Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial
Objectives Many patients with rheumatoid arthritis (RA) require treatment with tumour necrosis factor inhibitor (TNFi) to reach remission. It is debated whether tapering of TNFi to discontinuation should be considered in sustained remission. The aim of ARCTIC REWIND TNFi was to assess the effect of...
Published in: | Annals of the Rheumatic Diseases |
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Online Access: | http://hdl.handle.net/10852/107780 https://doi.org/10.1136/ard-2023-224476 |
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ftoslouniv:oai:www.duo.uio.no:10852/107780 2024-09-09T19:28:06+00:00 Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial ENEngelskEnglishEffect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial Lillegraven, Siri Paulshus Sundlisæter, Nina Aga, Anna-Birgitte Sexton, Joseph Olsen, Inge Christoffer Lexberg, Åse Madland, Tor Magne Fremstad, Hallvard Høili, Christian Bakland, Gunnstein Spada, Cristina Haukeland, Hilde Hansen, Inger Myrnes Moholt, Ellen Uhlig, Till Solomon, Daniel H Heijde, Desirée van der Kvien, Tore Kristian Aaserud Haavardsholm, Espen A. 2023-10-25T09:34:04Z http://hdl.handle.net/10852/107780 https://doi.org/10.1136/ard-2023-224476 EN eng HighWire Press NFR/328657 HSØ/2013103, 2019003, 2022028 NFR/229031 Lillegraven, Siri Paulshus Sundlisæter, Nina Aga, Anna-Birgitte Sexton, Joseph Olsen, Inge Christoffer Lexberg, Åse Madland, Tor Magne Fremstad, Hallvard Høili, Christian Bakland, Gunnstein Spada, Cristina Haukeland, Hilde Hansen, Inger Myrnes Moholt, Ellen Uhlig, Till Solomon, Daniel H Heijde, Desirée van der Kvien, Tore Kristian Aaserud Haavardsholm, Espen A. . Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial. Annals of the Rheumatic Diseases. 2023 http://hdl.handle.net/10852/107780 2188185 info:ofi/fmt:kev:mtx:ctx&ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Annals of the Rheumatic Diseases&rft.volume=&rft.spage=&rft.date=2023 Annals of the Rheumatic Diseases 82 11 1394 1403 0 https://doi.org/10.1136/ard-2023-224476 Attribution-NonCommercial 4.0 International https://creativecommons.org/licenses/by-nc/4.0/ 0003-4967 Journal article Tidsskriftartikkel Peer reviewed PublishedVersion 2023 ftoslouniv https://doi.org/10.1136/ard-2023-224476 2024-08-05T14:09:29Z Objectives Many patients with rheumatoid arthritis (RA) require treatment with tumour necrosis factor inhibitor (TNFi) to reach remission. It is debated whether tapering of TNFi to discontinuation should be considered in sustained remission. The aim of ARCTIC REWIND TNFi was to assess the effect of tapering TNFi to withdrawal compared with stable treatment on the risk of disease activity flares in patients with RA in remission ≥1 year. Methods This randomised, open-label, non-inferiority trial was undertaken at nine Norwegian rheumatology departments. Patients with RA in remission ≥12 months on stable TNFi therapy were allocated by computer-based block-randomisation to tapering to discontinuation of TNFi or stable TNFi. Conventional synthetic disease-modifying antirheumatic co-medication was unchanged. The primary endpoint was disease flare during the 12-month study period (non-inferiority margin 20%), assessed in the per-protocol population. Results Between June 2013 and January 2019, 99 patients were enrolled and 92 received the allocated treatment strategy. Eighty-four patients were included in the per-protocol population. In the tapering TNFi group, 27/43 (63%) experienced a flare during 12 months, compared with 2/41 (5%) in the stable TNFi group; risk difference (95% CI) 58% (42% to 74%). The tapering strategy was not non-inferior to continued stable treatment. The number of total/serious adverse events was 49/3 in the tapering group, 57/2 in the stable group. Conclusion In patients with RA in remission for more than 1 year while using TNFi, an increase in flare rate was reported in those who tapered TNFi to discontinuation. However, most regained remission after reinstatement of full-dose treatment. Article in Journal/Newspaper Arctic Universitet i Oslo: Digitale utgivelser ved UiO (DUO) Arctic Annals of the Rheumatic Diseases 82 11 1394 1403 |
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Universitet i Oslo: Digitale utgivelser ved UiO (DUO) |
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ftoslouniv |
language |
English |
description |
