CARE Perspectives - The Impact of Biosimilars in Canada

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Dr. John Marshall (McMaster University) and Dr. Vipul Jairath (University of Western Ontario) met at the Farncombe Family Digestive Health Research Institute (McMaster University) during the summer of 2017 to discuss a topic of great interest to the CARE Faculty, as well as practicing Canadian gastroenterologists and physicians around the world – biosimilars. 

Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). Many of the biologics used over the years are reaching their patent expiry, and with this loss of exclusivity, biosimilars have been developed. Biosimilars are relatively new to the Canadian landscape, and there is a lot to learn about their impact and how to effectively integrate them into clinical practice. What follows is a review by Dr. Marshall and Dr. Jairath on how existing and future clinical trials are shaping the use of biosimilars in Canada.


Part 1: What have we learned so far?


Part 2: What trials are underway in Crohn's disease?


Part 3: Where is the landscape headed?


Interested in Biosimilars?
Join the discussion at one of CARE's Regional Congresses on Biosimilars this fall! 

CARE Gastroenterology Guiding Principles on Biosimilars

This initiative is led by: 
Drs. John marshall, Remo Panaccione, Vipul Jairath, MD, & Anthony Otley

The CARE Faculty has been looking at the impact of biosimilars since 2015, given the significance of this topic across both chronic and disease entities. Select CARE Gastroenterology Faculty members have consolidated the following guiding principles based on the collective discussion from past CARE Education initiatives that explored the anticipated impact that the introduction of biosimilars will have in Canada.

Biosimilars have been a topic of interest for various CARE™ Faculties for several years now. To gauge levels of understanding along with perceptions and opinions on the impact that biosimilars will have on the Canadian landscape, a number of CARE faculties conducted needs assessments with their peers. Between 2014-2016, needs assessments were directed at specialists in gastroenterology, rheumatology, oncology, and hematology.

The aim of developing these principles is to provide Canadian health care providers with an overarching view of the positions from the CARE Faculties, which in turn may help inform their treatment decisions. 

CARE Perspectives on DDW 2017

Members of the CARE Gastroenterology Faculty recently attended the DDW 2017 conference held in Chicago, IL (May 6-9, 2017). At this conference, the 9th annual CARE at DDW education meeting was held. Attendees included academic and community specialists, and residents. This meeting brought together a pan-Canadian Faculty of KOLs to showcase cutting edge content in gastroenterology from DDW. Common themes that the CARE Gastroenterology
faculty focused on include:

- Optimization of current therapy

- Innovation that comes with research and new therapy

- Access to treatment

- The potential impact of technology - both from a specialist and patient perspective

The CARE Perspectives Conference Report from DDW 2017 summarizes the presentations of the participating faculty. The content that follows is written in the language in which it was presented and as applicable includes abstracts identified from DDW 2017. Perspectives are provided by the CARE Gastroenterology Faculty. 


For patients with inflammatory bowel disease (IBD), there are several currently available therapies that have helped to improve patient outcomes over the last few years. Emerging, innovative treatments are improving ways of managing patients with IBD and will provide us with more choice and greater treatment flexibility. The CARE Faculty is interested in the views of Canadian gastroenterologists with regards to the impact of new agents in Canada and access to these therapies. We thank you in advance for your valuable feedback! The results from this needs assessment will be shared in future CARE publications.


CARE Perspectives on ECCO/CDDW 2017

CARE (Community. Academic. Research. Education.) believes in: optimization of current therapy, innovation with new treatments, accessibility, and competition; considered in ways that deliver better healthcare solutions to Canadians.

In keeping with these beliefs, this issue of CARE Perspectives explores abstracts and research presented at both the 12th annual ECCO (European Crohn’s and Colitis Organisation) congress held in Barcelona, Spain (February 15-18, 2017) and the CDDW (Canadian Digestive Diseases Week) meeting in Banff, Alberta (March 3-6, 2017).  

This report includes content on inflammatory bowel disease and irritable bowel syndrome, as well as updates on what the CARE Gastroenterology Faculty has been working on. Content is contextualized and framed from a Canadian perspective.  We hope you find this valuable and stay tuned for more gastroenterology updates in 2017!

 

CARE Treatment Algorithm: The Management of Chronic Constipation

The CARE Gastroenterology Faculty, led by Dr. Louis Liu (UHN), recently developed a treatment algorithm for the management of chronic constipation that was published on February 8th 2017 in the Canadian Journal of Hepatology & Gastroenterology.

