Versus Mycophenolate Mofetil Research Articles

Post-Transplant Cyclophosphamide, Tacrolimus (TAC) or Cyclosporine a and Mycophenolate Mofetil Versus Anti-Thymocyte Globulin, TAC, Methotrexate Combinations As Graft-versus-Host Disease Prophylaxis Post Allogeneic Stem Cell Transplantation from Sibling and Unrelated Donors in Patients with Acute Myeloid Leukemia: a Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

Post-Transplant Cyclophosphamide, Tacrolimus (TAC) or Cyclosporine a and Mycophenolate Mofetil Versus Anti-Thymocyte Globulin, TAC, Methotrexate Combinations As Graft-versus-Host Disease Prophylaxis Post Allogeneic Stem Cell Transplantation from Sibling and Unrelated Donors in Patients with Acute Myeloid Leukemia: a Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

CO189 Comparative Efficacy of Voclosporin in Combination With Mycophenolate Mofetil Versus Other Treatments in Active Lupus Nephritis: Systematic Review and Network Meta-Analysis

CO189 Comparative Efficacy of Voclosporin in Combination With Mycophenolate Mofetil Versus Other Treatments in Active Lupus Nephritis: Systematic Review and Network Meta-Analysis

Effect of Rituximab Versus Mycophenolate Mofetil or Cyclophosphamide as Control in Lupus Nephritis: A Meta-Analysis

Objective: To evaluate the effects of rituximab versus mycophenolate mofetil or cyclophosphamide as control in lupus nephritis by meta-analysis. Methods: A systematic search was carried out up to January 2022, obtaining 7 studies involving 645 participants with lupus nephritis at the commencement of the investigation; 198 of them were treated with rituximab, while 447 were treated with mycophenolate mofetil or cyclophosphamide. We determined the odds ratio (OR) and mean difference (MD) with 95% confidence index (CI) to compare rituximab’s efficacy to that of mycophenolate mofetil or cyclophosphamide as control in lupus nephritis using random- or fixed-effects model by dichotomous or continuous techniques. Results: The rituximab group showed significantly higher complete renal remission rate (OR = 2.52; 95% CI 1.30–4.91, P = 0.006) and total renal remission rates (OR = 2.22; 95% CI 1.36–3.63, P = 0.001) than the control group. However, there was no significant difference in terms of end Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score (MD -1.16; 95% CI -2.88–0.57, P = 0.19), proteinuria (MD -0.31; 95% CI -0.70–0.09, P = 0.013), and serum creatinine (MD 0.01; 95% CI -0.04–0.07, P = 0.64) between the rituximab group and the control. Conclusion: Rituximab exhibited significantly greater complete renal remission rate and total renal remission rates, with no significant difference in terms of shorter-end SLEDAI, proteinuria, and serum creatinine, compared with the control in individuals with lupus nephritis.

Azathioprine Versus Mycophenolate Mofetil in Combination with Tacrolimus and Steroids Maintenance in Pediatric Kidney Transplantation

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A Prospective Randomized, Comparative Trial of High-Dose Mizoribine Versus Mycophenolate Mofetil in Combination With Tacrolimus and Basiliximab for Living Donor Renal Transplant: A Multicenter Trial.

Our objectives were to compare the clinical outcomes of mizoribine (12 mg/kg/d) and mycophenolate mofetil (2000 mg/d) in combination with tacrolimus, basiliximab, and corticosteroids. We enrolled 83 recipients of living-donor renal transplant (performed between 2008 and 2013) in this study. This prospective multi-institutional randomized comparative study compared mizoribine (n = 41) and mycophenolate mofetil (n = 42) in combination with tacrolimus, basiliximab, and corticosteroids for living-donor renal transplant recipients. We compared the acute rejection and graft survival rates and adverse event rates within 1 year of renal transplant between the 2 groups using intention-to-treat analyses. During the 1-year observation period, patient and graft survival rates were 100%. The acute rejection rate was 17.1% in the mizoribine group and 19% in the mycophenolate mofetil group. The incidence rate of cytomegalovirus infection seropositivity (recipient and donor with positive cytomegalovirus antibody status) was higher in the mycophenolate mofetil group than in the mizoribine group, although the difference in these rates was not statistically significant. The incidence of leukopenia was higher in the mizoribine group than in the mycophenolate mofetil group. High-dose mizoribine at 12 mg/kg/day was a safe and efficacious immunosuppressive alternative to mycophenolate mofetil in living-donor renal transplant recipients. Leukopenia should be closely monitored in the initial period of insufficient kidney function after renal transplant.

