Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-label extension of a randomized, double-blind, placebo-controlled trial.

Abstract:

OBJECTIVE:To obtain safety and efficacy data on combination treatment with iguratimod and methotrexate (MTX) in an open-label extension study in patients with active rheumatoid arthritis (RA). METHODS:Following a 28-week, randomized, double-blind trial of adding iguratimod or placebo to stable MTX therapy, patients entered a 24-week extension. Patients randomized to the iguratimod + MTX group continued treatment. Patients treated with placebo + MTX switched to iguratimod + MTX [the (placebo/iguratimod) + MTX group]. RESULTS:In the iguratimod + MTX group, the rate of 20% improvement in American College of Rheumatology criteria (ACR20) at week 52 (71.3%) was similar to that at week 24 (69.5%). ACR50, ACR70 and Health Assessment Questionnaire Disability Index at week 52 significantly improved compared with the values at week 24. In the (placebo/iguratimod + MTX) group, the switch to iguratimod treatment significantly improved ACR20 from 30.7% at week 24 to 72.1% at week 52. Frequent adverse events for 52 weeks in the iguratimod + MTX group were nasopharyngitis, upper respiratory tract inflammation, stomatitis, lymphocyte decrease, AST increase, ALT increase and blood iron decrease. These adverse events were predominantly mild or moderate in severity. No deaths occurred. CONCLUSION:Efficacy and tolerance of iguratimod + MTX therapy was maintained to 52 weeks in patients with active RA with inadequate response to MTX.

journal_name

Mod Rheumatol

journal_title

Modern rheumatology

authors

Hara M,Ishiguro N,Katayama K,Kondo M,Sumida T,Mimori T,Soen S,Nagai K,Yamaguchi T,Yamamoto K,Iguratimod-Clinical Study Group.

doi

10.3109/14397595.2013.843756

subject

Has Abstract

pub_date

2014-05-01 00:00:00

pages

410-8

issue

3

eissn

1439-7595

issn

1439-7609

journal_volume

24

pub_type

杂志文章,随机对照试验
  • The Japanese version of the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and the Fibromyalgia Symptom Scale: reliability and validity.

    abstract::The aim of this study was to investigate the reliability and the validity of the Japanese version of the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010-J), and its quantification scale, the Fibromyalgia Symptom Scale (FS-J). In this study, we divided patients with chro...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-011-0462-3

    authors: Usui C,Hatta K,Aratani S,Yagishita N,Nishioka K,Kanazawa T,Ito K,Yamano Y,Nakamura H,Nakajima T,Nishioka K

    更新日期:2012-02-01 00:00:00

  • Simultaneous herpes simplex virus esophagitis and lupus enteritis in a patient with systemic lupus erythematosus.

    abstract::A 52-year-old woman with a 6-year history of systemic lupus erythematosus (SLE) developed acute abdominal pain, nausea, vomiting, and diarrhea accompanied by hypocomplementemia. Herpes simplex virus (HSV) esophagitis and lupus enteritis were diagnosed on the basis of the results of endoscopic and histological examinat...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-009-0237-2

    authors: Wakui H,Togashi M,Omokawa A,Okuyama S,Masai R,Komatsuda A,Ogasawara H,Sawada K

    更新日期:2010-02-01 00:00:00

  • Clinical features and treatment outcomes of otitis media with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (OMAAV): A retrospective analysis of 235 patients from a nationwide survey in Japan.

    abstract:OBJECTIVE:We aimed to analyze clinical features and treatment outcomes of otitis media caused by antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), i.e. otitis media with AAV (OMAAV). METHODS:This survey was performed between December 2013 and February 2014. The study began with a preliminary surv...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1080/14397595.2016.1177926

    authors: Harabuchi Y,Kishibe K,Tateyama K,Morita Y,Yoshida N,Kunimoto Y,Matsui T,Sakaguchi H,Okada M,Watanabe T,Inagaki A,Kobayashi S,Iino Y,Murakami S,Takahashi H,Tono T

    更新日期:2017-01-01 00:00:00

  • The epigenetic alteration of synovial cell gene expression in rheumatoid arthritis and the roles of nuclear factor kappaB and Notch signaling pathways.

    abstract::Rheumatoid arthritis (RA) is a complex process of chronic and progressive inflammation associated with activation of numerous signaling molecules and transcription factors and hyperproliferation of synoviocytes of the affected joints, although the greater part of its pathophysiological process is explained by activati...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-004-0372-8

    authors: Okamoto T

    更新日期:2005-01-01 00:00:00

  • Inhibition of the NF-κB pathway as a candidate therapeutic strategy for cryopyrin-associated periodic syndrome.

