Skip to main content
Top
Published in: Modern Rheumatology 5/2008

Open Access 01-10-2008 | Original Article

Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: one-year outcome of joint destruction (RECONFIRM-2J)

Authors: Tsutomu Takeuchi, Hisashi Yamanaka, Eisuke Inoue, Hayato Nagasawa, Masao Nawata, Katsunori Ikari, Kazuyoshi Saito, Naoya Sekiguchi, Eri Sato, Hideto Kameda, Shigeru Iwata, Takeshi Mochizuki, Kouichi Amano, Yoshiya Tanaka

Published in: Modern Rheumatology | Issue 5/2008

Login to get access

Abstract

The anti-TNF-α chimeric monoclonal antibody infliximab is the first biologic to be approved for rheumatoid arthritis (RA) in Japan, and post-marketing surveillance of all of the Japanese cases treated with infliximab has been conducted to explore the safety of infliximab therapy. In addition, a retrospective clinical study on the notable efficacy and related factors of infliximab therapy in an RA management group in Japan (RECONFIRM and RECONFIRM-2) has demonstrated clinical responses. However, information on the effect of infliximab on joint destruction in Japanese RA patients remains insufficient. In this study, we retrospectively analyzed X-ray data from 67 patients in whom both hand and foot X-rays at baseline and at 54 weeks had been available among the 410 cases in the RECONFIRM-2 study. By scoring the X-rays according to the modified van der Heijde (vdH)–Sharp method, we found that the total vdH–Sharp score in the RA patients before infliximab therapy was 104.40 ± 87.34 and the yearly progression was 21.33, indicating relatively rapid progression. After infliximab therapy for 54 weeks, the total vdH–Sharp score at 54 weeks was 104.37 ± 86.87 and the estimated yearly progression was −0.03, indicating the almost complete inhibition of progression. The RECONFIRM-2J study confirmed the significant ability of infliximab to halt joint destruction in Japanese RA patients, and showed that joint destruction was significantly associated with disease activity and the dose of MTX in the patients with moderate and advanced disease durations, respectively, before infliximab therapy.
Literature
1.
go back to reference Scott DL, Grindulis KA, Struthers GR, Coulton BL, Popert AJ, Bacon PA. Progression of radiological changes in rheumatoid arthritis. Ann Rheum Dis. 1984;43:8–17.PubMedCrossRef Scott DL, Grindulis KA, Struthers GR, Coulton BL, Popert AJ, Bacon PA. Progression of radiological changes in rheumatoid arthritis. Ann Rheum Dis. 1984;43:8–17.PubMedCrossRef
2.
go back to reference Pincus T. Long-term outcomes in rheumatoid arthritis. Br J Rheumatol. 1995;34 Suppl 2:59–73.PubMed Pincus T. Long-term outcomes in rheumatoid arthritis. Br J Rheumatol. 1995;34 Suppl 2:59–73.PubMed
3.
go back to reference Scott DL, Pugner K, Kaarela K, Doyle DV, Woolf A, Holmes J, et al. The links between joint damage and disability in rheumatoid arthritis. Rheumatology (Oxford). 2000;39:122–32.CrossRef Scott DL, Pugner K, Kaarela K, Doyle DV, Woolf A, Holmes J, et al. The links between joint damage and disability in rheumatoid arthritis. Rheumatology (Oxford). 2000;39:122–32.CrossRef
4.
go back to reference Pincus T, Sokka T, Wolfe F. Premature mortality in patients with rheumatoid arthritis: evolving concepts. Arthritis Rheum. 2001;44:1234–6.PubMedCrossRef Pincus T, Sokka T, Wolfe F. Premature mortality in patients with rheumatoid arthritis: evolving concepts. Arthritis Rheum. 2001;44:1234–6.PubMedCrossRef
5.
go back to reference Doran MF, Pond GR, Crowson CS, O’Fallon WM, Gabriel SE. Trends in incidence and mortality in rheumatoid arthritis in Rochester, Minnesota, over a forty-year period. Arthritis Rheum. 2002;46:625–31.PubMedCrossRef Doran MF, Pond GR, Crowson CS, O’Fallon WM, Gabriel SE. Trends in incidence and mortality in rheumatoid arthritis in Rochester, Minnesota, over a forty-year period. Arthritis Rheum. 2002;46:625–31.PubMedCrossRef
6.
go back to reference Feldmann M, Brennan FM, Maini RN. Role of cytokines in rheumatoid arthritis. Annu Rev Immunol. 1996;14:397–440.PubMedCrossRef Feldmann M, Brennan FM, Maini RN. Role of cytokines in rheumatoid arthritis. Annu Rev Immunol. 1996;14:397–440.PubMedCrossRef
7.
