The ustekinumab safety experience in patients with moderate to severe psoriasis: Results from pooled analyses of phase II and phase III clinical trial data

2010 ◽  
Vol 62 (3) ◽  
pp. AB132
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Severe Psoriasis ◽  
Phase Iii ◽  
Phase Iii Clinical Trial

Tildrakizumab: A Review of Phase II and III Clinical Trials

2018 ◽  
Vol 53 (4) ◽  
pp. 413-418 ◽  
Author(s):  
Sree S. Kolli ◽  
Sarah D. Gabros ◽  
Adrian Pona ◽  
Abigail Cline ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Biological Therapy ◽  
Common Adverse Effect ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Severe Psoriasis ◽  
Phase Iii ◽  
Physician Global Assessment ◽  
Phase Ii And Iii

Objective: Tildrakizumab, an inhibitor of the p19 subunit of interleukin (IL)-23, was recently Food and Drug Administration (FDA) approved for patients with moderate to severe psoriasis. This article will review the phase II and III clinical trial data of tildrakizumab. Data Sources: A PubMed search from January 2000 to September 2018 was done with the search terms tildrakizumab, guselkumab, risankizumab, p19, interleukin-23, and psoriasis. Study Selection and Data Extraction: Articles discussing phase II and III clinical trial data for tildrakizumab were selected. Data Synthesis: In phase II and phase III trials, tildrakizumab was safe and efficacious compared with placebo and etanercept. More patients achieved Psoriasis Area and Severity Index 75 receiving tildrakizumab (200 mg, 62%-74%; 100 mg, 61%-66%; 25 mg, 64%; 5 mg, 33%) compared with placebo (4%-6%, P < 0.0001) and etanercept (48%, P = 0.01). More patients achieved Physician Global Assessment (PGA) response of “clear” or “minimal” receiving tildrakizumab (200 mg, 59%; 100 mg, 55%-58%) than the placebo group (4%-7%, P < 0.0001). 59% of patients who received tildrakizumab 200 mg achieved a PGA response of “clear” or “minimal” compared with etanercept (48%, P = 0.0031). The most common adverse effect was infection. Relevance to Patient Care and Clinical Practice: Tildrakizumab is a new, FDA-approved, physician-administered biological therapy for patients with moderate to severe psoriasis. It appears to be efficacious and safe so far. Conclusion: Tildrakizumab is efficacious and safe for the treatment of patients with moderate to severe psoriasis. IL-23/p19 inhibitors are a promising class of biological therapy.

Should positive phase III clinical trial data be required before proton beam therapy is more widely adopted? No

2008 ◽  
Vol 86 (2) ◽  
pp. 148-153 ◽  
Author(s):  
Herman Suit ◽  
Hanne Kooy ◽  
Alexei Trofimov ◽  
Jonathan Farr ◽  
John Munzenrider ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Proton Beam ◽  
Clinical Trial Data ◽  
Proton Beam Therapy ◽  
Trial Data ◽  
Phase Iii ◽  
Positive Phase ◽  
Phase Iii Clinical Trial

scholarly journals Advancing data science in drug development through an innovative computational framework for data sharing and statistical analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ann-Marie Mallon ◽  
Dieter A. Häring ◽  
Frank Dahlke ◽  
Piet Aarden ◽  
Soroosh Afyouni ◽  
...  
Keyword(s):  
Machine Learning ◽  
Clinical Trial ◽  
Drug Development ◽  
Phase Ii ◽  
Data Science ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Computational Framework ◽  
Data Set ◽  
Collaborative Development

Abstract Background Novartis and the University of Oxford’s Big Data Institute (BDI) have established a research alliance with the aim to improve health care and drug development by making it more efficient and targeted. Using a combination of the latest statistical machine learning technology with an innovative IT platform developed to manage large volumes of anonymised data from numerous data sources and types we plan to identify novel patterns with clinical relevance which cannot be detected by humans alone to identify phenotypes and early predictors of patient disease activity and progression. Method The collaboration focuses on highly complex autoimmune diseases and develops a computational framework to assemble a research-ready dataset across numerous modalities. For the Multiple Sclerosis (MS) project, the collaboration has anonymised and integrated phase II to phase IV clinical and imaging trial data from ≈35,000 patients across all clinical phenotypes and collected in more than 2200 centres worldwide. For the “IL-17” project, the collaboration has anonymised and integrated clinical and imaging data from over 30 phase II and III Cosentyx clinical trials including more than 15,000 patients, suffering from four autoimmune disorders (Psoriasis, Axial Spondyloarthritis, Psoriatic arthritis (PsA) and Rheumatoid arthritis (RA)). Results A fundamental component of successful data analysis and the collaborative development of novel machine learning methods on these rich data sets has been the construction of a research informatics framework that can capture the data at regular intervals where images could be anonymised and integrated with the de-identified clinical data, quality controlled and compiled into a research-ready relational database which would then be available to multi-disciplinary analysts. The collaborative development from a group of software developers, data wranglers, statisticians, clinicians, and domain scientists across both organisations has been key. This framework is innovative, as it facilitates collaborative data management and makes a complicated clinical trial data set from a pharmaceutical company available to academic researchers who become associated with the project. Conclusions An informatics framework has been developed to capture clinical trial data into a pipeline of anonymisation, quality control, data exploration, and subsequent integration into a database. Establishing this framework has been integral to the development of analytical tools.

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