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Editor, Senior Moderator
Ann Rheum Dis. 2018 Mar 23. pii: annrheumdis-2018-213222. doi: 10.1136/annrheumdis-2018-213222. [Epub ahead of print]
[h=1]Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial.[/h] Park JK[SUP]1[/SUP], Lee YJ[SUP]2[/SUP], Shin K[SUP]3[/SUP], Ha YJ[SUP]2[/SUP], Lee EY[SUP]1[/SUP], Song YW[SUP]1[/SUP], Choi Y[SUP]4[/SUP], Winthrop KL[SUP]5[/SUP], Lee EB[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] To determine whether a 2-week methotrexate (MTX) discontinuation after vaccination improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA).
[h=4]METHODS:[/h] In this prospective randomised parallel-group multicentre study, patients with RA on stable dose of MTX were randomly assigned at a ratio of 1:1 to continue MTX or to hold MTX for 2 weeks after 2016-2017 quadrivalent seasonal influenza vaccine containing H1N1, H3N2, B-Yamagata and B-Victoria. The primary outcome was frequency of satisfactory vaccine response, defined as greater than or equal to fourfold increase of haemagglutination inhibition (HI) antibody titre at 4 weeks after vaccination against ≥2 of four vaccine strains. Secondary endpoints included seroprotection (ie, HI titre ≥1:40) rate, fold change in antibody titres.
[h=4]RESULTS:[/h] The modified intention-to-treat population included 156 patients in the MTX-continue group and 160 patients in the MTX-hold group. More patients in MTX-hold group achieved satisfactory vaccine response than the MTX-continue group (75.5% vs 54.5%, p<0.001). Seroprotection rate was higher in the MTX-hold group than the MTX-continue group for all four antigens (H1N1: difference 10.7%, 95% CI 2.0% to 19.3%; H3N2: difference 15.9%, 95% CI 5.9% to 26.0%; B-Yamagata: difference13.7%, 95% CI 5.2% to 22.4%; B-Victoria: difference 14.7%, 95% CI 4.5% to 25.0%). The MTX-hold group showed higher fold increase in their antibody titres against all four influenza antigens (all p<0.05). Change in disease activity was similar between groups.
[h=4]CONCLUSIONS:[/h] A temporary MTX discontinuation for 2 weeks after vaccination improves the immunogenicity of seasonal influenza vaccination in patients with RA without increasing RA disease activity.
[h=4]TRIAL REGISTRATION:[/h] NCT02897011.
? Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
[h=4]KEYWORDS:[/h] discontinuation; influenza; methotrexate; rheumatoid arthritis; vaccination
PMID: 29572291 DOI: 10.1136/annrheumdis-2018-213222
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[h=1]Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial.[/h] Park JK[SUP]1[/SUP], Lee YJ[SUP]2[/SUP], Shin K[SUP]3[/SUP], Ha YJ[SUP]2[/SUP], Lee EY[SUP]1[/SUP], Song YW[SUP]1[/SUP], Choi Y[SUP]4[/SUP], Winthrop KL[SUP]5[/SUP], Lee EB[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] To determine whether a 2-week methotrexate (MTX) discontinuation after vaccination improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA).
[h=4]METHODS:[/h] In this prospective randomised parallel-group multicentre study, patients with RA on stable dose of MTX were randomly assigned at a ratio of 1:1 to continue MTX or to hold MTX for 2 weeks after 2016-2017 quadrivalent seasonal influenza vaccine containing H1N1, H3N2, B-Yamagata and B-Victoria. The primary outcome was frequency of satisfactory vaccine response, defined as greater than or equal to fourfold increase of haemagglutination inhibition (HI) antibody titre at 4 weeks after vaccination against ≥2 of four vaccine strains. Secondary endpoints included seroprotection (ie, HI titre ≥1:40) rate, fold change in antibody titres.
[h=4]RESULTS:[/h] The modified intention-to-treat population included 156 patients in the MTX-continue group and 160 patients in the MTX-hold group. More patients in MTX-hold group achieved satisfactory vaccine response than the MTX-continue group (75.5% vs 54.5%, p<0.001). Seroprotection rate was higher in the MTX-hold group than the MTX-continue group for all four antigens (H1N1: difference 10.7%, 95% CI 2.0% to 19.3%; H3N2: difference 15.9%, 95% CI 5.9% to 26.0%; B-Yamagata: difference13.7%, 95% CI 5.2% to 22.4%; B-Victoria: difference 14.7%, 95% CI 4.5% to 25.0%). The MTX-hold group showed higher fold increase in their antibody titres against all four influenza antigens (all p<0.05). Change in disease activity was similar between groups.
[h=4]CONCLUSIONS:[/h] A temporary MTX discontinuation for 2 weeks after vaccination improves the immunogenicity of seasonal influenza vaccination in patients with RA without increasing RA disease activity.
[h=4]TRIAL REGISTRATION:[/h] NCT02897011.
? Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
[h=4]KEYWORDS:[/h] discontinuation; influenza; methotrexate; rheumatoid arthritis; vaccination
PMID: 29572291 DOI: 10.1136/annrheumdis-2018-213222
Free full text