Risankizumab effectiveness and safety in psoriasis patients who failed other biologics: Real-life case series

Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Our objective is to improve postmarket safety studies by enabling safety analysts to seamlessly access a wide range of EHR sources for collecting deidentified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs. We have developed an ontological framework where EHR sources and target clinical research systems can continue using their own local data models, interfaces, and terminology systems, while structural interoperability and Semantic Interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in the SALUS Semantic Resource Set. SALUS Common Information Model at the core of this set acts as the common mediator. We demonstrate the capabilities of our framework through one of the SALUS safety analysis tools, namely, the Case Series Characterization Tool, which have been deployed on top of regional EHR Data Warehouse of the Lombardy Region containing about 1 billion records from 16 million patients and validated by several pharmacovigilance researchers with real-life cases. The results confirm significant improvements in signal detection and evaluation compared to traditional methods with the missing background information.

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1206P UNcommon EGFR mutations: International Case series on efficacy of Osimertinib in Real-life practice in first-liNe setting (UNICORN)

Annals of Oncology ◽

10.1016/j.annonc.2021.08.1811 ◽

2021 ◽

Vol 32 ◽

pp. S961-S962

Author(s):

J. Bar ◽

W. Kian ◽

M. Wolner ◽

S. Derijcke ◽

N. Girard ◽

...

Keyword(s):

Real Life ◽

Case Series ◽

Egfr Mutations ◽

First Line ◽

Line Setting

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Oral alitretinoin in chronic refractory hand eczema: a “real life” case-series of 12 patients

European Journal of Dermatology ◽

10.1684/ejd.2011.1396 ◽

2011 ◽

Vol 21 (3) ◽

pp. 454-456 ◽

Cited By ~ 2

Author(s):

Emmeline Kubica ◽

Khaled Ezzedine ◽

Nathalie Lalanne ◽

Yannick Dartial ◽

Alain Taieb ◽

...

Keyword(s):

Real Life ◽

Case Series ◽

Hand Eczema

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Four-Year Outcome of Aflibercept Treatment-Naïve Patients for Neovascular Age-Related Macular Degeneration: Evidence from a Clinical Setting

Journal of Ophthalmology ◽

10.1155/2020/7465270 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Yanel Gayadine-Harricham ◽

Virginie Rufin ◽

Sandrine Law-Koune ◽

Thi Ha Chau Tran

Keyword(s):

Macular Degeneration ◽

Clinical Setting ◽

Real Life ◽

Case Series ◽

Analysis Data ◽

Age Related Macular Degeneration ◽

Age Related ◽

Treatment Naïve ◽

Number Of Injections

Introduction. The objective of the study is to report 4-year treatment outcome with intravitreal Aflibercept injections for neovascular age-related macular degeneration (nAMD) as first life therapy in real-life. Patients and Methods. This is a prospective, monocenter, observational case series analysis. Data from treatment-naïve patients with nAMD with at least 4 years of follow-up were included in the analysis. Data including age, gender, and visual acuity measured on Early Treatment of Diabetic Retinopathy Study charts (ETDRS) and injection numbers were recorded. Spectral domain optical coherence tomography (SD-OCT) data at baseline, month 3, month 6, month 12, year 2, 3, and 4 were also recorded. Patients were treated with a modified treat and extend (T&E) regimen. Results. Of the 48 eyes with nAMD treated, only 31 eyes were available at the 4-year follow-up. The mean age was 81 ± 8 years. The VA gain was 7.3 ± 12.7 letters at 1 year 6.5 ± 12.5 letters at 2 years, VA gain 5.2 ± 17 letters at 3 years, and 6.2 ± 18.6 letters at 4 years. The reduction of central retinal thickness was 118 ± 187 μm at 4 years. Complete resolution of fluid was obtained in 18/31 eyes. The total number of injections was 5.7 ± 2.0 during the first year, 2.9 ± 2.9 during the second year, 3.5 ± 3.3 during the third year, and 4.0 ± 3.4 during the fourth year. The total number of injections was 16 ± 10.6, ranging from 3 to 52 injections. Ten eyes developed macular atrophy over the 4-year period. Conclusion. The results suggest that good long-term morphological and functional outcome can be achieved using Aflibercept in clinical setting.

