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The purpose of this study is to determine whether the 'procedural' inflixicex (IFX) treatment strategy (for which adjusting the dose of IFX based on baseline serum tumor necrosis factor alpha (TNF-alpha) is beneficial to induction of clinical remission after 54 weeks and continued deactivation of IFX1 for 1 year.
in this multicenter randomized trial, included in patients with IFX ineffective rheumatoid arthritis who did not respond to methotrexate, randomly divided into two groups, patients in the procedure treatment group received 3 mg/kg IFX treatment to 6 weeks, after 14 weeks adjusted IFX dose to 54 weeks according to serum TNF-alpha baseline levels;
patients who reached the Simplified Disease Activity Index (SDAI) at 54 weeks and 3.3 stopped using IFX. the primary endpoint of
is the proportion of patients who continue to disable IFX at 106 weeks.
results, the study included 337 patients.
in week 54, the program group 39.4% (67/170) and the standard group 32.3% (54/167) reached mitigation (SDAI 3.3).
106 weeks, there was no significant difference between the two groups of one-year continuous drug suspension rates, with 23.5% (40/170) in the programme group and 21.6% (36/167) in the standard group (difference of 2.2%, 95% CI-6.6% to 11.0% ;p .631).
Baseline SDAI slt;26.0 is a statistical indicator of IFX's successful continuous deactivation in week 106.
the above, the results show that after one year of discontinuation of IFX treatment, the programmed treatment strategy did not significantly increase the rate of continuous remission.
.