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  1. Article ; Online: Long-Term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis in Japan: 10-Year Analysis of the Real-World TRUST Study.

    Takeuchi, Tsutomu / Wakasugi, Naoko / Hashida, Tetsuji / Uno, Satoshi / Makino, Hirofumi

    The Journal of rheumatology

    2024  

    Abstract: Objective: To assess the long-term safety and effectiveness of tacrolimus as maintenance therapy in patients with lupus nephritis (LN) receiving treatment in real-world clinical settings in Japan.: Methods: An open-label, noncomparative, ... ...

    Abstract Objective: To assess the long-term safety and effectiveness of tacrolimus as maintenance therapy in patients with lupus nephritis (LN) receiving treatment in real-world clinical settings in Japan.
    Methods: An open-label, noncomparative, observational, prospective postmarketing surveillance study was conducted in 1395 patients with LN receiving maintenance treatment with tacrolimus at 278 medical institutions across Japan over a period of 10 years. Tacrolimus continuation rate and cumulative incidence of adverse drug reactions (ADRs), relapse, progression to renal failure, and progression to dialysis were calculated using Kaplan-Meier analysis.
    Results: Safety data were available for 1355 patients, almost half (49.3%) of whom remained on tacrolimus for the full 10 years of follow-up. A significant reduction in mean (SD) daily oral corticosteroid dose was observed from 16.0 (9.7) mg/day at 4 weeks after initiation of tacrolimus treatment to 7.2 (4.4) mg/day at year 10 (
    Conclusion: Tacrolimus was effective and generally well tolerated as maintenance therapy for LN in a large cohort of patients in Japan followed for 10 years, almost half of whom remained on therapy for the entire duration of follow-up. (ClinicalTrials.gov: NCT01410747).
    Language English
    Publishing date 2024-04-01
    Publishing country Canada
    Document type Journal Article
    ZDB-ID 194928-7
    ISSN 1499-2752 ; 0315-162X
    ISSN (online) 1499-2752
    ISSN 0315-162X
    DOI 10.3899/jrheum.2023-0210
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1168: Show issues Location:
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    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 135: Show issues

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  2. Article ; Online: Tacrolimus use and renal function in pregnancy with lupus nephritis: Analysis of post-marketing surveillance data in Japan.

    Suzuki, Kazuko / Uno, Satoshi / Wakasugi, Naoko

    Modern rheumatology

    2022  Volume 33, Issue 5, Page(s) 944–952

    Abstract: Objectives: Tacrolimus may be administered to pregnant women with lupus nephritis in Japan if considered therapeutically beneficial, but supporting data are limited. We assessed the safety and effectiveness of tacrolimus before, during, and after ... ...

    Abstract Objectives: Tacrolimus may be administered to pregnant women with lupus nephritis in Japan if considered therapeutically beneficial, but supporting data are limited. We assessed the safety and effectiveness of tacrolimus before, during, and after pregnancy in women with lupus nephritis receiving tacrolimus.
    Methods: This was an ad hoc analysis of data from a post-marketing surveillance study of tacrolimus in patients with lupus nephritis in Japan. Pregnancy outcomes, nephritis status, and adverse events were assessed for up to 2 years postpartum.
    Results: Data were available for 23 births in 21 patients (two patients had two births each). Tacrolimus for lupus nephritis was continued during 11 births in nine patients (during and after pregnancy) and discontinued in 12 patients (when pregnancy was known or when approaching delivery). Renal function was generally maintained in patients who gave birth while receiving tacrolimus; however, there were cases of increased urine protein and decreased renal function over 2 years. There were no unexpected adverse events/safety concerns.
    Conclusions: These data from clinical practice suggest that tacrolimus is a valid treatment option for lupus nephritis in fertile women in Japan and, with careful monitoring, pregnant women with lupus nephritis may continue their tacrolimus treatment.
    MeSH term(s) Humans ; Female ; Pregnancy ; Tacrolimus/adverse effects ; Immunosuppressive Agents/adverse effects ; Lupus Nephritis/drug therapy ; Japan ; Pregnancy Outcome ; Product Surveillance, Postmarketing ; Kidney/physiology
    Chemical Substances Tacrolimus (WM0HAQ4WNM) ; Immunosuppressive Agents
    Language English
    Publishing date 2022-08-18
    Publishing country England
    Document type Journal Article
    ZDB-ID 2078157-X
    ISSN 1439-7609 ; 1439-7595
    ISSN (online) 1439-7609
    ISSN 1439-7595
    DOI 10.1093/mr/roac094
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.B 2982: Show issues Location:
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  3. Article: Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan.

    Kuwana, Masataka / Wakasugi, Naoko / Furuya, Toshinori / Uno, Satoshi / Suda, Takafumi

    The Journal of rheumatology

    2022  Volume 49, Issue 7, Page(s) 707–718

    Abstract: Objective: The calcineurin inhibitor tacrolimus has been approved in Japan for the treatment of interstitial pneumonia (IP) in patients with polymyositis (PM) and dermatomyositis (DM). Postmarketing surveillance was initiated to examine long-term ... ...