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Forces and moments in knee–ankle–foot orthoses while walking on irregular surfaces: A case series study

Prosthetics and Orthotics International ◽

10.1177/0309364613489145 ◽

2013 ◽

Vol 38 (2) ◽

pp. 104-113 ◽

Cited By ~ 4

Author(s):

Jan Andrysek ◽

Susan Klejman ◽

John Kooy

Keyword(s):

Knee Flexion ◽

Real Life ◽

Case Series ◽

Assistive Devices ◽

Foot Orthoses ◽

Irregular Surfaces ◽

Case Series Study ◽

Peak Knee ◽

Ankle Foot Orthoses ◽

Series Study

Background: Kinetic data provide important information about the mobility performance of individuals with lower limb impairments and their assistive devices; however, there is limited understanding of this in real-life environments. Objective: To evaluate the effect of real-life irregular surfaces on forces and moments in knee–ankle–foot orthoses. Methods: In this case series study, a load cell was used to measure the forces and moments at the knee joint of knee–ankle–foot orthoses of individuals with unilateral muscle weakness as a result of poliomyelitis while walking on different ground surfaces and at different speeds. Results: Significantly higher shear forces and external peak knee flexion moments were found when walking on irregular surfaces. In individual cases, certain irregular ground conditions elicited large increases in peak flexion moments (>50%) when compared to walking on smooth level ground. Forces and moments were significantly higher at faster walking speeds. Conclusions: Higher external peak knee flexion moments during the stance phase suggest that greater demands for support and stability are placed on individuals and their assistive devices when negotiating real-life ground surfaces. Clinical relevance This study demonstrates that walking on irregular surfaces alters the loads placed on knee–ankle–foot orthoses and that the requirements for knee stabilization increase. This has important clinical implications on the design, prescription, and use of such devices given the structural and functional demands placed on them.

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Mo1896 - Ustekinumab for Crohn's Disease: A Nationwide Real-Life Observational Cohort Study (ICC Case Series)

Gastroenterology ◽

10.1016/s0016-5085(18)32860-9 ◽

2018 ◽

Vol 154 (6) ◽

pp. S-842-S-843

Author(s):

Vince Biemans ◽

Andrea Van Der Meulen ◽

Christien Janneke Van Der Woude ◽

Nanne de Boer ◽

Gerard Dijkstra ◽

...

Keyword(s):

Cohort Study ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Real Life ◽

Case Series ◽

Observational Cohort Study ◽

Observational Cohort

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Sustained Remission in Patients with Primary Immune Thrombocytopenia after Romiplostim Tapering and Discontinuation: A Case Series in Real Life Management in Spain

Case Reports in Hematology ◽

10.1155/2017/4109605 ◽

2017 ◽

Vol 2017 ◽

pp. 1-8 ◽

Cited By ~ 3

Author(s):

María-Eva Mingot-Castellano ◽

Carlos Grande-García ◽

David Valcárcel-Ferreiras ◽

Clara Conill-Cortés ◽

Loreto de Olivar-Oliver

Keyword(s):

