Efficacy Of Tacrolimus Research Articles

P550. Long - term efficacy of Tacrolimus in Inflammatory Bowel Disease: a retrospective pilot study

P550. Long - term efficacy of Tacrolimus in Inflammatory Bowel Disease: a retrospective pilot study

Tacrolimus for remission induction in ulcerative colitis: Mayo endoscopic subscore 0 and 1 predict long-term prognosis

BackgroundTacrolimus has shown efficacy in patients with ulcerative colitis. AimsTo evaluate the efficacy of tacrolimus as remission induction therapy and assess medium to long-term outcomes in patients who achieve remission. MethodsForty-four ulcerative colitis patients who were treated with tacrolimus in three institutes during 2009–2013 were retrospectively reviewed. Short-term efficacy was based on the clinical activity index and the Mayo endoscopic subscores. Clinical activity index≤4 meant clinical remission, while Mayo endoscopic subscore 0 or 1 meant mucosal healing. Medium to long-term prognosis was based on relapse free survival in relation to the Mayo endoscopic subscore and duration of tacrolimus therapy in patients who achieved remission. ResultsAt 12 weeks, clinical remission was achieved in 29 of 44 patients (65.9%). Thirty-two patients received endoscopic evaluations, and mucosal healing rate was 43.8%. Among patients with clinical remission, mucosal healing rate was 60.9%. Relapse-free survival at 6, 12, and 24 months were 66%, 56%, and 50%, respectively, and was higher in patients on long-term tacrolimus (over 4 months, P=0.03), and patients with better endoscopic subscore (P=0.009). ConclusionsMucosal healing observed within 12 weeks or after a longer duration of tacrolimus therapy was associated with significantly better remission maintenance time.

Efficacy of tacrolimus eyedrops topical application for herpes simplex disciform stromal keratitis and its influence on tear

Background Herpes simplex virus (HSV) disciform stromal keratitis is a T cell-mediated delayed-type hypersensitivity of corneal stroma.The treatment of HSV disciform stromal keratitis is the combination of glucocorticoid and antiviral drug before.However, the therapy is limited for intolerantble patients to glucocorticoid.In addition, the adverse reactions following usage of glucocorticoid can not be ignored.FK506 solution is proved to has the immunosuppressive and antiinflammatory acttions with less side effects than glucocorticoid drug.But the study on the application of FK506 solution in treatment of HSV disciform stromal keratitis is lack. Objective This prospective clinical trail was to evaluate the efficacy of topical tacrolimus for HSV disciform stromal keratitis and its safety. Methods A prospective study was performed on 18 consecutive cases (18 eyes) who were diagnosed as active HSV disciform stromal keratitis from June 2011 to June 2012 in Zhongshan Ophthalmic Center under the approval of the Ethic Committee of Zhongshan Ophthalmic Center and informed consent of the patients, including 3 patients with refractory to prior steroid eyedrops.All patients received a combination topical tacrolimus eyedrops 4 times per day with topical and systemic anti-viral therapy for mean (56.0±7.9)days.Corneal thickness by slit lamp biomicroscope, visual acuity, intraocular pressure, corneal fluorescein staining, SchirmerⅠtest (SⅠt) and tear break-up time (BUT) were performed on the patients before and 1 month, 2 months after treatment and at the drug withdrawal to assess the treating efficacy of FK506, and the adverse reactions of eyes were recorded. Results Corneal edema was alleviated in (8.3±2.5)days after treatment in all the patients and returned to normality in (25.3±11.5) days.Corneal edema of 2 eyes with refractory to previous steroid eyedrops showed a slower recovery procedure than that of the others.Corneal fluorescence staining scores were 4(6, 2), 1(2, 1), 1(1, 0) and 0(1, 0) before and 1 month, 2 months and at drug withdrawal, respectively, with a significant difference among the four time points (H=39.90, P<0.001), and the scores were significantly lower after treatment than before (all at P<0.01).The SⅠt values were (6.78±1.90), (7.39±3.53), (8.06±2.92) and (8.11±3.05)mm/5 min, respectively in the 4 time points, without statistically significant difference among various time points (F=0.94, P=0.43).The BUT values were (0.39±0.50), (1.11±0.90), (2.00±1.08) and (3.39±0.92)seconds, respectively, showing a significant difference among the 4 time points (F=34.54, P<0.01) and had the increased values after treatment of FK506.Recurrence was seen in 2 eyes in 2 months and 5 months after cessation of tacrolimus.However, the eyes were healed after a second round regimen.No elevation of intraocular pressure and secondary infection were found in the patients during the treatment and follow-up period. Conclusions The combination therapy of tacrolimus with antiviral drug is effective and safe for HSV disciform stromal keratitis by alleviating corneal edema and promoting the rehabilitation of tear film. Key words: Tacrolimus/administration & dosage; Immunosuppressive agents/administration & dosage; Keratitis, herpetic/therapy; Drug administration schedul; Treatment outcome