Objectives Many patients with rheumatoid arthritis (RA) require treatment with tumour necrosis factor inhibitor (TNFi) to reach remission. It is debated whether tapering of TNFi to discontinuation should be considered in sustained remission. The aim of ARCTIC REWIND TNFi was to assess the effect of tapering TNFi to withdrawal compared with stable treatment on the risk of disease activity flares in patients with RA in remission ≥1 year. Methods This randomised, open-label, non-inferiority trial was undertaken at nine Norwegian rheumatology departments. Patients with RA in remission ≥12 months on stable TNFi therapy were allocated by computer-based block-randomisation to tapering to discontinuation of TNFi or stable TNFi. Conventional synthetic disease-modifying antirheumatic co-medication was unchanged. The primary endpoint was disease flare during the 12-month study period (non-inferiority margin 20%), assessed in the per-protocol population. Results Between June 2013 and January 2019, 99 patients were enrolled and 92 received the allocated treatment strategy. Eighty-four patients were included in the per-protocol population. In the tapering TNFi group, 27/43 (63%) experienced a flare during 12 months, compared with 2/41 (5%) in the stable TNFi group; risk difference (95% CI) 58% (42% to 74%). The tapering strategy was not non-inferior to continued stable treatment. The number of total/serious adverse events was 49/3 in the tapering group, 57/2 in the stable group. Conclusion In patients with RA in remission for more than 1 year while using TNFi, an increase in flare rate was reported in those who tapered TNFi to discontinuation. However, most regained remission after reinstatement of full-dose treatment. |
format |
Article in Journal/Newspaper |
author |
Lillegraven, Siri Paulshus Sundlisæter, Nina Aga, Anna-Birgitte Sexton, Joseph Olsen, Inge Christoffer Lexberg, Åse Madland, Tor Magne Fremstad, Hallvard Høili, Christian Bakland, Gunnstein Spada, Cristina Haukeland, Hilde Hansen, Inger Myrnes Moholt, Ellen Uhlig, Till Solomon, Daniel H Heijde, Desirée van der Kvien, Tore Kristian Aaserud Haavardsholm, Espen A. |
spellingShingle |
Lillegraven, Siri Paulshus Sundlisæter, Nina Aga, Anna-Birgitte Sexton, Joseph Olsen, Inge Christoffer Lexberg, Åse Madland, Tor Magne Fremstad, Hallvard Høili, Christian Bakland, Gunnstein Spada, Cristina Haukeland, Hilde Hansen, Inger Myrnes Moholt, Ellen Uhlig, Till Solomon, Daniel H Heijde, Desirée van der Kvien, Tore Kristian Aaserud Haavardsholm, Espen A. Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial |
author_facet |
Lillegraven, Siri Paulshus Sundlisæter, Nina Aga, Anna-Birgitte Sexton, Joseph Olsen, Inge Christoffer Lexberg, Åse Madland, Tor Magne Fremstad, Hallvard Høili, Christian Bakland, Gunnstein Spada, Cristina Haukeland, Hilde Hansen, Inger Myrnes Moholt, Ellen Uhlig, Till Solomon, Daniel H Heijde, Desirée van der Kvien, Tore Kristian Aaserud Haavardsholm, Espen A. |
author_sort |
Lillegraven, Siri |
title |
Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial |
title_short |
Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial |
title_full |
Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial |
title_fullStr |
Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial |
title_full_unstemmed |
Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial |
title_sort |
effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial |
publisher |
HighWire Press |
publishDate |
2023 |
url |
http://hdl.handle.net/10852/107780 https://doi.org/10.1136/ard-2023-224476 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
0003-4967 |
op_relation |
NFR/328657 HSØ/2013103, 2019003, 2022028 NFR/229031 Lillegraven, Siri Paulshus Sundlisæter, Nina Aga, Anna-Birgitte Sexton, Joseph Olsen, Inge Christoffer Lexberg, Åse Madland, Tor Magne Fremstad, Hallvard Høili, Christian Bakland, Gunnstein Spada, Cristina Haukeland, Hilde Hansen, Inger Myrnes Moholt, Ellen Uhlig, Till Solomon, Daniel H Heijde, Desirée van der Kvien, Tore Kristian Aaserud Haavardsholm, Espen A. . Effect of tapered versus stable treatment with tumour necrosis factor inhibitors on disease flares in patients with rheumatoid arthritis in remission: a randomised, open label, non-inferiority trial. Annals of the Rheumatic Diseases. 2023 http://hdl.handle.net/10852/107780 2188185 info:ofi/fmt:kev:mtx:ctx&ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Annals of the Rheumatic Diseases&rft.volume=&rft.spage=&rft.date=2023 Annals of the Rheumatic Diseases 82 11 1394 1403 0 https://doi.org/10.1136/ard-2023-224476 |
op_rights |
Attribution-NonCommercial 4.0 International https://creativecommons.org/licenses/by-nc/4.0/ |
op_doi |
https://doi.org/10.1136/ard-2023-224476 |
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