PT  - JOURNAL ARTICLE
AU  - Yoshiya Tanaka
AU  - Koji Oba
AU  - Takao Koike
AU  - Nobuyuki Miyasaka
AU  - Tsuneyo Mimori
AU  - Tsutomu Takeuchi
AU  - Shintaro Hirata
AU  - Eiichi Tanaka
AU  - Hidekata Yasuoka
AU  - Yuko Kaneko
AU  - Kosaku Murakami
AU  - Tomohiro Koga
AU  - Kazuhisa Nakano
AU  - Koichi Amano
AU  - Kazuyasu Ushio
AU  - Tatsuya Atsumi
AU  - Masayuki Inoo
AU  - Kazuhiro Hatta
AU  - Shinichi Mizuki
AU  - Shouhei Nagaoka
AU  - Shinichiro Tsunoda
AU  - Hiroaki Dobashi
AU  - Nao Horie
AU  - Norihiro Sato
TI  - Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: the RRRR study, a randomised controlled trial
AID  - 10.1136/annrheumdis-2019-216169
DP  - 2020 Jan 01
TA  - Annals of the Rheumatic Diseases
PG  - 94--102
VI  - 79
IP  - 1
4099  - http://ard.bmj.com/content/79/1/94.short
4100  - http://ard.bmj.com/content/79/1/94.full
SO  - Ann Rheum Dis2020 Jan 01; 79
AB  - 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.