Efficacy and safety evaluation of a combination of iguratimod and methotrexate therapy for active rheumatoid arthritis patients: a randomized controlled trial

Abstract

This study aimed to investigate the efficacy and safety of iguratimod (T-614) in combination with methotrexate (MTX) for active rheumatoid arthritis (RA) patients. Sixty active RA patients were enrolled according to the 2010 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) classification criteria, and were randomized into MTX + T-614 group and MTX group. T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for 24 weeks. MTX was orally administered to RA patients at a stable weekly dosage of 10 mg/week for the first 4 weeks and subsequent 12.5 mg/week for the later 20 weeks. Clinical features at baseline and efficacy endpoints of the ACR 20 % response (ACR20), ACR50, ACR70, and adverse events at 24 weeks were evaluated, respectively. After 24 weeks of treatment, clinical features at baseline, including counts for tender joints and swelling joints, visual analog scale for pain, patient's and physician's global assessment, erythrocyte sedimentation rate, C-reactive protein, disease activity score 28, health assessment questionnaire, simplified disease activity index, and ACR50 in the MTX + T-614 group, showed statistically significant differences comparing with the MTX group (P < 0.05). There was no significant increase in adverse events in the MTX + T-614 group comparing with the MTX group (P > 0.05). The combination of MTX and T-614 therapy appeared to have a good efficacy and safety for active RA and was superior to MTX-alone therapy after 24 weeks of treatment.

Identification of Iguratimod as an Inhibitor of Macrophage Migration Inhibitory Factor (MIF) with Steroid-sparing Potential

“…Also known as iguratimod, T-614 is currently clinically available in Japan and China as a daily oral formulation administered at 25-50 mg daily, which has shown safety and efficacy in improving symptoms and disease progression in rheumatoid arthritis both as a monotherapy (92)(93)(94) and in combination with methotrexate (95). Several preclinical studies have suggested that the drug may also have utility in other settings, such as multiple sclerosis (62) and cachexia in the context of adenocarcinoma (96).…”

Iguratimod as a New Drug for Rheumatoid Arthritis: Current Landscape

“…Two 24-week clinical studies both showed similar results. The group of IGU combined with MTX had better outcomes than that of MTX alone, such as Patient's clinical manifestations including joint tenderness and swollen joint count, pain visual analogue scale overall assessment of patients and physicians, ESR, CRP, health assessment questionnaire, DAS28, simplified disease activity index, and ACR 50 (P < 0.05) ( Table 2) (Duan et al, 2015;Xia et al, 2016). Interestingly, there was no significant difference in the incidence of adverse events between the IGU+MTX group and the MTX group (P > 0.05).…”

Efficacy and safety of iguratimod combined with methotrexate vs. methotrexate alone in rheumatoid arthritis

“…After subsequent screening, an additional 33 were excluded: 30 randomized controlled trials (RCTs) did not include the ACR20/50/70, 2 RCTs did not report adverse events, and 1 RCT was repeated in more than one bibliographic source. After the selection process, a total of 7 RCTs consisting of 665 participants with 368 participants in the active arm and 297 in the placebo arm were included in the meta-analysis [1,[16][17][18][19][20][21]. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram is included in .…”

“…Three trials [16][17][18] reported that the primary efficacy endpoint was the rate at which patients (the full analysis set)…”