May 25, 2016

Rapid Funding for DSEN Targeted Research

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.

The longitudinal CATCH research database is a global resource enabling multiple types of discoveries. The present study combining detailed medication tracking (including switches and SAEs) with longitudinal measures of disease activity/ severity, disease flare, radiographic progression and multiple PROMs in a large sample of rheumatologist confirmed ERA cases seen in routine practice creates an ideal platform for carrying out robust real-time and real-world comparative effectiveness research. Outputs from this research program can help describe real-world practice patterns surrounding use of RA therapies as well as identify associations between RA therapies, outcomes and costs with the goal of improving health services and quality of care for RA patients.

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.

We retired long legacy questionnaires in favour of shorter forms shown to have stronger psychometric properties (e.g. MD-HAQ and PROMIS-29). We also shifted to longitudinal measures of patient reported comorbidities validated for use in rheumatic disease populations (Sangha Self-Administered Comorbidity Questionnaire /Rheumatic Disease Comorbidity Index).

Detailed recording of all RA medications are confirmed & entered by rheumatology team member, including steroids, csDMARDs, tsDMARDs, bDMARDs, SEBs/ biosimilars. Each medication entry includes the following information:

  • Name of medication
  • DIN
  • Start/ stop dates
  • Dose
  • Frequency
  • Route
  • Reason for stopping therapy (drop down list selection with additional option for free text entry)
  • Side effect (drop down list selection of 30+ potential with additional option for free text entry)

We added questions to be completed by the treating physician at each visit, asking about any comorbidities or serious adverse events (SAEs) possibly attributable to the patient’s RA medication, which medication(s) could be attributed, type of SAE/comorbidity, physician certainty the event is attributable to the medication, whether the medication needed to be interrupted, and the outcome/status of the event.

Joint counts, global assessments and labs used to calculate multiple clinical disease activity indices (DAS, CDAI, SDAI) are collected longitudinally at each catch visit. Serial radiographs allow for analyses of radiographic progression.

We added multiple key PROMs assessing the following:

  • Patients’ attitudes, beliefs and behaviors surrounding medication use including the beliefs about medications questionnaire (BMQ), Medications Adherence Questionnaire (MAQ), Patient activation measure (PAM)
  • Patient reports of RA disease flares (Rheumatoid Arthritis Flare Questionnaire (RA-FQ))
  • Mental health (Patient Health Depression Scale – 8 (PHQ-8)
  • Impacts on Work (Work productivity Impairment Scale)

We also added questions about potential economic and system factors related to medication use (e.g. insurance coverage, average costs of medication, access to local co-pay or subsidized medication programs. More detailed questions were developed with respect to patient infections and hospitalizations.

For more information contact: Jessica (Lifang) Wang. Research Coordinator. [email protected]   514.934.1934 ext.44718