Disposition of Basiliximab, an Interleukin-2 Receptor Monoclonal Antibody, in Recipients of Mismatched Cadaver Renal Allografts1

Kovarik, John M.; Wolf, Philippe; Cisterne, Jean‐Marc; Mourad, Georges; Lebranchu, Yvon; Lang, Ph.; Bourbigot, B.; Cantarovich, Diego; Girault, Danièle; Gerbeau, C; Schmidt, Arne; Jp, Soulillou

doi:10.1097/00007890-199712270-00012

Cited by 117 publications

(70 citation statements)

References 5 publications

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“…The rate of CMV-reactivation in our patients was within the expected range after allogeneic SCT. 18 A causal relation between fatal systemic inflammatory response syndrome and basiliximab in one of our patients more than 3 months after use of the antibody seems to be very unlikely, because basiliximab blocks IL-2-R for only 30-45 days 19 and the patient was still on low-dose prednisolone and cyclosporine A at that time. No further bacterial or fungal infections occurred in our patients, probably because all patients had reconstituted before receiving basiliximab.…”

Section: Discussionmentioning

confidence: 83%

Basiliximab is well tolerated and effective in the treatment of steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation

Massenkeil

Rackwitz

Genvresse

et al. 2002

Bone Marrow Transplant

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Summary:Basiliximab, a chimeric interleukin-2 receptor (IL-2-R) antagonist, was evaluated in 17 patients with steroidrefractory acute graft-versus-host disease (GVHD) after allogeneic stem cell transplantation (SCT). Patients were transplanted from a related (n = 6) or unrelated (n = 11) HLA-identical donor because of acute lymphoblastic leukemia (n = 4), acute myeloid leukemia (n = 3), chronic myeloid leukemia (n = 7), myelodysplastic syndrome (n = 1), non-Hodgkin's lymphoma (n = 1), and multiple myeloma (n = 1). Basiliximab was given at a dose of 2 ؋ 20 mg on 2 consecutive days after steroidrefractory acute GVHD had developed. Basiliximab was repeated on day 8 in cases of persistent GVHD. A median of four basiliximab infusions (range 1-12) were given to these patients. None had infusion-associated or cytokine-related side-effects after basiliximab. Twelve of 17 patients (71%) responded to basiliximab, 9/17 (53%) had a complete response (CR) of acute GVHD and 3/17 (18%) had a partial response (PR). Five of 17 patients (29%) did not respond. Chronic GVHD developed in 8/13 evaluable patients and only 2/8 had responded to basiliximab before. Five of 13 evaluable patients have no signs of chronic GVHD and all five had a CR or PR after basiliximab. This is the first report on the safety of basiliximab in patients with steroid-refractory acute GVHD. Our data suggest that basiliximab is effective in a substantial proportion of these patients.

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Section: Discussionmentioning

confidence: 83%

Basiliximab is well tolerated and effective in the treatment of steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation

Massenkeil

Rackwitz

Genvresse

et al. 2002

Bone Marrow Transplant

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“…The chimeric structure of basiliximab has both prolonged its half-life and reduced its immunogenicity. 13,14 Its convenient dosing regimen, just two 20-mg intravenous injections days 0 and 4, achieves blockade of the IL-2R for 4 to 6 weeks posttransplantation, precisely the period during which 80% to 90% of acute rejection episodes occur. Any more extensive blockade could increase the risk for excessive immunosuppression.…”

Section: Discussionmentioning

confidence: 99%

“…Early clinical studies 13,14 have shown that basiliximab is well tolerated, with no evidence of significant immunogenicity. These and other studies 15 also have shown that optimal administration of basiliximab is 20 mg intravenously the day of transplantation, followed by a second intravenous dose day 4 after transplantation.…”

mentioning

confidence: 99%

“…Administered in accordance with this convenient schedule, basiliximab achieves consistent suppression of CD25 for a period of 30 to 45 days, without the risk of prolonged immunosuppression. 14,16 Studies conducted in adult renal transplant recipients have shown that the addition of basiliximab to dual immunosuppressive therapy with CsA and steroids reduces the incidence of biopsy-confirmed acute rejection episodes by 28% to 32% compared with placebo. 17,18 This study is one of the first studies performed with basiliximab in liver transplantation.…”

mentioning

confidence: 99%

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Immunoprophylaxis with basiliximab, a chimeric anti[ndash ]interleukin-2 receptor monoclonal antibody, in combination with azathioprine-containing triple therapy in liver transplant recipients

