scholarly journals Perampanel in real‐world clinical care of patients with epilepsy: Interim analysis of a phase IV study

2020 ◽  
Author(s):  
James Wheless ◽  
Robert T. Wechsler ◽  
Marcelo Lancman ◽  
Sami Aboumatar ◽  
Anna Patten ◽  
...  
Keyword(s):  
Real World ◽  
Interim Analysis ◽  
Clinical Care ◽  
Patients With Epilepsy ◽  
Phase Iv

PROVE—Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Interim Analysis in Pediatric Patients

2022 ◽  
pp. 088307382110476
Author(s):  
Eric Segal ◽  
Katherine Moretz ◽  
James Wheless ◽  
Patricia Penovich ◽  
Marcelo Lancman ◽  
...  
Keyword(s):  
Medical Records ◽  
Interim Analysis ◽  
Pediatric Patients ◽  
Clinical Care ◽  
Retention Rates ◽  
Routine Clinical Care ◽  
Adolescent Patients ◽  
Patients With Epilepsy ◽  
Oral Doses ◽  
Phase Iv

PROVE is a retrospective, phase IV study assessing retention, dosing, efficacy, and safety of perampanel when administered to patients during routine clinical care. We report an interim analysis of preadolescent (1 to <12 years) and adolescent (12 to <18 years) patients. Data were obtained from medical records of patients with epilepsy initiating perampanel after January 1, 2014; cut-off date for this analysis was October 10, 2018. Overall, 151 preadolescent and 183 adolescent patients were included. Retention rates following 24 months on perampanel were 42.5% (preadolescent subgroup; n = 31/73) and 55.7% (adolescent subgroup; n = 54/97). Treatment-emergent adverse events occurred in 53 (35.1%) preadolescent (most common: aggression, irritability, and somnolence) and 78 (42.6%) adolescent patients (most common: somnolence, aggression, and dizziness). These data indicate that daily oral doses of perampanel are generally well tolerated during routine clinical care, with favorable retention rates for ≤2 years, in patients aged 1 to <18 years.

scholarly journals PROVE: retrospective, non‐interventional, Phase IV study of perampanel in real‐world clinical care of patients with epilepsy

2021 ◽  
Author(s):  
Robert T. Wechsler ◽  
James Wheless ◽  
Muhammad Zafar ◽  
Graham R. Huesmann ◽  
Marcelo Lancman ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Care ◽  
Patients With Epilepsy ◽  
Phase Iv

First "Real-World" Insights on Apremilast Treatment for Patients with Plaque Psoriasis from the LAPIS-PSO Study: An Interim Analysis

2017 ◽  
Vol 1 ◽  
pp. s15 ◽  
Author(s):  
Kristian Reich ◽  
Stefanie Bomas ◽  
Bernhard Korge ◽  
Maria Manasterski ◽  
Uwe Schwitchtenberg ◽  
...  
Keyword(s):  
Real World ◽  
Plaque Psoriasis ◽  
Interim Analysis

Abstract Not Available Disclosure: Study supported by Celgene.

scholarly journals The Value of Real-World Data in Understanding Prostate Cancer Risk and Improving Clinical Care: Examples from Swedish Registries

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 875
Author(s):  
Kerri Beckmann ◽  
Hans Garmo ◽  
Ingela Franck Lissbrant ◽  
Pär Stattin
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Clinical Care ◽  
Prostate Cancer Risk ◽  
Real World Data ◽  
Level Of Evidence ◽  
World Data ◽  
Cancer Data ◽  
Using Data ◽  
Randomised Controlled

Real-world data (RWD), that is, data from sources other than controlled clinical trials, play an increasingly important role in medical research. The development of quality clinical registers, increasing access to administrative data sources, growing computing power and data linkage capacities have contributed to greater availability of RWD. Evidence derived from RWD increases our understanding of prostate cancer (PCa) aetiology, natural history and effective management. While randomised controlled trials offer the best level of evidence for establishing the efficacy of medical interventions and making causal inferences, studies using RWD offer complementary evidence about the effectiveness, long-term outcomes and safety of interventions in real-world settings. RWD provide the only means of addressing questions about risk factors and exposures that cannot be “controlled”, or when assessing rare outcomes. This review provides examples of the value of RWD for generating evidence about PCa, focusing on studies using data from a quality clinical register, namely the National Prostate Cancer Register (NPCR) Sweden, with longitudinal data on advanced PCa in Patient-overview Prostate Cancer (PPC) and data linkages to other sources in Prostate Cancer data Base Sweden (PCBaSe).

