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PubMed1991

Treatment of aGVHD with OKT3: clinical outcome and side-effects associated with release of TNF alpha.

Monoclonal antibodies are increasingly used for treatment of acute graft-versus-host disease (aGVHD) in bone marrow transplantation. We treated seven patients with steroid resistant aGVHD with the monoclonal anti-T cell antibody OKT3. Though five patients showed improvement of aGVHD, only two became long-term survivors. OKT3 treatment was accompanied by deterioration of microangiopathy and prolonged increase of tumor-necrosis-factor alpha serum levels indicating activation of monocytes/macrophages in vivo, as this was not observed in a control group of patients receiving anti-T cell globulin. These findings may be related to immunostimulatory activity reported for OKT3 in vitro. Strategies interfering with cytokine release should improve clinical results of OKT3 treatment.

Acute Disease↗
PubMed1991

Laboratory monitoring of therapy with OKT3 and other murine monoclonal antibodies.

The first monoclonal antibody (MAb) approved by the Food and Drug Administration (FDA) for therapeutic use, OKT3, is now a standard treatment for organ allograft rejection. This article reviews the interpretation of laboratory tests used to manage patients treated with MAb. Emphasis is placed on OKT3, with which the experience is also the greatest, although comparisons with other MAbs in clinical trials is also discussed.

Animals↗
PubMedDate not supplied

Monoclonal versus polyclonal antibody therapy for prophylaxis against rejection after heart transplantation.

Between August 1986 and December 1987, 88 patients received either RATG or OKT3 for immunoprophylaxis before heart transplantation. By the end of the first month after transplantation, 25% of the patients who received RATG had experienced a rejection episode compared with 43% of those receiving OKT3. This difference was persistent as many as 4 months after transplantation. While 50% of the OKT3 patients had a second episode of rejection, only 35% of the RATG patients did so. Randomization of these agents was complicated by severe cardiopulmonary side effects attributed to the first dose of OKT3. Five hours after the first dose of OKT3, a 25% drop in mean arterial pressure, accompanied by significant hypoxia, was seen in a majority of patients. There was no difference in the incidence of infection between the two groups.

Antibodies, Monoclonal↗
PubMed1990

Prophylactic therapy for rejection after cardiac transplantation. A comparison of rabbit antithymocyte globulin and OKT3.

The value of prophylactic monoclonal or polyclonal antibody therapy early after cardiac transplantation is controversial. Between Jan. 1, 1987, and July 1, 1988, 32 consecutive patients underwent cardiac transplantation (cyclosporine, azathioprine, and prednisone maintenance therapy) with either early prophylactic rabbit antithymocyte globulin (n = 17) or monoclonal OKT3 (Ortho Diagnostic Systems, Inc., Raritan, N.J.) (10 days) (n = 15). Follow-up was through Sept. 1, 1988, for morbid events and through Jan. 1, 1989, for survival. All patients (100%) survived the study period (follow-up of 6 to 24 months). The efficacy of rabbit antithymocyte globulin and OKT3 prophylaxis was similar regarding median time (days) to first rejection (16 versus 21 days, p = 0.5), number of rejection episodes during first 2 months (1.5 versus 1.3 days, p = 0.8), and freedom from rejection at 2 months (18% versus 27%, p = 0.8). Early infections were slightly less common in the rabbit antithymocyte globulin group than the OKT3 group (median time to first infection: 318 versus 250 days, p = 0.5; freedom from rejection at 2 months: 82% versus 64%, p = 0.21), although differences were likely due to chance. Cytomegalovirus syndrome was common, with one case of cytomegalovirus pneumonia. T-cell markers during OKT3 treatment did not predict subsequent rejection (within 2 weeks after OKT3) as assessed by mean T3-lymphocyte count during OKT3 use (p = 0.3) or T3-lymphocyte count during the last 3 days of OKT3 use (p = 0.4). Inferences: (1) Prophylactic rabbit antithymocyte globulin or OKT3 with triple-drug immunosuppression yields excellent intermediate survival after heart transplantation. (2) These protocols for rabbit antithymocyte globulin and OKT3 provide similar protection against early rejection with a relatively low risk of early infection. (3) T-cell markers do not predict early rejection after OKT3.

Adult↗
PubMed1990

[OKT 3 treatment of kidney transplant recipients].

Anti-rejection therapy with the monoclonal antibody OKT 3 was effective in the treatment of acute rejection episodes in 66% (47/71) of OKT 3 treated kidney graft recipients. The success of OKT 3 therapy, however, appeared to be dependent on certain variables. Reversal of rejection differed significantly according to the indication, namely if patients were treated first line, as opposed to rescue therapy. Vascular components of rejection and/or severe interstitial rejection, as well as acute tubular necrosis were associated with a worse reversal rate. Non-responders to OKT 3 presented with significantly lower serum OKT 3 trough levels during the first three days of the treatment course. The presence of more than one of these risk factors was shown to decrease the reversal rate of rejection significantly. The variables appeared to exert their influence in an additive fashion. Administration of OKT 3 led to the induction of an acute phase reaction, which could be detected within one day after start of therapy. The incidence of both bacterial and viral infection was increased dramatically in OKT 3 treated patients as compared with graft recipients who were not treated with monoclonal or polyclonal antilymphocyte antibodies. The findings demonstrate that OKT 3 is of value in the treatment of acute rejection episodes but provide evidence of differential indications for OKT 3 therapy, which must be taken into account to optimize control of rejection and avoid unnecessary side effects where the drug is not indicated.

Antibodies, Monoclonal↗
PubMedDate not supplied

Fibrinoid necrosis of a temporal artery complicating the treatment of refractory cardiac allograft rejection with murine monoclonal CD3 antibody (OKT3).

The murine monoclonal CD3 antibody (OKT3) is effective in the treatment of refractory renal and cardiac allograft rejection and holds promise for improving rejection prophylaxis in heart transplantation. Although the administration of OKT3 is associated with many side effects, arteritis has not been previously reported. We report the development of acute necrotizing temporal arteritis associated with the deposition of mouse immunoglobulin G in a heart transplant recipient receiving OKT3 treatment of refractory rejection.

Antibodies, Monoclonal↗
PubMedDate not supplied

Treating cardiac allograft rejection: present approach--analysis of 100 consecutive patients.

In addition to rejection, complications of rejection prophylaxis and treatment are major causes of mortality and morbidity during the first year after heart transplantation. To decrease complications related to antirejection treatment, our present approach is to assess each rejection episode individually and to adjust treatment accordingly. This article presents the analysis of rejection in the last 100 patients who underwent heart transplantation at our institution.

Antibodies, Monoclonal↗
PubMedDate not supplied

Use of polyclonal antilymphocytic preparations for prophylaxis in heart transplantation.

Polyclonal antilymphocytic preparations, heterologous antibodies to human lymphoid cells, have been administered to heart transplant recipients prophylactically in the immediate perioperative period to avert rejection. The current status of the three classes of polyclonal preparations (antilymphoblast globulins, antithymocyte globulins, and antithymocyte sera) and their clinical role for prophylaxis in heart transplantation are summarized.

Adult↗