0.001) at week 24. About Guselkumab Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23 and is in Phase 3 development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, immune- mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis, the latter of which affects 125 million people worldwide. An estimated 600,000 Americans—and more than 12 million people worldwide—have PsA. While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30% may develop inflammatory arthritis. The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease. Learn more at www.janssen.com/EMEA.