A Multicenter, Prospective, Randomized, Parallel‐Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis
Objective This clinical trial was conducted to investigate whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is noninferior to discontinuing for 2 weeks after vaccination in patients with rheumatoid arthritis (RA). Methods In this multicenter, prospective, rand...
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Veröffentlicht in: | Arthritis & rheumatology (Hoboken, N.J.) N.J.), 2023-02, Vol.75 (2), p.171-177 |
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creator | Park, Jin Kyun Lee, Yun Jong Shin, Kichul Kang, Eun Ha Ha, You‐Jung Park, Jun Won Kim, Min Jung Kim, Mi Hyeon Choi, Se Rim Jung, Youjin Lee, Ju Ho In Jung, Ji Kim, Ju Yeon Winthrop, Kevin L. Lee, Eun Bong |
description | Objective
This clinical trial was conducted to investigate whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is noninferior to discontinuing for 2 weeks after vaccination in patients with rheumatoid arthritis (RA).
Methods
In this multicenter, prospective, randomized, parallel‐group noninferiority trial, RA patients receiving a stable dose of MTX were randomly assigned at a ratio of 1:1 to discontinue MTX for 1 week or for 2 weeks after they received the quadrivalent 2021–2022 seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains. The primary outcome measure was the proportion of patients with a satisfactory vaccine response, which was defined as ≥4‐fold increase in antibody titers, as determined with the hemagglutination inhibition assay, against ≥2 of the 4 vaccine strains at 4 weeks after vaccination.
Results
The modified intent‐to‐treat population included 90 patients in the 1‐week MTX hold group and 88 patients in the 2‐week MTX hold group. The mean ± SD MTX doses were 12.6 ± 3.4 mg/week in the 1‐week MTX hold group and 12.9 ± 3.3 mg/week in the 2‐week MTX hold group. The proportion of satisfactory vaccine responses did not differ between the groups (68.9% versus 75.0%; P = 0.364). The rate of seroprotection and the fold increase in antibody titers for each of the 4 influenza antigens were similar between the groups.
Conclusion
A temporary discontinuation of MTX for 1 week after vaccination was noninferior to a discontinuation of MTX for 2 weeks after vaccination, regarding induction of a satisfactory vaccine response to a seasonal influenza vaccine in patients with RA receiving a stable dose of MTX. |
doi_str_mv | 10.1002/art.42318 |
format | Article |
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This clinical trial was conducted to investigate whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is noninferior to discontinuing for 2 weeks after vaccination in patients with rheumatoid arthritis (RA).
Methods
In this multicenter, prospective, randomized, parallel‐group noninferiority trial, RA patients receiving a stable dose of MTX were randomly assigned at a ratio of 1:1 to discontinue MTX for 1 week or for 2 weeks after they received the quadrivalent 2021–2022 seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains. The primary outcome measure was the proportion of patients with a satisfactory vaccine response, which was defined as ≥4‐fold increase in antibody titers, as determined with the hemagglutination inhibition assay, against ≥2 of the 4 vaccine strains at 4 weeks after vaccination.
Results
The modified intent‐to‐treat population included 90 patients in the 1‐week MTX hold group and 88 patients in the 2‐week MTX hold group. The mean ± SD MTX doses were 12.6 ± 3.4 mg/week in the 1‐week MTX hold group and 12.9 ± 3.3 mg/week in the 2‐week MTX hold group. The proportion of satisfactory vaccine responses did not differ between the groups (68.9% versus 75.0%; P = 0.364). The rate of seroprotection and the fold increase in antibody titers for each of the 4 influenza antigens were similar between the groups.