scholarly journals Real-world dosing of regorafenib in metastatic colorectal cancer (mCRC): Interim analysis from the prospective, observational CORRELATE study

2017 ◽  
Vol 28 ◽  
pp. iii10 ◽  
Author(s):  
Manuel O’Connor Juan ◽  
Leopold Öhler ◽  
Werner Scheithauer ◽  
Jean-Philippe Metges ◽  
Louis-Marie Dourthe ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Interim Analysis

THU0399 HOW DO TNF-ALPHA-INHIBITORS IN MEDICAL HISTORY AFFECT PATIENT REPORTED OUTCOMES AND RETENTION IN ANKYLOSING SPONDYLITIS PATIENTS TREATED WITH SECUKINUMAB IN REAL WORLD? - GERMAN AQUILA STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 436-437
Author(s):  
U. Kiltz ◽  
J. Brandt-Juergens ◽  
P. Kästner ◽  
E. Riechers ◽  
D. Peterlik ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Treatment Outcomes ◽  
Medical History ◽  
Physical Functioning ◽  
Real World ◽  
Interim Analysis ◽  
Retention Rates ◽  
Research Support ◽  
Kaplan Meier

Background:Secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin 17A, is approved for treatment of patients with ankylosing spondylitis (AS). However, there is lack of real-world evidence on SEC treatment outcomes, disease activity, physical functioning and on its retention, especially in anti-tumor necrosis factor (anti-TNF) naïve patients and patients pretreated with different anti-TNFs in medical history.1Objectives:The aim of this interim analysis is to evaluate SEC treatment outcomes on disease activity, physical functioning and retention rates in AS patients stratified by number of anti-TNFs (naive, 1 or ≥2) in medical history.Methods:AQUILA is an ongoing, multi-center, non-interventional study. AS and psoriatic arthritis patients treated with SEC in daily practice are enrolled and observed from baseline (BL, d0 or d1 of study start) up to week 52 according to clinical routine. Real-world effectiveness of SEC was assessed prospectively and analyzed as observed. Here, we report interim results of SEC effectiveness on different treatment outcomes in AS patients by means of validated questionnaires such as patient´s global assessment (PGA), Bath Ankylosing Disease Activity Index (BASDAI), and Assessment of Spondyloarthritis Health Index (ASAS-HI). In addition, retention rates (time from study inclusion until premature SEC treatment discontinuation) were assessed through Kaplan-Meier plots. This interim analysis focuses onanti-TNF naïveand AS patients treated with1 anti-TNFor≥2 anti-TNFsin medical history. Wilcoxon tests were conducted to show significant differences between the subgroups.Results:At BL, 311 AS patients were included; 72 (23.2%) of them received SEC already for more than 1 day up to more than 6 months before BL. Most AS patients were anti-TNF-experienced (71.1%): 82 (26.4%) and 139 (44.7%) AS patients had 1 or ≥2 prior anti-TNF treatments, respectively. BL scores for PGA, BASDAI and ASAS-HI were similar between the different anti-TNF subgroups. Constant improvement was shown in all parameters from BL up to week 52, irrespective of prior anti-TNF treatment (PGA-anti-TNF naïve: 5.9 to 3.5, PGA-1 anti-TNF:6.1 to 4.2 and PGA-≥2 anti-TNFs:6.7 to 5.1; BASDAI-anti-TNF naïve: 5.3 to 3.4, BASDAI-1 anti-TNF:5.5 to 3.7 and BASDAI-≥2 anti-TNFs:5.7 to 4.7). However, overall better improvement was observed inanti-TNF naïvepatients, as seen by the example of ASAS-HI (Fig. 1). Between 30% and 40% of patients prematurely discontinued SEC treatment in the subgroups1 anti-TNFand≥2 anti-TNFs, respectively, while only about 20% did so in theanti-TNF naïveAS patients (Fig. 2).Conclusion:SEC has shown to improve disease activity, physical functioning and QoL in anti-TNF-naïve and pretreated AS patients in a real-world setting. The benefits of SEC were numerically more distinct in anti-TNF-naïve patients. Moreover, SEC demonstrated high retention rate, particularly in anti-TNF-naïve patients, thereby confirming previously reported real-world data on SEC from EuroSpA research collaboration network.2References:[1]Glintborg B, et al, Ann Rheum Dis 2013;72:1149-55; 2. Michelsen B, et al, Arthritis Rheumatol 2019:71(suppl10) #1822Disclosure of Interests:Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, SanofiFigure 1.Change of health in AS patients treated with SEC stratified by anti-TNF pretreatmentFigure 2.SEC treatment retention depending on anti-TNF pretreatment (Kaplan-Meier plot)

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