go back to reference Ivashkiv LB. Cytokine expression and cell activation in inflammatory arthritis. Adv Immunol. 1996;63:337–76.PubMedCrossRef Ivashkiv LB. Cytokine expression and cell activation in inflammatory arthritis. Adv Immunol. 1996;63:337–76.PubMedCrossRef
8.
go back to reference Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001;344:907–16.PubMedCrossRef Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001;344:907–16.PubMedCrossRef
9.
go back to reference Feldmann M, Maini RN. Anti-TNF alpha therapy of rheumatoid arthritis: what have we learned? Annu Rev Immunol. 2001;19:163–96.PubMedCrossRef Feldmann M, Maini RN. Anti-TNF alpha therapy of rheumatoid arthritis: what have we learned? Annu Rev Immunol. 2001;19:163–96.PubMedCrossRef
10.
go back to reference Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. N Engl J Med. 2000;343:1594–602.PubMedCrossRef Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. N Engl J Med. 2000;343:1594–602.PubMedCrossRef
11.
go back to reference St Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004;50:3432–43.CrossRef St Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004;50:3432–43.CrossRef
12.
go back to reference Taylor PC, Steuer A, Gruber J, McClinton C, Cosgrove DO, Blomley MJ, et al. Ultrasonographic and radiographic results from a two-year controlled trial of immediate or one-year-delayed addition of infliximab to ongoing methotrexate therapy in patients with erosive early rheumatoid arthritis. Arthritis Rheum. 2006;54:47–53.PubMedCrossRef Taylor PC, Steuer A, Gruber J, McClinton C, Cosgrove DO, Blomley MJ, et al. Ultrasonographic and radiographic results from a two-year controlled trial of immediate or one-year-delayed addition of infliximab to ongoing methotrexate therapy in patients with erosive early rheumatoid arthritis. Arthritis Rheum. 2006;54:47–53.PubMedCrossRef
13.
go back to reference Abe T, Takeuchi T, Miyasaka N, Hashimoto H, Kondo H, Ichikawa Y, et al. A multicenter, double-blind, randomized, placebo controlled trial of infliximab combined with low dose methotrexate in Japanese patients with rheumatoid arthritis. J Rheumatol. 2006;33:37–44.PubMed Abe T, Takeuchi T, Miyasaka N, Hashimoto H, Kondo H, Ichikawa Y, et al. A multicenter, double-blind, randomized, placebo controlled trial of infliximab combined with low dose methotrexate in Japanese patients with rheumatoid arthritis. J Rheumatol. 2006;33:37–44.PubMed
14.
go back to reference Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Post-marketing surveillance of the safety profile of infliximab in 5,000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189–94.PubMedCrossRef Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Post-marketing surveillance of the safety profile of infliximab in 5,000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189–94.PubMedCrossRef
15.
go back to reference Yamanaka H, Tanaka Y, Sekiguchi N, Inoue E, Saito K, Kameda H, et al. Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan (RECONFIRM). Mod Rheumatol. 2007;17:28–32.PubMedCrossRef Yamanaka H, Tanaka Y, Sekiguchi N, Inoue E, Saito K, Kameda H, et al. Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan (RECONFIRM). Mod Rheumatol. 2007;17:28–32.PubMedCrossRef
16.
go back to reference Tanaka Y, Takeuchi T, Inoue E, Saito K, Sekuguchi N, Iikuni N, et al. Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: 1-year clinical and ragiographic outcomes (RECONFIRM-II). Mod Rheum. 2008;18:146–152. Tanaka Y, Takeuchi T, Inoue E, Saito K, Sekuguchi N, Iikuni N, et al. Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: 1-year clinical and ragiographic outcomes (RECONFIRM-II). Mod Rheum. 2008;18:146–152.
17.
go back to reference Kameda H, Sekiguchi N, Nagasawa H, Amano K, Takei H, Suzuki K, et al. Development and validation of handy rheumatoid activity score with 38 joints (HRAS38) in rheumatoid arthritis patients receiving infliximab. Mod Rheumatol. 2006;16:381–8.PubMedCrossRef Kameda H, Sekiguchi N, Nagasawa H, Amano K, Takei H, Suzuki K, et al. Development and validation of handy rheumatoid activity score with 38 joints (HRAS38) in rheumatoid arthritis patients receiving infliximab. Mod Rheumatol. 2006;16:381–8.PubMedCrossRef
18.
