Background:Japanese double-blind clinical practice studies of Iguratimod (IGU) for active rheumatoid arthritis (RA) patients indicated an early and sustained efficacy as a new conventional synthetic disease-modyfing anti-rheumatic drugs (csDMARDs) [1] as well as the safety of the treatment[2]. IGU also inhibit activation of NFkB and production of RANKL, indicating strong inhibiting activity against bone destruction. However, studies focused on the inhibitory effects of joint destruction by IGU has been poorly documented in clinical practice (3).Objectives:To evaluate inhibitory effect during 1 year by additional IGU therapy in 116 RA patients despite csDMARDs therapy.Methods:Inhibitory effects of joint damage were evaluated by modified total Sharp scoring (mTSS) at baseline and 1 year after IGU prescription. RA activity was measured by DAS28-ESR.Results:The subjects were 116 cases, 30 male, age 63.2 yrs, disease duration 93.7 months. MTX was used weekly (84 cases, 72.4%), and cs DMARDs were used as BUC 43 cases, SASP 13 cases, TAC 5 cases, and LEF 1 cases. bDMARDs were used even in 8 cases, and steroids were used in 3.9 mg (70 cases, 60.3 %). Complications were observed in 70 cases (60.3%). DAS28-ESR were significantly improved from 4.29 (baseline) to 3.65 (6 months), 3.68 (12 months), respectively (P<0.0001). As shown in Figure 1, joint destruction measured by mTSS was significantly suppressed from 7.74 to 0.57 at 1 year (P<0.0001). 70.6% of patients satisfied structural remission (ΔmTSS≤0.5). Clinically relevant radiographic progression (CRRP)(mTSS>3) was observed in 10 cases (8.6%), and rapid radiographic progression(RRP) (mTSS≥5) was observed in 2 cases (1.6%). Adverse events were observed in 26 cases (22.4 %).To investigate prognostic factor for CRRP, clinical data in baseline, 6, 12 months between ten patients with CRRP and 82 patients with structural remission were compared. As shown in Table 1, longer disease duration, more SJC (P<0.05), High CRP level(P<0.005) were prognostic for CRRP in IGU treated patients.Conclusion:Iguratimod suppressed not only clinical activities but also joint destruction in RA patients resistant to csDMARDs therapy.Table 1. Prognostic factor for CRRPReferences:[1]Ishiguro N, Yamamoto K, Katayama K et al. Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate a randomized, double-blind, placebo-controlled trial. Mod Rheumatol. 2013;23(3):430-9[2]Hara M, Ishiguro N, Katayama K et al. Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-level extension of a randomized, double-blind, placebo-controlled trial. Mod Rheumatol. 2014;24(3):410–8.[3]Ishikawa K, Ishikawa J.Iguratimod, a synthetic disease modifying anti-rheumatic drug inhibiting the activation of NF-jB and production of RANKL: Its efficacy, radiographic changes,safety and predictors over two years’ treatment for Japanese rheumatoid arthritis patients. Mod.Rheumatol.2019,29(3), 418–429.Disclosure of Interests:None declared
The efficacy, safety, and cost-effectiveness of conventional synthetic disease-modifying anti-rheumatic drugs triple therapy in preventing relapse in rheumatoid arthritis patients: a randomized controlled trial (ESCoRT study)