scholarly journals AB0882-HPR ANCA-ASSOCIATED VASCULITIS: A CLINICAL PRACTICE ASSESSMENT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1464.2-1465
Author(s):  
S. Mendly ◽  
G. Boutsalis
Keyword(s):  
Clinical Practice ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Remission Induction ◽  
Refractory Disease ◽  
Maintenance Strategy ◽  
Combination Therapies ◽  
Research Support ◽  
Educational Grant ◽  
Anca Associated Vasculitis

Background:AAV (ANCA-associated vasculitis) is a group of progressive, rare, severe autoimmune diseases1,2. AAV can affect blood vessels in different parts of the body resulting in damage to vital organs such as the lungs, kidneys, nervous system, gastrointestinal system, skin, eyes, and heart.2 There are currently no approved therapies for remission-induction in patients with AAV. The current treatment armamentarium for AAV is comprised of various immunosuppressive therapies in combination with steroid treatment. Understanding clinical practice gaps in the management of AAV, can inform development of tools to improve physician practices.Objectives:This medical education activity aims to assess physicians’ knowledge on the various manifestations of antineutrophil cytoplasmic antibody-associated vasculitis (AAV), current guideline-recommended treatment strategies for remission induction in patients with AAV, as well as recent clinical trial data for combination therapies used for remission induction.Methods:A 24-question survey consisting of multiple-choice knowledge and case-based questions was made available to nephrologists and rheumatologists without monetary compensation or charge. The questions were designed to evaluate knowledge regarding the various manifestations of AAV and the results from clinical trials that have compared the efficacy of combination therapies used for remission induction in patients with AAV. As well as application of guideline-recommended therapies and clinical trial data for remission induction in patients with AAV within clinical practice. The survey launched online on a website dedicated to continuous professional development. (www.medscape.org/viewarticle/920320) on July 15, 2020. Data were collected until October 1, 2020.Results:363 nephrologists and 190 rheumatologists completed the survey. Physicians demonstrated gaps in the following areas:TopicIncorrect Responses to Knowledge and Clinical Decision-Making Questions (%)NephrologistsRheumatologistsSystemic diseases associated with AAV59%45%How to confirm diagnosis of AAV42%25%Therapy selection to induce remission that would be consistent with guidelines recommendations71%51%Guideline-recommended therapy for patients that do not respond to the induction regimen32%34%Definition of refractory disease95%94%Most effective maintenance strategy for a patient once remission is achieved80%64%Where would an emerging therapy such as a C5a receptor inhibitor fit into the therapeutic armamentarium of AAV?62%47%What are the guideline-recommended therapies to reduce remission in patients without organ-threatening disease?71%51%Most effective maintenance strategy for a patient once remission is achieved80%64%Guideline-recommendations on length of time to continue maintenance therapy31%35%Conclusion:This educational research on assessment of physicians’ (nephrologists and rheumatologists) clinical practices yielded important insights into clinical gaps related to understanding of the disease pathophysiology and progression of AAV, guideline recommendations on diagnosing and managing AAV with guideline-directed medical therapies (GDMTs), strategies for the management of relapsing and refractory disease in AAV and positioning of emerging therapies in the treatment paradigm.References:[1]www.medscape.org/viewarticle/920320.[2]Hutton HL, et al. Semin Nephrol 2017;37(5):418–35.[3]Al-Hussain T, et al. Adv Anat Pathol 2017;24(4):226–34.Disclosure of Interests:Sarah Mendly Grant/research support from: Supported by an independent educational grant from Vifor Pharma, George Boutsalis Grant/research support from: Supported by an independent educational grant from Vifor Pharma

scholarly journals THU0585 ONLINE EDUCATION YIELDS SIGNIFICANT GAINS IN RHEUMATOLOGISTS’ KNOWLEDGE OF THE JAK INHIBITORS MODE OF ACTION AND CLINICAL TRIAL DATA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 534.2-534
Author(s):  
A. Stan ◽  
M. Calle ◽  
C. Scot-Smith ◽  
R. Van Vollenhoven
Keyword(s):  
Clinical Trial ◽  
Online Education ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Janus Kinase ◽  
Jak Inhibitors ◽  
Research Support ◽  
Educational Grant ◽  
Trial Outcomes ◽  
Post Assessment

