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

1.	Birck MG, Lukusa L, Choquette C, Boire G, Maksymowych WP, Inman RD, Singh H, Targownik LE, Leung Y, Afif A, Bernatsky S. Comparison of serious infections between infliximab biosimilar and bio-originator initiators in Canada: Population-based analyses. ISPE’s 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2023), August 23-27, 2023. Poster Presentation. 
2.	Moura CS, Choquette C, Boire G, Maksymowych WP, Lukusa L, Yan L, Birck MG, Bernatsky S. Time to first remission and prevalence of sustained remission after etanercept biosimilar (ETA-B) or originator (ETA-O) initiation in rheumatoid arthritis (RA). European Congress of Rheumatology (EULAR 2023), May 31-June 3, 2023. Abstract Publication. 
3.	Moura CS, Lukusa L, Afif W, Lakatos PL, Bessissow T, Singh H, Oketola B, Narula N, Leung Y, Bernatsky S. Time to first remission and prevalence of sustained remission in inflammatory bowel disease: comparison between infliximab biosimilar and originator. 2023 Digestive Disease Week (DDW 2023), Chicago, IL. May 6-9, 2023. Poster Presentation. 
4.	Moura CS, Lukusa L, Yan L, Maksymowych MP, Choquette D, Boire G, Bernatsky S. Time to first remission and prevalence of sustained remission after etanercept biosimilar (ETA-B) or originator (ETA-O) initiation in rheumatoid arthritis (RA). 2023 Canadian Rheumatology Association & AHPA Annual Scientific Meeting, Quebec City, QC, February 8-11, 2023. Poster Presentation. 
5.	Moura CS, Lukusa L, Yan L, Maksymowych MP, Choquette D, Boire G, Bernatsky S. Time to first remission and prevalence of sustained remission after etanercept biosimilar (ETA-B) or originator (ETA-O) initiation in rheumatoid arthritis. 2022 American College of Rheumatology Annual Conference, Philadelphia, Pennsylvania, November 10-14, 2022. Poster Presentation.
6.	Moura CS, Lukusa L, Wong EC, Lakatos PL, Afif W, Narula N, Bernatsky S. Comparison of discontinuation/switching between infliximab biosimilar and originator among inflammatory bowel disease patients: a real-world analysis of two Canadian cohorts. 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), Vienna, Austria, February 16-19, 2022. Abstract EC-22-1562, Poster Presentation.
7.	Moura CS, Lukusa L, Keeling SO, Maksymowych MP, Bernatsky S. Discontinuation/switching after etanercept biosimilar (ETA-B) and originator (ETA-O) initiation in rheumatoid arthritis. 2022 Canadian Rheumatology Association Meeting Virtual Congress, February 2-5, 2022. Poster Presentation.
8.	Moura C, Curtis JR, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, Lakatos P, Svenson L, Targownik L, Afif W, Bernatsky S. Recent Use, Missed Doses and Discontinuation of Infliximab in New-Users: Comparisons of Biosimilar and Originator Exposures. 2021 Canadian Rheumatology Association Meeting Virtual Congress, February 24 – 26, 2021. J Rheum 2021. 47(7); 1106-1189. Abstract #27
9.	Lee A*, Moura C, Boire G, Choquette D, Targownik L, Afif W, Lakatos P, Thorne C, Bernatsky S. Potential Savings for Canadian Public Drug Insurance Plans Related to Biosimilar Adalimumab. 2021 Canadian Rheumatology Association Meeting Virtual Congress, February 24 – 26, 2021. J Rheum 2021. 47(7); 1106-1189. Abstract #90
10.	Moura C, Curtis JR, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych WP, Lakatos P, Svenson L, Targownik L, Afif W, Bernatsky S. Recent Use, Missed Doses and Discontinuation of Infliximab in New-Users: Comparisons of Biosimilar and Originator Exposures. 2020 American College of Rheumatology Annual Conference (Virtual), November 5-9, 2020. Arthritis Rheumatol. 2020; 72 (suppl 10). Poster #0556
11.	Moura CS, Choquette D, Coupal L, Schieir O, Bykerk VP, Valois MF, Boire G, Maksymowych WP and Sasha Bernatsky. Persistence in Rheumatoid Arthritis Patients on Biosimilar and Bio-originator Etanercept: A Pooled Analysis of Pan-Canadian Cohorts. Canadian Association for Population Therapeutics (CAPT) Virtual Conference, October 26-27, 2020. JPTCP 2020. 27(4); Abstract 33. Oral presentation
12.	Moura CS, Choquette D, Coupal L, Schieir O, Bykerk VP, Valois MF, Boire G, Maksymowych WP and Bernatsky S. Persistence in Rheumatoid Arthritis Patients on Biosimilar and Bio-originator Etanercept: A Pooled Analysis of Pan-Canadian Cohorts., 36th International Conference on Pharmacoepidemiology and Therapeutic Risk annual meeting, Virtual, All Access, September 16-17, 2020. PDS. 2020;29. Oral presentation
13.	Moura CS, Curtis J, Choquette D, Boire G, Bykerk V, Maksymowych WP, Lakatos PL, Afif W and Bernatsky S. Switching from originator infliximab to biosimilar: missed dose and discontinuation in a population-based cohort. 36th International Conference on Pharmacoepidemiology and Therapeutic Risk annual meeting, Virtual, All Access, September 16-17, 2020. PDS. 2020;29 [abstract - Spotlight Session]
