Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis

2016 ◽  
Vol 75 (1) ◽  
pp. 83-98.e4 ◽  
Author(s):  
Peter C.M. van de Kerkhof ◽  
Christopher E.M. Griffiths ◽  
Kristian Reich ◽  
Craig L. Leonardi ◽  
Andrew Blauvelt ◽  
...  
2018 ◽  
Vol 76 (1) ◽  
pp. 53-64
Author(s):  
Tiago Torres ◽  
Paulo Filipe

Psoriasis is a chronic, inflammatory, immune-mediated, potentially disfiguring and disabling skin disorder, affecting over 100 million individuals worldwide. Calcipotriol plus betamethasone fixed-combination (0.005% Cal/0.064% BD) is the recommended topical treatment for psoriasis. However, topical treatments are associated to lack of efficacy and low adhesion rates due to poor cosmetic characteristics’ formulations, and vehicle issues. To answer the need for improving patients’ acceptability and adherence, an innovative Cal/BD aerosol foam formulation was developed for the topical treatment of adults with plaque psoriasis. Phase II and III clinical trials have consistently shown that the two-compound formulation is more effective and safer than its individual ingredients in the same vehicle. Cal/BD aerosol foam formulation has proved higher efficacy in clinical studies, and a pooled analysis of the main clinical studies has demonstrated that this does not occur at the safety profile expense. Furthermore, Cal/BD aerosol foam has shown a significantly improved efficacy compared with more traditional formulations, such as ointments, gels, and lotions. The improved efficacy and safety profile of this new formulation, together with the once-daily treatment, a more acceptable tolerability profile, and an early and rapid response, offers improved convenience and better acceptance over the twice- -daily applications required for the respective monotherapies, which may improve adherence to treatment, leading to faster and greater improvements in HR-QoL, representing a useful therapeutic option to the management of patients with plaque psoriasis. Further clinical investigations to explore the possibility of Cal/BD aerosol foam treatment ability to provide long-term psoriasis’ management are required.


2019 ◽  
Vol 95 (3) ◽  
pp. 54-64 ◽  
Author(s):  
A. L. Bakulev ◽  
A. V. Samtsov ◽  
A. A. Kubanov ◽  
V. R. Khairutdinov ◽  
M. M. Kokhan ◽  
...  

Netakimabis original monoclonal antibody against IL-17. This article outlines the key results of a phase II open-label extension trial of netakimab 80 mg and 120 mg in patients with moderate-to-severe psoriasis.The main aim of the trial is to estimate efficacy, safety and immunogenicity of long-term treatment with netakimab 80 mg and 120 mg in patients with moderate-to-severe psoriasis.Materials and methods. The BCD-085-2-ext study is a comparative, open-label phase 2 clinical study of the effi - cacy and safety of netakimab in patients with moderate-to-severe plaque psoriasis who had finished BCD-085-2 (NCT02762994) trial. Main efficacy endpoints includePASI75, PASI90, PASI100, sPGA = 0–1 on week 38 of the trial, long-term PASI75/90/100 retention, efficacy keeping after switch from once every 2 week regimen to once every 4 week regimen. Safety endpoints include adverse events, serious adverse events number and their profile.Results. 103 patients were included. PASI75 at week 38 was reached by 98.06 %, PASI90 — by 92.23 %, PASI100 — by 59.22 % of patients. There were no cases of serious adverse event, early with drawal due to adverse events and cases of grade 4 toxicity according to CTCAE 4.03. There were no cases of binding antibodies to netakimab during the 38 weeks of the study.Conclusion. The first Russian original IL-17 inhibitor netakimabis promising modern medicine for moderate-to-severe plaque psoriasis treatment. Netakimabshowed high efficacy, favorable safety profile and low immunogenicity during one year of the treatment.


2017 ◽  
Vol 34 (6) ◽  
pp. 1327-1339 ◽  
Author(s):  
Sandra Adsit ◽  
Enrique Rivas Zaldivar ◽  
Howard Sofen ◽  
Ignacio Dei-Cas ◽  
César Maldonado-García ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document