Calmus

2002

Liver Transplantation

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Acute graft rejection remains a major problem among additional sequelae in liver transplant recipients. Basiliximab, a chimeric monoclonal antibody with high affinity for the CD25 chain of the interleukin-2 receptor, has significantly reduced the incidence of acute rejection episodes in renal transplant recipients. This single-arm, open-label, multicenter study investigated the efficacy and tolerability of basiliximab immunoprophylaxis in adult patients undergoing first elective liver transplantation. One hundred one patients (70 hepatitis C virus [HCV]-negative patients, 31 HCV-positive patients) were administered basiliximab, 20 mg, by intravenous bolus injection the day of transplantation (day 0) and day 4. In addition, all patients were administered triple immunosuppressive therapy with cyclosporine, steroids, and azathioprine. The efficacy of basiliximab was assessed by conventional parameters, and tolerability was assessed by the incidence of adverse events, infections, and laboratory test result abnormalities. At 6 months, the incidence of first acute biopsy-confirmed rejection episodes was 22.8%. Rejections were more frequent in the HCV-positive (29.0%) than HCV-negative subgroup (20.0%; P ‫؍‬ .441). No rejection episode was graded histologically as severe, and no patient required antibody therapy for the management of acute rejection. Ten patients (9.9%) required treatment with tacrolimus for acute rejection episodes. Patient and graft survival rates at 12 months were 90.1% and 88.1%, respectively. Basiliximab caused no injection-site reactions, anaphylaxis, or cytokine release syndrome. Five malignancies were reported at 12 months: of these, three malignancies predated transplantation surgery. Compared with earlier studies, the addition of basiliximab immunoprophylaxis to triple immunosuppressive therapy provides increased efficacy in reducing the incidence of acute rejection episodes, with no clinically significant increase in adverse events. (Liver Transpl 2002;8: 123-131.)

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“…There are two chimaeric monoclonal IL-2 receptor antagonists with different pharmacokinetic features: basiliximab, with a terminal half-life of 7 d, and daclizumab, with a terminal half-life of 20 d (Kovarik et al, 1997;Vincenti et (Henry & Rajab, 2002;Van Gelder et al, 2004;Webster et al, 2004). To the best of our knowledge, there has only been one prospective trial investigating the chimaeric IL-2 receptor antagonist daclizumab in steroid-refractory aGVHD (Przepiorka et al, 2000).…”

mentioning

confidence: 99%

Efficacy of the interleukin‐2 receptor antagonist basiliximab in steroid‐refractory acute graft‐versus‐host disease

et al. 2005

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Acute graft-versus-host disease (aGVHD) occurs in up to 80% of patients who undergo allogeneic stem cell transplantation (SCT) and contributes significantly to transplant-related mortality (TRM). We conducted a prospective phase II trial to assess the efficacy and feasibility of treating steroid-refractory aGVHD with basiliximab, a chimaeric monoclonal antibody directed against the alpha chain of the interleukin-2 (IL-2) receptor. Basiliximab was administered intravenously at a dose of 20 mg on days 1 and 4. Twenty-three patients were enrolled between October 1999 and July 2004. We found a primary overall response rate of 82AE5% with four patients (17AE5%) showing a complete response and 15 patients (65%) a partial response. Six patients were again treated successfully with an IL-2 receptor antagonist because of recurrence of aGVHD. The rates of infections, chronic GVHD, malignancy recurrence and 1-year TRM following immunosuppression with basiliximab were comparable with those found with other treatment modalities for aGVHD. We conclude that basiliximab is efficient and feasible for steroid-refractory aGVHD and merits further evaluation.

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Disposition of Basiliximab, an Interleukin-2 Receptor Monoclonal Antibody, in Recipients of Mismatched Cadaver Renal Allografts1

Abstract: Total basiliximab doses of 40-60 mg were well tolerated, nonimmunogenic, and estimated to provide immunoprophylaxis to cover the first posttransplant month.

Cited by 117 publications

References 5 publications

Basiliximab is well tolerated and effective in the treatment of steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation

Basiliximab is well tolerated and effective in the treatment of steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation

Immunoprophylaxis with basiliximab, a chimeric anti[ndash ]interleukin-2 receptor monoclonal antibody, in combination with azathioprine-containing triple therapy in liver transplant recipients

Efficacy of the interleukin‐2 receptor antagonist basiliximab in steroid‐refractory acute graft‐versus‐host disease

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