Click here for the full publication: http://buff.ly/2lMQyjC

Gastro-Times: The Changing Landscape of Inflammatory Bowel Disease

Introduction :

We are in the golden age of Inflammatory Bowel Disease clinical care. Biologics have revolutionized the treatment of chronic inflammatory conditions in the past two decades, leading to significant improvements in efficacy and manageable safety. In order to ultimately improve patient outcomes, research continues to consider how to optimize the use of current biologic agents (i.e. via dose optimization & therapeutic drug monitoring), drive innovation of new agents, and investigate how increased competition will affect practice, due to the introduction of biosimilars. 

This issue of Gastro-Times will review these three key topics as they apply to the Canadian landscape. In order to provide real-world insight on IBD management, case studies will also be considered for pediatric patients, new patients (biologic naïve), and stable patients.

 

CARE Gastroenterology Faculty who have contributed to this report :

Dr. John Marshall - McMaster University

Dr. Remo Panaccione - University of Calgary

Dr. Thomas Walters - Sick Kids Hospital

 

Perspectives de CARE Essai NOR-SWITCH

Les agents biologiques ont révolutionné le traitement des maladies inflammatoires de l’intestin et amélioré la vie des patients de façon significative. Quelques biologiques sur le marché vont perdre leur brevet et d’autres molécules (biosimilaires) sont maintenant en train d’apparaître. L’arrivéedes biosimilaires aura beaucoup d’impact sur notre pratique médicale, sur les budgets alloués et sur la façon dont nous allonsdispenser les soins de santé au Canada.

L’étude NOR-SWITCH est une étude randomisée à double insu qui évalue une cohorte de patients qui avaient une maladie stable avec le biologique innovateur infliximab (REMICADE®). Les patients étaient randomisés soit pour continuer l’infliximab ou soit pour changer à la version biosimilaire de l’infliximab (INFLECTRA® au Canada). Cette étude portait sur des patients adultes avec plusieurs diagnostics dont la maladie de Crohn, colite ulcéreuse, arthite rheumatoïde, spondylarthrite, arthrite psoriasique et psoriasis en plaques. Chaque groupe a été suivi pendant 52 semaines et a été évalué au moyen de paramètres différents selon le groupe.

 

La version anglaise de cette interview avec Dr John Marshall et Dr Brian Feagan:

CARE Perspectives on the NOR-SWITCH Trial

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A Discussion between Dr. John Marshall and Dr. Brian Feagan

Biologic therapy has revolutionized the treatment of IBD and improved patient outcomes drastically. Many of the biologic therapies we routinely use are now or soon going off patent and competitive molecules, biosimilars, are now being introduced. Biosimilars have potential implications for our own practices but also for how we manage our pharmacy budgets and how we deliver health care in Canada.

The NOR-SWITCH trial was a randomized, double-blind trial studying a cohort of patients who were stable on the innovator biologic, infliximab (REMICADE®). Patients were randomized to either continue with infliximab or switch to a biosimilar version of infliximab (INFLECTRA™ in Canada). This was a cross specialty trial that included adult patients from a variety of diagnoses, including:  rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, Ulcerative Colitis (UC), Crohn’s Disease (CD) and chronic plaque psoriasis. Each group was followed for disease worsening as the primary endpoint measured by their respective disease activity indices. 

CARE Gastroenterology Faculty lead, Dr. John Marshall (McMaster University), sat down with Dr. Brian Feagan (Professor of Medicine at the University of Western) to critically assess this study and discuss how the results should be interpreted and applied in Canadian practice. 

The video interview from their conversation is also available below: 

CARE Perspectives on ACG/UEGW 2016

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Highlights from ACG/UEGW 2016

Members of the CARE Gastroenterology Faculty recently attended the ACG 2016 conference held in Las Vegas, Nevada (October 14-19) and the UEGW 2016 conference in Vienna, Austria (October 15-19).

The CARE Perspectives Conference Report from ACG/UEGW 2016 provides a summary of the most compelling stories and news presented at this event, and provides Canadian perspectives from the CARE Gastroenterology Faculty. Video clips are included throughout which highlight some of the key news in video format. The content that follows is written in the language in which it was presented. 

CARE Gastroenterology Faculty who have contributed to this report:

John Marshall, MD, FRCP(C), AGAF - McMaster University

Louis Liu, MD, FRCP(C) - University Health Network

Remo Panaccione, MD, FRCP(C) - University of Calgary

 

CARE Perspectives on DDW 2016

Highlights from DDW 2016

Members of the CARE Gastroenterology Faculty recently attended the DDW 2016 conference held in San Diego, California (May 21-24). At this conference, the annual CARE at DDW education meeting was held. This meeting brought together a pan-Canadian Faculty of KOLs to showcase news and developments in gastroenterology. Presentations featured cutting edge content with discussion on relevant cases and treatment strategies. CARE at DDW was attended by Canadian gastroenterology professionals. Attendees included academic and community specialists, and residents.