Background:Physicians face challenges staying up-to-date with the latest research and accessing the ever-growing field of knowledge is time-consuming. Online education can make these clinician’s tasks more efficient and less time-consuming.Objectives:This study assessed whether the online CME accredited round-table-discussion with title “Meet the JAKs: Understanding the Role of Janus Kinase Inhibition in RA” improves physicians’ understanding mechanism of action (MOA) of current and emerging Janus kinase (JAK) inhibitors and rationale for their development in rheumatoid arthritis (RA).Methods:Rheumatologists participated in an online CME activity (https://www.medscape.org/viewarticle/913625) consisting of a 30-minute video discussion between 2 experts with accompanying slides. Educational effect was assessed using a 4-question repeated pairs, pre-/post-assessment. A chi-square test was used to determine if a statistically significant improvement (P<.05 significance level) existed in the number of correct responses from the pretest and posttest scores. Cramer’s V was used to estimate the level of impact of the education. The CME activity launched on June 4, 2019, and the data were collected through September 3, 2019.Results:A total of 107 rheumatologists completed the pre- and post activity assessments. Overall the activity had a signficiant impact (P<.001) on rheumatologists’ knowledge of JAK inhibitors and relatedclinical trial data with a Cramer’s V value of 0.319 indicating an extensive educational impact. The average percentage of correct responses rose from 47% pre-activity to 78% post-activity. The repeated pairs analysis (each individual learner tracked pre- and post-education) showed that 34% of learners improved their knowledge and 44% reinforced their knowledge. The change in percentage of correct responses from pre- to post-assessment achieved statistical significance for all 3 questions presented: (1) understanding the MOA of JAK inhibitors vs biologics (64% at baseline rising to 82% post acivity;P<0.01), (2) understanding the specificity of different JAK inhibitors (49% at baseline rising to 85% post acivity;P<.001), (3) knowledge of clinical trial outcomes with JAK inhibitors (29% at baseline rising to 67% post acivity;P<.001) and (4) 60% of rheumatologists gained confidence in their ability to describe the MOA of current and emerging JAK inhibitors.Conclusion:This online CME activity significantly improved rheumatologists’ understanding of JAK inhibitors mode of action. However, there is clearly room for further improving physicians’ knowledge of clinical trial outcomes with these agents, since one third of rheumatologists provided incorrect answers to question 3 post-activity) and this topic can be further addressed in future education.Acknowledgments:This CME-certified activity was supported by anindependent educational grant from AbbVie.Disclosure of Interests:Adriana Stan Grant/research support from: The CME-certified activity was supported by anindependent educational grant from Sandoz., Marinella Calle Grant/research support from: This CME-certified activity was supported by anindependent educational grant from Novartis AG, Camille Scot-Smith Grant/research support from: This CME-certified activity was supported by anindependent educational grant from AbbVie, Ronald van Vollenhoven Grant/research support from: BMS, GSK, Lilly, UCB, Pfizer, Roche, Consultant of: AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Gilead, Janssen, Pfizer, Servier, UCB, Speakers bureau: AbbVie, Pfizer, UCB

THU0304 CLINICAL PRACTICE VARIATION BETWEEN ACADEMIC AND NON-ACADEMIC CENTERS IN THE MANAGEMENT OF ANCA ASSOCIATED VASCULITIS IN THE NETHERLANDS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 380-381
Author(s):  
E. Dirikgil ◽  
A. Rutgers ◽  
S. Tas ◽  
C. A. Verburgh ◽  
D. Soonawala ◽  
...  
Keyword(s):  
Clinical Practice ◽  
The Netherlands ◽  
Induction Therapy ◽  
Granulomatosis With Polyangiitis ◽  
Practice Variation ◽  
Oral Cyclophosphamide ◽  
Research Support ◽  
Anca Associated Vasculitis ◽  
Academic Hospitals ◽  
Number Of Patients

