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AIM:

Cyclosporine (CsA), dosed to achieve C2 targets, has been shown to provide safe and efficacious immunosuppression when used with a mycophenolate and steroids for de novo kidney transplant recipients. This study examined whether use of enteric-coated mycophenolate sodium (EC-MPS) together with basiliximab and steroids would enable use of CsA dosed to reduced C2 targets in order to achieve improved graft function.

METHODS:

Twelve-month, prospective, randomized, open-label trial in de novo kidney transplant recipients in Australia. Seventy-five patients were randomized to receive either usual exposure (n = 33) or reduced exposure (n = 42) CsA, EC-MPS 720 mg twice daily, basiliximab and corticosteroids.

RESULTS:

There was no significant difference in mean Cockcroft-Gault CrCl (creatinine clearance) (60.2 ± 17.6 mL/min per 1.73 m(2) vs 63.2 ± 24.3, P = 0.64 for usual versus reduced exposure respectively) at 6 months. There was no significant difference between treatment groups in the incidence of treatment failure defined as biopsy proven acute rejection, graft loss or death (secondary endpoint: 30.3% full exposure vs 35.7% reduced exposure). At 12 months the incidence of overall adverse events was the same in both groups.

CONCLUSION:

This exploratory study suggests de novo renal transplant patients can safely receive a treatment regimen of either full or reduced exposure CsA in combination with EC-MPS, corticosteroids and basiliximab, with no apparent difference in efficacy or graft function during the first year after transplant.

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INTERVENTION:

Trade Name: Simulect Product Name: Basiliximab Pharmaceutical Form: Powder for infusion* Other descriptive name: Basiliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Powder for infusion* Route of administration of the placebo: Intravenous use

CONDITION:

Steroid‐refractory ulcerative colitis ; MedDRA version: 8.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative

PRIMARY OUTCOME:

Main Objective: Efficacy: ; Assess the efficacy, relative to placebo, of 40 mg basiliximab given intravenously, at 2 week intervals for a total of 3 doses, with concomitant oral corticosteroids, in subjects with steroid‐refractory, moderate to severe Ulcerative Colitis. A total of 3 doses will be administered during the 8 week duration of the trial. ; ; ; Safety: ; Evaluate the overall safety of this multiple‐dose regimen in this patient population.; Primary end point(s): The primary efficacy endpoint will be clinical remission at week 8.; ; Secondary efficacy endpoints will include:; ; • Clinical remission at week 4 ; • Clinical response at weeks 4 and 8; • Mucosal healing at weeks 4 and 8; • Use of rescue medication; • Hospitalization or colectomy; • Concomitant steroid use (median dose over time and cumulative dose) Secondary Objective: Secondary objectives are to assess: ; • Efficacy, relative to placebo, of basiliximab 20 mg, given with concomitant ; oral corticosteroids, according to the same schedule; • Safety of basiliximab 20 mg multiple‐dose regimen; • Pharmacokinetics of both basiliximab regimens in this population; • Immunogenicity of multiple doses of basiliximab through measurement of ; formation of antibodies to basiliximab, and monitoring for hypersensitivity ; reactions;

INCLUSION CRITERIA:

Subjects must satisfy all of the following inclusion criteria to be eligible for the study: 1. Male or female subjects, age =18 years and =75 years 2. Weight of 40 kg or greater 3. Signed a current IRB/IEC‐approved informed consent form 4. Diagnosis of ulcerative colitis confirmed through screening endoscopy performed no more than 3 days prior to day of randomization (Day ‐2 to Day 0, with randomization on Day 1). At the time of endoscopy, a rectal biopsy will be obtained and reviewed by a local pathologist to confirm histopathology compatible with the diagnosis of ulcerative colitis. Randomization can proceed without the screening biopsy result if a previous biopsy result compatible with ulcerative colitis is documented and available in the subject’s medical record. 5. Extent of disease must involve at least the left colon (i.e., greater than 15 cm beyond the anal verge as the endoscope is withdrawn) 6. Moderate to severe

