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PubMedDate not supplied

A prospective randomized controlled trial of initial immunosuppression with ALG versus OKT3 in recipients of cardiac allografts.

Thirty-nine heart transplant recipients were randomized prospectively to receive OKT3 or antilymphoblast globulin (ALG) for 7 days, having otherwise identical protocols (group 1: OKT3, n = 20 patients; group 2: ALG, n = 19 patients). No preoperative immunosuppression was given. The protocol consisted of methylprednisolone, 500 mg intraoperatively, followed by 1 mg/kg/day, intravenously or orally, tapering to 0.2 mg/kg/day at 1 month; oral cyclosporine starting 3 to 5 days after transplantation; selective use of azathioprine, 1 to 4 mg/kg/day; and either OKT3, 5 mg/day for 7 days, or ALG, 15 mg/kg/day for 7 days. Of the 39 patients in the study, 34 are alive 6 months to 2 years after transplantation. The actuarial survival at 2 years for the OKT3 and ALG groups was 92% (+/- 0.07%) and 83% (+/- 0.09%), respectively (not significant [NS]). The time to first rejection for group 1 was 5.6 weeks and for group 2 was 5.3 weeks (NS). The mean number of rejections for group 1 and group 2 was 2.1 episodes per patient and 1.4 per patient, respectively (NS). Three patients in each group were free of rejection at 6 months. The total number of infections at 6 months was 1.05 per patient in group 1, 0.74 per patient in group 2 (NS), with 35% of patients receiving OKT3 and 52% of patients receiving ALG actuarially free of infection by 6 months after surgery (NS). During the first 24 hours after surgery, no significant differences were noted in mean blood pressure, central venous pressure, or Po2 between the groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Actuarial Analysis↗
PubMedDate not supplied

Vascular rejection and its relationship to allograft coronary artery disease.

We have prospectively monitored 268 patients by our previously described method of routine immunofluorescence of endomyocardial biopsy specimens. We have classified these patients according to their rejection pattern: cellular, vascular, and mixed. The criteria for these designations have been previously described. In this study we retrospectively reviewed coronary angiograms of these patients to assess the presence and time-course of developing allograft coronary artery disease. All available explanted hearts and postmortem hearts were also assessed by light microscopic examination for acute coronary vasculitis and allograft coronary artery disease and by immunofluorescent microscopy for vascular immune complex deposition in a manner identical to immunofluorescent microscopic examination of endomyocardial biopsy specimens. Patients were also monitored for sensitization to immunoprophylactically administered murine monoclonal CD3 antibody (OKT3) and those demonstrated to be sensitized were separately analyzed. Clinical features and treatment of patients were retrospectively reviewed. We found that 141 patients could be classified as having cellular rejection, 76 as having vascular rejection, and 52 as having a mixed rejection pattern. The allograft survival in vascular rejection patients was significantly worse than in allografts of patients with cellular or mixed rejection, confirming our earlier results. Most importantly, we found a significant difference in the time to the development of allograft coronary artery disease based on the rejection pattern. This difference existed whether or not patients sensitized to OKT3 were excluded from evaluation. Patients with mixed rejection had an intermediate time to the development of allograft coronary artery disease between that of patients with cellular and vascular rejection.(ABSTRACT TRUNCATED AT 250 WORDS)

Coronary Disease↗
PubMedDate not supplied

OKT3 induction and steroid-free maintenance immunosuppression for treatment of high-risk heart transplant recipients.

