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PubMed1992

Diffuse anterior scleritis during OKT3 monoclonal antibody therapy for renal transplant rejection.

OKT3, a murine monoclonal antibody, is a potent, specific immunosuppressive agent used in solid-organ transplantation both as an adjunct during induction therapy and for treatment of steroid-resistant graft rejection. Minor, self-limiting ocular complications are often seen with this drug, of which conjunctivitis is the most common, occurring in approximately three-quarters of patients. We describe the more serious and previously unreported complication of diffuse anterior scleritis, which developed on the fifth day of OKT3 therapy in a 47-year-old man who had undergone cadaveric renal transplantation. Despite continuation of OKT3 treatment the scleritis resolved rapidly with increased dosages of prednisone.

Glucocorticoids↗
PubMedDate not supplied

Steroid-free maintenance immunotherapy: Minneapolis Heart Institute experience.

Recent advances in immunotherapy have resulted in improved survival after heart transplantation. The use of OKT3 as an induction agent has allowed the identification of a subset of patients who can be successfully withdrawn from prednisone and maintained on only cyclosporine and azathioprine. The latter regimen offers several theoretic advantages in terms of freedom from complications of long-term steroid therapy. To compare both the long-term efficacy and toxicity of steroid-free maintenance immunosuppression with triple-drug therapy, the medical records of 68 patients undergoing transplantation at the Minneapolis Heart Institute during a 3-year period (1988 through 1990) were reviewed. Thirty-six patients were treated with OKT3 induction immunotherapy, 29 were successfully tapered off prednisone by 114 +/- 44 days after transplantation, whereas 32 patients were maintained on triple-drug therapy. The incidence of treated rejection was equivalent in both groups; however, the time to first rejection was longer in patients treated with OKT3/steroid-free maintenance (205 +/- 214 vs 27 +/- 17 days) (p = 0.02). Bacterial infections during the early posttransplant period were more common in the OKT3/steroid-free maintenance group (p = 0.008); however, fungal and viral infections were equally distributed between both groups. The incidence of hypertension was slightly higher in patients maintained on prednisone (67% vs 51%; p = 0.242).(ABSTRACT TRUNCATED AT 250 WORDS)

Female↗
PubMedDate not supplied

Initial success of steroid weaning late after heart transplantation.

Steroid-free maintenance immunosuppression is frequently initiated early after transplantation. There is concern that later steroid withdrawal, particularly after previous rejection, may cause more serious rejection. To determine the safety of gradual weaning from steroid maintenance, 68 patients (more than 6 months from transplantation) were weaned from 5 mg/day by decreasing the daily dose by 1 mg each month, with monthly biopsies. Asymptomatic moderate rejection occurred in 13 compliant patients. Rejection with hemodynamic compromise occurred in two patients with documented medication noncompliance, who were excluded from further analysis. Successful weaning without rejection was possible in 53 of 66 (80%) compliant patients. Compared with the rejection group, there were no differences in the number of women, previous rejection episodes, or time from transplantation. All moderate rejection episodes responded to oral steroid pulse therapy. The two serious rejections after noncompliance responded to OKT3. There were no symptoms from steroid withdrawal that required taper alteration. We conclude that regardless of previous rejection episodes, weaning from maintenance steroids can be attempted safely if guided by frequent biopsy procedures, but compliance is critical.

Biopsy↗
PubMed1992

The pharmacokinetics and pharmacodynamics of immunosuppressive agents.

Designing immunosuppressive regimens for the pediatric transplant patient is challenging because one must balance the need to provide adequate immunosuppression without interfering with normal growth processes or causing long-term adverse consequences. To optimize immunosuppressive therapy and minimize toxicity, it is necessary for the nurse to be knowledgeable of the pharmacokinetic and pharmacodynamic characteristics of the various agents. It is also important to understand which drugs interact with immunosuppressive agents and how to manage these interactions.

Adrenal Cortex Hormones↗
PubMedDate not supplied

Prophylactic cytolytic therapy in heart transplantation: monoclonal versus polyclonal antibody therapy.

The value of immunoprophylaxis with monoclonal anti-CD3 antibodies (OKT3) was evaluated in 44 consecutive, nonrandomized heart transplant patients. The control group (n = 22) was treated with polyclonal rabbit antithymocyte globulin (RATG) for 5 days. The study group (n = 22) was treated with OKT3 for 14 days. All patients had identical perioperative immunosuppressive therapy and similar maintenance therapy, with cyclosporine, azathioprine, and low-dose prednisone (starting prednisone: OKT3 group immediately, RATG group 3 weeks [n = 11] or greater than 3 months [n = 11] after transplantation). The mean histologic rejection grade (Texas classification) in the RATG and the OKT3 groups was 2.5 +/- 1.9 and 0.6 +/- 0.8 (p less than 0.005) after 1 week and 4.3 +/- 1.6 and 2.0 +/- 1.5 (p less than 0.001) after 2 weeks, but there was no difference in the first year. The linearized rejection rate (rejections per 100 patient days) was higher in the RATG group in the first 2 weeks (2.6 vs 0, p less than 0.05 respectively, 7.8 vs 0.7, p less than 0.001) and higher in the OKT3 group in the second month (1.4 vs 2.8, p less than 0.01). In the RATG group the rejection rate fell continuously, to 0.1 at the end of the first year, whereas in the OKT3 group it remained 0.4 (NS). The cumulative first-year incidence was similar for persistent rejections (RATG 0.38 +/- 0.29 vs OKT3 0.48 +/- 1.13, NS) and insignificantly higher for severe rejections in the OKT3 group (RATG 0.21 +/- 0.32 vs OKT3 0.49 +/- 1.10). Rejection-related mortality in the first year was 0% (RATG) and 9% (OKT3).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
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↗