This phase I trial studies the side effects and best dose of yttrium Y 90 basiliximab when given together with standard combination chemotherapy before a stem cell transplant in treating patients with mature T-cell non-Hodgkin lymphoma. Radioactive substances linked to monoclonal antibodies, such as yttrium Y 90 basiliximab, can bind to cancer cells and give off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving yttrium Y 90 basiliximab and chemotherapy before a stem cell transplant may help kill any cancer cells that are in the body and help make room in the patient\'s bone marrow for new blood-forming cells (stem cells) to grow. Stem cells that were collected from the patient\'s blood and stored before treatment are later returned to the patient to replace the blood-forming cells that were destroyed.

Acute graft versus host disease (aGVHD) remains a major problem after allogeneic hematopoietic stem cell transplantation. Standard frontline therapy for aGVHD involves corticosteroids. However, fewer than half of patients have a lasting complete response. The long-term mortality rate of steroid-refractory aGVHD (SR-aGVHD) remains around 70%. To date, no consensus has been reached regarding the optimal salvage treatment for SR-aGVHD. We performed the first prospective, multi-center clinical trial to assess the efficacy and safety of a novel approach to treat severe (grades III-IV) SR-aGVHD with the combination of basiliximab and etanercept. Sixty-five patients with severe SR-aGVHD from six centers were included. The median number of basiliximab infusions was 4 (range 2-11) and of etanercept was 9 (range 2-12). At day 28 after starting the combination treatment, overall response (complete and partial response: CR+PR) to second-line treatment was 90.8% with 75.4% being CR. The incidences of CR per organ were 100%, 73.8%, and 79.7% for skin, liver, and gut involvement, respectively. Patients >30-y old (p = 0.043, RR = 3.169), development of grades III-IV liver aGVHD (p = 0.007, RR = 5.034) and cytomegalovirus (CMV) reactivation (p = 0.035, RR = 4.02) were independent predictors for incomplete response. Combined treatment with basiliximab and etanercept resulted in improved CR to visceral aGVHD and significantly superior 2-y overall survival (54.7% vs. 14.8%, p <0.001) compared with classical salvage treatments. Our data suggest that the combination of basiliximab and etanercept may constitute a promising new treatment option for SR-aGVHD.

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.

INTERVENTION:

Trade Name: MabCampath Product Name: MabCampath Pharmaceutical Form: Solution for injection Trade Name: Simulect Product Name: Simulect Pharmaceutical Form: Powder for injection* Trade Name: CellCept Product Name: CellCept Pharmaceutical Form: Capsule*

CONDITION:

MabCampath / Alemtuzumab will be used as part of the immunosuppression regime following renal transplant.

PRIMARY OUTCOME:

Main Objective: The purpose of this study is to compare the efficacy of two tacrolimus‐based steroid avoidance immunosuppressive regimens.; The primary objective of this study is to determine whether we can use a regime of immunosuppression that is both as effective as our standard regime and that offers advantages in terms of a lack of some of the specific side effects of our standard regime and one that is simpler and more cost effective. Primary end point(s): 1. DTPA Isotopic Glomerular Filtration Rate (GFR) at 12 months Secondary Objective: Secondary endpoints can be categorised: 1‐ contains a number of standard clinical variables anticipated to be similar in both study groups, including rejection rates, patient and graft survival rates and rates of delayed graft function. 2‐ comprises a number of surrogate markers for cardiovascular outcome which are particularly important in this setting of studying steroid‐free patients. These include 24 hour blood pressure monitoring, pulse wave analysis and metabolic studies including glucose tolerance. 3‐ various socioeconomic endpoints with quality of life assessment, adherence monitoring and a cost analysis. 4‐ follows a number of scientific endpoints capitalising on the various expertise available both on and off site;

INCLUSION CRITERIA:

