Comparative effectiveness and safety of biosimilars and legacy drugs

Q# 17-05: Comparative Effectiveness and Safety of Biosimilars and Legacy Drugs

This is a proof of concept project that aims to demonstrate the feasibility of creating a network of clinical cohorts and other resources to provide real-world information on the use of biosimilar agents in Canada.

The core of our proposal revolves around clinical datasets, which is complement with health administrative databases. According to our timeline, an update on this project (January-December 2019) is anticipated in our annual report, which will be coming out in January 2020.

In Canada, and worldwide, there is a need for updated, independent, real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs.

CAN-AIM was awarded DSEN funds to build a biologic registry to study this important issue. The request for these data came from the Pharmaceutical Policy Division in the Office of Pharmaceutical Management at Health Canada’s Strategic Policy Branch. Our five year study includes adults (aged 18 years and older) with inflammatory rheumatic disease (primarily rheumatoid arthritis and ankylosing spondylitis) or inflammatory bowel disease who are initiating therapy with a biosimilar or the originator biologic drug.

Primary aims:

To compare, in patients who are starting on/switching to biosimilar drugs or their equivalent legacy drugs:

  1. Frequency of discontinuation of the initial therapy
  2. Persistence on the initial therapy (time until drug discontinuation)
  3. Frequency of patients starting or increasing prednisone or other immunosuppressive drugs
  4. Frequency of and time to discontinuation of treatment due to ineffectiveness
  5. Frequency of and time to clinical remission/induction of response
  6. Frequency of and time to serious adverse events

Secondary aims

To describe in patients who are starting on/switching to biosimilar drugs or their equivalent legacy drugs:

  1. Change in disease activity over time
  2. The frequency of, and time to, long-term outcomes (sustained remission, erosions in RA, radiographic progression in AS, and endoscopic mucosal healing scores in CD and UC).
  3. Change in quality of life measures over time

CAN-AIM Biosimilar Protocol

We have presented some initial results of our analyses at the 2019 Canadian Rheumatology Association Annual Scientific Meeting and at the 2018 American College of Rheumatology (ACR) Annual Meeting. We have also submitted abstracts for presentation at the 2019 ACR meeting and at the 35th International Society for Pharmacoepidemiology (ISPE) annual meeting. Further details on these publications and updates on the project (January-July 2018) will be submitted in a separate detailed report.

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

Fluconazole and risk fetal events during pregnancy

Q# 16-09: Fluconazole and Risk Fetal Events during Pregnancy

This project aims to investigate the association between use of fluconazole, a systemic azole antifungal drug treating vulvovaginal candidiasis, during pregnancy and the risk of spontaneous abortion, still birth or major birth defects/congenital malformations and under what conditions these situations occur (timing [first, second or third trimester, or throughout pregnancy], dosing [single 150 mg or less fluconazole dose, cumulative dosing]).

A full report for this query was prepared and submitted to query submitters and DSEN.

Berard A, Sheehy O, Zhao JP, Gorgui J, Bernatsky S, de Moura CS, Abrahamowicz M. Associations between low-and high-dose oral fluconazole and pregnancy outcomes: 3 nested case-control studies. CMAJ. 2019 Feb;191(7):E179-187.

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