A group of high-risk heart transplant patients (n = 35) were treated from May 1987 through June 1990, with murine-derived monoclonal CD3 antibody (OKT3) induction therapy and steroid-free maintenance immunosuppression. This group was compared with a group of transplant patients (n = 47) who were not considered high risk and who were treated simultaneously with triple-drug immunosuppression (cyclosporine, azathioprine, and prednisone). The 1- and 3-year actuarial survival rates were similar: 97% and 91% for the OKT3 and 92% and 85% for the triple-drug immunosuppression groups, respectively. The overall incidence of rejection was equal for both groups (56%). No rejection occurred during the OKT3 course and rejection episodes occurred significantly later in patients treated with OKT3, with a mean first rejection episode of 111 +/- 104 days versus 27 +/- 21 days for the triple-drug immunosuppression group (p less than or equal to 0.05). Bacterial infections were seen more frequently (29% vs 6% of the patients treated) in the early period (less than 3 months) in the OKT3 group (p = 0.01) and were associated with the use of mechanical assistance in this group. The incidence of late infections or cytomegalovirus disease was similar for both groups. Patients treated with OKT3 and subsequent steroid-free maintenance immunosuppression had no significant posttransplantation increases of serum cholesterol levels, and hypertension was less common. Initial hospitalization was longer (p less than or equal to 0.05) in the OKT3 group (23 +/- 19 vs 13 +/- 5 days) but after the initial discharge the number of hospital days for the first year was similar for both groups (8 +/- 14 vs 9 +/- 13 days). Ventricular function at 1 year after transplantation was similar for both groups with average ejection fraction of 57% and 59% for the OKT3 and triple-drug immunosuppression groups, respectively. In conclusion, high-risk patients treated with OKT3 and steroid-free maintenance immunosuppression were managed on smaller doses of immunosuppressive drugs in the early postoperative period, and had excellent long-term survival rates. In this group of patients, rejection was delayed and the incidence of hypercholesterolemia, hypertension, and steroid-induced complications was decreased. Such a regimen offers a relatively drug-free period in the early posttransplant stages and freedom from the long-term complications of steroids.

Actuarial Analysis↗
PubMed1991

[Experiences with monoclonal antibody orthoclone OKT3 following liver transplantation].

In 7 patients 10 cycles (5 to 21 days, dosage: 30 to 430 mg, median 138 mg) of OKT3 therapy were performed after liver transplantation. In all patients reactivation of an EBV-infection with hepatitis was observed. Two patients treated with high dosages (430 mg respectively 195 mg) developed lymphoproliferative lesions. In one patient with persistent EBV-infection (dosage: 360 mg) a B-cell-lymphoma was diagnosed. This patient died 26 months after transplantation.

Female↗
PubMedDate not supplied

[Levels of interleukin-4 (IL-4) in lymphocyte cultures of subjects with HIV-1 infection].

The authors report IL-4 levels in peripheral blood mononuclear cells (PBMC), stimulated with MoAb anti-CD3, in subjects with HIV-1 infection, classified according to the criteria of Centers for Disease Control (CDC) in various stages. The results "in vitro" have indicate that PBMC IL-4 levels were in normal range also in advanced stages of retroviral infection, and were correlated to low levels of CD4+ lymphocytes and, sometimes, to high levels of IgE immunoglobulins. The normality of IL-4 levels in advanced stages or in presence of decreased CD4+ cells, suggests that the production of this cytokine is also present in other subsets of mononuclear cells not involved in this infection. Moreover the presence of significant correlation between high levels of Ig E and IL-4 suggests a possible pathogenetic role of IL-4 in the determination of isotypic switch of this immunoglobulin.

CD4-Positive T-Lymphocytes↗
PubMed1991

Incidence and treatment of rejection episodes in primary orthotopic liver transplantation under FK 506.

FK 506 therapy with low doses of steroids was adequate to control rejection in most liver recipients. Rejection episodes were readily reversed with single IV doses of methylprednisone or hydrocortisone. Short courses of OKT3 (3 to 5 days 5-10 mL) controlled severe rejections. The rate of retransplantation directly due to rejection was low (1.6%). There was a limited need for steroids either early or out to 6 to 12 months.

Anti-Bacterial Agents↗
PubMed1991

Cardiovascular side effects after renal allograft rejection therapy with Orthoclone: prevention with nitrendipine.

Orthoclone (OKT-3), a monoclonal antibody, is an effective immunosuppressant in organ graft recipients. One of the reported side effects is serious pulmonary edema, heart failure, hyperdynamia, and elevation of blood pressure. It should be assessed whether patients treated with OKT-3 benefit from antihypertensive therapy with a calcium channel blocker before and during the allograft rejection therapy to prevent from cardiovascular side effects. To assess a preventive cardiovascular effect of therapy with nitrendipine before and during the OKT-3 rejection therapy, the patients studied (n = 28) were randomly allocated to two study groups. Group a without nitrendipine comprised 15 patients, and group b with 2 x 10 mg of nitrendipine daily comprised 13 patients. In study group a (without nitrendipine therapy), in 8 of 15 patients, there was a short-lasting increase in blood pressure during 3 h after the first injection of OKT-3 by 20.0 +/- 12.8 (systolic)/10.1 +/- 6.7 (diastolic) mm Hg. Whereas this initial rise of blood pressure on the first day was accompanied by an increase in heart rate by 24.1 +/- 10.8 beats/min, the longer-lasting increase in blood pressure at day 2 was not associated with significant changes in heart rate. In group b (patients receiving 2 x 10 mg of nitrendipine before OKT-3 therapy was started and during the whole treatment course), in 3 of 13 patients, a short increase in blood pressure (13.7 +/- 2.9/7.8 +/- 5.1 mm Hg) was recorded 5 h after the first dose of OKT-3.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

[Differential diagnosis of transplant function disorders in therapy with monoclonal antibodies OKT3].

