Ig Governance - Criteria for the clinical use of immunoglobulin in Australia

This medical condition has either been superseded or has become inactive

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Specific Conditions	Kidney transplant Liver and kidney transplant Heart and kidney transplant Pancreas and kidney transplant Heart transplant Lung transplant Heart and lung transplant Liver transplant Heart and liver transplant Other transplant
Indication for Ig Use	Immediate pre and/or post-transplant where donor specific antibody(s) prevent transplantation or threaten transplantation Initial treatment of acute antibody mediated transplant rejection Treatment of ongoing active antibody mediated transplant rejection Ongoing desensitisation of patients to improve the likelihood of transplantation Treatment or prevention of graft rejection where the use of conventional immunosuppressive therapies is contraindicated or poses a threat to the graft or patient
Level of Evidence	Clear evidence of benefit (Category 1)
Description and Diagnostic Criteria	Transplant rejection occurs when a recipient’s immune system attacks a transplanted organ or tissue. Both cellular and humoral (antibody-mediated) effector mechanisms may play a role. Acute rejection occurs in 15 to 30 percent of organ transplants and may impact on long term graft survival. Over 90 percent of cases respond to steroids. Other anti-rejection treatments include anti-T cell antibody therapy, or if there is a component of AbMR, IVIg and plasma exchange may be required. In transplants that have been performed with a compatible cross match, antibody mediated rejection (AbMR) occurs in 5 to 10 percent of renal transplants and 10 to 20 percent of heart transplants. However, AbMR may be significantly higher in more sensitised recipients. AbMR is associated with an increased incidence of graft dysfunction, e.g. allograft nephropathy (kidney), coronary allograft vasculopathy (heart) and bronchiolitis obliterans (lung). Rejection is diagnosed histologically on tissue biopsy, with contributory information from clinical assessment, radiological and laboratory tests including determination of the presence and strength of antibodies against donor antigens. The diagnostic criteria (Banff Criteria) for AbMR in kidney transplants continues to evolve (Haas, 2014). In heart transplant, diagnostic criteria for AbMR must be consistent with the ISHLT Criteria (IHSLT working formulation for pathologic diagnosis of antibody-mediated rejection in heart transplantation: Evolution and current status [2005–2011] Berry et al JHLT 2011). In non-kidney solid organ transplants, AbMR responds to IVIg with or without plasma exchange in more than 85 percent of patients. While the use of IVIg and plasma exchange forms the basis of treatment for acute AbMR, management of chronic AbMR is more challenging and there are currently very few controlled trials to guide clinicians on the optimal treatment of chronic AbMR.
Justification for Evidence Category	Kidney Desensitisation: The only randomised controlled trial (RCT) to date on desensitising patients awaiting kidney transplantation found that intravenous immunoglobulin (IVIg) was better than placebo in reducing allosensitisation in highly sensitised patients with end stage kidney disease (followed for two years after transplant), and that transplant rates were improved with IVIg therapy (Jordan et al 2004). Nonrandomised clinical observational studies suggest that a combination of plasmapheresis and low-dose IVIg is effective and provides a survival benefit for recipients (Montgomery 2011). Treatment of Acute Rejection: Multiple case series and some controlled trials have been reported in the literature indicating efficacy of IVIg in treating acute/active antibody mediated rejection, and it is recommended by a consensus conference (Takemoto et al 2004). There are no randomized controlled studies that have specifically studied the benefits of IVIg in acute AbMR, despite its common use in this context. Since 2008 there have been four non RCTs and three RCTs examining management of AbMR, all but one included IVIg and usually used both in the control and intervention arm of the trial (Lee 2016, Montgomery 2016, Choi 2016, Einecke 2016, Vigglietti 2016, Sautenet 2016, Zarkhin 2008). Chronic antibody mediated rejection (AbMR): This is a challenging and evolving area, despite the significant adverse impact of chronic AbMR, there is limited literature to guide clinical practice and no widely accepted standard of care (Cooper 2014, Gupta 2014). Solid organ - other than kidney Ig therapy plays an important immunomodulatory role in incompatible organ transplantation with proven benefit (Level 1 evidence) for desensitisation of highly sensitised patients pre-transplant to improve transplant rates and clinical outcomes (Jordan, 2004). For desensitisation, trials have demonstrated improved outcomes when IVIg is used in association with rituximab and/or other immunosuppressant agents, and plasmapheresis. Jordan et al (1998) combined data from seven renal transplant recipients and three heart transplant recipients with steroid-resistant combined antibody-mediated (AbMR) and cellular rejection. All patients in this series were successfully treated with high-dose IVIg. Findings from an International Consensus Conference in 2011 noted that IVIg has never been systematically studied in patients after transplant to prophylactically reduce the incidence of AbMR. Despite being routinely used for the treatment of AbMR, only one study has reported the efficacy of Ig therapy in this setting. Five patients with evidence of AbMR were treated with a combination of IVIg and plasmapheresis. Hemodynamics initially improved in all five patients, but two patients later required further therapy with rituximab because of recurrent hemodynamic rejection. The role of Ig therapy in antibody mediated rejection is confirmed in a recent Scientific Statement of the American Heart Association (Colvin, 2015).
Diagnosis Requirements	A diagnosis must be made by a Transplantation Medicine Specialist.