Conclusion
A temporary discontinuation of MTX for 1 week after vaccination was noninferior to a discontinuation of MTX for 2 weeks after vaccination, regarding induction of a satisfactory vaccine response to a seasonal influenza vaccine in patients with RA receiving a stable dose of MTX.</description><identifier>ISSN: 2326-5191</identifier><identifier>EISSN: 2326-5205</identifier><identifier>DOI: 10.1002/art.42318</identifier><identifier>PMID: 35930728</identifier><language>eng</language><publisher>Boston, USA: Wiley Periodicals, Inc</publisher><subject>Antibodies ; Antigens ; Antirheumatic Agents - therapeutic use ; Arthritis ; Arthritis, Rheumatoid ; Brief Report ; Hemagglutination inhibition ; Humans ; Immunization ; Influenza ; Influenza A Virus, H1N1 Subtype ; Influenza A Virus, H3N2 Subtype ; Influenza Vaccines - administration & dosage ; Influenza, Human - chemically induced ; Influenza, Human - drug therapy ; Influenza, Human - prevention & control ; Methotrexate ; Methotrexate - therapeutic use ; Prospective Studies ; Rheumatoid Arthritis ; Seasons ; Vaccination ; Vaccines</subject><ispartof>Arthritis & rheumatology (Hoboken, N.J.), 2023-02, Vol.75 (2), p.171-177</ispartof><rights>2022 The Authors. published by Wiley Periodicals LLC on behalf of American College of Rheumatology.</rights><rights>2022 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.</rights><rights>2022. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4448-a83319902cf2cb52386b842bc855ba5f1ff068db20918db3d8ef34eb0b3be30f3</citedby><cites>FETCH-LOGICAL-c4448-a83319902cf2cb52386b842bc855ba5f1ff068db20918db3d8ef34eb0b3be30f3</cites><orcidid>0000-0001-8982-6869 ; 0000-0001-6107-9523 ; 0000-0002-8624-2582 ; 0000-0003-2167-9393 ; 0000-0003-0703-1208 ; 0000-0001-7615-8611 ; 0000-0002-3892-6947</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fart.42318$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fart.42318$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35930728$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Park, Jin Kyun</creatorcontrib><creatorcontrib>Lee, Yun Jong</creatorcontrib><creatorcontrib>Shin, Kichul</creatorcontrib><creatorcontrib>Kang, Eun Ha</creatorcontrib><creatorcontrib>Ha, You‐Jung</creatorcontrib><creatorcontrib>Park, Jun Won</creatorcontrib><creatorcontrib>Kim, Min Jung</creatorcontrib><creatorcontrib>Kim, Mi Hyeon</creatorcontrib><creatorcontrib>Choi, Se Rim</creatorcontrib><creatorcontrib>Jung, Youjin</creatorcontrib><creatorcontrib>Lee, Ju Ho</creatorcontrib><creatorcontrib>In Jung, Ji</creatorcontrib><creatorcontrib>Kim, Ju Yeon</creatorcontrib><creatorcontrib>Winthrop, Kevin L.</creatorcontrib><creatorcontrib>Lee, Eun Bong</creatorcontrib><title>A Multicenter, Prospective, Randomized, Parallel‐Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis</title><title>Arthritis & rheumatology (Hoboken, N.J.)</title><addtitle>Arthritis Rheumatol</addtitle><description>Objective
This clinical trial was conducted to investigate whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is noninferior to discontinuing for 2 weeks after vaccination in patients with rheumatoid arthritis (RA).
Methods
In this multicenter, prospective, randomized, parallel‐group noninferiority trial, RA patients receiving a stable dose of MTX were randomly assigned at a ratio of 1:1 to discontinue MTX for 1 week or for 2 weeks after they received the quadrivalent 2021–2022 seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains. The primary outcome measure was the proportion of patients with a satisfactory vaccine response, which was defined as ≥4‐fold increase in antibody titers, as determined with the hemagglutination inhibition assay, against ≥2 of the 4 vaccine strains at 4 weeks after vaccination.
Results
The modified intent‐to‐treat population included 90 patients in the 1‐week MTX hold group and 88 patients in the 2‐week MTX hold group. The mean ± SD MTX doses were 12.6 ± 3.4 mg/week in the 1‐week MTX hold group and 12.9 ± 3.3 mg/week in the 2‐week MTX hold group. The proportion of satisfactory vaccine responses did not differ between the groups (68.9% versus 75.0%; P = 0.364). The rate of seroprotection and the fold increase in antibody titers for each of the 4 influenza antigens were similar between the groups.
