A Randomized Clinical Trial of Induction Therapy With Okt3 in Kidney Transplantation

Norman, Douglas J.; Kahana, Lawrence; Stuart, Frank P.; Thistlethwaite, J. Richard; Shield, Charles F.; Monaco, Anthony P.; Dehlinger, Jennifer; Wu, Shu; Horn, A.; Haverty, Thomas P.

doi:10.1097/00007890-199301000-00009

Cited by 152 publications

(41 citation statements)

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“…OKT3 induction is associated with fever, aseptic meningitis, and noncardiogenic pulmonary edema, as well as profound immunosuppression and an increased risk for opportunistic infections and neoplasia, especially posttransplant lymphoproliferative disease. 5,6,[15][16][17] In our study, the OKT3 group had the greatest rate of infections. Similar results were published by Reding et al, 18 who noted that 49% of infectious processes occurred in their OKT3 group.…”

Section: Discussionmentioning

confidence: 81%

“…[1][2][3] Suggested regimens include OKT3 induction in combination with azathioprine and steroids, with or without low doses of calcineurin inhibitors. [4][5][6] A new option in this circumstance is the use of daclizumab with mycophenolate mofetil (MMF) and steroids. Daclizumab is a human immunoglobulin G1 monoclonal antibody that blocks the ␣ chain of interleukin-2 receptors on activated T lymphocytes.…”

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confidence: 99%

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Use of daclizumab as initial immunosuppression in liver transplant recipients with impaired renal function

et al. 2001

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The addition of daclizumab (a human immunoglobulin G1 monoclonal antibody that blocks interleukin-2 receptors on T lymphocytes) to mycophenolate mofetil (MMF) and steroids is a new option for initial immunosuppression in patients undergoing liver transplantation (LT) with impaired renal function. We evaluated the efficacy and safety of daclizumab in preventing rejection in 25 patients with impaired kidney function undergoing LT. Patients with serum creatinine (Cr) levels greater than 2 mg/dL immediately before LT were administered initial immunosuppression with daclizumab, 1 mg/kg, in addition to MMF, 2 g/d, and methylprednisolone. Tacrolimus was added after kidney function improved (when Cr levels improved by >25% of initial value). Daclizumab-treated patients were compared retrospectively with 2 other groups of patients who underwent LT with kidney impairment (Cr > 2 mg/dL): 56 patients were administered OKT3 induction, and 48 patients were administered lowdose tacrolimus. The incidence of rejection and infection (bacterial, fungal, and viral), need for preoperative and postoperative dialysis, Cr level immediately post-LT and at 3 months, and graft and patient survival were analyzed. There was no difference among the groups in 3-month Cr levels or the incidence of rejection or fungal or viral infection. The daclizumab group had fewer bacterial infections (n ‫؍‬ 13) than the tacrolimus group (n ‫؍‬ 28) and significantly fewer than the OKT3 group (n ‫؍‬ 58; P ‫؍‬ .006). Only 1 patient (4%) in the daclizumab group required dialysis post-LT versus 13 patients in each of the other groups (OKT3, 23.21%; P < .05; tacrolimus, 27%). In the daclizumab group, 2-year patient and graft survival rates were statistically significant compared with the lowdose tacrolimus group (89% and 81% v 73% and 69%, respectively; P ‫؍‬ .06). There were no side effects related to daclizumab use, and all patients tolerated the drug well. In patients with impaired renal function before LT, daclizumab-based initial immunosuppression can be used safely to reduce the risk for infection and need for dialysis post-LT, with improved long-term graft and patient survival. (Liver Transpl 2001;7:220-225.)T here is no agreement on initial immunosuppressive regimens in patients undergoing liver transplantation (LT) with impaired renal function. [1][2][3] Suggested regimens include OKT3 induction in combination with azathioprine and steroids, with or without low doses of calcineurin inhibitors. [4][5][6] A new option in this circumstance is the use of daclizumab with mycophenolate mofetil (MMF) and steroids. Daclizumab is a human immunoglobulin G1 monoclonal antibody that blocks the ␣ chain of interleukin-2 receptors on activated T lymphocytes. [7][8][9] Previous studies have shown the efficacy of daclizumab in preventing rejection in kidney transplantation and LT without immediate side effects. [7][8][9][10][11] In particular, daclizumab does not cause cytokine release syndrome, neurotoxicity, or nephrotoxicity, which makes it an appealing alternative t...