Efficacy of tacrolimus in a case of adult onset Still’s disease

Efficacy of tacrolimus in a case of adult onset Still’s disease

Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up

ObjectiveTo compare the efficacy of tacrolimus (TAC) and mycophenolate mofetil (MMF) for the initial therapy of lupus nephritis (LN).Study designThis is an open randomised controlled parallel group study.MethodsAdult patients with...

Low-dose antithymocyte globulin enhanced the efficacy of tacrolimus and mycophenolate for GVHD prophylaxis in recipients of unrelated SCT

We performed a retrospective analysis of the outcome of 197 consecutive unrelated donor transplant recipients who received GVHD prophylaxis either TM regimen (tacrolimus and mycophenolate) (121 patients) or TM/ATG-G regimen (TM with low-dose antithymocyte globulin (ATG) of 4.5 mg/kg, ATG-G, Genzyme) (76 patients). Cumulative incidences of grade II-IV acute GVHD for the TM and TM/ATG-G cohorts were 49% and 61% (P=0.11) and grade III-IV acute GVHD for the TM and TM/ATG-G cohorts were 27% and 14% (P=0.02), respectively. There was no difference in the incidence of relapse or disease progression between TM and TM/ATG-G-16% and 23% (P=0.64). TM/ATG-G cohort had lower incidence of non-relapse mortality (NRM; 37% vs 20%, P=0.01), chronic GVHD (56% vs 43%, P<0.001) and more favorable global chronic GVHD severity (P<0.001). Univariate analyses showed improved OS and PFS of patients who received TM/ATG-G. Multivariate analysis confirmed TM/ATG-G had a favorable influence on OS (P=0.05) but not on PFS (P=0.07). We concluded that low-dose ATG of 4.5 mg/kg given in conjunction with TM improved GVHD prophylaxis without increased risk of relapse. Lower NRM, lower incidence and severity of chronic GVHD could potentially improve survival.

Efficacy of tacrolimus in the treatment of children with focal segmental glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS) is the most common glomerular condition leading to end-stage renal disease (ESRD) and the third most common cause of ESRD in pediatric patients. This is a retrospective study consisting of 22 pediatric patients with FSGS and heavy proteinuria. After demonstrating steroids resistance, the patients were treated with tacrolimus, targeting a trough level 5-8 ng/mL. The primary outcome is the induction of remission with tacrolimus. Thirteen patients (59%) achieved remission (complete in 31.8% and partial in 27.2%) and 12 patients showed stable or improved renal function over an average follow-up of 2.9 years (range: 0.5-7 years). There was no significant difference in response rate between African American and Caucasian patients. None of the patients had significant side-effect to tacrolimus and none of the repeat biopsies showed an increase in interstitial fibrosis compared to baseline. The best renal outcome was for patients who achieved complete remission. Partially responsive patients had improved renal function compared with resistant patients. Tacrolimus is a viable option in the treatment of children with idiopathic steroid resistant FSGS.