    Abstract Objective: The calcineurin inhibitor tacrolimus has been approved in Japan for the treatment of interstitial pneumonia (IP) in patients with polymyositis (PM) and dermatomyositis (DM). Postmarketing surveillance was initiated to examine long-term outcomes of immunosuppressive regimens containing tacrolimus in real-world settings.
    Methods: Observational, prospective, postmarketing surveillance is ongoing in 179 patients with PM/DM-associated IP initiating treatment with tacrolimus. We report interim findings after 2 years of follow-up. Cumulative overall survival was assessed using Kaplan-Meier analysis. Potential prognostic factors for mortality were assessed by univariate Cox proportional hazards analysis.
    Results: A total of 170 patients were included in this analysis. At the time of starting treatment with tacrolimus, almost all patients were receiving corticosteroids (98.8%), and cyclophosphamide was additionally used in 42 patients (24.7%). Forty-nine patients (28.8%) discontinued tacrolimus during follow-up, mainly due to loss to follow-up, patient death, and adverse events. Mean (SD) oral corticosteroid dose decreased from 32.4 (21.6) mg/day at baseline to 7.6 (4.2) mg/day at 2 years. Overall survival at 2 years was 90.3%; corresponding progression-free survival was 62.5%. Factors found to be associated with all-cause mortality included diagnosis of clinically amyopathic DM (hazard ratio [HR] 9.04, 95% CI 1.18-69.51 vs PM), ferritin level 500 to < 1500 ng/mL (HR 8.61, 95% CI 2.51-29.45 vs < 500 ng/mL), and presence of antimelanoma differentiation-associated gene 5 antibodies (HR 8.16, 95% CI 1.03-64.47 vs absence).
    Conclusion: Immunosuppressive regimens containing tacrolimus appear useful for the management of IP in patients with PM/DM. [ClinicalTrials.gov: NCT02159651].
    MeSH term(s) Adrenal Cortex Hormones/adverse effects ; Dermatomyositis/complications ; Dermatomyositis/diagnosis ; Dermatomyositis/drug therapy ; Humans ; Immunosuppressive Agents/adverse effects ; Japan ; Lung Diseases, Interstitial/diagnosis ; Polymyositis/drug therapy ; Polymyositis/epidemiology ; Prospective Studies ; Retrospective Studies ; Tacrolimus/adverse effects
    Chemical Substances Adrenal Cortex Hormones ; Immunosuppressive Agents ; Tacrolimus (WM0HAQ4WNM)
    Language English
    Publishing date 2022-04-15
    Publishing country Canada
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 194928-7
    ISSN 1499-2752 ; 0315-162X
    ISSN (online) 1499-2752
    ISSN 0315-162X
    DOI 10.3899/jrheum.210322
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1168: Show issues Location:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
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    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 135: Show issues

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  4. Article: Long-term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis: 5-year Interim Postmarketing Surveillance Study in Japan (TRUST).

    Takeuchi, Tsutomu / Wakasugi, Naoko / Uno, Satoshi / Makino, Hirofumi

    The Journal of rheumatology

    2020  Volume 48, Issue 1, Page(s) 74–81

    Abstract: Objective: To assess the long-term safety and effectiveness of tacrolimus for treating lupus nephritis (LN) in the real-world clinical setting.: Methods: This is an ongoing, open-label, noncomparative, observational, postmarketing surveillance study ... ...

    Abstract Objective: To assess the long-term safety and effectiveness of tacrolimus for treating lupus nephritis (LN) in the real-world clinical setting.
    Methods: This is an ongoing, open-label, noncomparative, observational, postmarketing surveillance study conducted across 275 sites in Japan. Registered patients with LN were followed for 10 years. Here we report data relating to 5 years of tacrolimus maintenance therapy at the interim data cutoff in August 2016.
    Results: Of 1395 registered patients, 1355 received tacrolimus maintenance therapy for LN and provided safety data. The most common serious adverse drug reactions (ADR) included pneumonia (1.1%), herpes zoster (1.0%), cellulitis (1.0%), and diabetes mellitus (1.0%). ADR occurred mainly within the first 28 weeks of tacrolimus treatment, and no marked increase was observed during the follow-up period. Subgroup analyses suggested that risk factors for commonly observed ADR associated with tacrolimus included inpatient management, LN disease severity, increasing age, abnormal renal or hepatic function, and comorbid or previous disease. The cumulative rate of progression to renal failure (based on the attending physician's assessment) was 0.8% at Year 1 and 6.6% at Year 5. Cumulative relapse rates were 7.8% and 30.6%, respectively. Urine protein:creatinine ratio, serum anti-dsDNA antibody levels, complement C3 levels, and steroid-sparing effects were all significantly improved from 4 weeks after tacrolimus treatment initiation (
    Conclusion: Long-term tacrolimus maintenance treatment over 5 years in the real-world clinical setting was well tolerated and effective in a large population of patients with LN (www.ClinicalTrials.gov: NCT01410747).
    MeSH term(s) Humans ; Immunosuppressive Agents/adverse effects ; Japan ; Lupus Nephritis/drug therapy ; Tacrolimus/adverse effects ; Treatment Outcome
    Chemical Substances Immunosuppressive Agents ; Tacrolimus (WM0HAQ4WNM)
    Language English
    Publishing date 2020-04-01
    Publishing country Canada
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 194928-7
    ISSN 1499-2752 ; 0315-162X
    ISSN (online) 1499-2752
    ISSN 0315-162X
    DOI 10.3899/jrheum.191008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1168: Show issues Location:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 135: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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