Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis

Background:Psoriasis is a chronic inflammatory skin disease,affecting about 0.6%of the Chinese population.Many patients are not well controlled by conventional treatments,thus there is need for new treatment regimens.In this study,we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.Methods:This study was a 52-week,multicentre,randomized,double-blind,placebo-controlled,parallel-group,Phase 3 trial.A sub-population of study participants(≥18 years)of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab,or placebo.The co-primary endpoints were psoriasis area severity index(PASI)75 and Investigator’s Global Assessment(IGA)0/1 at Week 12.Results:A total of 441 Chinese patients were enrolled in this study.Co-primary outcomes were achieved;300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75(97.7%and 87.2%vs.3.7%,respectively;P<0.001),and IGA 0/1(82.3%and 69.7%vs.2.7%;P<0.001)at Week 12.Treatment efficacy was maintained until Week 52.There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.Conclusion:Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.

Efficacy and Safety of Ixekizumab in Chinese Patients With Moderate-to-Severe Plaque Psoriasis: 60-Week Results From a Phase 3 Study

Objective:Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is approved for treating moderate-to-severe psoriasis.This phase 3,multicenter,randomized,double-blind,placebo-controlled trial(NCT03364309;registered December 6,2017)evaluated the safety and efficacy of ixekizumab in Chinese patients with moderate-to-severe psoriasis.Methods:438 patients were randomized 2:2:1 to 80 mg ixekizumab every 2 weeks(IXE Q2W,n=176),80 mg ixekizumab every 4 weeks(IXE Q4W,n=174),or placebo(n=88).Efficacy was assessed by evaluating the static Physician’s Global Assessment score of 0 or 1(sPGA[0,1])and Psoriasis Area and Severity Index(PASI)75/90/100 responses,and nonresponder imputation was used for handling missing data.The safety profile was evaluated by assessing treatment emergent adverse events(AEs)and serious AEs.Results:At week 12,the sPGA(0,1)response rates were 3.4%,79.9%,and 86.4%in the placebo,IXE Q4W,and IXE Q2W groups,respectively.The PASI 75/90/100 response rates were 8.0%/2.3%/0.0%,87.4%/75.9%/29.3%,and 93.8%/82.4%/33.0%in the placebo,IXE Q4W,and IXE Q2W groups,respectively.Ixekizumab led to rapid PASI 50 responses,as early as week 1,whereas PASI 75 and sPGA(0,1)responses were observed from week 2.sPGA(0,1)and sPGA(0)responses were maintained through week 60 in a higher proportion of patients receiving IXE Q4W vs.placebo.The safety profile was consistent with previous studies of ixekizumab in psoriasis.Conclusion:Ixekizumab showed a rapid onset of action and high efficacy that was maintained through 60 weeks and was well tolerated with no unexpected AEs,in Chinese patients with moderate-to-severe plaque psoriasis.