27434 Early trends of disease improvement in adult patients with atopic dermatitis treated with dupilumab: Real-world data from the PROSE registry

2021 ◽  
Vol 85 (3) ◽  
pp. AB32
Author(s):  
Jerry Bagel ◽  
Gil Yosipovitch ◽  
David M. Pariser ◽  
Robert Y. Lin ◽  
Haixin Zhang ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Real World ◽  
Adult Patients ◽  
Real World Data ◽  
World Data

Real-world data on initial treatment strategies for older adult patients with endometrial cancer in Japan

2019 ◽  
Vol 84 (5) ◽  
pp. 1051-1058
Author(s):  
Mayu Yunokawa ◽  
Shinsuke Sasada ◽  
Yae Takehara ◽  
Kenta Takahashi ◽  
Tatsunori Shimoi ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Older Adult ◽  
Real World ◽  
Initial Treatment ◽  
Treatment Strategies ◽  
Adult Patients ◽  
Real World Data ◽  
World Data

scholarly journals Burden Of Disease And Health Care Costs Of Adult Patients With Severe Refractory Asthma In A Big Real-World Data Base (Arco)

2016 ◽  
Vol 19 (3) ◽  
pp. A112
Author(s):  
A Pedrini ◽  
E Rossi ◽  
S Calabria ◽  
L Dondi ◽  
I Esposito ◽  
...  
Keyword(s):  
Health Care ◽  
Data Base ◽  
Health Care Costs ◽  
Real World ◽  
Burden Of Disease ◽  
Adult Patients ◽  
Real World Data ◽  
World Data ◽  
Care Costs ◽  
Refractory Asthma

PIN79 Real-World DATA Analysis of Antiretroviral Treatment for HIV-Infected Adult Patients in Ukraine

2021 ◽  
Vol 24 ◽  
pp. S120-S121
Author(s):  
O. Vysotska ◽  
O. Piniazhko ◽  
V. Vysotskyi ◽  
A. Masheiko ◽  
V. Serediuk ◽  
...  
Keyword(s):  
Data Analysis ◽  
Real World ◽  
Antiretroviral Treatment ◽  
Adult Patients ◽  
Real World Data ◽  
World Data ◽  
Infected Adult

scholarly journals P17 Clinical evidence supported by a model-based approach and real world data for the development of c.e.r.a. (continuous erythropoietin receptor activator) in pediatric patients with anemia due to chronic kidney disease

2019 ◽  
Vol 104 (6) ◽  
pp. e24.1-e24
Author(s):  
P Chanu ◽  
A Weichert ◽  
F Schaefer ◽  
S Meyer Reigner ◽  
B Reigner ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Treatment Outcomes ◽  
Real World ◽  
Pediatric Patients ◽  
Clinical Evidence ◽  
Adult Patients ◽  
List Type ◽  
Real World Data ◽  
World Data

BackgroundC.E.R.A. indicated in Chronic Kidney Disease adult patients to correct and maintain hemoglobin (Hb) levels is approved in Europe and US since 2007; pediatric development is ongoing. A 20-week open-label Phase II study (NH19707) of intravenous (IV) C.E.R.A. in patients aged 5–17 years was conducted and data collected was analysed with adult data1. Objectives were to determine the pharmacokinetic/pharmacodynamic (PK/PD) characteristics of C.E.R.A. in a broad population, to simulate treatment outcomes of C.E.R.A. administered IV and subcutaneous (SC) in pediatric patients and compare them to NH19707 data and Real World Data (RWD).MethodsPK and Hb data from 63 pediatric patients were pooled with 400 adult patients IV and SC data and analysed using models previously developed in adults2. Simulations of treatment outcomes with C.E.R.A. administered IV and SC were performed. Assumptions on SC bioavailability in pediatric patients were based on previous darbepoetin data3. Model inferences were challenged versus RWD obtained in 158 pediatric patients receiving C.E.R.A. SC (N=126) or IV (N=32) from registries maintained by the International Pediatric Dialysis Network (IPDN, www.pedpd.org).ResultsThe adult PK and PK/PD models adequately described the pediatric data and indicated a similar exposure-response relationship in both populations. C.E.R.A. doses were adjusted to Hb levels during the simulation process to reflect clinical practice; simulated Hb levels matched observations. Furthermore, simulated median monthly C.E.R.A. doses following Hb stabilization were 105 µg (95% prediction interval 72–159 µg) for SC and 84 µg (60–123 µg) for IV, in good agreement with those reported in the IPDN registry: 100 µg and 80.4 µg, respectively.ConclusionThe PK/PD characteristics of C.E.R.A. are similar between adult and pediatric populations. Simulations of clinical outcomes in accordance with clinical trial data and RWD provided sufficient clinical evidence to support pediatric plans optimization subsequently approved by FDA and EMA.References1.Fischbach M, Wühl E, Reigner SCM, Morgan Z, Schaefer F. Efficacy and long-term safety of C.E.R.A. maintenance in pediatric hemodialysis patients with anemia of CKD. Clin J Am Soc Nephrol. 2018;13(1):81–90.Chanu P, Gieschke R, Charoin JE, Pannier A, Reigner B. Population pharmacokinetic/pharmacodynamic model for C.E.R.A. in both ESA-naïve and ESA-treated CKD patients with renal anemia. Journal of Clinical Pharmacology. J Clin Pharmacol. 2010;50(5):507–520.3.Amgen Inc. ARANESP® (darbepoetin alfa) prescribing information.Disclosure(s)Chanu P is employee and holds stocks in F Hoffmann-La Roche Ltd, was employee of Certara Consulting Services, Certara, Princeton, NJ, USA and contractor to F Hoffmann-La Roche Ltd at the time of this work. Weichert A is employee of F Hoffmann-La Roche Ltd. Schaefer F has received consulting and speaker honoraria from F Hoffmann-La Roche Ltd. Meyer Reigner S is employee of F Hoffmann-La Roche Ltd. Reigner B is employee and holds stocks in F Hoffmann-La Roche Ltd. Frey N is employee of F Hoffmann-La Roche Ltd.

Treatment strategies for recurrent ovarian cancer in older adult patients in Japan: a study based on real-world data

2020 ◽  
Vol 146 (5) ◽  
pp. 1335-1341
Author(s):  
Mayumi Kobayashi Kato ◽  
Mayu Yunokawa ◽  
Seiko Bun ◽  
Tatsunori Shimoi ◽  
Kan Yonemori ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Older Adult ◽  
Real World ◽  
Treatment Strategies ◽  
Recurrent Ovarian Cancer ◽  
Adult Patients ◽  
Real World Data ◽  
World Data

scholarly journals The Use of Real-World Data to Evaluate the Association Between Atopic Dermatitis and Cardiovascular Disease: A Retrospective Claims Analysis

2021 ◽  
Vol 11 (5) ◽  
pp. 1707-1715
Author(s):  
Jashin J. Wu ◽  
Caroline Amand ◽  
Daniel J. No ◽  
Puneet Mahajan ◽  
Abhijit Gadkari ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Atopic Dermatitis ◽  
Real World ◽  
Claims Analysis ◽  
Real World Data ◽  
World Data
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