The CARE Perspectives Conference Report from DDW 2016 provides a summary of the most compelling stories and news presented at this event, and is augmented with additional perspectives from the CARE Gastroenterology Faculty. The content that follows is written in the language in which it was presented. 

CARE Gastroenterology Faculty who have contributed to this report:

John Marshall, MD - McMaster University

Alexandra Ilnyckyj, MD - University of Manitoba

Brian Bressler, MD - University of British Columbia

Alain Bitton, MD - McGill University

David Wong, MD - University of Toronto

 

CARE Perspectives on ECCO 2016

Highlights from ECCO 2016

Members of the CARE Gastroenterology Faculty recently attended the ECCO 2016 conference held in Amsterdam, Netherlands from March 16-19.

The CARE Perspectives Conference Report from ECCO 2016 provides a summary of the most compelling stories and news presented at this event, and is augmented with additional perspectives from the CARE Gastroenterology Faculty. 

CARE Gastroenterology Faculty who have contributed to this report:

John Marshall, MD, FRCP(C), AGAF
McMaster University 

 

CARE Perspectives on CDDW 2016

Members of the CARE Gastroenterology Faculty recently attended the CDDW 2016 conference held in Montreal, QC from February 26-29th.

The CARE Perspectives Conference Report from CDDW 2016 covers a wide variety of content presented at the conference within irritable bowel syndrome and inflammable bowel disease, given the influx of research which is influencing clinical practice. This report provides a summary of the most compelling stories and news presented in these two conditions, and is augmented with additional perspectives from the CARE Gastroenterology Faculty. 

CARE Gastroenterology Faculty who have contributed to this report:

John Marshall, MD, FRCP(C), AGAF
McMaster University 

Louis Liu, MD, FRCP(C)
University Health Network

GASTRO-TIMES: Subsequent Entry Biologics Needs Assessment Results

Biologics have revolutionized the treatment of chronic inflammatory conditions, with significant improvements in efficacy and a manageable safety profile. In the last few years, subsequent entry biologics (SEBs) have been developed. SEBs are monoclonal antibodies that are similar but not identical to the reference biologic drug. There is no SEB approved in the gastroenterology space yet in Canada, however they are expected to enter the market in the near future. In order to understand both current perception and knowledge of SEBs with gastroenterologists, a needs assessment was conducted by the CARE Gastroenterology Faculty in the fall of 2015. The needs assessment was distributed by mail and electronically to 400 Canadian gastroenterologists working in teaching centres (49%) and/or community practices (51%). Response rate to this questionnaire was 20% (n=80). We are gratified by the high rate of participation and intent to continue this process of surveys and sharing the feedback results. Responding physicians are from the desired audience, as they all use biologics in their practice.

The current steering chair of the CARE Gastroenterology Faculty, Dr. John Marshall (McMaster University) presented the findings from this analysis at the annual CDDW 2016 meeting. What follows is an overview of results.

 

Gastroenterology Year in Review 2015

There were a number of exciting developments in Gastroenterology this year. This Gastroenterology Year in Review 2015 Publication is an interactive report that covers some of the most exciting stories in the field of gastroenterology throughout 2015. An overview of programs that various CARE faculties have developed in 2015 and upcoming conferences in 2016 have also been highlighted in this report.


CARE Perspectives AASLD 2015

Members of the CARE Liver Disease Faculty recently attended the AASLD conference held in San Francisco, California (November 13-17). The CARE Perspectives Conference Report from AASLD 2015 provides a summary of the most compelling stories and news presented at this event, and is augmented with additional perspectives from the CARE Liver Disease Faculty. While AASLD covers a number of different types of liver diseases, the focus of this report is on hepatitis C (HCV). Advances in HCV research and drug development over the last few years have provided potentially curative therapy options for many patients. Moving forward, the goal will be to continue to improve on the identification of HCV in Canada (45% of population remain undiagnosed) so that patients can receive necessary treatment. In doing so, this could significantly reduce the risk of disease progression and in some cases provide a cure. While data for future combinations is very promising, access to currently available, highly effective regimens warrants attention as there are a subset of patients that need to be treated now.

The CARE Liver Disease Faculty looks forward to pursuing these considerations further and providing continued medical education in this exciting medical field. The content that follows is written in the language in which it was presented. The following content is adapted from the most up-to-date presentations made at the AASLD 2015 meeting, and is augmented with content and perspectives from the CARE Liver Disease Faculty

Please see below for a link to the full report:

CLICK HERE to view the full report

CLICK HERE to view the full report

 

CARE Perspectives ACG/UEGW 2015

Members of the CARE Gastroenterology Faculty recently attended and reviewed the ACG 2015 conference held in Honolulu, Hawaii (October 16th-21st) and UEGW 2015 in Barcelona, Spain (October 24th-28th). 