Su1402 Short and Long Term Outcomes of Severe Ulcerative Colitis Patients Treated With Tacrolimus and Infliximab

[Background&Aim] The therapeutic strategy of severe ulcerative colitis (UC) is challenging. There are a few studies evaluating the efficacy of tacrolimus (TAC) or infliximab (IFX) in severe UC patients. In current situation, the safety and efficacy of the sequential approaches (TAC→IFX / IFX→TAC) in severe UC patients remain unknown. The aim of this study was to assess short and long term outcomes of severe UC patients treated with TAC and IFX. [Methods] From October 2001 to October 2013, consecutive 29 severe UC patients treated with TAC or IFXwere retrospectively enrolled (mean follow up 27months). Clinical remission was defined as modified Truelove Witts severity index (MTWSI) of less than 5. Clinical response was defined as a decrease of MTWSI of at least 4 points from baseline. TAC was administered orally at the initial dose of 0.1 mg/kg per day and was adjusted to produce whole-blood trough levels of 10 to 15 ng/mL. IFX was administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks as induction therapy and every 8 weeks as maintenance therapy. The primary endpoint of this study was short-term response at 8 weeks after induction of TAC or IFX. Secondary endpoints included colectomy-free survival and treatment safety. Cumulative colectomy free survival was assessed using the Kaplan-Meir method. A univariate analysis was performed to detect the predictive valuables related to colectomy. [Results] Of the 29 patients, 22 and 7 patients were firstly treated with TAC (TAC group) and with IFX (IFX group), respectively. Induction of remission ratio at 8weeks in TAC and IFX group were 64% and 57%, respectively. No significant difference of induction of remission was observed between two groups. During this observational study, in TAC group, 11 patients (50%) kept clinical remission by TAC or thiopurines and 6 patients (27%) required IFX (TAC→IFX) for maintaining clinical remission. In IFX group, 3 patients (43%) kept clinical remission by IFX and 3 patients (43%) required TAC (IFX→TAC) formaintaining clinical remission. Of the 29 patients, 6 patients (21%) required colectomy, and 5 of them did not respond to the sequential approaches. Cumulative colectomy free survival rate was 79.3 % at 118 months. The positivity of CMV-DNA in colonic mucosa was a significant predictor in colectomy. The initial treatment (TAC or IFX), gender, age, extent of disease, MTWSI and endoscopic Mayo score were not predictors in colectomy. No severe adverse event was observed during this observational study. [Conclusion] Our data suggested that treatment with TAC and IFX, and the sequential approaches (TAC→IFX or IFX→TAC) made it possible to avoid colectomy in severe UC patients, although greater consideration should be given to the serious infection.

The efficacy of tacrolimus in patients with interstitial lung diseases complicated with polymyositis or dermatomyositis.

Interstitial lung diseases (ILDs) complicated with PM or DM are frequently aggressive and refractory to treatment. Recently some reports have suggested the potential benefit of tacrolimus for severe ILD complicated with PM/DM. However, little evidence has yet shown the efficacy of tacrolimus in these settings. The aim of this study was to evaluate the efficacy of tacrolimus as a treatment for PM-/DM-related ILD. This retrospective study comprised 49 previously untreated patients diagnosed as PM-/DM-related ILD admitted to Hokkaido University Hospital from January 2000 to July 2013. These patients were treated with tacrolimus plus conventional therapy or only with conventional therapy (prednisolone, i.v. CYC and/or ciclosporin). The primary endpoint was defined as the time to relapse or death of respiratory cause or a serious adverse event. The secondary endpoint was defined as the time from the initiation of immunosuppressive treatment to relapse or death of respiratory cause. Endpoints were compared by adjusted Cox regression model by using inverse probability of treatment weighting in order to reduce the impact of these selection biases and potential confounding factors. After adjustment, the tacrolimus group (n = 25) had significantly longer event-free survival as compared with the conventional therapy group (n = 24). The weighted hazard ratio (HR) was 0.32 (95% CI 0.14, 0.75, P = 0.008). In addition, the tacrolimus group had significantly longer disease-free survival as compared with the conventional therapy group. The weighted HR was 0.25 (95% CI 0.10, 0.66, P = 0.005). The addition of tacrolimus to conventional therapy significantly improved the prognosis of patients with PM-/DM-related ILD.