The use of OKT3 monoclonal antibodies has improved the immunosuppressive therapy. Due to the high efficiency of this treatment there is an increased risk of overimmunosuppression and occurrence of life-threatening viral infections. Therefore a cautious application of OKT3 is mandatory, a reliable differential diagnosis of the deteriorating graft function essential. In this study the high diagnostic value of urinary neopterin in the early and reliable diagnosis of CMV infection under OKT3 therapy in contrast to serum amyloid A as a marker of rejection could be shown. A differential therapy, supporting or reducing the immunosuppression, might be facilitated by daily monitoring of the neopterin and serum amyloid A.

Adult↗
PubMed1991

Antimouse antibody response after OKT3 administration for steroid resistant rejection.

OKT3 has become one of the more effective antirejection therapies for patients receiving kidney transplants. However, its usefulness is diminished or blocked by the development of antimouse/anti-OKT3 antibodies. We evaluated 17 children receiving OKT3 for steroid-resistant acute rejection for the development and persistence of antibodies after therapy. OKT3 was successful in reversing acute rejection in 14 of 17 patients. Eight children developed antimouse antibodies, 7 at a low titer (1:100). The retesting of all children 6 months later showed no detectable antibodies. Children develop anti-OKT3 antibodies at a rate similar to adults and with time lose detectable levels which may have significance if a subsequent course of OKT3 is needed.

Animals↗
PubMed1991

[T lymphocyte activation induced by monoclonal anti-CD3 antibodies: physiopathology of cytokine release].

Anti-CD3 monoclonal antibodies are largely used as therapeutic agents in clinical transplantation. Constrating with their potent immunosuppressive activity anti-CD3 antibodies also transiently express T cell activating properties. In vitro they promote T cell mitogenesis and in vivo, the self-limited cytokine release (including TNF, IFN gamma, IL-2, IL-3, IL-6) observed following the first anti-CD3 injection, is responsible for an acute clinical syndrome. Clinical studies as well as the experimental data obtained in mice, confirmed that TNF plays a fundamental role in the anti-CD3 induced syndrome. The administration of anti-TNF monoclonal antibodies prior to the first anti-CD3 injection prevents the syndrome not only by blocking TNF bioactivity but also, by modulating the circulating levels of the other anti-CD3-induced cytokins. In particular, this model allowed the description of regulatory pathways existing between TNF and IFN gamma, which in turn regulate IL-3 and IL-6 release.

Animals↗
PubMed1991

Registry report: International Society for Heart and Lung Transplantation.

Orthotopic heart transplantation continues to be a highly successful therapy for end-stage cardiac disease. Recent advances have extended the benefits of this procedure to neonatal patients. The number of patients undergoing single- and double-lung transplantation increases steadily and the indications for transplantation are being expanded. Evaluation of the early results indicates that patients undergoing lung transplantation for vascular disease do not fare as well as those undergoing transplantation for parenchymal disease. Presently, the results of retransplantation are far inferior to primary transplantation and require ongoing evaluation.

Adolescent↗
PubMed1991

[T and B lymphocytes and NK cells in hemolytic uremic syndrome].

Hemolytic uremic syndrome (HUS) is a serious problem in Argentina, where 50% of the known cases are reported to come from. In the so-called "typical" HUS, anemia, thrombocytopenia and acute renal failure are usually preceded by an episode of infection. Many agents such as bacteria, toxins and viruses have been linked with the prodromal episode, but the reason for the occurrence of HUS in only a small portion of individuals with identical previous symptoms, is not clear. The hypothesis of a particular immune response modifying the susceptibility of some hosts to develop the syndrome after an otherwise well tolerated infection is not formally excluded. The aim of our work was to explore some immunological parameters in order to add more data concerning the immunologic changes occurring during the acute phase of HUS in 24 pediatric patients. We coincide with previous authors on the normal values of serum complement levels and the increase of IgG, IgA and IgM concentrations. (Table 1). We also report a significant and transient decrease in the percentage of T lymphocytes and an increase in the relative number of B lymphocytes.(ABSTRACT TRUNCATED AT 250 WORDS)

B-Lymphocytes↗