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
Hauptverfasser: 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
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container_end_page 177
container_issue 2
container_start_page 171
container_title Arthritis & rheumatology (Hoboken, N.J.)
container_volume 75
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.
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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 &amp; dosage ; Influenza, Human - chemically induced ; Influenza, Human - drug therapy ; Influenza, Human - prevention &amp; control ; Methotrexate ; Methotrexate - therapeutic use ; Prospective Studies ; Rheumatoid Arthritis ; Seasons ; Vaccination ; Vaccines</subject><ispartof>Arthritis &amp; 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 &amp; 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 &amp; 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. 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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 &amp; dosage</topic><topic>Influenza, Human - chemically induced</topic><topic>Influenza, Human - drug therapy</topic><topic>Influenza, Human - prevention &amp; 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 &amp; 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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. 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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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