Assessment of the adjuvant effect of tacrolimus in the management of pemphigus vulgaris: A randomized controlled trial

Introduction: To investigate the therapeutic efficacy of tacrolimus compared with azathioprine in the treatment of pemphigus vulgaris.Methods: About 23 patients received prednisolone and azathioprine, and 23 patients prednisolone and tacrolimus for 6 months. Pemphigus activity scores, the time that new bulla formation stopped, the time corticosteroid was tapered, cumulative steroid dosage and medication side effects were analyzed.Results: In the control group, the new bulla formation was ceased after a mean ± SD of 11.8 ± 4.7 days, and steroid tapering was done after a mean ± SD of 28.3 ± 5.45 days. Of the 23 patients receiving prednisolone and tacrolimus, the new bulla formation was ceased after a mean ± SD of 12.9 ± 5.26 days, and steroid tapering was done after a mean ± SD of 28.2 ± 5.39 days. About 8.6% of patients did not reach remission in each group. In patients receiving azathioprine, life-threatening side effects were seen in 1 (4.7%), moderate side effects in 2 (9.5%) and mild side effects in 1 (4.7%). In patients receiving tacrolimus, moderate side effect was seen in 1 (5%) and mild in 1 (5%).Conclusion: Tacrolimus effects are comparable to azathioprine as pemphigus vulgaris adjuvant treatment, also it has less severe side effects. Trial registration No. IRCT2012073010450N1 available at www.IRCT.ir

Impact of the CYP3A5, CYP3A4, COMT, IL-10 and POR Genetic Polymorphisms on Tacrolimus Metabolism in Chinese Renal Transplant Recipients

Tacrolimus is a widely used immunosuppressive drug for preventing the rejection of solid organ transplants. The efficacy of tacrolimus shows considerable variability, which might be related to genetic variation among recipients. We conducted a retrospective study of 240 Chinese renal transplant recipients receiving tacrolimus as immunosuppressive drug. The retrospective data of all patients were collected for 40 days after transplantation. Seventeen SNPs of CYP3A5, CYP3A4, COMT, IL-10 and POR were identified by the SNaPshot assay. Tacrolimus blood concentrations were obtained on days 1–3, days 6–8 and days 12–14 after transplantation, as well as during the period of the predefined therapeutic concentration range. Kruskal–Wallis test was used to examine the effect of genetic variation on the tacrolimus concentration/dose ratio (C 0/D) at different time points. Chi-square test was used to compare the proportions of patients who achieved the target C 0 range in the different genotypic groups at weeks 1, 2, 3 and 4 after transplantation. After correction for multiple testing, there was a significant association of C 0/D with CYP3A5*3, CYP3A4*1G and CYP3A4 rs4646437 T>C at different time points after transplantation. The proportion of patients in the IL-10 rs1800871-TT group who achieved the target C 0 range was greater (p = 0.004) compared to the IL-10 rs1800871-CT and IL-10 rs1800871-CC groups at week 3 after transplantation. CYP3A5*3, CYP3A4 *1G, CYP3A4 rs4646437 T>C and IL-10 rs1800871 C>T might be potential polymorphisms affecting the interindividual variability in tacrolimus metabolism among Chinese renal transplant recipients.

Comparison of efficacy of tacrolimus among different prescribing patterns in patients with rheumatoid arthritis

Comparison of efficacy of tacrolimus among different prescribing patterns in patients with rheumatoid arthritis

P-086 Short-Term and Long-Term Therapeutic Outcomes of Tacrolimus Treatment for Refractory Ulcerative Colitis, and the Prognostic Factors for Surgery

