Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: The RRRR study, a randomised controlled trial

Yoshiya Tanaka, Koji Oba, Takao Koike, Nobuyuki Miyasaka, Tsuneyo Mimori, Tsutomu Takeuchi, Shintaro Hirata, Eiichi Tanaka, Hidekata Yasuoka, Yuko Kaneko, Kosaku Murakami, Tomohiro Koga, Kazuhisa Nakano, Koichi Amano, Kazuyasu Ushio, Tatsuya Atsumi, Masayuki Inoo, Kazuhiro Hatta, Shinichi Mizuki, Shouhei NagaokaShinichiro Tsunoda, Hiroaki Dobashi, Nao Horie, Norihiro Sato

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3 Citations (Scopus)

Abstract

Objectives The aim of this study is to determine whether the 'programmed' infliximab (IFX) treatment strategy (for which the dose of IFX was adjusted based on the baseline serum tumour necrosis factor α (TNF-α)) is beneficial to induction of clinical remission after 54 weeks and sustained discontinuation of IFX for 1 year. Methods In this multicentre randomised trial, patients with IFX-naïve rheumatoid arthritis with inadequate response to methotrexate were randomised to two groups; patients in programmed treatment group received 3 mg/kg IFX until week 6 and after 14 weeks the dose of IFX was adjusted based on the baseline levels of serum TNF-α until week 54; patients in the standard treatment group received 3 mg/kg of IFX. Patients who achieved a simplified disease activity index (SDAI) ≤3.3 at week 54 discontinued IFX. The primary endpoint was the proportion of patients who sustained discontinuation of IFX at week 106. Results A total of 337 patients were randomised. At week 54, 39.4% (67/170) in the programmed group and 32.3% (54/167) in the standard group attained remission (SDAI ≤3.3). At week 106, the 1-year sustained discontinuation rate was not significantly different between two groups; the programmed group 23.5% (40/170) and the standard group 21.6% (36/167), respectively (2.2% difference, 95% CI-6.6% to 11.0%; p=0.631). Baseline SDAI <26.0 was a statistically significant predictor of the successfully sustained discontinuation of IFX at week 106. Conclusion Programmed treatment strategy did not statistically increase the sustained remission rate after 1 year discontinuation of IFX treatment.

Original languageEnglish
Pages (from-to)94-102
Number of pages9
JournalAnnals of the rheumatic diseases
Volume79
Issue number1
DOIs
Publication statusPublished - 2020 Jan 1

Keywords

  • TNF-α
  • infliximab
  • randomized controlled trials
  • remission
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

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    Tanaka, Y., Oba, K., Koike, T., Miyasaka, N., Mimori, T., Takeuchi, T., Hirata, S., Tanaka, E., Yasuoka, H., Kaneko, Y., Murakami, K., Koga, T., Nakano, K., Amano, K., Ushio, K., Atsumi, T., Inoo, M., Hatta, K., Mizuki, S., ... Sato, N. (2020). Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: The RRRR study, a randomised controlled trial. Annals of the rheumatic diseases, 79(1), 94-102. https://doi.org/10.1136/annrheumdis-2019-216169