Interleukin-2 receptor antibodyinduced alterations of ciclosporin dose requirements in paediatric transplant recipients

Strehlau, J.; Pape, Lars; Offner, G.; Nashan, Bjoern; Ehrich, J. H. H.

doi:10.1016/s0140-6736(00)02822-1

Cited by 76 publications

(56 citation statements)

References 2 publications

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“…The finding that the CsA dose that was required to maintain comparable trough levels was not different in the two arms of this study indicates that the theoretical possibility of interference between basiliximab and CsA metabolism (45) is not an issue here. That renal function recovery tended to be faster in those who were receiving the dual induction regimen as compared with standard RATG permits exclusion also of any nephrotoxic effect.…”

Section: Discussionmentioning

confidence: 57%

Basiliximab Combined with Low-Dose Rabbit Anti-Human Thymocyte Globulin

Ruggenenti

Codreanu²,

Cravedi³

et al. 2006

Clinical Journal of the American Society of Nephrology

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In high-risk kidney transplant recipients, induction therapy with rabbit anti-human thymocyte globulin (RATG) reduces the risk for acute rejection but is associated with significant toxicity, opportunistic infections, and cancer. Using reduced doses of RATG combined with anti-IL-2 antibodies may achieve the same antirejection activity of standard-dose RATG but with a better safety profile. This randomized, open-label study compared the efficacy, tolerability, and costs of low-dose RATG (0.5 mg/kg per d) plus basiliximab (20 mg 4 d apart) versus standard-dose RATG (2 mg/kg per d) in 33 consecutive high-risk renal transplant recipients (living-related transplant recipients, sensitized patients or patients who received another transplant, and patients with delayed graft function) over 6 mo of follow-up. All patients received concomitant therapy with steroids, cyclosporin A, and azathioprine or mycophenolate mofetil. Seventeen patients received low-dose RATG plus basiliximab, and 16 received standard-dose RATG. Patient (100 versus 100%) and graft (94 versus 100%) survival were comparable in the two groups, but the incidence of fever (17.6 versus 56.5%; P ‫؍‬ 0.01), leukopenia (23.5 versus 56.3%; P < 0.05), anemia (29.4 versus 62.5%; P < 0.05), cytomegalovirus reactivations (17.6 versus 56.5%; P ‫؍‬ 0.01), the number of transfused units (0.5 ؎ 0.9 versus 2.0 ؎ 2.4; P < 0.001), and treatment costs (3652 ؎ 704 versus 5400 ؎ 1960 euro; P ‫؍‬ 0.001) were lower with low-dose RATG plus basiliximab than with standard-dose RATG. There was one episode of biopsy-proven acute rejection on low-dose RATG plus basiliximab, and there were two on standard-dose RATG. In renal transplantation, induction therapy with basiliximab plus low-dose RATG effectively prevents acute rejection and is safer and more cost-effective than induction with standard-dose RATG.

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Section: Discussionmentioning

confidence: 57%

Basiliximab Combined with Low-Dose Rabbit Anti-Human Thymocyte Globulin

Ruggenenti

Codreanu²,

Cravedi³

et al. 2006

Clinical Journal of the American Society of Nephrology

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“…Basiliximab and cyclosporine are administered in the treatment of kidney transplant [22]. It is important to note that studies have shown that basiliximab slows cyclosporine elimination from the body (it is believed that cytochrome P450 plays an important role in this process).…”

Section: Production and Medical Use Of Interleukin 2 (Il-2)mentioning

confidence: 99%

Physiology and Pathology of Cytokine: Commercial Production and Medical Use

Zdravković¹,

Rosić²,

Lutovac³

et al. 2017

Physiology and Pathology of Immunology

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Cytokines are small, short-lived proteins secreted by many diferent cell types. As signaling molecules, cytokines provide communication between cells and play a crucial role in modulating innate and adaptive immune response. The family of cytokines includes interferons, interleukins, chemokines, mesenchymal growth factors, tumor necrosis factor family and adipokines. Interferons (IFNs) are a multigene family of inducible cytokines with antiviral, antiproliferative, and immunomodulatory function. Recombinant DNA technology can be useful in the production of human IFNs. This process includes fermentation, puriication, and formation of the inal product. Interleukins are classiied in families based on sequence homology, receptor-binding properties, biological function, and cellular sources. TNF and IL-1 are considered to be key mediators of inlammatory response, while IL-6 plays a key role in the transition from acute to chronic inlammation. The inhibition of TNF includes administration of anti-TNF antibody and TNF receptor (TNFR). The reduction of IL-1 level can be achieved by the administration of anti-IL-1 antibody or IL-1 receptor antagonist (IL-1Ra), and the reduction of IL-6 level in the treatment of chronic inlammatory diseases can be achieved by the administration of anti-IL-6 antibody and anti-IL-6 receptor antibody. Recombinant cytokines and cytokine antagonists (antibodies and receptors) can be used in treating many diferent diseases.

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“…In another example, both muromonab-CD3 and basiliximab, when co-administered with cyclosporine, increase its concentration in blood (26,27), but they cause this TP-DDI through different mechanisms. Muromonab-CD3 can induce a limited "cytokine storm" after the first injection which releases cytokines such as TNF-α, interferon, and IL-2 (28).…”

Section: Ivive Challengesmentioning

confidence: 99%

“…Basiliximab, in contrast, binds to the IL-2 receptor (IL-2R) on activated T cells. It has been hypothesized that basiliximab displaces IL-2 from the IL-2R, and that displaced IL-2 may act on CYP3A (27).…”

Section: Ivive Challengesmentioning

confidence: 99%

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

Kenny¹,

Liu²,

Chow

et al. 2013

AAPS J

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Abstract. The investigation of therapeutic protein drug-drug interactions has proven to be challenging. In May 2012, a roundtable was held at the American Association of Pharmaceutical Scientists National Biotechnology Conference to discuss the challenges of preclinical assessment and in vitro to in vivo extrapolation of these interactions. Several weeks later, a 2-day workshop co-sponsored by the U.S. Food and Drug Administration and the International Consortium for Innovation and Quality in Pharmaceutical Development was held to facilitate better understanding of the current science, investigative approaches and knowledge gaps in this field. Both meetings focused primarily on drug interactions involving therapeutic proteins that are pro-inflammatory cytokines or cytokine modulators. In this meeting synopsis, we provide highlights from both meetings and summarize observations and recommendations that were developed to reflect the current state of the art thinking, including a four-step risk assessment that could be used to determine the need (or not) for a dedicated clinical pharmacokinetic interaction study.

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Interleukin-2 receptor antibodyinduced alterations of ciclosporin dose requirements in paediatric transplant recipients

Cited by 76 publications

References 2 publications

Basiliximab Combined with Low-Dose Rabbit Anti-Human Thymocyte Globulin

Basiliximab Combined with Low-Dose Rabbit Anti-Human Thymocyte Globulin

Physiology and Pathology of Cytokine: Commercial Production and Medical Use

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

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