Little is known about the long-term therapeutic outcomes of tacrolimus (Tac) treatment for refractory ulcerative colitis (UC) and the prognostic factors for surgery. The aim of this study was to ascertain both the short- and long-term therapeutic outcomes of Tac for refractory UC and the prognostic factors for surgery. A total of 66 refractory UC patients (median age, 39 years; median disease duration, 43 months; median disease activity index [DAI] score, 11) undergoing treatment with Tac at our hospital between 2004 and 2012 were enrolled in this study. This study investigated the following items:(1) short-term clinical response was evaluated based on a partial DAI score (DAI score without endoscopy) at week 6. Remission was defined as a partial DAI score of 1 point or lower. Improvement was defined as a reduction in partial DAI score of more than 3 points, but not a remission. No response was defined other than above; (2) long-term therapeutic outcomes, with the overall cumulative colectomy -free survival was calculated using the Kaplan-Meier method. We also calculated a Colectomy-free survival according to short-term efficacy of tacrolimus; (3) factors affecting short-term surgery, assessed by comparing clinical attributes, laboratory findings, and endoscopic findings at the time of first Tac use both in patients who underwent short-term surgery and in those who did not. Multivariate analysis was also performed. (1) Six weeks after starting Tac, 19 patients had achieved remission, 29 had achieved improvement, and no response was seen in 18, indicating a short-term efficacy rate of 48/66 (73%). Ten of the 18 patients in whom no response was seen underwent surgery within 6 weeks of starting Tac, indicating a short-term surgery avoidance rate of 56/66 (85%). (2) The median follow-up period was 32.8 months, and 18 of the 66 patients (27%) underwent surgery, with a cumulative colectomy-free survival was estimated to be 67% at 98 months. The colectomy-free survival was significantly higher in the group with a favorable short-term response to tacrolimus than the group with an unfavorable response (P = 0.026). (3) Multivariate analysis revealed that deep excavated ulcers were a risk factor for short-term surgery (odds ratio, 13.4; 95% confidence interval [CI], 1.5–117.2). Tac was effective for inducing clinical remission of patients with steroid refractory ulcerative colitis, although approximately one-third of patients required surgery in the long term. Deep excavated ulcers were a risk factor for short-term surgery, and poor short-term response to Tac was a risk factor for long-term surgery. Our study suggested that it might be important to take these risk factors into consideration when evaluating the use of Tac.

Antithymocyte Globulin (Rabbit) Enhanced The Efficacy Of Tacrolimus and Mycophenolate For Graft-Versus-Host Disease Prophylaxis In Recipients Of Unrelated Stem Cell Transplant Resulting In Improvement Of Survival

