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Takeuchi T.,Keio University | Yamanaka H.,Tokyo Womens Medical University | Ishiguro N.,Nagoya University | Miyasaka N.,Tokyo Medical and Dental University | And 7 more authors.
Annals of the Rheumatic Diseases | Year: 2014

Objectives To evaluate the efficacy and safety of adalimumab+methotrexate (MTX) in Japanese patients with early rheumatoid arthritis (RA) who had not previously received MTX or biologics. Methods This randomised, double-blind, placebo-controlled, multicentre study evaluated adalimumab 40 mg every other week+MTX 6-8 mg every week versus MTX 6-8 mg every week alone for 26 weeks in patients with RA (≤2-year duration). The primary endpoint was inhibition of radiographic progression (change (Δ) from baseline in modified total Sharp score (mTSS)) at week 26. Results A total of 171 patients received adalimumab+MTX (mean dose, 6.2±0.8 mg/week) and 163 patients received MTX alone (mean dose, 6.6±0.6 mg/week, p<0.001). The mean RA duration was 0.3 years and 315 (94.3%) had high disease activity (DAS28>5.1). Adalimumab+MTX significantly inhibited radiographic progression at week 26 versus MTX alone (ΔmTSS, 1.5±6.1 vs 2.4±3.2, respectively; p<0.001). Significantly more patients in the adalimumab+MTX group (62.0%) did not show radiographic progression (ΔmTSS≤0.5) versus the MTX alone group (35.4%; p<0.001). Patients treated with adalimumab+MTX were significantly more likely to achieve American College of Rheumatology responses and achieve clinical remission, using various definitions, at 26 weeks versus MTX alone. Combination therapy was well tolerated, and no new safety signals were observed. Conclusions Adalimumab in combination with low-dose MTX was well tolerated and efficacious in suppressing radiographic progression and improving clinical outcomes in Japanese patients with early RA and high disease activity.

Funahashi K.,Pharm C | Matsubara T.,Matsubara Mayflower Hospital
Clinical Rheumatology | Year: 2012

We conducted a survey among Japanese rheumatoid arthritis (RA) patients to better understand what they expect from treatment and whether there is a difference between expectations of biologics-treated and diseasemodifying antirheumatic drugs (DMARDs)-treated patients. An anonymous survey was conducted with 165 outpatients from our clinic (with informed written consent). On the survey, they wrote their age, gender, medical history, and commented on: (1) expectations for treatment, (2) disappointment with treatment, (3) experience of, and thoughts about switching treatments, (4) information wanted before starting a new treatment, (5) expectations before administration and noticeable differences after treatment, (6) level of satisfaction with current treatment, and (7) expectations of possible treatments. Patients who had never been treated with DMARDs were excluded from the survey. For "treatment goals before administration," 86% responded with "assured efficacy," while 73% responded "suppress joint destruction" or "recover from joint destruction." Also, more patients hoped for "long-lasting efficacy" (67%) over "fast acting" (41%), which suggests significance of the long-term improvement of QOL. Related to "disappointment with treatment," patients also felt anxiety over switching treatment for possibilities of not responding enough, or side effects. RA patients have high expectations for medication in terms of assured improvement of conditions and long-lasting efficacy of drugs, while the biggest concern was if they would have side effects or not, and if so, what type. The results suggest patients hope to have worries over switching medications dispelled. The results also verified those who have used biologics before have higher treatment goals than those who have not. © Clinical Rheumatology 2012.

Harigai M.,Tokyo Medical and Dental University | Takeuchi T.,Keio University | Tanaka Y.,University of Occupational and Environmental Health Japan | Matsubara T.,Matsubara Mayflower Hospital | And 2 more authors.
Modern Rheumatology | Year: 2012