WITHDRAWN: Efficacy and Safety of Mycophenolate Mofetil Versus Levamisole in Children and Adolescents With Idiopathic Nephrotic Syndrome: Results of a Randomized Clinical Trial.

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A 1-Year Randomized Controlled Study of Everolimus Versus Mycophenolate Mofetil With Reduced-Dose Cyclosporine in Maintenance Heart Transplant Recipients

BackgroundThe aim of this study was to demonstrate noninferiority of everolimus with reduced cyclosporine (CsA) vs mycophenolate mofetil (MMF) with reduced CsA in improving renal function. MethodsIn this 1-year randomized, open-label, noninferiority study in maintenance heart transplant recipients with impaired renal function 70 patients received everolimus (n = 36) or MMF (n = 34) in combination with reduced CsA. The planned sample size was not reached as the study was prematurely discontinued due to slow recruitment. ResultsNoninferiority of the everolimus regimen could not be shown: In the total population MMF seemed to be favorable on renal function assessed by serum creatinine and filtration rates, but not in the subset of patients who reached the intended reduced CsA level. Incidence rates of rejection episodes were significantly higher under MMF at month 6 (P = .0332). ConclusionsOverall, the results of this trial using reduced CsA in combination with either everolimus or MMF show that there is evidence to reduce the CsA level when everolimus is given concomitantly and that the benefit of MMF with reduced CsA levels is limited due to insufficient immunosuppression.

Long-term Outcome of Azathioprine Versus Mycophenolate Mofetil in Cyclosporine-Based Immunosuppression in Kidney Transplantation: 10 Years of Experience at a Single Center

BackgroundMycophenolate mofetil (MMF) has been used worldwide as part of maintenance immunosuppression since initial large cyclosporine-based trials reported that compared with azathioprine (AZA), MMF reduced acute rejection episodes after renal transplantation. However, long-term benefits of MMF have not been established; the follow-up period of previous studies was within 5 years. The aim of this study was to compare the acute rejection rates, allograft function, and graft and patient survivals of these 2 drugs in conjunction with cyclosporine and steroids over a period of 10 years. MethodsWe reviewed recipients who had undergone kidney transplantation from January 1998 to January 2002. Eighty-six patients were divided into 2 groups (MMF = 43, AZA = 43). All patients received cyclosporine and steroids concomitantly as maintenance immunosuppressive therapy. ResultsBaseline characteristics were similar between the 2 groups except donor type. Multiple logistic regression analysis showed MMF therapy to reduce the acute rejection rate in the first 12 months after transplantation (relative risk [RR], 0.181; 95% confidence interval [CI], 0.035–0.936; P = .042). Cox proportional hazard analysis revealed MMF to was not associated with improved graft and patient survival. Graft function was comparable between the 2 groups over 10 years. No significant differences were observed in the incidence of serious infections or malignancy. ConclusionsCompared with AZA, MMF offered the clinical benefit of prevention of acute rejection episodes, but displayed similar effects on long-term graft and patient survivals in kidney transplant recipients undergoing cyclosporine-based immunosuppression.

Mizoribine Versus Mycophenolate Mofetil in Combination Therapy With Tacrolimus for De Novo Kidney Transplantation: Evaluation of Efficacy and Safety

The present study compared the efficacy and safety of mizoribine (MZR) with mycophenolate mofetil (MMF) in kidney transplantation. This multicenter, randomized clinical trial. Employed doses of study drug tailored to the immunosuppressive need. The primary efficacy outcome was the incidence of biopsy-proven acute rejection episodes (BPAR). The safety of the study drug was assessed using the incidences of adverse events, drug discontinuations, and abnormal laboratory results. The 7 (6.4%) BPARs above grade II were observed in the MZR group noninferior to the 2 (1.8%) in the MMF group (95% confidence interval, −0.007–0.097 > noninferiority limit [−0.2]). BPAR was significantly decreased in the MZR group after the dose change (17/41 [41.4%] vs 8/69 [11.6%]; P < .0001) and the incidence of BPAR was similar between the MZR and MMF groups after the dose change (P = .592). The uric acid level was significantly elevated in the MZR group (P = .002). In conclusion, the efficacy and safety of MZR were similar and statistically noninferior to MMF in combination therapy with tacrolimus.

DGI-050 Off-Label Uses of Mycophenolate Mofetil

BackgroundThe implementing Law 1015/2009 normalises the compassionate use of investigational drugs, access to off-label and unauthorised drugs in Spain.Mycophenolate mofetil/Mycophenolic Acid (MM/MA) have been used in off-label conditions to treat...