The annual CARE at ACG education meeting was run on October 17th and was attended by community specialists and residents from across Canada. The CARE Gastroenterology Faculty, led by Dr. John Marshall, presented on a number of key topics in the field.

The CARE Perspectives Conference Report from ACG 2015, augmented with content from UEGW 2015, provides a summary of the most compelling stories and news presented at these events. Additional perspectives from the CARE Gastroenterology Faculty is also included.

CLICK HERE FOR THE FULL REPORT

CLICK HERE FOR THE FULL REPORT

CLICK HERE FOR THE SEBs QUESTIONNAIRE

CLICK HERE FOR THE SEBs QUESTIONNAIRE

 

CARE Perspectives DDW 2015

Click here to view the full CARE Perspectives DDW 2015 Conference Report. 

Click here to view the full CARE Perspectives DDW 2015 Conference Report. 

Members of the CARE Gastroenterology and Liver Disease Faculties recently met at the DDW 2015 conference held in Washington, DC from May 16-19. The annual CARE (Community Academic Research Education) meeting was held on May 15th from 5:00-9:00pm and was led by CARE Faculty member, Dr. John Marshall (McMaster University). CARE at DDW 2015 provided community and trainee gastroenterologists and hepatologists an opportunity to explore news and developments from DDW within a Canadian context. The program also allowed participants to network and engage in lively discussion with other conference attendees.

This program also included a CME accredited portion focused on hepatitis C, led by Dr. Hemant Shah. Topics included screening, assessment, and treatment of hepatitis C, and was aimed towards community liver disease specialists. An overview of this program can be found as a supplement.

The CARE Perspectives Conference Report from DDW 2015 provides a summary of the most compelling stories and news presented at this event, and is augmented with additional perspectives from the CARE Gastroenterology and Liver Disease Faculties. The Liver Disease section of this report is supplemented with abstracts and perspectives from EASL 2015 (Vienna, Austria). 

Below is a link to the full report as well as supplementary publications: 

Click here for the full report.

Click here for the full report.

Click here to read the full CME Accredited interactive training session: Hepatitis C (HCV) Recap. 

Click here to read the full CME Accredited interactive training session: Hepatitis C (HCV) Recap. 

Click here to read the full Ulcerative Colitis Guidelines. 

Click here to read the full Ulcerative Colitis Guidelines. 

Ulcerative Colitis Canadian Clinical Practice Guidelines

Click here to view the Ulcerative Colitis Canadian Clinical Practice Guidelines

Click here to view the Ulcerative Colitis Canadian Clinical Practice Guidelines

This document is based on the clinical practice guidelines for the medical management of non-hospitalized ulcerative colitis published in Gastroenterology in May 2015. CARE Faculty member Dr. Brian Bressler was involved in the development of these guidelines and spoke to the key points during the 'CARE at DDW 2015' education program held on May 15th. The content that follows is drawn from his presentation and augmented with commentary from the CARE Gastroenterology Faculty. 

Below is a link to the guidelines:

Click here for the full guidelines. 

Click here for the full guidelines. 

 

CME Accredited Interactive Training Session: Hepatitis C (HCV)

This event was an Accredited Group Learning Activity (Section 1) as defined by the Maintenance of Certification program of The Royal College of Physicians and Surgeons of Canada, and approved by the University of Calgary Office of Continuing Medical Education and Professional Development. Participants claimed 1.0 study credit for their participation. 

During the CARE at DDW 2015 Education Program , CARE Liver Disease Faculty member Dr. Hemant Shah (Toronto Western Hospital) ran an interactive training session that provided
a review of the major developments in the Hepatitis C Virus (HCV) in recent years. Topics included in his presentation were epidemiology of HCV, how to screen and assess patients, and most prominently, preferred treatment options available.

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CARE Perspectives EASL & DDW 2015

Members of the CARE Liver Disease Faculty recently attended the European Association for
the Study of the Liver (EASL) 2015 conference held in Vienna, Austria (April 22-26), as well
as the Digestive Disease Week (DDW) conference held in Washington, DC (May 16-19). An
accredited education program focused on HCV was held at DDW on May 17th, and led by Dr.
Hemant Shah (please see insert for more information on this program).


The CARE Perspectives Conference Report from EASL & DDW 2015 provides a summary
of the most compelling stories and news presented at these events, and is augmented with
additional perspectives from members of the CARE Liver Disease Faculty.

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