26
May

Drs. Sasha Bernatsky and Louise Pilote received funding from the Drug Safety and Effectiveness Network (DSEN) Rapid Funding for DSEN Targeted Research to continue developing novel methods using prospective longitudinal cohorts and responding to key knowledge gaps regarding drug safety and effectiveness through the Enhanced Cohort project.

 

Research Project Title: Canadian Early Arthritis Cohort (CATCH)

NPI: Sasha Bernatsky

Co PI: Vivian Bykerk and Louise Pilote

Duration: 1 year

We have been funded to answer a query related to the comparative effectiveness and safety between currently available agents (biologics, traditional DMARDs) and JAK inhibitors. We will expand our aims in CATCH (Canadian Early Arthritis Cohort) to more carefully track safety events in relation to patient and disease related factors, extent of inflammation and effectiveness of prior therapies.

This project was funded by CIHR and aims to enhance a multicenter ongoing observational cohort study of patients with early rheumatoid arthritis (ERA). This project has been focused on expanding the aims in CATCH to more carefully track safety events in relation to patient and disease related factors extent of inflammation and effectiveness of prior therapies.

We conducted analysis in the CATCH cohort to describe treatment failure, discontinuation, and switching across various treatment strategies. Over the study interval, 61% patients had a treatment failure, primarily due to inefficacy. In further analysis among patients exposed to MTX who had an initial treatment failure, we found that those on biologics and those on triple therapy had a longer time to failure, compared to the group taking MTX oral monotherapy. Two abstracts describing these results were presented at the American College of Rheumatology annual meeting. Additionally, one abstract related to the DSEN project was presented at the Canadian Rheumatology Association (CRA) scientific meeting in October 2016. Three abstracts describing the same results were submitted to the 2018 Canadian Rheumatology Association (CRA) annual meeting. One manuscript with results for treatment strategies in managing early rheumatoid arthritis is currently under review with Arthritis Care & Research. A guide poster tour was presented at the 2018 EUropean League Against Rheumatism (EULAR) Annual Scientific Meeting.

 

Research Project Title: Pharmacoepidemiology in Multiple Sclerosis (PiMS) Research Group

NPI: Sasha Bernatsky

Co-PI: Helen Tremlett and Louise Pilote

Duration: 1 year

We have been funded to answer a query related to the comparative safety of new oral disease-modifying drugs (DMDs) agents in multiple sclerosis (MS).  With the enhanced cohort project, we will focus on the linkage of prospectively collected, patient-level population-based data to create a unique and powerful dataset of administrative health, prescription, and laboratory monitoring information. Additionally, we will enable the study to be expanded and we plan to include a pharmacogenomic component to enable saliva collection.

This project was funded by CIHR and aims to enhance the clinical cohort in multiple sclerosis (MS) and new oral DMDs. This project has been focused on describing the use of the new oral DMDs in multiple sclerosis (MS), as well as the incidence and potential predictors of adverse events. It also involves developing a pharmacogenomic component to study genetic predictors of responses and risk. The following activities were completed:

  •  149 patients were enrolled in the pharmacogenomic sub-study from Vancouver and Winnipeg, and are expecting an estimated 15 additional samples in the coming weeks from these two sites. Collaborators in Bern, Switzerland are currently summarizing their clinical data and coordinating sample collection from the MS clinic at the Universität Bern.
  • Working through expanding the collection of samples and acquiring research ethics board approvals to include the largest MS clinic in Canada, located at St. Michal’s Hospital in Toronto, Ontario with Dr. Dalia Rotstein and Dr. Jiwon Oh.
  • 18 patients were enrolled for a micro-biome sub-study

The PiMS research team submitted a pilot grant application to the National Multiple Sclerosis Society in the United States for $50,000 USD in May 2018 with the aim to investigate the genomic variants associated with dimethyl fumarated-induced lymphopenia in MS. This would provide funding for genotyping.

 

A publication was accepted at BMJ open on April 2017: Kowalec K, Kingwell E, Carruthers R, Marrie RA, Traboulsee A, Bernatsky S, Ross CJD, Carleton B, Tremlett H. (2017) Application of pharmacogenomics to investigate adverse drug reactions to the disease-modifying treatments for multiple sclerosis: a case-control study protocol for dimethyl fumarate induced lymphopenia. BMJ Open, 7(5): e016276. Additionally, one abstract related to the DSEN project was presented at the American Society for Human Genetics (ASHG) annual meeting in Vancouver  (October 18-22, 2016).

 

Research Project Title: Canadian Network on Hepatitis C (CanHepC)

NPI: Sasha Bernatsky

Co-PI: Marina Klein, Jordan Feld, and Louise Pilote

Duration: 1 year

We have been funded to answer a query related to the comparative effectiveness and safety of direct-acting antiviral agents (DAA) in combination or not with PEG + RBV (triple therapy). For the current project, aimed at enhancing drug safety and effectiveness research through the CanHepC network, we aim to harmonize existing data already collected around the country in varying clinical settings, as well as broadening the focus, to enroll on populations poorly represented in prior studies. In addition to merging existing data, we will collect new data in a prospective manner.

This project aims to enhance the clinical cohort on hepatitis C and the first generation of direct-acting antivirals (DAAs). This project has been focused on collecting high quality observational data on the use of novel therapeutics for HCV infection and to harmonizing datasets on HCV collected at centres across Canada. It also involves broadening the scope of the original cohort to enroll on populations poorly represented in prior studies. During this period, both linkage of existing retrospective data and prospective data collection were initiated. We are actively collecting data.  We have over 500 patients with more than 900 visits in the database so far and we are expecting that to increase significantly very soon as we will be adding six new sites over the next three months. We presented two abstracts at the EASL conference, the International Liver Congress in April.

 

Research Project Title: GENdEr and Sex DetermInantS of Cardiovascular Disease (GENESIS-PRAXY)

NPI: Louise Pilote

Co-PI Sasha Bernatsky

Duration: 1 year

This project aims to determine whether sex differences in clopidogrel metabolism genes in young acute coronary syndrome (ACS) patients exist. The GENESIS PRAXY cohort was enriched through the genotyping of the relevant CYP genes. DNA from the PRAXY cohort was sent to the genome center for genotyping. The results were analysed and provided pilot data to calculate the required sample size for more definitive results. Since, our collaborations with similar cohorts have been established, including the VIRGO cohort (an international collaboration between United States, Spain, and Australia). The VIRGO database is especially useful given its large sample size and similar patient baseline characteristics. In November 2017, we received funding from CIHR catalyst grant to amalgamate these aforementioned cohorts. We have signed the Data User Agreement for acquiring VIRGO data with collaboration of PI’s Dr. Rachel Dreyer and Dr. Harlan Krumholz from Yale University. We now have access the VIRGO cohort data along with exome sequencing data. We have started the preliminary analysis and hope to have the results by the end of summer 2018. We aim to submit an abstract to the American College of Cardiology meeting (deadline Oct 16, 2018).

 

 

For more information contact: Autumn Neville. Research Coordinator. autumn.neville@rimuhc.ca   514.934.1934 ext.44844 or ext.44718

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