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Section: Discussionmentioning

confidence: 81%

mentioning

confidence: 99%

Use of daclizumab as initial immunosuppression in liver transplant recipients with impaired renal function

et al. 2001

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“…Survival and freedom rates from OB in this review compare very favorably with data available from the Registry of the International Society of Heart and Lung Transplantation, without any significant increase in the risk of infection [lo]. In renal allograft studies, individual randomized trials comparing induction therapy with conventional immunosuppression alone failed to show that induction therapy has benefit with regard to allograft survival [16,20]. However a meta-analysis of individual patient-level data showed a benefit in graft survival at 2 years, especially in presensitized patients [24].…”

Section: Discussionmentioning

confidence: 75%

Rabbit antithymocyte globulin versus OKT3 induction therapy after heart-lung and lung transplantation: effect on survival, rejection, infection, and obliterative bronchiolitis

Barlow¹,

Moon²,

Green³

et al. 2001

Transplant Int

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The superiority of different induction therapies after heartlung and lung transplantation is not clearly established; specifically, whether monoclonal (OKT3) or polyclonal antibody induction therapy provides any advantage. Between 1989 and 1991 we used induction therapy with either rabbit antithymocyte globulin (RATG) or OKT3, given at random based on the availability of RATG. RATG was used in 25 patients (RATG group 1) and OKT3 in 38 patients (OKT3 group 1). Early results suggested a survival advantage with RATG. From 1992 until 1997 we used RATG induction therapy in 108 patients (RATG group 2). This study analyzed longer-term survival, infection, rejection, and obliterative bronchiolitis (OB) rates for RATG group 1 and OKT3 group 1 and assessed outcomes for RATG group 2. The 1-, 3-, and 5-year survival for RATG group 1 was 72 YO, 72 9'0, and 52% and for OKT3 group 1 was 63 YO, 49 %, and 34 Yo (P < 0.05).The 1-and 3-year survival for RATG group 2 was 84 YO and 74 % . The 1-, 3-, and 5-year actuarial freedom rates from Iung rejection for RATG group 1 were 38 YO, 38 YO, and 31 % and for OKT3 group 1 were21Y0,0%,and0% (P<0.01). The linearized rate (eventdl00 patient days) of all infections at 3 months was 1.55 * 0.28 for RATG group 1 and 2.19 i 0.27 for OKT3 group 1 ( P = NS). The infection rate for RATG group 2 was 1.60 f 0.13. The actuarial rates of freedom from OB at 1,3, and 5 years for RATG group 1 were 84 'YO, 51 YO, and 45 YO and for OKT3 group 1 were 77 YO, 61 Y , and 36 YO ( P = NS), while for RATG group 2 the rates were 97 % and 92 Yo at 1 and 3 years ( P < 0.01 vs RATG group 1 and OKT3 group 1). The use of RATG induction therapy from 1989 through 1991 resulted in improved actuarial survival and less rejection, without increased infection rates. The use of RATG since 1992 has continued to result in similar outcomes for survival, infection, and rejection. The time to onset of OB has improved further in recent years. This may be a result of recent improvements in cytomegalovirus (CMV) prophylaxis.

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“…[11][12][13][14][15][16][17] This demonstrated an overall reduction in deceased-donor graft failure with ALA and a 6% increase in survival in the first 2 years. 3 19 Basiliximab was given at standard dose and rATG was given at 1.5 mg/kg for 5 to 7 days.…”

Section: Meta-analyses Investigating the Use Of Depleting Antilymphocmentioning

confidence: 99%

Untitled

Buttigieg

Julie

Sharma³

et al. 2016

Exp Clin Transplant

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Kidney transplant remains the best type of renal replacement therapy in most patients with end-stage kidney disease, even in those with high immunologic risk. Immunosuppression in these patients is regarded as more complex, owing to the higher risk of both acute and chronic rejection. The advent of induction immunosuppression has resulted in a lower incidence of acute rejection and consequently improved shortterm patient and allograft outcomes. Indeed, the use of these agents, especially in high-risk recipients, has become standard of care at most transplant centers. Transplant physicians are constantly faced with the challenge of estimating the recipients' immunologic risk and tailoring their immunosuppression ac cordingly. This review article aims to provide an up-to-date evaluation of the various studies available, which investigated the use of induction agents in kidney transplant, specifically in high-risk recipients. It evaluates the use of the most frequently used polyclonal antibody (rabbit antithymocyte globulin) versus the less commonly used monoclonal antibody alemtuzumab, superseded agents such as muromonab-CD3, and potentially emerging agents such as rituximab, bortezomib, and eculizumab. With this systematic review, we hope to inform the scientific community and facilitate this controversial decision through the implementation of robust scientific evidence.

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A Randomized Clinical Trial of Induction Therapy With Okt3 in Kidney Transplantation

Cited by 152 publications

References 0 publications

Use of daclizumab as initial immunosuppression in liver transplant recipients with impaired renal function

Use of daclizumab as initial immunosuppression in liver transplant recipients with impaired renal function

Rabbit antithymocyte globulin versus OKT3 induction therapy after heart-lung and lung transplantation: effect on survival, rejection, infection, and obliterative bronchiolitis

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