Long-term effectiveness and safety of infliximab, golimumab and golimumab-IV in rheumatoid arthritis patients from a Canadian prospective observational registry

BMC Rheumatology

article

Rahman, Proton¹  Kelsall, John²  Rampakakis, Emmanouil³  Lehman, Allen J.⁴  Nantel, Francois⁴  Baer, Philip¹  Keystone, Ed⁵  Choquette, Denis⁶  Thorne, Carter¹  Haraoui, Boulos⁶  Chow, Andrew¹  Faraawi, Rafat⁷  Olszynski, Wojciech⁸ 

[1]Memorial University

[2]Providence Health

[3]JSS Medical Research

[4]Janssen Inc.

[5]University of Toronto

[6]Institut de Rhumatologie de Montréal

[7]McMaster University

[8]University of Saskatchewan

关键词: Rheumatoid arthritis;    Registry;    Infliximab;    Golimumab;    Effectiveness;    Safety;   

DOI  :  10.1186/s41927-020-00145-4

学科分类：社会科学、人文和艺术（综合）

来源: BioMed Central

【 摘 要 】

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. 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. Of the 890 IFX-, 530 GLM- 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- 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- and GLM-IV-treated patients, respectively. 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. ClinicalTrials.gov Identifier: NCT00741793 (Retrospectively registered on August 26, 2008).

【 授权许可】

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