Conclusion
A temporary discontinuation of MTX for 1 week after vaccination was noninferior to a discontinuation of MTX for 2 weeks after vaccination, regarding induction of a satisfactory vaccine response to a seasonal influenza vaccine in patients with RA receiving a stable dose of MTX.</description><subject>Antibodies</subject><subject>Antigens</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis</subject><subject>Arthritis, Rheumatoid</subject><subject>Brief Report</subject><subject>Hemagglutination inhibition</subject><subject>Humans</subject><subject>Immunization</subject><subject>Influenza</subject><subject>Influenza A Virus, H1N1 Subtype</subject><subject>Influenza A Virus, H3N2 Subtype</subject><subject>Influenza Vaccines - administration & dosage</subject><subject>Influenza, Human - chemically induced</subject><subject>Influenza, Human - drug therapy</subject><subject>Influenza, Human - prevention & control</subject><subject>Methotrexate</subject><subject>Methotrexate - therapeutic use</subject><subject>Prospective Studies</subject><subject>Rheumatoid Arthritis</subject><subject>Seasons</subject><subject>Vaccination</subject><subject>Vaccines</subject><issn>2326-5191</issn><issn>2326-5205</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1Uk1PFTEUnRiNEGThHzBN3GjCg37M58q8ICIJBPN8wrLpzNw6xZl2bDsgrPwJ_kE3_hLv4wFRE7u5be65pyfnniR5zuguo5TvKR93Uy5Y-SjZ5ILns4zT7PH9nVVsI9kO4YLiqQqa0-xpsiGyStCCl5vJzzk5mfpoGrAR_A754F0YoYnmEnbIQtnWDeYGWmwor_oe-l_ffxx6N41k6Y3qibMkdkAOtMahQJwmSxhG55W_JicQOxc9fFMRyFsTGmejsZOKBqe08-TUAjkH-ELOwIcpkOWVu32HFe1HUMFZ_OLI6n4Ce6PImWoaY9fzxqKkaFB2IOcmdmTRwTSo6ExL5j523kQTniVPtOoDbN_VreTTu4Pl_vvZ8enh0f78eNakaVrOVCkEqyrKG82bOuOizOsy5XVTZlmtMs20pnnZ1pxWDItoS9AihZrWogZBtdhK3qx5x6keoF2ZiW7J0ZsBjZBOGfl3x5pOfnaXklGGe0gzZHh1x-Dd1wlClAMaBn2vLLgpSJ5XuL2syAVCX_4DvXCTR6cQVRS0YILyFeHrNarBjQYP-kENo3IVHInBkbfBQeyLP-U_IO9jgoC9NeDK9HD9fyY5XyzXlL8BgfzTNQ</recordid><startdate>202302</startdate><enddate>202302</enddate><creator>Park, Jin Kyun</creator><creator>Lee, Yun Jong</creator><creator>Shin, Kichul</creator><creator>Kang, Eun Ha</creator><creator>Ha, You‐Jung</creator><creator>Park, Jun Won</creator><creator>Kim, Min Jung</creator><creator>Kim, Mi Hyeon</creator><creator>Choi, Se Rim</creator><creator>Jung, Youjin</creator><creator>Lee, Ju Ho</creator><creator>In Jung, Ji</creator><creator>Kim, Ju Yeon</creator><creator>Winthrop, Kevin L.</creator><creator>Lee, Eun Bong</creator><general>Wiley Periodicals, Inc</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-8982-6869</orcidid><orcidid>https://orcid.org/0000-0001-6107-9523</orcidid><orcidid>https://orcid.org/0000-0002-8624-2582</orcidid><orcidid>https://orcid.org/0000-0003-2167-9393</orcidid><orcidid>https://orcid.org/0000-0003-0703-1208</orcidid><orcidid>https://orcid.org/0000-0001-7615-8611</orcidid><orcidid>https://orcid.org/0000-0002-3892-6947</orcidid></search><sort><creationdate>202302</creationdate><title>A Multicenter, Prospective, Randomized, Parallel‐Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis</title><author>Park, Jin Kyun ; Lee, Yun Jong ; Shin, Kichul ; Kang, Eun Ha ; Ha, You‐Jung ; Park, Jun Won ; Kim, Min Jung ; Kim, Mi Hyeon ; Choi, Se Rim ; Jung, Youjin ; Lee, Ju Ho ; In Jung, Ji ; Kim, Ju Yeon ; Winthrop, Kevin L. ; Lee, Eun Bong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4448-a83319902cf2cb52386b842bc855ba5f1ff068db20918db3d8ef34eb0b3be30f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antibodies</topic><topic>Antigens</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis</topic><topic>Arthritis, Rheumatoid</topic><topic>Brief Report</topic><topic>Hemagglutination inhibition</topic><topic>Humans</topic><topic>Immunization</topic><topic>Influenza</topic><topic>Influenza A Virus, H1N1 Subtype</topic><topic>Influenza A Virus, H3N2 Subtype</topic><topic>Influenza Vaccines - administration & dosage</topic><topic>Influenza, Human - chemically induced</topic><topic>Influenza, Human - drug therapy</topic><topic>Influenza, Human - prevention & control</topic><topic>Methotrexate</topic><topic>Methotrexate - therapeutic use</topic><topic>Prospective Studies</topic><topic>Rheumatoid Arthritis</topic><topic>Seasons</topic><topic>Vaccination</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Park, Jin Kyun</creatorcontrib><creatorcontrib>Lee, Yun Jong</creatorcontrib><creatorcontrib>Shin, Kichul</creatorcontrib><creatorcontrib>Kang, Eun Ha</creatorcontrib><creatorcontrib>Ha, You‐Jung</creatorcontrib><creatorcontrib>Park, Jun Won</creatorcontrib><creatorcontrib>Kim, Min Jung</creatorcontrib><creatorcontrib>Kim, Mi Hyeon</creatorcontrib><creatorcontrib>Choi, Se Rim</creatorcontrib><creatorcontrib>Jung, Youjin</creatorcontrib><creatorcontrib>Lee, Ju Ho</creatorcontrib><creatorcontrib>In Jung, Ji</creatorcontrib><creatorcontrib>Kim, Ju Yeon</creatorcontrib><creatorcontrib>Winthrop, Kevin L.