Real-world utilization of methotrexate or prednisone co-therapy with etanercept among Canadian patients with rheumatoid arthritis: a retrospective cohort study

Abstract

Objective: To evaluate whether initiation of etanercept therapy among patients with rheumatoid arthritis (RA) impacts use of co-therapy with methotrexate or prednisone, and to describe etanercept dosing dynamics compared to product monograph in the Canadian real-world setting.

Methods: A retrospective cohort study was conducted using claims-level data from IQVIA Private Drug Plan database, Ontario Public Drug Plan database and Régie de l’assurance maladie du Québec database. Bio-naïve RA patients initiating etanercept between July 2014 and June 2015 were identified and their claims for methotrexate or prednisone were analyzed. Utilization of methotrexate or prednisone was calculated as average weekly dose in milligrams, and compared in the 6 months pre-initiation versus 12 months post-initiation of etanercept. Weekly etanercept dosing of each patient was calculated and analyzed to determine whether patients had at least 20% higher or lower average dose than monograph recommended dose (50 mg/week), and were then flagged as above-monograph or below-monograph, respectively.

Results: A total of 2876 patients with RA (66% female, 76% aged 18–65) were included; 62% (n = 1,140) used methotrexate and 27% used prednisone (n = 498) both pre- and post-initiation of etanercept. In methotrexate patients, the average weekly dose dispensed was 25.4 mg in the 6 months pre-etanercept, and 25.0 mg in the 12 months post-etanercept initiation (p = .5282). In prednisone patients, the average weekly dose dispensed reduced from 122.6 mg pre-etanercept to 107.1 mg post-etanercept initiation (p = .2173). Among patients who were already on methotrexate or prednisone, after initiating on etanercept 16% (n = 213) and 34% (n = 254) of patients stopped methotrexate and prednisone, respectively. When compared to the recommended dose, 12% (n = 168) of patients were below-monograph and 7.1% of patients were above-monograph during their first year of etanercept therapy. Average etanercept dosing was consistently lower than product monograph during the follow-up year.

Conclusions: Patients had a modest but not statistically significant decrease in prescribed doses of co-therapy with methotrexate and prednisone when etanercept was added to patients’ therapy. In addition, 12–14% of patients stopped their co-therapy with methotrexate or prednisone. Further study is needed to understand the impact on patient outcomes and safety.

Keywords:

• Ankylosing spondylitis
• etanercept
• immune-mediated inflammatory disease
• methotrexate
• prednisone
• real-world evidence
• rheumatoid arthritis

Notes

Transparency

Declaration of funding

Financial support for the study was provided by Pfizer. Pfizer participated in the design of the study, interpretation of data, review and approval of this publication.

Author contributions: All authors made substantial contributions to the conception, design, acquisition, analysis and interpretation of data, and drafting of the work and revising it critically for intellectual content. All authors contributed to the development of the publication and maintained control over the final content.

Declaration of financial/other relationships

M.K. has disclosed that he is an advisor for Pfizer and Amgen. J.I., M.-J.B. and B.M. have disclosed that they are employees of IQVIA and have collaborated on this study as consultants paid by Pfizer. Y.Z. has disclosed that she was an employee of IQVIA at the time of data generation and manuscript development. J.W. and C.C. have disclosed that they are employees of Pfizer and own stock in Pfizer. H.J. has disclosed that she was an employee of Pfizer at the time of data generation and manuscript development. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

Medical writing support was provided by Dr. Jelena Ivanovic of IQVIA and was funded by Pfizer.

Previous presentations

Poster presented at the Annual Congress of European League Against Rheumatism (EULAR); 2017 Jun 14–17; Madrid, Spain.

Data availability statement

Data subject to third party restrictions; the data that support the findings of this study are available from IQVIA. Restrictions apply to the availability of these data, which were used under license for this study. Data are available from IQVIA Canada, at https://www.iqvia.com/locations/canada, with the permission of IQVIA.

Notes

1 Enbrel is a registered trade mark of Immunex Corporation, Thousand Oaks, CA, USA.

2 Actemra is a registered trade mark of Chugai Seiyaku Kabushiki Kaisha Corporation, Tokyo, Japan.

3 Cimzia is a registered trade mark of Ucb Pharma, Brussels, Belgium.

4 Humira is a registered trade mark of Abbvie Biotechnology Ltd, Hamilton, Bermuda.

5 Kineret is a registered trade mark of Swedish Orphan Biovitrum, Stockholm, Sweden.

6 Orencia is a registered trade mark of Bristol-Myers Squibb Company, New York, NY, USA.

7 Remicade is a registered trade mark of Janssen Biotech, Horsham, PA, USA.

8 Rituxan is a registered trade mark of Biogen MA Inc., Cambridge, MA, USA.

9 Simponi is a registered trade mark of Johnson & Johnson Corporation, New Brunswick, NJ, USA.