24-Month Safety and Efficacy of Concentration Controlled Everolimus with Reduced Cyclosporine Versus Mycophenolate Mofetil in 721 De Novo Heart Transplant Recipients: Results from the A2310 Study

24-Month Safety and Efficacy of Concentration Controlled Everolimus with Reduced Cyclosporine Versus Mycophenolate Mofetil in 721 De Novo Heart Transplant Recipients: Results from the A2310 Study

Long-Term Outcome of Azathioprine Versus Mycophenolate Mofetil in a Cyclosporine-Based Immunosuppression in Kidney Transplant: 10 Years Experience at Single Center

Introduction: Mycophenolate mofetil (MMF) has been used worldwide as a part of maintenance immunosuppression since initial cyclosporine-based large trials found that MMF reduced acute rejection episodes compared with azathioprine (AZA) after renal transplantation. However, long-term benefits of MMF have not been established and the follow-up period of the previous studies was within 5 years. We aimed to compare acute rejection rate and graft and patient survival of these two drugs in conjunction with cyclosporine and steroids over 10 years. Methods: We reviewed kidney transplant recipients who had been transplanted from January 1998 to January 2002. Eighty-six patients were recruited and divided into two groups (MMF group=43 vs. AZA group=43). All patients received cyclosporine and steroids concomitantly as maintenance immunosuppressive therapy. We analyzed for the incidence of biopsy-proven acute rejection, allograft function, and graft and patient survival. Results: Baseline characteristics were similar between both groups except donor type. The deceased donor was 8 patients in the MMF group and 1 patient in the AZA group. Over 10 years after transplantation, fewer biopsy-proven acute rejection occurred in MMF group than AZA group (11.6% vs. 30.2%, respectively, p=0.037). The 10-years graft survival was 93% in MMF group and 81.4% in AZA group, but the difference was not significant (p=0.113). During 10 years, one patient (2.3%) in the MMF group and 4 patients (9.3%) in the AZA group died (p=0.184). Graft function was comparable between the two groups over 10 years. There was no significant difference in the incidence of serious infections. Over the 10 year posttransplant period, 5 patients developed malignancies (one in the MMF group vs. 4 in the AZA group). Conclusions: MMF offered clinical benefit for preventing acute rejection and had similar effects on the long term graft and patient survival in kidney transplant recipients with cyclosporine-based immunosuppression.

Long-Term Outcome of Azathioprine Versus Mycophenolate Mofetil in a Cyclosporine-Based Immunosuppression in Kidney Transplant: 10 Years Experience at Single Center

Introduction: Mycophenolate mofetil (MMF) has been used worldwide as a part of maintenance immunosuppression since initial cyclosporine-based large trials found that MMF reduced acute rejection episodes compared with azathioprine (AZA) after renal transplantation. However, long-term benefits of MMF have not been established and the follow-up period of the previous studies was within 5 years. We aimed to compare acute rejection rate and graft and patient survival of these two drugs in conjunction with cyclosporine and steroids over 10 years. Methods: We reviewed kidney transplant recipients who had been transplanted from January 1998 to January 2002. Eighty-six patients were recruited and divided into two groups (MMF group=43 vs. AZA group=43). All patients received cyclosporine and steroids concomitantly as maintenance immunosuppressive therapy. We analyzed for the incidence of biopsy-proven acute rejection, allograft function, and graft and patient survival. Results: Baseline characteristics were similar between both groups except donor type. The deceased donor was 8 patients in the MMF group and 1 patient in the AZA group. Over 10 years after transplantation, fewer biopsy-proven acute rejection occurred in MMF group than AZA group (11.6% vs. 30.2%, respectively, p=0.037). The 10-years graft survival was 93% in MMF group and 81.4% in AZA group, but the difference was not significant (p=0.113). During 10 years, one patient (2.3%) in the MMF group and 4 patients (9.3%) in the AZA group died (p=0.184). Graft function was comparable between the two groups over 10 years. There was no significant difference in the incidence of serious infections. Over the 10 year posttransplant period, 5 patients developed malignancies (one in the MMF group vs. 4 in the AZA group). Conclusions: MMF offered clinical benefit for preventing acute rejection and had similar effects on the long term graft and patient survival in kidney transplant recipients with cyclosporine-based immunosuppression.