    abstract:OBJECTIVES:Cryopyrin-associated periodic syndrome (CAPS) is caused by unrestricted IL-1β release due to mutation of the gene coding NLRP3. This study aimed to clarify whether NLRP3-related IL-1β release is dependent on the NF-κB pathway. METHODS:Peripheral blood mononuclear cells (PBMCs) from healthy subjects or patie...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.3109/14397595.2013.844298

    authors: Shimogaki S,Ito S,Komatsu S,Koike R,Miyasaka N,Umezawa K,Kubota T

    更新日期:2014-05-01 00:00:00

  • Therapeutic angiogenesis in patients with systemic sclerosis by autologous transplantation of bone-marrow-derived cells.

    abstract::We examined the efficacy and safety of autologous transplantation of bone-marrow-derived cells in patients with intractable ulcers caused by systemic sclerosis. Eight patients with ulcers resistant to treatment were enrolled. Bone marrow cells were gathered from the bilateral iliac crests with multiple repositioning b...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-010-0274-x

    authors: Ishigatsubo Y,Ihata A,Kobayashi H,Hama M,Kirino Y,Ueda A,Takeno M,Shirai A,Ohno S

    更新日期:2010-06-01 00:00:00

  • Prospective study of methotrexate treatment for rheumatoid arthritis treated legitimately according to the government recommended 8 mg/week dose.

    abstract::Clinical squeal of the treatment of rheumatoid arthritis patients with methotrexate (MTX) according to the Japanese government recommended dose of 8 mg/week was evaluated prospectively. A total of 176 patients with active RA attending Konan Kakogawa Hospital and Kobe University Hospital were enrolled. Patients' profil...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-009-0205-x

    authors: Hashiramoto A,Shiozawa K,Tanaka Y,Yamane T,Murata M,Tanaka C,Terashima Y,Koyama K,Nakagawa N,Abe S,Yoshihara R,Saegusa Y,Tsumiyama K,Komai K,Sakai Y,Shiozawa S

    更新日期:2009-01-01 00:00:00

  • Imbalanced expression of dysfunctional regulatory T cells and T-helper cells relates to immunopathogenesis in polyarteritis nodosa.

    abstract:OBJECTIVES:We investigated the characteristics of circulating T-helper (Th) cells and CD4+ regulatory T cells (Tregs) in polyarteritis nodosa (PAN). METHODS:Peripheral blood samples were obtained from 14 patients with PAN. Nine patients having granulomatosis with polyangiitis (GPA) and 11 healthy individuals (HC) were...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.3109/14397595.2016.1172999

    authors: Shimojima Y,Ishii W,Kishida D,Fukushima K,Ikeda SI

    更新日期:2017-01-01 00:00:00

  • Prevalence of Helicobacter pylori infection and risk of upper gastrointestinal ulcer in patients with rheumatoid arthritis in Japan.

    abstract::We evaluated the prevalence of Helicobacter pylori infection and the association of H. pylori infection and/or nonsteroidal anti-inflammatory drug (NSAID) use with upper gastrointestinal (UGI) ulcers in a cohort of Japanese patients with rheumatoid arthritis (RA). Using the clinical database of the cohort of RA patien...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-005-0419-5

    authors: Tanaka E,Singh G,Saito A,Syouji A,Yamada T,Urano W,Nakajima A,Taniguchi A,Tomatsu T,Hara M,Saito T,Kamatani N,Yamanaka H

    更新日期:2005-01-01 00:00:00

  • Effectiveness of golimumab for rheumatoid arthritis in patients with an inadequate response to tocilizumab.

    abstract:OBJECTIVES:Several biological disease-modifying antirheumatic drugs (bDMARDs) are currently available for the treatment of rheumatoid arthritis (RA). Increasing evidence indicates that second-line bDMARDs are effective for inadequate responders to first-line bDMARDs. However, all previous studies investigated the use o...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1080/14397595.2016.1206242

    authors: Matsuno H,Katayama K

    更新日期:2017-03-01 00:00:00

  • Assessment of fatigue in a large series of 1492 Brazilian patients with Spondyloarthritis.

