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Efficacy and safety of tacrolimus in patients with rheumatoid arthritis - A systematic review and meta-analysis.
Kaneko, Y, Kawahito, Y, Kojima, M, Nakayama, T, Hirata, S, Kishimoto, M, Endo, H, Seto, Y, Ito, H, Nishida, K, et al
Modern rheumatology. 2021;(1):61-69
Abstract
OBJECTIVES To evaluate the efficacy and safety of tacrolimus in adult patients with rheumatoid arthritis (RA) by using the GRADE approach. METHODS We searched PubMed, Japana Centra Revuo Medicina Web (Ichu-shi web), and the Cochrane Database of Systematic Reviews. Articles fulfilling the predefined inclusion criteria were appraised and used for meta-analysis. The primary outcomes were American College of Rheumatology 20 (ACR20) and serum creatinine elevation. Other outcomes included ACR50, ACR70, changes in C-reactive protein, modified Health Assessment Questionnaire Disability Index, gastrointestinal disorders, metabolic and nutritional disorders, and infections and infestations. RESULTS We identified five randomized controlled studies, four of which compared tacrolimus to placebo and were included in the meta-analysis. The risk ratio of ACR20 achievement was 1.71 (95% confidence interval [CI] 1.20-2.42) for 1-2 mg/day and 2.30 (95% CI 1.79-2.96) for 3 mg/day. The risk ratio of creatinine elevation was 1.95 (95% CI 1.18-3.23) for 1-2 mg/day and 3.81 (95% CI 2.43-5.99) for 3 mg/day. CONCLUSION Tacrolimus is effective with acceptable safety in the management of RA.
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Depressive Symptoms in Middle-Aged and Elderly Women Are Associated with a Low Intake of Vitamin B6: A Cross-Sectional Study.
Odai, T, Terauchi, M, Suzuki, R, Kato, K, Hirose, A, Miyasaka, N
Nutrients. 2020;12(11)
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Depression and anxiety are common mental disorders, which are more prominent in women undergoing menopause. Large hormonal fluctuations are thought to be the driving factor, however treatments for this may have side effects such as heart disease and cancer. Interest in complementary therapies has increased and associations between several nutrients and mental health disorders has been reported, however their affects in perimenopausal and post-menopausal women is still unknown. This cross-sectional study of 289 women aged 40 and over aimed to look at associations between dietary nutrient consumption and anxiety/depressive symptoms. The results showed that over half of the women reported some symptoms of anxiety or depression. Of the 43 nutrients examined, only decreased vitamin B6 intake was associated with symptoms of moderate-severe depression but not symptoms of anxiety. It was concluded that moderate to severe depressive symptoms were associated with a lower dietary intake of vitamin B6. However, it should be noted that dietary intake and not serum levels were used to make associations. This study could be used by healthcare professionals to recommend increased dietary vitamin B6 intake for symptoms of moderate to severe depression in women aged 40 or over.
Abstract
This study investigated the nutritional factors that are associated with anxiety and depressive symptoms in Japanese middle-aged and elderly women. We conducted a cross-sectional study with 289 study participants aged ≥40 years (mean age = 52.0 ± 6.9 years). Their dietary habits, menopausal status and symptoms, and varied background factors, such as body composition, lifestyle factors, and cardiovascular parameters, were assessed. Their anxiety and depressive symptoms were evaluated using the Hospital Anxiety and Depression Scale (HADS), where scores of 0-7 points, 8-10 points, and 11-21 points on either the anxiety or depression subscales were categorized as mild, moderate, and severe, respectively. The dietary consumption of nutrients was assessed using a brief self-administered diet history questionnaire. The relationships between the moderate-to-severe anxiety/depressive symptoms and the dietary intake of 43 major nutrients were investigated using multivariate logistic regression analyses. After adjusting for age, menopausal status, and the background factors that were significantly related to depressive symptoms, moderate and severe depression was significantly inversely associated with only vitamin B6 (adjusted odds ratio per 10 μg/MJ in vitamin B6 intake = 0.89, 95% confidence interval = 0.80-0.99). A higher intake of vitamin B6 could help relieve depressive symptoms for this population.
