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Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry
Francois Nantel
Janssen Inc
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7970-3328
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Rheumatology.
Background: Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care.
Methods: RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival.
Results: Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively.
Conclusion: Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.
Trial Registration: NCT00741793
Keywords
Rheumatoid arthritis, registry, infliximab, golimumab, effectiveness, safety
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CURRENT STATUS: Published
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Posted 14 May, 2020
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On 19 Sep, 2020
No community comments so far
Review #3 received
Received 26 May, 2020
Review #1 received
Received 20 May, 2020
Reviewer #3 agreed
On 05 May, 2020
Review #2 received
Received 05 May, 2020
Reviewer #2 agreed
On 05 May, 2020
Reviewer #1 agreed
On 03 May, 2020
Reviewers invited
Invitations sent on 02 May, 2020
Editor assigned
On 29 Apr, 2020
Editor invited
On 28 Apr, 2020
Submission checks complete
On 25 Feb, 2020
No comments provided
Review #2 received
Received 26 Mar, 2020
Editorial decision: Major revision
On 26 Mar, 2020
Review #1 received
Received 25 Mar, 2020
Review #3 received
Received 16 Mar, 2020
Reviewer #3 agreed
On 15 Mar, 2020
Reviewers invited
Invitations sent on 12 Mar, 2020
Reviewer #1 agreed
On 12 Mar, 2020
Reviewer #2 agreed
On 12 Mar, 2020
Editor assigned
On 18 Feb, 2020
Submission checks complete
On 17 Feb, 2020
Editor invited
On 17 Feb, 2020
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Subject Areas
Rheumatology
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This preprint is under consideration at BMC Rheumatology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry
Francois Nantel
Janssen Inc
Corresponding Author
ORCiD: https://orcid.org/0000-0002-7970-3328
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 14 May, 2020
Published
On 19 Sep, 2020
No community comments so far
Review #3 received
Received 26 May, 2020
Review #1 received
Received 20 May, 2020
Reviewer #3 agreed
On 05 May, 2020
Review #2 received
Received 05 May, 2020
Reviewer #2 agreed
On 05 May, 2020
Reviewer #1 agreed
On 03 May, 2020
Reviewers invited
Invitations sent on 02 May, 2020
Editor assigned
On 29 Apr, 2020
Editor invited
On 28 Apr, 2020
Submission checks complete
On 25 Feb, 2020
No comments provided
Review #2 received
Received 26 Mar, 2020
Editorial decision: Major revision
On 26 Mar, 2020
Review #1 received
Received 25 Mar, 2020
Review #3 received
Received 16 Mar, 2020
Reviewer #3 agreed
On 15 Mar, 2020
Reviewers invited
Invitations sent on 12 Mar, 2020
Reviewer #1 agreed
On 12 Mar, 2020
Reviewer #2 agreed
On 12 Mar, 2020
Editor assigned
On 18 Feb, 2020
Submission checks complete
On 17 Feb, 2020
Editor invited
On 17 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Rheumatology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Rheumatology.
Background: Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care.
Methods: RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival.
Results: Of the 890 IFX-, 530 GLM-SC- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0-86.6%, the mean ages from 55.8-57.7 and the mean disease duration from 6.5-8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM-SC and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM-SC and GLM-IV-treated patients, respectively.
Conclusion: Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.
Trial Registration: NCT00741793
Figure 1
Figure 2
Figure 3
Figure 4