Clinical Practice ◽

Predictive Factors ◽

Immune Thrombocytopenia ◽

Real Life ◽

Case Series ◽

Sustained Remission ◽

Platelet Counts ◽

Thrombopoietin Receptor ◽

Primary Immune Thrombocytopenia ◽

Effective Option

Romiplostim, a thrombopoietin-receptor agonist (TPO-ra), is a highly effective option in primary immune thrombocytopenia (ITP), with 80–90% of patients achieving platelet responses after few weeks of treatment. The evidence showing remissions, that is, sustained platelet counts after romiplostim discontinuation, in patients with ITP refractory to immunosuppressive therapy is steadily increasing. However, there is a lack of guidelines or recommendations addressing how and when to taper romiplostim in clinical practice in patients maintaining elevated and stable platelet counts. Furthermore, given the high heterogeneity of ITP patients, no associated predictive factors have been currently identified. Here, we present 4 representative clinical cases of the daily clinical practice in Spain comprising newly diagnosed, persistent, and both splenectomized and nonsplenectomized chronic ITP patients treated with romiplostim, achieving and maintaining clinical remission (platelet count ≥ 50×109/L for 24 consecutive weeks in the absence of any treatment for ITP) after treatment tapering and discontinuation, without observed safety concerns. Prospective studies identifying clinical and biological predictive factors of sustained response are warranted.

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Optical Coherence Tomography Imaging in the Management of the Argus II Retinal Prosthesis System

European Journal of Ophthalmology ◽

10.5301/ejo.5000852 ◽

2017 ◽

Vol 27 (1) ◽

pp. 16-21 ◽

Cited By ~ 14

Author(s):

Francesco Parmeggiani ◽

Katia De Nadai ◽

Angela Piovan ◽

Andrea Binotto ◽

Sara Zamengo ◽

...

Keyword(s):

Optical Coherence Tomography ◽

Retinitis Pigmentosa ◽

Real Life ◽

Case Series ◽

Retinal Prosthesis ◽

Implant Design ◽

Pathologic Myopia ◽

Optical Coherence ◽

Argus Ii ◽

Blind Patients

Purpose To report a real-life experience with the Argus II retinal prosthesis system in blind patients with end-stage retinitis pigmentosa (RP) or choroideremia (CHM), focusing on the pivotal role of optical coherence tomography (OCT) in both preoperative and postoperative management. Methods This hospital-based case series included 3 blind patients who were uneventfully implanted with Argus II epiretinal device. These patients (2 with RP and 1 with CHM) were selected during the Argus™ II Retinal Prosthesis System PostMarket Surveillance Study Protocol. Complete screening procedures had involved 66 eyes of 33 patients afferent to the Center for Retinitis Pigmentosa of the Veneto Region. Results Preoperative OCT examination resulted in the exclusion of 8 eyes in 4 patients with bilateral posterior staphyloma diagnosing unexpected staphylomatous macular patterns in 2 patients with RP and no sign of pathologic myopia. Postoperative OCT study of Argus II proximity to retinal surface indicated a plausible correlation between electrode–retina distance and perceptual threshold in 2 of our 3 patients. In particular, during the first 6 months of follow-up, the patient with the closest contact between device and macula showed a continuous vision-related improvement in the performance of several real-life tasks. Conclusions The present findings illustrate the modalities by which each different OCT examination is an essential tool to optimize safety and efficacy profiles during Argus II protocol. Optical coherence tomography will be crucial for future investigative approaches on patient selection criteria and next-generation implant design.

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Special Conditions in Venous Thrombembolism – Case Series

PRILOZI ◽

10.2478/prilozi-2019-0021 ◽

2019 ◽

Vol 40 (2) ◽

pp. 103-111

Author(s):

Marijan Bosevski ◽

Irena Mitevska ◽

Marica Pavkovic ◽

Milka Klincheva ◽

Emilija Trajkovska Lazarova ◽

...

Keyword(s):

Randomized Clinical Trials ◽

Real Life ◽

Case Series ◽

Vascular Diseases ◽

The Elderly ◽

Hospital Death ◽

High Risk Population ◽

Vein Thrombosis ◽

Cancer Associated Thrombosis ◽

Deep Vein

Abstract Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a preventable cause of in-hospital death, and one of the most prevalent vascular diseases. There is a lack of knowledge with regards to contemporary presentation, management, and outcomes of patients with VTE. Many clinically important subgroups (including the elderly, those with recent bleeding, renal insufficiency, disseminated malignancy or pregnant patients) have been under-represented in randomized clinical trials. We still need information from real life data (as example RIETE). The paper presents case series with VTE in special conditions, including cancer associated thrombosis, malignant homeopathies, as well in high risk population.

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