IntroductionAntithymocyte globulin (ATG, Thymoglobulin, Genzyme) derived from New Zealand rabbit immunized with fresh thymocytes has diverse biologic activities against immune response antigens, adhesion and cell-trafficking molecules. These properties are conceptually critical for effective immunosuppression to prevent organ rejection or GVHD. In this study we tested the efficacy of the combination of ATG, tacrolimus (T) and mycophenolate mofetil (M) in the prevention of GVHD in the recipients of allogeneic stem cell transplant from unrelated donor (UHCT). MethodsFrom June 2008 to December 2012, we performed UHCT in 197 consecutive patients with hematologic malignancies: ALL (N=24), AML (N=85), CLL (N=16), CML (N=8), Hodgkin lymphoma (N=2), MDS/MPN (N=35), non-Hodgkin lymphoma (N=25), myeloma (N=1) and prolymphocytic leukemia (N=1). Patients received either TM (N=121) or ATG-TM (N=76) for GVHD prophylaxis. The distribution of diagnosis between TM and ATG-TM was not different (P=0.72). TM was started on day -3. T dose was 0.03 mg/kg continuous IV daily, M was administered IV at the dose of 10 mg per kg every 8 hours and converted to oral route when patients tolerated oral intake. M was discontinued on day 30 if patients did not develop acute GVHD. ATG total dose of 4.5 mg/kg IV was given daily over 3 days. Stem cell graft was infused within 24 hours of the last dose of ATG. The intensity of the regimen was categorized according to CIBMTR criteria. Disease-risk category was classified as low-risk if CR1, intermediate-risk if CR2 and high-risk if presence of active disease. DemographicsATG-TM cohorts were older, median age 56 vs 52 (P=0.04). Patients with high-risk disease were more likely to receive RIC (P=0.004). There were higher proportion of patients with mismatched graft (P=0.004), and RIC (P=0.005) who received ATG-TM. The remaining other characteristics - HCT-CI score and sex were evenly distributed between TM and ATG-TM. Median follow up for survivors was 20 months. ResultsCumulative incidence of grade II-IV acute GVHD for the TM and ATG-TM cohorts were 49% (95% CI, 39%-59%) and 61% (95%CI, 49%-73%)(P=0.11). Incidence of grade III-IV acute GVHD for the TM and ATG-TM cohorts were 27% (95% CI, 19%-35%) and 14% (95%CI, 4%-24%)(P=0.02) (Fig A). There was no difference in the incidence of relapse or disease progression between TM and ATG-TM cohorts, 16% (95%CI, 8%-24%) vs 23% (95%CI, 0%-47%) (P=0.64). Non-relapse mortality was significantly lower in ATG-TM cohort, 20% (95%CI, 10%-30%) vs 37% (95%CI, 29%-45%) (P=0.01) (Fig B). Cumulative incidence of chronic GVHD was 43% (95%CI, 40% - 72%) in patients who received ATG-TM and 56% (95%CI, 46% - 66%) in TM cohort (P<0.001). Patients receiving ATG-TM had a significantly lower severity of chronic GVHD than patients receiving TM (P=0.004). In univariate analysis, disease-risk status correlated with PFS. PFS at 4 years for low-risk disease was 72% (95%CI, 60%-84%, N=66), 44% (95%CI, 24%-64%, N=24) for intermediate-risk and 36% (95%CI, 24%-48%, N=107) for high-risk disease (P<0.001). PFS at 2 years was better in ATG-TM cohort compared to TM cohort: 54% (95%CI, 32%-76%, N=76) vs 43% (95%CI, 33%-53%, N=121) (P=0.02) (Fig C). Multivariate analysis showed high-risk disease status was independently predictive of poor PFS (P<0.001) and intermediate-risk disease was marginally significant (P=0.05). ATG-TM cohort showed a trend of improved PFS (P=0.07). Disease-risk status at the time of transplant correlated with overall survival (OS) at 4 years: 72% (95%CI, 60%-84%, N=66)) for low risk, 51% (95%CI, 26%-76%, N=24) for intermediate risk and 34% (95%CI, 20%-48%, N=107) for high-risk group (P<0.001), respectively. OS at 2 years was significantly better in ATG-TM cohort: 64% (95%CI, 48%-80%, N=76) vs 49% (95%CI, 39%-59%) (P=0.01) in TM cohort. There were no significant difference among patients who received 9/10 vs 10/10 matched donor, intensity of preparative regimen, and HCT-CI. Multivariate analysis revealed unfavorable impact of high-risk disease and favorable OS in patients who received ATG-TM for GVHD prophylaxis. ConclusionATG dose of 4.5 mg/kg given in conjunction with TM improved the efficacy of GVHD prophylaxis without increased risk of relapse. Lower non-relapse mortality, lower incidence of severe acute and chronic GVHD resulting in improvement of OS and PFS in the ATG-TM cohort. [Display omitted] [Display omitted] [Display omitted] Disclosures:Off Label Use: Thymoglobulin is approved only for renal transplant rejection. Al-Kadhimi:Genzyme: Research Funding.

Safety and Efficacy of Tacrolimus in Connective Tissue Disease-Related Interstitial Lung Disease

Safety and Efficacy of Tacrolimus in Connective Tissue Disease-Related Interstitial Lung Disease

Tacrolimus Decreases Albuminuria in Patients with IgA Nephropathy and Normal Blood Pressure: A Double-Blind Randomized Controlled Trial of Efficacy of Tacrolimus on IgA Nephropathy