Objective We implemented a retrospective study to explore discontinuation of therapy with adalimumab (ADA) without exacerbation in rheumatoid arthritis (RA) patients who had achieved low disease activity (LDA) with the biological agent. Methods We enrolled 46 RA patients who had completed open extension of a double-blind, placebo-controlled trial of ADA monotherapy in Japan and who had LDA (DAS28- CRP <2.7) at the last administration of ADA in the extension trials; this date was defined as week 0 in the present study. Treatment of RA was at the discretion of the attending physician after week 0. The primary endpoint of this study was the percentage of patients who maintained discontinuation of biological agents and LDA for 52 weeks. Results Twenty-four of the enrolled patients continued ADA while the rest discontinued ADA after the administration of the drug at week 0. Fourteen of the 22 patients did not restart biological agents, and 4 (18.2%) of these maintained LDA through week 52. All 4 of these patients had received ADA monotherapy before week 0. Conclusion Some RA patients who have achieved LDA with ADA monotherapy can discontinue the biologic without incurring increased disease activity. A prospective randomized study is required to confirm the results of our study. © Japan College of Rheumatology 2012.

Nakamura T.,Matsubara Mayflower Hospital
Nihon rinsho. Japanese journal of clinical medicine | Year: 2013

Rheumatoid arthritis (RA) is an autoimmune disease that targets synovial joints and leads to bone destruction and joint deformity. T cell activations were shown to be involved in the onset of RA. T cells may control downstream inflammatory mediators reaching the synovium, where inflammation leads to joint destruction. However the treatment of RA has improved considerably in recent years through the introduction of DMARDs such as MTX, and anti-tumor necrosis factor therapy, there is still unmet medical need. Not a few patients experience an inadequate response to these therapies. Abatacept, a fusion protein of the extracellular domain of CTLA4 (a molecule inhibits the costimulatory pathway in T cell activation) and the Fc domain of human IgG1, was developed for the treatment of RA. Abatacept has shown long-term efficacy and safety in RA patients who were inadequate to MTX and/or anti-tumor necrosis factor therapy.

Yurube T.,Kobe University | Sumi M.,Kobe Rosai Hospital | Nishida K.,Kobe University | Miyamoto H.,Kobe medical center | And 5 more authors.
Spine | Year: 2012

STUDY DESIGN. A prospective minimum 5-year follow-up study of the cervical spine in patients with rheumatoid arthritis (RA) initially without cervical involvement. OBJECTIVE. To clarify the incidence and aggravation of cervical spine instabilities and their predictive risk factors in patients with RA. SUMMARY OF BACKGROUND DATA. Many reports have shown the progression of cervical spine involvement in RA. However, few articles have described comprehensive evaluation of its prognostic factors. METHODS. A total of 140 patients with "definite" or "classical" RA initially without cervical involvement were prospectively followed for more than 5 years. Radiographical cervical findings were classified into 3 instabilities: atlantoaxial subluxation (AAS: atlantodental interval >3 mm), vertical subluxation (VS: Ranawat value <13 mm), and subaxial subluxation (SAS: irreducible translation ≥2 mm). "Severe" extents were defined as AAS with atlantodental interval 10 mm or more, VS with Ranawat value 10 mm or less, and SAS with translation 4 mm or more or at multiple levels. Incidence of these developments and predictors for "severe" instabilities were investigated. RESULTS. During 6.0 ± 0.5 years, 43.6% of 140 patients developed cervical instabilities: AAS in 32.1%, VS in 11.4%, and SAS in 16.4% with some combinations. "Severe" instabilities were exhibited in 12.9% of patients: AAS in 3.6%, VS in 6.4%, and SAS in 5.0%. Furthermore, 4.3% presented canal stenosis, with 13 mm or less space available for the spinal cord (SAC) due to "severe" AAS or "severe" VS in 2.9% and 12 mm or less SAC due to "severe" SAS in 2.1%. Multivariable logistic regression analysis identified corticosteroid administration, mutilating changes at baseline, and the development of nonmutilating into mutilating changes during the follow-up period correlated with "severe" instabilities (P < 0.05). CONCLUSION. A minimum 5-year follow-up reveals the occurrence of cervical instabilities in 43.6%, "severe" aggravation in 12.9%, and decreased SAC in 4.3% of patients with RA. Characteristics of severe disease activity - established mutilating changes, progressive development into mutilating changes, and potentially concomitant corticosteroid treatment - are indicators for poor prognosis of the cervical spine in RA. © 2012, Lippincott Williams & Wilkins.

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