A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
NCT ID: NCT04115423
Last Updated: 2020-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
9508 participants
OBSERVATIONAL
2020-04-01
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Tocilizumab initiators
Patients over 18 years of age with a diagnosis of RA (ICD-10 codes: M05-06) and receiving tocilizumab at least once from January 2013 to December 2018. Tocilizumab initiators are required to have no record of tocilizumab within 1 year prior to the first prescription of tocilizumab.
Tocilizumab
A humanized monoclonal antibody against the interleukin-6 receptor, which is mainly for the treatment of rheumatoid arthritis.
Tumor necrosis factor inhibitors (TNFi) users
Patients over 18 years of age with a diagnosis of RA (ICD-10 codes: M05-06) and receiving TNFi at least once from January 2013 to December 2018. TNFi users will be patients who had no record of tocilizumab and given specific TNFi during 1 year before the first prescription of TNFi.
Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)
Tumor Necrosis Factor inhibitors (TNFi) are a group of medicines that suppresses the physiologic response to TNF, a protein involved in early inflammatory events. We will include etanercept, infliximab, adalimumab, and golimumab as TNFis since these drugs are commercialized in Korea.
Interventions
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Tocilizumab
A humanized monoclonal antibody against the interleukin-6 receptor, which is mainly for the treatment of rheumatoid arthritis.
Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)
Tumor Necrosis Factor inhibitors (TNFi) are a group of medicines that suppresses the physiologic response to TNF, a protein involved in early inflammatory events. We will include etanercept, infliximab, adalimumab, and golimumab as TNFis since these drugs are commercialized in Korea.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Having no records of prescription of tocilizumab or TNFi at least once between 2013 and 2018
18 Years
ALL
No
Sponsors
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Ministry of Food and Drug Safety, Korea
OTHER_GOV
Sungkyunkwan University
OTHER
Responsible Party
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Ju-Young Shin
Assistant Professor
Principal Investigators
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Ju-Young Shin, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sungkyunkwan University
Locations
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Sungkyunkwan University
Suwon, Gyeonggi-do, South Korea
Countries
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References
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Jones G, Panova E. New insights and long-term safety of tocilizumab in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2018 Oct 7;10(10):195-199. doi: 10.1177/1759720X18798462. eCollection 2018 Oct.
Ramiro S, Sepriano A, Chatzidionysiou K, Nam JL, Smolen JS, van der Heijde D, Dougados M, van Vollenhoven R, Bijlsma JW, Burmester GR, Scholte-Voshaar M, Falzon L, Landewe RBM. Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis. Ann Rheum Dis. 2017 Jun;76(6):1101-1136. doi: 10.1136/annrheumdis-2016-210708. Epub 2017 Mar 15.
Singh JA. Infections With Biologics in Rheumatoid Arthritis and Related Conditions: a Scoping Review of Serious or Hospitalized Infections in Observational Studies. Curr Rheumatol Rep. 2016 Oct;18(10):61. doi: 10.1007/s11926-016-0609-5.
Singh JA, Hossain A, Tanjong Ghogomu E, Mudano AS, Maxwell LJ, Buchbinder R, Lopez-Olivo MA, Suarez-Almazor ME, Tugwell P, Wells GA. Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2017 Mar 10;3(3):CD012591. doi: 10.1002/14651858.CD012591.
Nishimoto N, Ito K, Takagi N. Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with rheumatoid arthritis: meta-analysis of six initial trials and five long-term extensions. Mod Rheumatol. 2010 Jun;20(3):222-32. doi: 10.1007/s10165-010-0279-5. Epub 2010 Mar 11.
Sakai R, Cho SK, Nanki T, Watanabe K, Yamazaki H, Tanaka M, Koike R, Tanaka Y, Saito K, Hirata S, Amano K, Nagasawa H, Sumida T, Hayashi T, Sugihara T, Dobashi H, Yasuda S, Sawada T, Ezawa K, Ueda A, Fujii T, Migita K, Miyasaka N, Harigai M; REAL Study Group. Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice: results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry. Arthritis Res Ther. 2015 Mar 23;17(1):74. doi: 10.1186/s13075-015-0583-8.
Pawar A, Desai RJ, Solomon DH, Santiago Ortiz AJ, Gale S, Bao M, Sarsour K, Schneeweiss S, Kim SC. Risk of serious infections in tocilizumab versus other biologic drugs in patients with rheumatoid arthritis: a multidatabase cohort study. Ann Rheum Dis. 2019 Apr;78(4):456-464. doi: 10.1136/annrheumdis-2018-214367. Epub 2019 Jan 24.
Gron KL, Arkema EV, Glintborg B, Mehnert F, Ostergaard M, Dreyer L, Norgaard M, Krogh NS, Askling J, Hetland ML; ARTIS Study Group. Risk of serious infections in patients with rheumatoid arthritis treated in routine care with abatacept, rituximab and tocilizumab in Denmark and Sweden. Ann Rheum Dis. 2019 Mar;78(3):320-327. doi: 10.1136/annrheumdis-2018-214326. Epub 2019 Jan 5.
Yun H, Xie F, Delzell E, Levitan EB, Chen L, Lewis JD, Saag KG, Beukelman T, Winthrop KL, Baddley JW, Curtis JR. Comparative Risk of Hospitalized Infection Associated With Biologic Agents in Rheumatoid Arthritis Patients Enrolled in Medicare. Arthritis Rheumatol. 2016 Jan;68(1):56-66. doi: 10.1002/art.39399.
Rutherford AI, Subesinghe S, Hyrich KL, Galloway JB. Serious infection across biologic-treated patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Ann Rheum Dis. 2018 Jun;77(6):905-910. doi: 10.1136/annrheumdis-2017-212825. Epub 2018 Mar 28.
Other Identifiers
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SKKU-2019-TCZ
Identifier Type: -
Identifier Source: org_study_id
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