</creatorcontrib><creatorcontrib>Lee, Eun Bong</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Wiley Online Library Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Park, Jin Kyun</au><au>Lee, Yun Jong</au><au>Shin, Kichul</au><au>Kang, Eun Ha</au><au>Ha, You‐Jung</au><au>Park, Jun Won</au><au>Kim, Min Jung</au><au>Kim, Mi Hyeon</au><au>Choi, Se Rim</au><au>Jung, Youjin</au><au>Lee, Ju Ho</au><au>In Jung, Ji</au><au>Kim, Ju Yeon</au><au>Winthrop, Kevin L.</au><au>Lee, Eun Bong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Multicenter, Prospective, Randomized, Parallel‐Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis</atitle><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle><addtitle>Arthritis Rheumatol</addtitle><date>2023-02</date><risdate>2023</risdate><volume>75</volume><issue>2</issue><spage>171</spage><epage>177</epage><pages>171-177</pages><issn>2326-5191</issn><eissn>2326-5205</eissn><abstract>Objective
This clinical trial was conducted to investigate whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is noninferior to discontinuing for 2 weeks after vaccination in patients with rheumatoid arthritis (RA).
Methods
In this multicenter, prospective, randomized, parallel‐group noninferiority trial, RA patients receiving a stable dose of MTX were randomly assigned at a ratio of 1:1 to discontinue MTX for 1 week or for 2 weeks after they received the quadrivalent 2021–2022 seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains. The primary outcome measure was the proportion of patients with a satisfactory vaccine response, which was defined as ≥4‐fold increase in antibody titers, as determined with the hemagglutination inhibition assay, against ≥2 of the 4 vaccine strains at 4 weeks after vaccination.
Results
The modified intent‐to‐treat population included 90 patients in the 1‐week MTX hold group and 88 patients in the 2‐week MTX hold group. The mean ± SD MTX doses were 12.6 ± 3.4 mg/week in the 1‐week MTX hold group and 12.9 ± 3.3 mg/week in the 2‐week MTX hold group. The proportion of satisfactory vaccine responses did not differ between the groups (68.9% versus 75.0%; P = 0.364). The rate of seroprotection and the fold increase in antibody titers for each of the 4 influenza antigens were similar between the groups.
Conclusion
A temporary discontinuation of MTX for 1 week after vaccination was noninferior to a discontinuation of MTX for 2 weeks after vaccination, regarding induction of a satisfactory vaccine response to a seasonal influenza vaccine in patients with RA receiving a stable dose of MTX.</abstract><cop>Boston, USA</cop><pub>Wiley Periodicals, Inc</pub><pmid>35930728</pmid><doi>10.1002/art.42318</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-8982-6869</orcidid><orcidid>https://orcid.org/0000-0001-6107-9523</orcidid><orcidid>https://orcid.org/0000-0002-8624-2582</orcidid><orcidid>https://orcid.org/0000-0003-2167-9393</orcidid><orcidid>https://orcid.org/0000-0003-0703-1208</orcidid><orcidid>https://orcid.org/0000-0001-7615-8611</orcidid><orcidid>https://orcid.org/0000-0002-3892-6947</orcidid><oa>free_for_read</oa></addata></record> |
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source | Wiley Online Library - AutoHoldings Journals; MEDLINE; Alma/SFX Local Collection |
subjects | Antibodies Antigens Antirheumatic Agents - therapeutic use Arthritis Arthritis, Rheumatoid Brief Report Hemagglutination inhibition Humans Immunization Influenza Influenza A Virus, H1N1 Subtype Influenza A Virus, H3N2 Subtype Influenza Vaccines - administration & dosage Influenza, Human - chemically induced Influenza, Human - drug therapy Influenza, Human - prevention & control Methotrexate Methotrexate - therapeutic use Prospective Studies Rheumatoid Arthritis Seasons Vaccination Vaccines |
title | A Multicenter, Prospective, Randomized, Parallel‐Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis |
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