BackgroundTreatment remains uncertain for IgA nephropathy patients with mild to moderate proteinuria, for whom anti-hypertensive medication or the RAS blocker is not applicable due to low blood pressure.Trial designA double blinded randomized trial.MethodsThe anti-proteinuric effect of tacrolimus was explored for 40 biopsy-proven mild IgA nephropathies for 16 weeks. We randomly assigned patients either to receive tacrolimus or placebo with stratification by using a renin angiotensin system blocker. The primary outcome was the percentage change of final UACR compared to the baseline value (pcUACR).ResultsThe mean value of pcUACR at 12-week and 16-week visits (primary outcome) was decreased more in the Tac group compared to the control group (–52.0±26.4 vs –17.3±29.3%, p = 0.001). At each visit, pcUACR was also decreased more in the Tac group compared to the control group. In the Tac group, the pcUACRs were –60.2±28.2%, –62.2±33.9%, –48.5±29.8%, and –55.5±24.0%, and, in the control group, –6.8±32.2%, –2.5±35.9%, –12.7±34.2%, and –21.9±30.6%, at 4-week, 8-week, 12-week, and 16-week visits, respectively. The pre-defined secondary outcomes were better in the Tac group compared to the control group. The frequency of decrease in pcUACR and percentage change of UPCR (pcUPCR) ≥50% at 16 weeks were 65.0% (13/20) and 55.0% (11/20)in the Tac group, and 25.0% (5/20) and 15.0% (3/20), in the control group, respectively (p = 0.025 for pcUACR and p = 0.019 for pcUPCR). However, tacrolimus wasn't effective with a dose of 0.05 mg/kg/day in patients taking ARB. The adverse events were tolerable.ConclusionTacrolimus effectively reduced proteinuria in IgA nephropathy with normal blood pressure. This suggested that tacrolimus could be an alternative to corticosteroid and RAS blocker for IgA nephropathy patients who cannot endure anti-hypertensive medication.Trial RegistrationClinicaltrial.gov NCT1224028

Efficacy of adjunct tacrolimus treatment in patients with rheumatoid arthritis with inadequate responses to methotrexate

Objectives We aimed to assess the efficacy of tacrolimus (TAC) as an add-on therapy in patients with rheumatoid arthritis (RA) who were previously treated with methotrexate (MTX) but not with biologics.Methods The study group (MTX + TAC group) consisted of 157 patients (selected from among the patients in the Institute of Rheumatology, Rheumatoid Arthritis [IORRA] RA cohort from April 2005 to October 2009) who received add-on therapy with TAC in addition to MTX, but without biologics. A propensity score (PS) for the use of TAC was derived, and 471 PS-matched patients who received MTX alone or MTX with other non-biologic disease-modifying antirheumatic drugs (except for TAC), but not with biologics, were selected and served as the control group. Changes in disease activity in the two groups during three consecutive IORRA phases were analyzed by adjusting for confounding factors.Results The median 28-joint disease activity score (DAS28) decreased from 4.58 to 3.70 in the MTX + TAC group and from 4.12 to 3.61 in the control group. After adjusting for confounding factors, the decrease in the DAS28 score in the MTX + TAC group was significantly larger (by 0.273 points) than that in the control group (P < 0.05).Conclusion: This study demonstrated the efficacy of add-on therapy with TAC to MTX in patients with RA in daily practice.

AB0614 Comparison of efficacy of tacrolimus among defferent prescribing patterns in patients with rheumtoid arthritis

BackgroundTacrolimus (TAC), a calcineurin inhibitor, is used in the treatment of rheumatoid arthritis (RA) in Japan. Efficacy of TAC has been reported in several studies [1, 2]. TAC is prescribed...

THU0285 Long-Term Safety and Efficacy of Tacrolimus for Lupus Nephritis Patients –Interim Analysis of Post Marketing Surveillance in 1375 Patients in Japan (Trust Study)

BackgroundTacrolimus (TAC) is an immunosuppressive macrolide that blocks T cell activation by specifically inhibiting calcineurin, and it is widely administered following organ transplantation. Recently some randomized studies have shown that...

AB0377 Efficacy of tacrolimus combination therapy during the maintenance phase of systemic lupus erythematosus

BackgroundIn Japan, a placebo-controlled clinical trial of tacrolimus for lupus nephritis was performed to investigate the efficacy and safety of this agent. Based on the results obtained, administration of tacrolimus...