14.	Moura CS, Choquette D, Coupal L, Schieir O, Valois MF, Bykerk V, Boire G, Maksymowych WP, Bernatsky S, on behalf of CATCH, RHUMADATA, RAPPORT, and EUPA Investigators. Persistence in Rheumatoid Arthritis Patients on Biosimilar and Bio-Originator Etanercept: A Pooled Analysis of Pan-Canadian Cohorts. EULAR 2020 E-Congress, June 3-6, 2020. Ann Rheum Dis. 2020; 79, (Suppl 1):302. Abstract THU0179
15.	Moura C, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, Lakatos P, Svenson L, Targownik L, Afif W, Bernatsky S. Risk Factors Associated with Serious Infections among Users of Biosimilar and Originator Infliximab Therapies. 2020 Canadian Rheumatology Association & AHPA Annual Scientific Meeting, Victoria BC, February 26-29, 2020. J Rheum 2020. 47(7); 1033. Abstract 137
16.	Moura C, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, Lakatos P, 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. 2020 Canadian Rheumatology Association & AHPA Annual Scientific Meeting, Victoria BC, February 26-29, 2020. J Rheum 2020. 47(7); 1033. Abstract 146
17.	Moura C, Bernatsky S, Coupal L, Bessette L, Choquette D. Biosimilar Etanercept Use in Rheumatoid Arthritis: The RHUMADATA® Registry Experience. 2020 Canadian Rheumatology Association & AHPA Annual Scientific Meeting, Victoria BC, February 26-29, 2020. J Rheum 2020. 47(7); 1033. Abstract 176
18.	Moura CS, Afif W, Bessissow T, Boire G, Bykerk VP, Choquette D, Lakatos PL, Maksymowych WP, Svenson L, Targownik L, Thorne C, and Bernatsky S Adherence and Discontinuation for Infliximab Biosimilar and Originator Drugs Covered by Public Provincial Insurance in Canada. 35th International Conference on Pharmacoepidemiology and Therapeutic Risk annual meeting, Philadelphia, PA, USA, August 24-28, 2019. PDS. 2019;28, S2. [abstract - Spotlight Session]
19.	Moura C, Choquette D, Coupal L, Bessette L, Bernatsky S. Biosimilar Etanercept Use in Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis: The RHUMADATA® Registry Experience. 2019 American College of Rheumatology ACR/ARP Annual Meeting, November 8-13, 2019, Atlanta, Georgia. Arthritis Rheumatol. 2019; 71 (suppl 10), #1080
20.	Moura C, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, Lakatos P, Svenson L, Targownik L, Afif W, Bernatsky S. Risk Factors Associated with Serious Infections Among Users of Biosimilar and Originator Infliximab Therapies. 2019 American College of Rheumatology ACR/ARP Annual Meeting, November 8-13, 2019, Atlanta, Georgia. Arthritis Rheumatol. 2019; 71 (suppl 10), Abstract #202
21.	Moura C, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, Lakatos P, 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. 2019 American College of Rheumatology ACR/ARP Annual Meeting, November 8-13, 2019, Atlanta, Georgia. Arthritis Rheumatol. 2019; 71 (suppl 10), Abstract #203
22.	Moura C, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, Lakatos P, Svenson L, Targownik L, Afif W, Bernatsky S. Risk Factors Associated with Serious Infections Among Users of Biosimilar and Originator Infliximab Therapies. 2019 American College of Rheumatology ACR/ARP Annual Meeting, November 8-13, 2019, Atlanta, Georgia. Arthritis Rheumatol. 2019; 71 (suppl 10), Abstract #202
23.	Moura C, Curtis J, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, Lakatos P, 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. 2019 American College of Rheumatology ACR/ARP Annual Meeting, November 8-13, 2019, Atlanta, Georgia. Arthritis Rheumatol. 2019; 71 (suppl 10), Abstract #203
24.	Moura C, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, 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. 2019 Canadian Rheumatology Association (CRA) Annual Meeting, February 27- March 2, 2019, Montreal, Quebec. J Rheumatol 2019;46;757-865, Abstract #178
25.	Moura C, Choquette D, Coupal L, Bessette D, Bernatsky S. Infliximab Biosimilar use in Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients: The RHUMADATA® Registry Experience. 2019 Canadian Rheumatology Association (CRA) Annual Meeting, February 27-March 2, 2019, Montreal, Quebec. J Rheumatol 2019;46;757-865, Abstract #134
26.	Moura C, Choquette D, Boire G, Bykerk V, Thorne C, Maksymowych W, 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. 2019 Canadian Rheumatology Association (CRA) Annual Meeting, February 27-March 2, 2019, Montreal, Quebec. J Rheumatol 2019;46;757-865, Abstract #178
27.	Moura CS, Choquette D, Boire G, Bykerk VP, Thorne C, Maksymowych W, 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. 2018 American College of Rheumatology ACR/ARP Annual Meeting, October 20-24, 2018, Chicago, IL, USA. Arthritis Rheumatol 2018; 70 (Suppl 10). S216. 

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