July 23, 2018

Comparative effectiveness and safety of biosimilars and legacy drugs

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.  Our proof of concept project 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.

Our 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

Publications
2018 American College of Rheumatology (ACR) Annual Meeting
Moura CS, Choquette D, Boire G, Bykerk VP, Thorne C, Maksymowych WP, Lakatos P, Bessissow T, Svenson L, Targownik L, Afif W, Bernatsky S.
Inflectra and Remicade Use and Cost in Canada Under Provincial Drug Plans in 2016. Arthritis Rheumatol. 2018;70(suppl 10).

2019 Canadian Rheumatology Association (CRA) Annual Meeting
Moura CS, Choquette D, Coupal L, Bessette L, Bernatsky S.
Infliximab Biosimilar use in Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients: The RHUMADATA® Registry Experience. J Rheumatol. 2019;46(7).

35th International Society for Pharmacoepidemiology (ISPE) annual meeting
Moura CS, Afif W, Bessissow T, Boire G, Bykerk VP, Choquette D, Lakatos PL, Maksymowych WP, Svenson L, Targownik L, Thorne C, Bernatsky S.
Adherence and Discontinuation for Infliximab Biosimilar and Originator Drugs Covered by Public Provincial Insurance in Canada. PDS. 2019;28(S2).

2019 American College of Rheumatology (ACR) Annual Meeting
Moura CS, Choquette D, Coupal L, Bessette L, Bernatsky S.
Biosimilar Etanercept Use in Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis: The RHUMADATA┬« Registry Experience. Arthritis Rheumatol.2019;71(suppl 10).

Moura CS, Curtis J, Choquette D, Boire G, Bykerk VP, Thorne C, Maksymowych WP, Lakatos PL, Svenson L, Targownik L, Afif W, Bernatsky S.
Risk Factors Associated with Serious Infections Among Users of Biosimilar and Originator Infliximab Therapies. Arthritis Rheumatol. 2019;71(suppl 10).

Moura CS, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych WP, Lakatos PL, Svenson L, Targownik L, Afif W, Bernatsky S.
Recent Use, Missed Doses and Discontinuation of Infliximab in a Population-Based Cohort: Comparisons of Biosimilar and Originator Exposures. Arthritis Rheumatol. 2019;71(suppl 10).

2020 Canadian Rheumatology Association (CRA) Annual Meeting
Moura CS, Curtis J, Choquette D, Boire G, Bykerk VP, Thorne C, Maksymowych WP, Lakatos PL, Svenson L, Targownik L, Afif W, Bernatsky S.
Risk Factors Associated with Serious Infections Among Users of Biosimilar and Originator Infliximab Therapies. J Rheumatol. 2020;47(7).

Moura CS, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych WP, Lakatos PL, Svenson L, Targownik L, Afif W, Bernatsky S.
Missed Doses and Discontinuation of Infliximab in a Population-Based Cohort: Comparisons of Biosimilar and Originator Exposures. J Rheumatol. 2020;47(7).

Moura CS, Choquette D, Coupal L, Bessette L, Bernatsky S.
Biosimilar Etanercept Use in Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis: The RHUMADATA® Registry Experience. J Rheumatol. 2020;47(7).

36th International Conference on Pharmacoepidemiology and Therapeutic Risk annual meeting
Moura CS, Choquette D, Coupal L, Schieir O, Bykerk VP, Valois MF, Boire G, Maksymowych WP, Bernatsky S.
Persistence in rheumatoid arthritis patients on biosimilar and bio-originator etanercept: a pooled analysis of pan-Canadian cohorts. Oral presentation. PDS. 2020;29(S3).

Moura CS, Curtis J, Choquette D, Boire G, Bykerk V, Maksymowych WP, Lakatos PL, Afif W, Bernatsky S.
Switching from originator infliximab to biosimilar: missed dose and discontinuation in a population-based cohort.  PDS. 2020;29(S3).

2020 Canadian Association for Population Therapeutics annual meeting
Moura CS, Choquette D, Coupal L, Schieir O, Bykerk VP, Valois MF, Boire G, Maksymowych WP, Bernatsky S.
Persistence in rheumatoid arthritis patients on biosimilar and bio-originator etanercept: a pooled analysis of pan-Canadian cohorts. Oral presentation, CAPT, 2020.

2020 American College of Rheumatology (ACR) Annual Meeting (Convergence)
Moura CS, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych WP, Lakatos PL, Svenson L, Targownik L, Afif W, Bernatsky S.
Recent Use, Missed Doses and Discontinuation of Infliximab in a Population-Based Cohort: Comparisons of Biosimilar and Originator Exposures. Arthritis Rheumatol. 2020;72(suppl 10).

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

Rapid Funding for DSEN Targeted Research
Query 17-05 raised by Health Canada’s Pharmaceutical Policy Division, Office of Pharmaceutical Management