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Effects of Grape Seed Proanthocyanidin Extract on Vascular Endothelial Function in Participants with Prehypertension: A Randomized, Double-Blind, Placebo-Controlled Study.
Odai, T, Terauchi, M, Kato, K, Hirose, A, Miyasaka, N
Nutrients. 2019;(12)
Abstract
This study aimed to investigate the effects of grape seed proanthocyanidin extract (GSPE) on blood pressure and vascular endothelial function in middle-aged Japanese adults with prehypertension. We conducted a randomized, double-blind, placebo-controlled study on 6 men and 24 women aged 40-64 years old. The participants were randomized to receive tablets containing either low-dose (200 mg/day) or high-dose (400 mg/day) GSPE, or placebo, for 12 weeks. Systolic and diastolic blood pressures (SBP and DBP, respectively), brachial flow-mediated dilation (FMD), and other cardiovascular parameters were measured before and after 4, 8, and 12 weeks of treatment. The mean SBP in the high-dose group significantly decreased by 13 mmHg after 12 weeks (P = 0.028), although FMD did not change. In an ad hoc analysis of non-smoking participants (n = 21), the mean SBP, DBP, stiffness parameter β, distensibility, incremental elastic modulus (Einc), and pulse wave velocity (PWV) also significantly improved in the high-dose group after 12 weeks. Changes in Einc and PWV from baseline to 12 weeks were significantly greater in the high-dose group than in the placebo group (Einc, P = 0.023; PWV, P = 0.03). GSPE consumption could help maintain vascular elasticity and normal blood pressure in this population.
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Balloon-Occluded Carbon Dioxide Gas Angiography for Internal Iliac Arteriography and Intervention.
Kishino, M, Nakaminato, S, Kitazume, Y, Miyasaka, N, Kudo, T, Saida, Y, Tateishi, U
Cardiovascular and interventional radiology. 2018;(7):1106-1111
Abstract
INTRODUCTION The usefulness of carbon dioxide (CO2) gas digital subtraction angiography (DSA) has been reported for patients with renal insufficiency and allergy to iodinated contrast agents. However, CO2 gas cannot replace the iodinated contrast agent in all cases owing to some disadvantages. We describe balloon-occluded CO2 DSA (B-CO2 DSA) as an improved CO2 DSA procedure for interventions in the internal iliac artery (IIA) region and compare the quality of images obtained using conventional CO2 DSA and B-CO2 DSA. MATERIALS AND METHODS B-CO2 DSA-guided embolization was performed for one case of genital bleeding with an acute anaphylactic reaction to the iodinated contrast agent and for three cases of type II endoleaks after endovascular abdominal aortic aneurysm repair with renal dysfunction. A 9-mm occlusion balloon catheter was placed just after the orifice of the IIA. Then, 10-15 ml of CO2 gas was injected manually via the catheter with and without balloon occlusion. The quality of sequential digital subtraction angiograms was analyzed based on a scoring criterion. RESULTS In all four cases, image quality was improved with B-CO2 DSA; the poor quality of images without balloon occlusion was because of reflux of the CO2 gas. CONCLUSIONS B-CO2 DSA improves the image quality of CO2 DSA in the IIA region and is useful for vascular intervention. LEVEL OF EVIDENCE Level IV.
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Effects of intravenous immunoglobulin therapy in Japanese patients with polymyositis and dermatomyositis resistant to corticosteroids: a randomized double-blind placebo-controlled trial.