Mizoribine Versus Mycophenolatemofetil in Combination Therapy with Tacrolimus for De Novo Kidney Transplantation: Efficacy and Safety Evaluation

Mizoribine Versus Mycophenolatemofetil in Combination Therapy with Tacrolimus for De Novo Kidney Transplantation: Efficacy and Safety Evaluation

Randomized Trial of Mycophenolate Mofetil Versus Enteric-Coated Mycophenolate Sodium in Primary Renal Transplantation With Tacrolimus and Steroid Avoidance: Four-Year Analysis

Our single-center, open-labeled randomized trial of 150 adult, primary kidney transplant recipients receiving 2 g mycophenolate mofetil (group A, n=75) versus 1.440 g enteric-coated mycophenolate sodium (group B, n=75), with reduced maintenance tacrolimus dosing, steroid elimination at 1 week, and combined rabbit antithymocyte globulin/daclizumab induction, previously showed at 1 year posttransplant low biopsy-proven acute rejection (BPAR), acceptably high renal function, and no differences in incidence of symptomatic gastrointestinal (GI) side effects between the two groups. This report includes 3 additional years of follow-up with similar endpoints as in the original study. Rates of developing first BPAR, graft failure (death censored and uncensored), death, and adverse events (GI toxicity, infections requiring hospitalization, and new onset diabetes mellitus after transplantation) during the first 48 months posttransplant were compared between the two groups using an intent-to-treat approach. At 48 months posttransplant, patient/graft survival in groups A and B was 97%/90% vs. 96%/86%, respectively (not significant [NS]). Twenty-seven patients experienced BPAR (including borderline), with actuarial 19% (14/75) vs. 18% (13/75) in groups A and B, respectively (NS). Geometric mean*/standard error serum creatinine level and arithmetic mean calculated glomerular filtration rate (±standard error) at 48 months in groups A and B, respectively, were 1.25*/1.06 and 69.2±3.9 vs. 1.20*/1.05 and 71.2±3.2 (NS). Incidence of new onset diabetes mellitus after transplantation (22% vs. 15%), infections requiring hospitalization (31% vs. 39%), and GI side effects (45% vs. 52%) seemed equivalent. This is the first long-term, randomized trial comparing enteric-coated mycophenolate sodium versus mycophenolate mofetil along with reduced maintenance tacrolimus dosing and steroid avoidance, which resulted in similarly low-BPAR rates, acceptably high renal function at 48 months, and an equivalent side effect profile.

Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance: A Multicenter, Double-Blind, Randomized Study

Two open-label studies demonstrated that conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) significantly reduces gastrointestinal (GI) symptom burden and improves GI-specific health-related quality of life. Using a randomized design, this study evaluated changes in GI symptoms and health-related quality of life in patients converted from MMF to EC-MPS versus patients who continued with MMF-based treatment. In this 4-week, multicenter, randomized, prospective, double-blind, parallel-group trial, renal transplant recipients with GI symptoms receiving MMF plus a calcineurin inhibitor ± corticosteroids were randomized to an equimolar dose of EC-MPS+MMF placebo or continue on their MMF-based regimen+EC-MPS placebo. The primary efficacy outcome was a change from baseline in total Gastrointestinal Symptom Rating Scale score of a minimally important difference of more than or equal to 0.3. Three hundred ninety-six patients (EC-MPS group: n=199; MMF group: n=197) were included. A greater proportion of EC-MPS patients (62%) reached the primary efficacy outcome compared with MMF patients (55%); however, the difference was not statistically significant (P=0.15). EC-MPS patients had a significantly greater decrease in the Gastrointestinal Symptom Rating Scale indigestion syndrome dimension versus MMF patients. Within the subgroups of patients with diabetes, patients transplanted 6 to 12 months of study enrollment, and patients on steroids, a statistically significant greater proportion of EC-MPS versus MMF patients reached the primary efficacy outcome. Conversion from MMF to EC-MPS may be associated with improvements in presence and severity of GI symptoms, particularly in patients with indigestion, diabetes, on steroids, and in patients converted between 6 and 12 months posttransplantation.

Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil Maintenance Immunosuppression: Outcomes Analysis of the United Network for Organ Sharing/Organ Procurement and Transplantation Network Database

A large, retrospective database analysis was conducted to evaluate the long-term outcomes of patients who received enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) maintenance immunosuppression at the time of discharge. All primary kidney transplant patients who received either EC-MPS or MMF at time of discharge in the United Network for Organ Sharing/Organ Procurement and Transplantation Network database from 2004 to 2007 were included. Patients were excluded if they had received a previous kidney transplant, multiple organs, or combination therapy with everolimus at the time of discharge. Outcomes included graft failure, death-censored graft failure, and death with functioning graft, biopsy-proven acute rejection (BPAR), new-onset diabetes mellitus, and renal function. The propensity score method was used to adjust for nonrandomized treatment selection. A total of 48,458 patients were included in the analysis. At time of discharge, 10.4% of patients received EC-MPS (n=5057) and 89.6% received MMF (n=43,401). Propensity score-adjusted regression analysis showed that patients who received EC-MPS were at increased risk of BPAR (hazards ratio, 1.167; 95% confidence interval, 1.056-1.129; P=0.002). The adjusted BPAR rate difference at 3 years posttransplantation was less than 2% (13.6% vs. 11.7%); statistically significant because of the large number of patients included in the analysis, but a difference that may not be clinically meaningful. No differences in graft survival, new-onset diabetes mellitus, or renal function were observed between the treatment groups.

Efficacy and Adverse Events of Mycophenolate Mofetil Versus Cyclophosphamide for Induction Therapy of Lupus Nephritis

We performed a systematic review and meta-analysis of randomized controlled trials to compare complete remission and adverse events (that is, infection, leukopenia, and gastrointestinal [GI] symptoms) between mycophenolate mofetil (MMF) and cyclophosphamide (CYC) for the treatment of lupus nephritis (LN). We identified trials from MEDLINE using the PubMed and Ovid search engines, and from The Cochrane Central Register of Randomized Controlled Trials. Eligible studies were randomized controlled trials comparing MMF with CYC with 1 of following outcomes: complete remission, complete/partial remission, infection, leukopenia, GI symptoms, serum creatinine, 24-hour urine protein, and urine albumin. Data were independently extracted by 2 reviewers. Five trials with a total of 638 patients were eligible for review. While the MMF group tended to achieve complete remission more frequently than the CYC group, this was not significant (pooled risk ratio [RR], 1.60; 95% confidence interval [CI], 0.87-2.93). Pooling based on the 4 homogeneous trials yielded similar results-that is, no benefit of MMF compared with CYC groups (RR, 1.15; 95% CI, 0.74-1.77). The complete or partial remission rates were also not different (pooled RR, 1.21; 95% CI, 0.97-1.48) among the groups. The adverse events (infection, renal function, and GI symptoms) were not significantly different, except for leukopenia, which was lower in the MMF group. In summary, patients treated with MMF and CYC had similar remission rates, but the MMF group had less frequent leukopenia than the CYC group. Further large-scale trials are needed to confirm these results.

Mycophenolate Mofetil Versus Enteric-Coated Mycophenolate Sodium: A Large, Single-Center Comparison of Dose Adjustments and Outcomes in Kidney Transplant Recipients

Although enteric-coated mycophenolate sodium (EC-MPS) was developed to reduce gastrointestinal (GI) side effects in kidney transplantation, a multicenter clinical trial of patients undergoing de novo renal transplantation found that efficacy failure and adverse GI event rates for EC-MPS were comparable with mycophenolate mofetil (MMF). A common strategy to mitigate mycophenolic acid-related GI adverse events includes dose manipulations such as split dosing, dose reduction, and discontinuation. Several studies have demonstrated that dose alterations with MMF are associated with poorer graft outcomes. To determine whether there was a clinically significant difference in dose alterations and outcomes with EC-MPS compared with MMF, we conducted a retrospective study comparing MMF and EC-MPS in all consecutive kidney transplants (n=1709) between 2000 and 2006. Graft survival between MMF and EC-MPS patients was not different during the study period (P=0.9928). The incidence of biopsy-proven acute rejection at 2 years was higher in the MMF group (30.2% MMF vs. 21.9% EC-MPS, P=0.0004). The adjusted risk of dose reductions was significantly higher in MMF-treated patients (hazard ratio=1.703, P<0.0001). Similarly, the adjusted risk of drug discontinuation was higher in the MMF group (hazard ratio=1.507, P=0.0002). EC-MPS patients also demonstrated a trend toward a lower incidence of infections and a significantly lower incidence of fungal infections. EC-MPS was associated with fewer dose reductions or discontinuations, which may have translated into the observed significantly lower incidence of biopsy-proven rejection. EC-MPS has become the mycophenolic acid agent of choice at this large center.

Mycophenolate Mofetil Versus Azathioprine in Organ Transplantation

Mycophenolate Mofetil Versus Azathioprine in Organ Transplantation