• Male and female patients who must be over age 18 years. • Patients must be recipients of heart‐beating cadaveric, non‐heart beating or living donors. • Patients receiving a 2nd or subsequent grafts must have maintained their primary graft for a minimum of 6 months, except if graft failure was due to technical reasons. • Written Informed consent • Women at risk of pregnancy must have a negative pregnancy test before commencing the trial and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuing the trial. The manufacturer of Alemtuzumab advises effective contraception for 6 months after administration to men or women. Advice will be given to patients to discuss with the transplant medical staff if a pregnancy is planned. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for t

A prospective evaluation was performed to study the potential benefits of the use of interleukin-2 receptor antibody (IL-2Rab) in the induction therapy with early elimination of steroid and reduction of tacrolimus dosage in liver transplant recipients among whom 94% had chronic hepatitis B infection. Thirty-one liver transplant recipients who underwent right-lobe live donor (n = 19) or cadaveric (n = 12) liver transplantation received IL-2Rab, basiliximab 20 mg intravenously within 6 hours of graft reperfusion and on postoperative day 4 (IL-2ab group). Two doses of steroid injection were given intraoperatively and on postoperative day 1. Postoperative immunosuppression was maintained with oral tacrolimus and mycophenolate mofetil without the use of steroids. The operative outcomes were compared with those of 49 patients who received standard immunosuppressive regimen consisting of tacrolimus and corticosteroid (steroid group). The overall postoperative morbidity and hospital stay were comparable between the 2 groups. There were significantly lower incidences of postoperative new-onset diabetes (0% vs 28%, P =.011), acute cellular rejection (6% vs 27%, P =.038), and cytomegalovirus (CMV) antigenemia (0% vs 18%, P =.011) in the IL-2Rab group compared with the steroid group. The blood cholesterol level at 6 months after transplantation was significantly lower in the IL-2Rab group (median, 4.0 vs 4.4 mmol/L, P =.007). On follow-up, none of the patients in the IL-2Rab group had hepatitis B viral breakthrough or hepatocellular carcinoma (HCC) recurrence, whereas 1 and 3 patients in the steroid group developed these complications, respectively. In conclusion, treatment of liver transplant recipients with IL-2Rab with early withdrawal of steroids and reduction of tacrolimus dosage is associated with lower incidences of postoperative new-onset diabetes, acute cellular rejection, and CMV antigenemia, as well as a lower serum cholesterol level. Further studies and long-term follow-up are required to document their potential benefits on hepatitis B and HCC recurrences.

Objective: Acute rejections (ARs) have a negative impact on long-term graft survival and are the major predictor of chronic rejection. Induction therapy is used to reduce AR and prevent delayed graft function (DGF). Anti-thymocyte globulin (ATG) and basiliximab are mainly used for this purpose. In this prospective, cohort study, we analyzed and compared the safety and efficacy of ATG and basiliximab in induction therapy for live donor kidney transplant recipients. Methods: Graft survival, AR-free survival, renal function, DGF, and tolerability were compared in patients who underwent live donor transplantation between January 2014 and August 2014 at Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India. Results and Discussion: A total of 85 live donor kidney transplant recipients who enrolled were followed up for 12 months. The incidence of AR was greater in the basiliximab group, as compared with the ATG group (25.6% vs. 7.1%, p<0.05). The incidence of antibody-treated AR was also greater (18.6% vs. 2.4 %, p<0.05). Patient survival rate and graft survival rate were 95.2% and 92.9% in the ATG group, respectively, compared with 90.4% and 90.7% in the basiliximab group, respectively. The incidence of adverse events was higher in the ATG group compared with the basiliximab group (71.4% vs. 48.3%, p<0.05).Conclusion: The incidence of AR and antibody-treated AR was significantly higher in the basiliximab group than in the ATG cohort. However, ATG was associated with the significantly higher incidence of adverse events and leukopenia than basiliximab. Both the strategies were achieved similar patient and graft survival.