Miyasaka, N, Hara, M, Koike, T, Saito, E, Yamada, M, Tanaka, Y, ,
Modern rheumatology. 2012;(3):382-93
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High-dose intravenous immunoglobulin (IVIG) therapy has been effective in treating various autoimmune and systemic inflammatory diseases. Here, we assessed the efficacy and safety of IVIG therapy with polyethylene glycol-treated human IgG (drug code GB-0998) for patients with corticosteroid-refractory polymyositis (PM) and dermatomyositis (DM) by means of a randomized, double-blind, placebo-controlled study. We randomly assigned 26 subjects (16 PM and 10 DM) to receive either GB-0998 or placebo. Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint (manual muscle test score) and secondary endpoints (serum creatine kinase level and activities of daily living score). However, significant improvements were also found in the placebo group, and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups. We discuss possible reasons for the absence of a clear intergroup difference in efficacy. Nineteen adverse drug reactions were observed in 11 of 26 subjects (42.3%), of which 2 events (decreased muscle strength and increased serum creatine kinase) were assessed as serious; however, they are previously known events. These results indicate that GB-0998 can be safely used with the same precautions as other current IVIG therapy.
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Humanized anti-interleukin-6-receptor antibody (tocilizumab) monotherapy is more effective in slowing radiographic progression in patients with rheumatoid arthritis at high baseline risk for structural damage evaluated with levels of biomarkers, radiography, and BMI: data from the SAMURAI study.
Hashimoto, J, Garnero, P, van der Heijde, D, Miyasaka, N, Yamamoto, K, Kawai, S, Takeuchi, T, Yoshikawa, H, Nishimoto, N
Modern rheumatology. 2011;(1):10-5
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Our aim was to assess the ability of tocilizumab monotherapy to reduce progressive structural joint damage in rheumatoid arthritis patients at high risk of progression. This study was a subanalysis from a prospective 1-year, multicenter, X-ray-reader-blinded, randomized controlled trial of tocilizumab [Study of Active Controlled Monotherapy Used for Rheumatoid Arthritis, an IL-6 Inhibitor (SAMURAI) trial]. All patients were categorized into two or three groups according to four independent predictive markers for progressive joint damage [urinary C-terminal crosslinking telopeptide (uCTX-II), urinary pyridinoline/deoxypyridinoline (uPYD/DPD) ratio, body mass index (BMI), and joint-space narrowing (JSN) score at baseline]. One-year progression of joint destruction was assessed in high-risk versus low-risk groups receiving tocilizumab monotherapy and compared with patients receiving conventional disease-modifying antirheumatic drugs (DMARDs) (n = 157 and 145, respectively). In patients at high risk of progression of erosion as estimated by high uCTX-II, uPYD/DPD, or low BMI, and at high risk of progression of JSN as estimated by low BMI or high JSN score, the 52-week changes in radiological erosion and JSN, respectively, were significantly less in patients treated with tocilizumab monotherapy compared with those receiving DMARDs for each type of risk factor. In patients at low risk, those receiving tocilizumab also progressed less than those on DMARDs, although the difference did not reach statistical significance. Tocilizumab monotherapy is more effective in reducing radiological progression in patients presenting with risk factors for rapid progression than in low-risk patients. Patients at high risk for progression may benefit more from tocilizumab treatment.
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A combination of biochemical markers of cartilage and bone turnover, radiographic damage and body mass index to predict the progression of joint destruction in patients with rheumatoid arthritis treated with disease-modifying anti-rheumatic drugs.
Hashimoto, J, Garnero, P, van der Heijde, D, Miyasaka, N, Yamamoto, K, Kawai, S, Takeuchi, T, Yoshikawa, H, Nishimoto, N
Modern rheumatology. 2009;(3):273-82
Abstract
The aim of this study was to evaluate the predictive value of biological, radiological and clinical parameters for the progression of radiographic joint damage in rheumatoid arthritis (RA) patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). We analyzed the 145 patients with active RA for less than 5 years who were participating in the prospective 1-year randomized controlled trial of tocilizumab (SAMURAI trial) as a control arm treated with conventional DMARDs. Progression of joint damage was assessed by sequential radiographs read by two independent blinded X-ray readers and scored for bone erosion and joint space narrowing (JSN) using the van der Heijde-modified Sharp method. Multivariate analysis revealed that increased urinary levels of C-terminal crosslinked telopeptide of type II collagen (U-CTX-II), an increased urinary total pyridinoline/total deoxypyridinoline (U-PYD/DPD) ratio and low body mass index (BMI) at baseline were independently associated with a higher risk for progression of bone erosion. In addition to these three variables, the JSN score at baseline was also significantly associated with an increased risk of progression of the JSN score and total Sharp score. High baseline U-CTX-II levels, U-PYD/DPD ratio and JSN score and a low BMI are independent predictive markers for the radiographically evident joint damage in patients with RA treated with conventional DMARDs.
