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BackgroundMethotrexate (MTX) has been well-known anchor drug for rheumatoid arthritis (RA), however, dose regimen varies and it depends on countries. The divided dosage of MTX was frequently prescribed in Japan, however, the differences of safety and efficacy between divided and single dose regimens were not fully examined.ObjectivesWe conducted a preliminary study for RA patients to compare the safety, efficacy profile and MTX-polyglutamates (PGs) concentration between single- and divided dosage regimens.MethodsSingle-center Random Controlled Trial was designed. Thirty-one patients who had been insufficiently controlled by MTX (8 mg/week) were randomly assigned to 2 groups (single dose regimen/week: 15 patients; three-dose regimen/week: 16 patients). MTX dose of all patients was allowed to increase up to 16 mg/week. Safety and efficacy parameters (adverse events, the elevation of liver function tests (LFTs), WBC counts and DAS28 were monitored at baseline, 4, 8, 12 and 19 weeks. MTX-PGs in red blood cells were also detected by LC-MS/MS at same interval.ResultsThere were no significant differences in the average of age (66.3±9.2yr), disease duration (5.8yr), and baseline DAS28(CPR) (2.84±0.98) between two groups. There were also no differences in the improvement of DAS28(CPR) between two groups (-0.95±1.66 vs -0.75±1.09 respectively) and weekly MTX dose (11.5±1.6mg/week vs 11.4±1.4mg/week). Three adverse events were observed only in 3-dose regimen group (18.8%, increase in LTFs). The remarkable difference was observed in MTX-PGs, 3-dose regimen group showed significantly higher concentration of MTX-PG1+2 than single-dose group. On the other hand, 3-doses regimen group showed slight lower MTX-PG4+5 than single-dose regimen group, and there was no difference in MTX-PG3.ConclusionsThe efficacy did not show significant difference between two groups. Liver function may be affected by concentration of MTX-PG1+2, which elevated in divided dosage regimen group. Further investigation is required in a larger population.AcknowledgementsClinical registration: UMIN000012473Disclosure of InterestA. Ihata: None declared, K. Kobayashi: None declared, A. Osada: None declared, H. Sakuma: None declared, F. Tsuji Employee of: Santen Pharmaceutical. CO.,Ltd., T. Yoshimura Employee of: Santen Pharmaceutical. CO.,Ltd., C. Setoguchi Employee of: Santen Pharmaceutical. CO.,Ltd., M. Okamoto Employee of: Santen Pharmaceutical. CO.,Ltd., S. Nagaoka: None declared

Background Liver magnetic resonance imaging (MRI) is rarely used to evaluate sarcopenia. This study sought to develop new diagnostic criteria for MRI in Asians and investigate the relationship between adipopenia and sarcopenia using MRI proton density fat fraction (PDFF), which is correlated with body fat mass. Methodology This study included 512 patients with chronic liver disease (CLD) who underwent magnetic resonance elastography (MRE). The following parameters were assessed: paraspinal muscle area/height index (PSMI) measured at the level of the superior mesenteric artery and PDFF. The cutoff PSMI and PDFF values for the diagnosis of sarcopenia and adipopenia, respectively, were determined using receiver operating characteristic analysis of Asians with low body mass index. Results Among patients with CLD, the prevalence rates of sarcopenia and adipopenia were 25% and 17%, respectively. We found that sarcopenia increased from stage 3 fibrosis and was inversely correlated with steatosis grade. Multivariate analysis found that MRI-PDFF was associated with sarcopenia. The Kaplan-Meier method in cirrhosis (n = 122) showed that the non-sarcopenia, sarcopenia, and sarcopenia/adipopenia groups had three-year survival rates of 97%, 55% (p < 0.01), and 23%, respectively. The Cox proportional hazards model identified the Child-Pugh score and sarcopenia/adipopenia as independent prognostic factors. Conclusions The new diagnostic criteria for sarcopenia confirmed that the prognosis of cirrhosis can be stratified. Furthermore, sarcopenia with adipopenia was shown to be a phenotype of severe sarcopenia in cirrhosis, and screening for sarcopenia should include cases in the precirrhotic stage.

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