Post-marketing surveillance study of the long-term use of mizoribine for the treatment of lupus nephritis: 2-Year results

Takeuchi, Tsutomu; Okada, Kenya; Yoshida, Hisao; Yagi, Nobuyuki

doi:10.1080/14397595.2017.1349573

Cited by 12 publications

(5 citation statements)

References 26 publications

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“…The combination of MZR and CNI was enrolled as part of the same group as the combination of MMF and CNI in the present study, because it is a commonly used multi-targeted therapy for lupus nephritis in Japan [ 10 , 11 ]. Seroconversion rate and antibody titres were 75% and 473.5 U/ml (IQR, 233–1524.5) in patients with MZR and CNI ( n = 4), and 53.3% and 2.67 U/ml (IQR, 0–16.8) in those with MMF and CNI ( n = 15), respectively.…”

Section: Discussionmentioning

confidence: 99%

Antibody response to SARS-CoV-2 mRNA vaccines in patients with rheumatic diseases in Japan: Interim analysis of a multicentre cohort study

Kashiwado

Kimoto

Sawabe

et al. 2022

Modern Rheumatology

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Objectives To evaluate the impact of medication on antibody response to SARS-CoV-2 mRNA vaccines in Japanese patients with rheumatic diseases. Methods This prospective multicenter cohort study evaluated the humoral response in 12 different medication groups. Antibody levels before the first vaccination and 3-6 weeks after the second vaccination were measured using the Elecsys Anti-SARS-CoV-2 S assay. Statistical analysis included comparing antibody titers among the different medication groups using the Kruskal–Wallis test followed by the Bonferroni–Dunn test and multiple linear regression analysis. Results Two hundred and ninety-five patients were analyzed. The seroconversion rate was 92.2% and the median antibody titer was 255 U/ml (interquartile range, 34.1-685) after the second mRNA vaccination. Antibody levels were significantly lower in the groups treated with TNF inhibitor (TNFi) with methotrexate (MTX), abatacept, mycophenolate mofetil (MMF), MMF or mizoribine (MMF/MZR) combined with calcineurin inhibitor (CNI), and rituximab or cyclophosphamide (RTX/CPA) compared with those treated with sulfasalazine and/or bucillamine or CNI (p<0.01). The correlation between antibody titer and treatment was significant after adjusting for age, gender, and glucocorticoid dose (p<0.01). Conclusions Additional early vaccination is required in patients treated with TNFi and MTX, abatacept, MMF, MMF or MZR combined with CNI and CPA/RTX.

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Section: Discussionmentioning

confidence: 99%

Antibody response to SARS-CoV-2 mRNA vaccines in patients with rheumatic diseases in Japan: Interim analysis of a multicentre cohort study

Kashiwado

Kimoto

Sawabe

et al. 2022

Modern Rheumatology

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“…Overall, 63.3% of patients achieved complete or partial remission, and only 3.6% of patients experienced serious adverse drug reactions within 2 years of mizoribine treatment, and the authors concluded that mizoribine was safe and effective (Figure 93). 800 Practice Point 10.2.3.2.5: The total duration of initial immunosuppression plus combination maintenance immunosuppression for proliferative LN should not be <36 months.…”

Section: Rationalementioning

confidence: 99%

KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases

Rovin¹,

Adler²,

Barratt³

et al. 2021

Kidney International

1,214

883

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S28 Introduction S30 Summary of recommendation statements and practice points S88 Chapter 1: General principles for the management of glomerular disease S115 Chapter 2: Immunoglobulin A nephropathy (IgAN)/immunoglobulin A vasculitis (IgAV) S128 Chapter 3: Membranous nephropathy S140 Chapter 4: Nephrotic syndrome in children S153 Chapter 5: Minimal change disease (MCD) in adults S161 Chapter 6: Focal segmental glomerulosclerosis (FSGS) in adults S172 Chapter 7: Infection-related glomerulonephritis S187 Chapter 8: Immunoglobulin-and complement-mediated glomerular diseases with a membranoproliferative glomerulonephritis (MPGN) pattern of injury S193 Chapter 9: Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis S207 Chapter 10: Lupus nephritis S231 Chapter 11: Anti-glomerular basement membrane (Anti-GBM) antibody glomerulonephritis S235 Methods for guideline development S243 Biographic and disclosure information S254 Acknowledgments S256 ReferencesThis guideline is published as a supplement supported by KDIGO. The development and publication of this guideline are strictly funded by KDIGO, and neither KDIGO nor its guideline Work Group members sought or received monies or fees from corporate or commercial entities in connection with this work. The opinions or views expressed in this professional education supplement are those of the authors and do not necessarily reflect the opinions or recommendations of the International Society of Nephrology or Elsevier. Dosages, indications, and methods of use for products that are referred to in the supplement by the authors may reflect their clinical experience or may be derived from the professional literature or other clinical sources. Because of the differences between in vitro and in vivo systems and between laboratory animal models and clinical data in humans, in vitro and animal data may not necessarily correlate with clinical results.

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“…146,147 A post-marketing surveillance study that included 559 patients on mizoribin plus steroids (with or without tacrolimus) showed renal remission in 63.3% of patients, with 26.5% achieving complete renal remission at week 24, and a good safety profile. 148 More studies are needed in order to establish mizoribin efficacy versus placebo or other drugs in LN patients.…”

Section: Other Immunosuppressantsmentioning

confidence: 99%

Promising Experimental Treatments for Lupus Nephritis: Key Talking Points and Potential Opportunities

Neves¹,

Viveiros²,

Venturelli³

et al. 2023

RRU

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Lupus nephritis (LN) is a frequent and serious complication of systemic lupus erythematosus (SLE), impairing patients' quality of life and significantly increasing mortality. Despite optimizing the use of conventional immunosuppressants and other biological drugs, its management remains unsatisfactory. This is mainly due to the heterogeneity of SLE, but also to insufficiently effective treatment regimens and clinical trial limitations (strict criteria, low number of patients included, and side effects). Most clinical trials of new biological therapies have failed to meet their primary endpoints in both general SLE and LN, with only two biological drugs (belimumab and anifrolumab) being approved by the Food and Drug Administration (FDA) for the treatment of SLE. Recently, several Phase II randomized controlled trials have evaluated the efficacy and safety of new biologics in LN, and some of them have demonstrated an improvement in clinical and laboratory measures. Multi-target therapies are also being successfully developed and encourage a belief that there will be an improvement in LN outcomes.

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Post-marketing surveillance study of the long-term use of mizoribine for the treatment of lupus nephritis: 2-Year results

Cited by 12 publications

References 26 publications

Antibody response to SARS-CoV-2 mRNA vaccines in patients with rheumatic diseases in Japan: Interim analysis of a multicentre cohort study

Antibody response to SARS-CoV-2 mRNA vaccines in patients with rheumatic diseases in Japan: Interim analysis of a multicentre cohort study

KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases

Promising Experimental Treatments for Lupus Nephritis: Key Talking Points and Potential Opportunities

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