go back to reference Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American rheumatism association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315–24.PubMedCrossRef Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American rheumatism association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315–24.PubMedCrossRef
19.
go back to reference Miyasaka N, Takeuchi T, Eguchi K. Proposed [corrected] Japanese guidelines for the use of infliximab for rheumatoid arthritis. Mod Rheumatol. 2005;15:4–8.PubMedCrossRef Miyasaka N, Takeuchi T, Eguchi K. Proposed [corrected] Japanese guidelines for the use of infliximab for rheumatoid arthritis. Mod Rheumatol. 2005;15:4–8.PubMedCrossRef
20.
go back to reference Inoue E, Yamanaka H, Hara M, Tomatsu T, Kamatani N. Comparison of disease activity score (DAS)28− erythrocyte sedimentation rate and DAS28− C-reactive protein threshold values. Ann Rheum Dis. 2007;66:407–9.PubMedCrossRef Inoue E, Yamanaka H, Hara M, Tomatsu T, Kamatani N. Comparison of disease activity score (DAS)28− erythrocyte sedimentation rate and DAS28− C-reactive protein threshold values. Ann Rheum Dis. 2007;66:407–9.PubMedCrossRef
21.
go back to reference van der Heijde D, Lassere M, Edmonds J, Kirwan J, Strand V, Boers M. Minimal clinically important difference in plain films in RA: group discussions, conclusions, and recommendations. OMERACT imaging task force J Rheumatol. 2001;28:914–7.PubMed van der Heijde D, Lassere M, Edmonds J, Kirwan J, Strand V, Boers M. Minimal clinically important difference in plain films in RA: group discussions, conclusions, and recommendations. OMERACT imaging task force J Rheumatol. 2001;28:914–7.PubMed
22.
go back to reference Maini RN, Breedveld FC, Kalden JR, Smolen JS, Furst D, Weisman MH, et al. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum. 2004;50:1051–65.PubMedCrossRef Maini RN, Breedveld FC, Kalden JR, Smolen JS, Furst D, Weisman MH, et al. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum. 2004;50:1051–65.PubMedCrossRef
23.
go back to reference Strand V, Landewe R, van der Heijde D. Using estimated yearly progression rates to compare radiographic data across recent randomised controlled trials in rheumatoid arthritis. Ann Rheum Dis. 2002;61(suppl 2):ii61–4. Strand V, Landewe R, van der Heijde D. Using estimated yearly progression rates to compare radiographic data across recent randomised controlled trials in rheumatoid arthritis. Ann Rheum Dis. 2002;61(suppl 2):ii61–4.
24.
go back to reference Wick MC, Anderwald C, Weiss RJ, Imhof H, Kainberger F, Smolen JS. Radiological progression of joint damage in a longitudinal cohort of early DMARD-treated rheumatoid arthritis patients followed for 10 years. Scand J Rheumatol. 2004;33:162–6.PubMedCrossRef Wick MC, Anderwald C, Weiss RJ, Imhof H, Kainberger F, Smolen JS. Radiological progression of joint damage in a longitudinal cohort of early DMARD-treated rheumatoid arthritis patients followed for 10 years. Scand J Rheumatol. 2004;33:162–6.PubMedCrossRef
25.
go back to reference Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an X-ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007;66:1162–7. Nishimoto N, Hashimoto J, Miyasaka N, Yamamoto K, Kawai S, Takeuchi T, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMURAI): evidence of clinical and radiographic benefit from an X-ray reader-blinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007;66:1162–7.
26.
go back to reference Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26–37.PubMedCrossRef Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26–37.PubMedCrossRef
Metadata
Title
Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: one-year outcome of joint destruction (RECONFIRM-2J)
Authors
Tsutomu Takeuchi
Hisashi Yamanaka
Eisuke Inoue
Hayato Nagasawa
Masao Nawata
Katsunori Ikari
Kazuyoshi Saito
Naoya Sekiguchi
Eri Sato
Hideto Kameda
Shigeru Iwata
Takeshi Mochizuki
Kouichi Amano
Yoshiya Tanaka
Publication date
01-10-2008
Publisher
Springer Japan
Published in
Modern Rheumatology / Issue 5/2008
Print ISSN: 1439-7595
Electronic ISSN: 1439-7609
DOI
https://doi.org/10.1007/s10165-008-0077-5

Other articles of this Issue 5/2008

Modern Rheumatology 5/2008 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.