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Efficacy of high-dose intravenous immunoglobulin therapy in Japanese patients with steroid-resistant polymyositis and dermatomyositis.
Saito, E, Koike, T, Hashimoto, H, Miyasaka, N, Ikeda, Y, Hara, M, Yamada, H, Yoshida, T, Harigai, M, Ichikawa, Y
Modern rheumatology. 2008;(1):34-44
Abstract
Intravenous immunoglobulin (IVIG) therapy was administered to 15 patients who were refractory to traditional steroid therapy [eight with polymyosis (PM), seven with dermamyosis (DM)] to evaluate its efficacy. Serum creatine kinase (CK) significantly decreased from week 1, and manual muscle test scores (MMT) and activities of daily living (ADL) significantly increased from week 2. Efficacy rates were 93.3% (14/15 patients) as assessed using the MMT score, 80.0% (12/15 patients) using the ADL score, and 100% (15/15 patients) using the serum CK level. When changes in the serum CK level over two four-week periods, one before IVIG therapy (from week -4 to week 0) and one after IVIG therapy (from week 0 to week 4), were transformed to natural logarithms, the four-week change after IVIG therapy was significantly greater than that before IVIG therapy. The estimated duration of the serum CK level remaining normal in 50% of the patients after IVIG therapy was 334.5 days. Adverse reactions were observed in seven of 16 patients (43.8%) during the study period, but none of the adverse reactions were considered to be serious or required emergency treatment. In conclusion, the present study indicates that IVIG therapy is effective for steroid-resistant PM/DM.
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[Diagnosis and therapy for mixed connective tissue diseases].
Nonomura, Y, Miyasaka, N
Nihon Naika Gakkai zasshi. The Journal of the Japanese Society of Internal Medicine. 2007;(10):2196-200
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Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a multicenter, double-blind, placebo-controlled trial.
Nishimoto, N, Yoshizaki, K, Miyasaka, N, Yamamoto, K, Kawai, S, Takeuchi, T, Hashimoto, J, Azuma, J, Kishimoto, T
Arthritis and rheumatism. 2004;(6):1761-9
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OBJECTIVE Interleukin-6 (IL-6) is a pleiotropic cytokine that regulates the immune response, inflammation, and hematopoiesis. Overproduction of IL-6 plays pathologic roles in rheumatoid arthritis (RA), and the blockade of IL-6 may be therapeutically effective for the disease. This study was undertaken to evaluate the safety and efficacy of a humanized anti-IL-6 receptor antibody, MRA, in patients with RA. METHODS In a multicenter, double-blind, placebo-controlled trial, 164 patients with refractory RA were randomized to receive either MRA (4 mg/kg body weight or 8 mg/kg body weight) or placebo. MRA was administered intravenously every 4 weeks for a total of 3 months. The clinical responses were measured using the American College of Rheumatology (ACR) criteria. RESULTS Treatment with MRA reduced disease activity in a dose-dependent manner. At 3 months, 78% of patients in the 8-mg group, 57% in the 4-mg group, and 11% in the placebo group achieved at least a 20% improvement in disease activity according to the ACR criteria (an ACR20 response) (P < 0.001 for 8-mg group versus placebo). Forty percent of patients in the 8-mg group and 1.9% in the placebo group achieved an ACR50 response (P < 0.001). The overall incidences of adverse events were 56%, 59%, and 51% in the placebo, 4-mg, and 8-mg groups, respectively, and the adverse events were not dose dependent. A blood cholesterol increase was observed in 44.0% of the patients. Liver function disorders and decreases in white blood cell counts were also observed, but these were mild and transient. There was no increase in antinuclear antibodies or anti-DNA antibodies. Anti-MRA antibodies were detected in 2 patients. CONCLUSION Treatment with MRA was generally well tolerated and significantly reduced the disease activity of RA.