    abstract:BACKGROUND:The aim of the present study was to analyze the score of fatigue in a large cohort of Brazilian patients with SpA, comparing different disease patterns and its association with demographic and disease-specific variables. METHODS:A common protocol of investigation was prospectively applied to 1492 Brazilian ...

    journal_title:Modern rheumatology

    pub_type: 杂志文章,多中心研究

    doi:10.3109/14397595.2014.906049

    authors: Bianchi WA,Elias FR,Carneiro S,Bortoluzzo AB,Gonçalves CR,da Silva JA,Ximenes AC,Bértolo MB,Ribeiro SL,Keiserman M,Skare TL,Menin R,Azevedo VF,Vieira WP,Albuquerque EN,Bonfiglioli R,Campanholo C,Carvalho HM,Costa IP,

    更新日期:2014-11-01 00:00:00

  • Absence of a relationship between joint space narrowing and osteophyte formation in early knee osteoarthritis among Japanese community-dwelling elderly individuals: A cross-sectional study.

    abstract:OBJECTIVES:Joint space narrowing and osteophyte formation, radiographic features of knee osteoarthritis (OA), are not necessarily synchronous processes. We evaluated the relationship between medial minimum joint space width (mJSW) and osteophyte formation. METHODS:We conducted a retrospective study of 1050 individuals...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1080/14397595.2016.1232775

    authors: Komatsu D,Hasegawa Y,Kojima T,Seki T,Higuchi Y,Ishiguro N

    更新日期:2017-07-01 00:00:00

  • The mid-term efficacy of intra-articular hyaluronic acid injections on joint structure: a nested case control study.

    abstract:OBJECTIVE:Intra-articular (IA) injection of hyaluronic acid (HA) has been shown to relieve osteoarthritis (OA)-related pain and improve joint structure within a 1-year period. We examined the mid-term (2-year) efficacy of IA-HA in Japanese subjects by using a large-scale population-based cohort of the Research on Osteo...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-012-0725-7

    authors: Oka H,Akune T,Muraki S,Tanaka S,Kawaguchi H,Nakamura K,Yoshimura N

    更新日期:2013-07-01 00:00:00

  • Efficacy of adalimumab for a refractory case of relapsing polychondritis with reduction of pro-inflammatory cytokines.

    abstract::A 68-year-old man with a fever of unknown origin was admitted to our hospital. Bilateral auricularis and nasal root inflammation, with auricular perichondritis positive for anti-type II collagen (CII) antibody, led to a diagnosis of relapsing polychondritis (RP). Because the patient was refractory for high-dose glucoc...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-011-0453-4

    authors: Nakamura H,Suzuki T,Nagaoka K,Yamasaki S,Tamai M,Hayashi T,Kawakami A

    更新日期:2011-12-01 00:00:00

  • Potential therapeutics for antiphospholipid antibody associated thrombocytopenia: A systematic review and meta-analysis.

    abstract::Objectives: Thrombocytopenia is frequently observed in antiphospholipid antibody (aPL) carriers. Due to the paradoxical risks of thrombosis and hemorrhage, the management of aPL-associated thrombocytopenia (APAT) is often deductive. We aimed to investigate the efficacy and safety of therapeutic approaches for APAT thr...

    journal_title:Modern rheumatology

    pub_type: 杂志文章,meta分析

    doi:10.1080/14397595.2018.1558934

    authors: Abe N,Oku K,Amengual O,Fujieda Y,Kato M,Bohgaki T,Yasuda S,Mori R,Morishita E,Suzuki-Inoue K,Atsumi T

    更新日期:2020-01-01 00:00:00

  • Open reduction of the dislocated hip in juvenile idiopathic arthritis: a case report.

    abstract::An 8-year-old girl with systemic-onset juvenile idiopathic arthritis (JIA) required surgical reduction for a dislocated left hip joint following failure of skin traction for 1 week. Unaided walking was achieved by 3 months postoperatively. Incongruence and irregularity of the hip joint remained but may resolve with ma...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-004-0330-5

    authors: Inui K,Maeno T,Tada M,Takaoka K,Koike T

    更新日期:2004-01-01 00:00:00

  • IL-6 inhibitor for the treatment of rheumatoid arthritis: A comprehensive review.

    abstract::Tocilizumab (TCZ) is an interleukin-6 (IL-6) inhibitor used for the treatment of rheumatoid arthritis (RA). It was developed in 2008, and its effectiveness is supported by evidence from all over the world based on its first decade of use. Although the overall efficacy and safety profiles of TCZ are similar to those of...

