BackgroundSecukinumab, a fully human monoclonal antibody that selectively neutralizes IL‐17A, has been shown to have significant efficacy and a favourable safety profile in the treatment of moderate‐to‐severe psoriasis and psoriatic arthritis.ObjectiveTo assess the efficacy and safety of secukinumab through 5 years of treatment in moderate‐to‐severe psoriasis.MethodsIn the core SCULPTURE study, Psoriasis Area and Severity Index (PASI) 75 responders at Week 12 continued receiving subcutaneous secukinumab until Year 1. Thereafter, patients entered the extension phase and continued treatment as per the core trial. Treatment was double‐blinded until the end of Year 3 and open‐label from Year 4. Here, we focus on the 300 mg fixed‐interval (every 4 weeks) treatment, the recommended per label dose. Efficacy data are primarily reported as observed, but multiple imputation (MI) and last observation carried forward (LOCF) techniques were also undertaken as supportive analyses.ResultsAt Year 1, 168 patients entered the extension study and at the end of Year 5, 126 patients completed 300 mg (every 4 weeks) treatment. PASI 75/90/100 responses at Year 1 (88.9%, 68.5% and 43.8%, respectively) were sustained to Year 5 (88.5%, 66.4% and 41%). PASI responses were consistent regardless of the analysis undertaken (as observed, MI, or LOCF). The average improvement in mean PASI was approximately 90% through 5 years compared with core study baseline. DLQI (dermatology life quality index) 0/1 response also sustained through 5 years (72.7% at Year 1 and 65.5% at Year 5). The safety profile of secukinumab remained favourable, with no cumulative or unexpected safety concerns identified.ConclusionSecukinumab 300 mg treatment delivered high and sustained levels of skin clearance and improved quality of life through 5 years in patients with moderate‐to‐severe psoriasis. Favourable safety established in the secukinumab phase 2/3 programme was maintained through 5 years.
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.
Trial Registration:
ClinicalTrials.gov, NCT03066609;
https://clinicaltrials.gov/ct2/show/record/NCT03066609
.
In the last few years, notable technical progress has taken place in ultrasound elastography. Qualitative methods have been replaced by quantitative ones, such as: transient elastography, acoustic radiation force impulse and shear wave elastography. Owing to the fact that the spleen is superficially located, it is possible to obtain reliable measuring accuracy of its hardness using sonoelastography. Lately, many researchers have been investigating how spleen elasticity changes in patients infected with hepatitis B virus or hepatitis C virus and in patients suffering from liver fibrosis, portal hypertension, esophageal varices or myelofibrosis. In this article, we review the role and current status of accessible qualitative ultrasound elastography methods, including recent advances in the evaluation of spleen stiffness and its clinical utility. As study results demonstrate, spleen stiffness correlates with liver fibrosis and is helpful in determining the level of fibrosis in the METAVIR scoring system. In patients infected with hepatitis B virus or hepatitis C virus, spleen stiffness increases even when liver elasticity remains unaltered. Furthermore, it is useful in diagnosing portal hypertension or predicting existence of esophageal varices. Moreover, in patients suffering from biliary atresia after Kasai portoenterostomy, spleen sonoelastography may be helpful in selecting patients for liver transplantation as well as for choosing the best strategy for portal vein reconstruction before liver transplantation. In myelofibrosis, spleen stiffness correlates with bone marrow fibrosis and may be used to assess the response to treatment. Spleen sonoelastography is also useful in the monitoring of transjugular intrahepatic portosystemic shunt function.
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