Background:ANCA associated vasculitis (AAV) is a complex, rare systemic autoimmune disease with an estimated prevalence of 5-18 patients per 100.000 individuals worldwide. Managing a low prevalent disease can be challenging which is reflected in clinical practice variation.Objectives:This study investigated clinical practice variation of the care for AAV patients in the Netherlands.Methods:In a nationwide online survey, AAV patients were selected from academic and non-academic centers. Within centers, patients were eligible when they had a confirmed diagnosis of microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA) or eosinophilic granulomatosis with polyangiitis (eGPA) according to the treating physician. There were no exclusion criteria. In each center a comparable number of patients was included. Data capture encompassed a wide set of variables on diagnosis, management and outcomes.Results:From December 2018 to November 2019, 230 AAV patients were recruited in 6 non-academic and 3 academic hospitals (120 vs 110 patients respectively). Differences in clinical diagnoses (GPA, MPA and eGPA) were observed between non-academic and academic centers (p=0.05), which was mainly caused by a higher number of MPA patients in non-academic centers. The year of diagnosis was comparable (median 2013 [2009-2016], p=0.150). The median follow up since diagnosis was 4.8 years [1.8-9.6] with a median in-hospital time-to-diagnosis of 13 days [2-50]. Patients were diagnosed at a mean age of 63 years (±11.18) in non-academic centers and 53 years (±16.92) in academic centers (p<0.001). Besides steroids, oral cyclophosphamide was the most preferred drug (54%) for induction therapy, whereas rituximab was given significantly more often as (part of the) induction therapy in patients treated in academic centers compared to patients in non-academic centers (27% vs 8%, p<0.001). In non-academic centers pneumocystis pneumonia (PCP) prophylaxis was prescribed significantly less (76% vs 91%, p=0.003). Also, screening for Staphylococcus aureus carriership was significantly less (17% vs 68%, p<0.001). With respect to mortality and co-morbidity, 22 patients (10%) died, 100 patients (44%) had at least one infection and 24 patients (10%) suffered from at least one malignancy. We observed no significant differences on these endpoints between academic and non-academic centers.Conclusion:The present study highlights important practice variation in the management of AAV between academic and non-academic hospitals in the Netherlands. A high proportion of patients is treated with oral cyclophosphamide as induction therapy while rituximab is increasingly used in academic centers. Rates of mortality, infections and malignancies were not different. Altogether, this study raises awareness into the variation of management for AAV patients and allows the identification of areas for improvement of clinical care for Dutch AAV patients.Disclosure of Interests:Ebru Dirikgil: None declared, Abraham Rutgers: None declared, Sander Tas: None declared, Cornelis A. Verburgh: None declared, Darius Soonawala: None declared, A. Elisabeth Hak: None declared, Hilde H.F. Remmelts: None declared, Daphne IJpelaar: None declared, Gozewijn D. Laverman: None declared, Jacob M. van Laar Grant/research support from: MSD, Genentech, Consultant of: MSD, Roche, Pfizer, Eli Lilly, BMS, H.J. Bernelot Moens: None declared, Peter Verhoeven: None declared, Willem Jan W. Bos: None declared, Y.K. Onno Teng Grant/research support from: GSK, Consultant of: GSK, Aurinia Pharmaceuticals, Novartis

Challenges in Using Real-World Clinical Practice Records for Retrospective Validation of Clinical Trial Data: Lessons Learned

2016 ◽  
Vol 111 ◽  
pp. S324-S325
Author(s):  
Sunanda V. Kane ◽  
Anita Afzali ◽  
Doug Wolf ◽  
Ira Shafran ◽  
Matthew A. Ciorba ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Lessons Learned

Integrating clinical trial data into clinical practice

Neurology ◽  
2002 ◽  
Vol 58 (Issue 12, Supplement 7) ◽  
pp. S6-S12 ◽  
Author(s):  
T. A. Glauser
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Clinical Trial Data ◽  
Trial Data