    journal_title:Modern rheumatology

    pub_type: 杂志文章,评审

    doi:10.1080/14397595.2018.1546357

    authors: Ogata A,Kato Y,Higa S,Yoshizaki K

    更新日期:2019-03-01 00:00:00

  • Consensus-based identification of factors related to false-positives in ultrasound scanning of synovitis and tenosynovitis.

    abstract:INTRODUCTION:We aimed to identify causes of false-positives in ultrasound scanning of synovial/tenosynovial/bursal inflammation and provide corresponding imaging examples. METHODS:We first performed systematic literature review to identify previously reported causes of false-positives. We next determined causes of fal...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.3109/14397595.2015.1091123

    authors: Ikeda K,Narita A,Ogasawara M,Ohno S,Kawahito Y,Kawakami A,Ito H,Matsushita I,Suzuki T,Misaki K,Ogura T,Kamishima T,Seto Y,Nakahara R,Kaneko A,Nakamura T,Henmi M,Fukae J,Nishida K,Sumida T,Koike T

    更新日期:2016-01-01 00:00:00

  • Rapid decrease in salivary epidermal growth factor levels in patients with Sjögren's syndrome: A 3-year follow-up study.

    abstract:OBJECTIVES:To assess changes in salivary epidermal growth factor (EGF) levels within three years and investigate the correlation between these changes and the severity of intraoral manifestations in patients with Sjögren's syndrome (SS). METHODS:Twenty-three SS patients (14 primary SS and 9 secondary SS) and 14 contro...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.3109/14397595.2015.1034941

    authors: Azuma N,Katada Y,Kitano S,Sekiguchi M,Kitano M,Nishioka A,Hashimoto N,Matsui K,Iwasaki T,Sano H

    更新日期:2015-01-01 00:00:00

  • Picture superiority effect as one of the potential advantages of musculoskeletal ultrasound complementation for verbal explanation.

    abstract::Objective: We conducted a questionnaire survey within a standard clinical setting to clarify that picture superiority effect (PSE) could be obtained by musculoskeletal ultrasound (MSKUS) examination.Methods: One hundred patients with rheumatoid arthritis or arthralgia, who visited the Rheumatology Unit, Department of ...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1080/14397595.2019.1645382

    authors: Matsuki-Muramoto Y,Ogasawara M,Kawamoto T,Yamaji K,Tamura N

    更新日期:2020-07-01 00:00:00

  • Effect of anti-tumor necrosis factor α treatment on radiographic progression in patient with ankylosing spondylitis: A systematic review and meta-analysis.

    abstract:BACKGROUND:Efficacy of anti-tumor necrosis factor (anti-TNF)α treatment in patient with active ankylosing spondylitis (AS) had been proved by many clinical studies. Inflammation and new bone formation in spine were two pivotal aspects in AS. TNF α inhibitor could eliminate inflammation including clinical and laboratory...

    journal_title:Modern rheumatology

    pub_type: 杂志文章,meta分析

    doi:10.1080/14397595.2018.1525017

    authors: Zong HX,Xu SQ,Tong H,Wang XR,Pan MJ,Teng YZ

    更新日期:2019-05-01 00:00:00

  • Near-infrared fluorescence imaging with indocyanine green-lactosomes in a mouse model of rheumatoid arthritis.

    abstract:OBJECTIVES:The early diagnosis and treatment of rheumatoid arthritis (RA) is important to reduce joint destruction. Many of the current imaging techniques have disadvantages, such as the need for contrast agents and interpretation by specialists. Fluorescence imaging is an emerging technique that overcomes some of thes...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.3109/14397595.2016.1170946

    authors: Onishi S,Sakane M,Tsukanishi T,Funayama T,Ozeki E,Hara I,Yamazaki M

    更新日期:2016-11-01 00:00:00

  • IgG4-related periaortitis/periarteritis: An under-recognized condition that is potentially life-threatening.

    abstract::Periaortitis and periarteritis are one of the clinical features of IgG4-related disease. Such vascular manifestations are reported to be present in 10-30% of overall IgG4-related disease, and they may also appear as an isolated lesion of IgG4-related disease. As other types of large vessel vasculitis, IgG4-related vas...

    journal_title:Modern rheumatology

    pub_type: 杂志文章,评审

    doi:10.1080/14397595.2018.1546367

    authors: Mizushima I,Kasashima S,Fujinaga Y,Kawano M,Ishizaka N

    更新日期:2019-03-01 00:00:00

  • Cytophagic histiocytic panniculitis with haemophagocytosis in a patient with familial multiple lipomatosis and review of the literature.