Translation of clinical trial data to changes in clinical practice: rapid transition from tenofovir disoproxil fumarate to tenofovir alafenamide-based therapies in a Sydney HIV clinic

2018 ◽  
Vol 29 (10) ◽  
pp. 1011-1013
Author(s):  
Don E Smith ◽  
Merrion Tom ◽  
Bruce H Bowden
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Antiviral Therapy ◽  
Tenofovir Disoproxil Fumarate ◽  
Clinical Trial Data ◽  
Routine Clinical Practice ◽  
Trial Data ◽  
Slow Process ◽  
Rapid Transition ◽  
Tenofovir Alafenamide

The transition of clinical trial data to changes in routine clinical practice is often a slow process. We describe a rapid transition of patients from one form of antiviral therapy to a modified and potentially safer version that can occur quickly when there are no financial or organisational restrictions on the prescribers.

PP81 Real World Data: The Early Access To Medicines Scheme Catches The Worm

2019 ◽  
Vol 35 (S1) ◽  
pp. 53-53
Author(s):  
Adam Hall ◽  
Lok Wan Liu ◽  
Richard Macaulay ◽  
Sean Walsh
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Real World ◽  
Clinical Trial Data ◽  
Access To Medicines ◽  
Trial Data ◽  
Real World Data ◽  
World Data ◽  
Early Access ◽  
Nice Guidance

IntroductionThe Early Access to Medicines Scheme (EAMS) aims to provide access to medicines prior to market authorization for patients with severe, life-threatening diseases who do not have adequate treatment options. An EAMS designation enables the potential collection of United Kingdom-specific real world evidence (RWE) prior to health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE). This research evaluates whether RWE is being gathered through the EAMS and utilized to support HTA submissions.MethodsAll EAMS designations as of 7 November 2018 were identified from the Medicines and Healthcare products Regulatory Agency website. For products with final NICE guidance, all publicly-available NICE documentation was reviewed.ResultsSixteen product and indication pairings with an EAMS designation were identified, with 12 having received final NICE guidance (11 were recommended, 3 were recommended for temporary reimbursement via the Cancer Drugs Fund, and 2 were not recommended). Of the 11 recommended products, seven had references to the number of patients or sites with product access through the EAMS, but only one (dupilumab for atopic dermatitis) had detailed data collected during the EAMS period. The manufacturer of dupilumab reported baseline demographics and disease characteristics from a cohort of 35 patients treated under the EAMS to inform the generalizability of trial populations for clinical practice. Follow-up results from this cohort demonstrated that real-world data on dupilumab effectiveness was comparable with the clinical trial data, despite a higher proportion of patients in the real-world cohort receiving immunosuppressant therapy, which makes improvements in efficacy harder to achieve. The committee also noted that the RWE presented supported the understanding of dupilumab's long-term clinical effectiveness and informed assumptions for the economic model.ConclusionsTo date, the majority of products receiving an EAMS designation have not presented RWE at NICE reappraisal. The case of dupilumab illustrated how RWE collected through the EAMS can be used to reduce uncertainty around how clinical trial data can be translated into clinical practice. In the future, RWE may increasingly be used to help inform NICE decisions.

Expectations in the Care of Lung Cancer

2015 ◽  
pp. e420-e424
Author(s):  
Rogerio Lilenbaum ◽  
Natasha B. Leighl ◽  
Marcus Neubauer
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Decision Making ◽  
Clinical Practice ◽  
Statistical Significance ◽  
Real Life ◽  
Clinical Trial Data ◽  
Routine Clinical Practice ◽  
Trial Data ◽  
Decision Making Process

One of the main challenges oncologists face in the care of patients with lung cancer is the decision to incorporate new clinical trial data into routine clinical practice. Beyond the question of statistical significance, which is a more objective metric, are the results meaningful and applicable to a broader population? Furthermore, in an era of value care, do the results justify a potential increase in costs? This article discusses the main points that clinicians consider in their decision-making process and illustrates the arguments with real-life examples.

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