    abstract::We report a patient with the extremely rare familial multiple lipomatosis syndrome, who developed the uncommon autoimmune disease cytophagic histiocytic panniculitis, manifested as inflammation of preexisting lipomas. Despite his initial critical condition and unsuccessful treatment with steroids, he responded to cycl...

    journal_title:Modern rheumatology

    pub_type: 杂志文章,评审

    doi:10.1007/s10165-011-0487-7

    authors: Krilis M,Miyakis S

    更新日期:2012-02-01 00:00:00

  • Tapering and discontinuation of oral glucocorticoids without deterioration of disease status in patients with rheumatoid arthritis under a stable treatment.

    abstract:OBJECTIVE:To retrospectively evaluate whether oral glucocorticoid (GC) administration can be tapered or discontinued over a 2-year observation period in patients with rheumatoid arthritis (RA) undergoing a stable oral GC treatment, without deterioration in the disease status. METHODS:Methotrexate (MTX) and prednisolon...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1080/14397595.2020.1864914

    authors: Hirata S,Kohno H,Watanabe H,Tokunaga T,Yoshida Y,Sugimoto T,Mokuda S,Oda K,Nojima T,Sugiyama E

    更新日期:2020-12-16 00:00:00

  • Cutaneous polyarteritis nodosa in a patient with Crohn's disease.

    abstract::A 19-year-old Japanese woman with a 4-year history of Crohn's disease (CD) developed high fever, polyarthralgia, and painful subcutaneous nodules of the legs. A skin biopsy showed panarteritis with fibrinoid necrosis in the deep dermis. Endoscopic examination showed aphthous lesions in the entire colon. She was diagno...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-008-0110-8

    authors: Komatsuda A,Kinoshita K,Togashi M,Maki N,Masai R,Niitsu H,Ohtani S,Sageshima M,Sawada K,Wakui H

    更新日期:2008-01-01 00:00:00

  • Prevention of joint destruction by tacrolimus in patients with early rheumatoid arthritis: a post hoc analysis of a double-blind, randomized, placebo-controlled study.

    abstract:OBJECTIVES:A multicenter, randomized, double-blind, placebo-controlled study of the oral calcineurin inhibitor tacrolimus was performed in patients with early rheumatoid arthritis who had responded poorly to disease-modifying antirheumatic drugs (DMARDs), and factors related to suppression of joint destruction were inv...

    journal_title:Modern rheumatology

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s10165-012-0817-4

    authors: Tanaka Y,Kawai S,Takeuchi T,Yamamoto K,Miyasaka N

    更新日期:2013-11-01 00:00:00

  • Central sensitization and its relationship with health profile in Behçet's disease.

    abstract::Objectives: In this study, we aimed to evaluate the level of central sensitization (CS) and its relationship with health profile, including neuropathic pain and sleep quality in Behçet's disease (BD).Method: Eighty-eight patients with BD and 60 healthy controls (HCs) were included in the study between May 2018 and Feb...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1080/14397595.2020.1780076

    authors: Ayar K,Ökmen BM,Altan L,Öztürk EK

    更新日期:2020-07-06 00:00:00

  • Sjögren's syndrome with bilateral spontaneous fracture of the femoral neck following aseptic necrosis of the femoral head.

    abstract::Abstract A woman with Sjögren's syndrome concurrently suffered bilateral fractures of the femoral neck without any proximate cause, while she had aseptic necrosis of the femoral head resulting from the treatment for Sjögren's syndrome. According to previous reports, fractures of the femoral neck following aseptic necr...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.3109/s10165-004-0346-x

    authors: Kamiya M,Ueno M,Yamaguchi H,Kanata S,Sohen S

    更新日期:2004-12-01 00:00:00

  • Infliximab and brucellosis: not the usual suspects, this time.

    abstract::Tumor necrosis factor (TNF) plays an important role in the host defense mechanism, and anti-TNF antibody therapies may increase the risk of serious infections. We herein report a case of 57-year-old male with rheumatoid arthritis who developed brucellosis during treatment with infliximab in combination with methotrexa...

    journal_title:Modern rheumatology

    pub_type: 杂志文章

    doi:10.1007/s10165-010-0388-1

    authors: Akgul O,Ozgocmen S

    更新日期:2011-06-01 00:00:00