Qualifying Criteria for Ig Therapy	Immediate pre and/or post-transplant where donor specific antibody(s) prevent transplantation or threaten transplantation ABO incompatible transplant, HLA antibody(s) (at least 500 MFI) or non-HLA antibody(s) threaten organ transplantation Initial treatment of acute antibody mediated transplant rejection Presence of incompatible ABO blood group donor specific antibody(s), donor specific HLA antibody(s) (at least 500 MFI) and/or donor specific non-HLA antibody(s) AND Organ biopsy demonstrates antibody mediated rejection according to Banff criteria (Haas et al, 2014) or ISHLT or other Criteria OR Presence of incompatible ABO blood group donor specific antibody(s), donor specific HLA antibody(s) (at least 500 MFI) or donor specific non-HLA antibody(s) AND Current clinical and laboratory evidence of graft dysfunction where a biopsy is not available OR There is a high clinical suspicion that it is antibody-mediated rejection and evidence is not yet available (one-off request in early period of acute rejection) Treatment of ongoing active antibody mediated transplant rejection Ongoing antibody mediated rejection as demonstrated by biopsy in accordance with BANFF, ISHLT or other criteria Review by a transplantation specialist is required within two months of treatment to determine whether the patient has responded. If no response, Ig therapy should be ceased. Subsequent review by a transplantation specialist is required every four months where cessation of Ig therapy should be considered. Documentation of clinical effectiveness is necessary for continuation of IVIg therapy. Ongoing desensitisation of patients to improve the likelihood of transplantation Highly sensitised patient and/or known presence of high level donor specific antibody(s), resulting in a low likelihood of receiving an organ AND Circumstances indicate that the likelihood of receiving an organ is very low Review by a transplantation specialist is required within two months of treatment to determine whether the patient has responded. If no response, Ig therapy should be ceased. Subsequent review by a transplantation specialist is required every four months where cessation of Ig therapy should be considered. Documentation of clinical effectiveness is necessary for continuation of IVIg therapy. Treatment or prevention of graft rejection where the use of conventional immunosuppressive therapies is contraindicated or poses a threat to the graft or patient Conventional immunosuppressive therapy is contraindicated and a reason is provided AND A transplant has been received AND History of response to Ig therapy
Review Criteria for Assessing the Effectiveness of Ig Use	Immediate pre and/or post-transplant where donor specific antibody(s) prevent transplantation or threaten transplantation Review is not mandated for this indication however the following criteria may be useful in assessing the response to Ig therapy: Reduction in antibody level AND Transplantation proceeds Initial treatment of acute antibody mediated transplant rejection Review is not mandated for this indication however the following criteria may be useful in assessing response to Ig therapy: Reduction in antibody level AND Reduction in evidence of graft rejection on biopsy AND Improvement in graft function Treatment of ongoing active antibody mediated transplant rejection Review by a transplantation specialist is required within two months of treatment to determine whether the patient has responded. If no response, Ig therapy should be ceased. Subsequent review by a transplantation specialist is required every four months where cessation of Ig therapy should be considered. Documentation of clinical effectiveness is necessary for continuation of IVIg therapy. Clinical effectiveness of Ig therapy can be assessed by: On review of the initial authorisation period Improvement in evidence of biopsy and graft function compared to the qualifying assessment AND Evidence of response to Ig therapy as compared to the qualifying assessment On review of a continuing authorisation period Improvement in evidence of biopsy and graft function compared to the previous assessment AND Evidence of response to Ig therapy as compared to the previous assessment AND Consideration of cessation of Ig therapy Ongoing desensitisation of patients to improve the likelihood of transplantation Review, idenally undertaken by a transplantation specialist, is required within two months of treatment to determine whether the patient has responded. If no response, Ig therapy should be ceased. Subsequent review by a transplantation specialist is required every four months where cessation of Ig therapy should be considered.. Patients who have received an organ are not eligible for Ig under this indication but may be eligible under a different indication. Documentation of clinical effectiveness is necessary for continuation of IVIg therapy. Clinical effectiveness of Ig therapy can be assessed by: Reduction in the level of HLA or other donor specific antibodies as demonstrated by a decrease in the MFI or a reduced antibody reactivity or reduction in the number of Non-HLA antibodies compared to the qualifying assessment AND Specific circumstances exist to justify treatment for a further course AND The patient has not received an organ Treatment or prevention of graft rejection where the use of conventional immunosuppressive therapies is contraindicated or poses a threat to the graft or patient Review is not mandated for this indication however the following criteria may be useful in assessing the effectiveness of Ig therapy. Improvement in evidence of biopsy and graft function compared to the qualifying assessment AND Evidence of response to Ig therapy as compared to the qualifying assessment
Dose	Immediate pre and/or post-transplant where donor specific antibody(s) prevent transplantation or threaten transplantation Single dose (IVIg) - Up to 2 g/kg to a maximum of 140g as a single dose. Repeated Dose (IVIg) - 0.1 to 0.5 g/kg which may be given in separate doses up to a total maximum dose of 2g/Kg/8 week period. The aim should be to use the lowest dose possible that achieves the appropriate clinical outcome for each patient. Refer to the current product information sheet for further information on dose, administration and contraindications. Initial treatment of acute antibody mediated transplant rejection Single Dose (IVIg) - Up to 2 g/kg to a maximum of 140 g as a single dose. Recurrent Dose (IVIg) - 0.1 to 0.5 g/kg which may be given in divided doses up to a total maximum dose of 2g/Kg/8 week period. The aim should be to use the lowest dose possible that achieves the appropriate clinical outcome for each patient. Refer to the current product information sheet for further information on dose, administration and contraindications. Treatment of ongoing active antibody mediated transplant rejection IVIg with plasma exchange (IVIg) - 0.1 to 0.5 g/kg which may be given in divided doses up to a total maximum dose of 2g/Kg/4 week period. The aim should be to use the lowest dose possible that achieves the appropriate clinical outcome for each patient. Refer to the current product information sheet for further information on dose, administration and contraindications. Ongoing desensitisation of patients to improve the likelihood of transplantation Maintenance Dose (IVIg) - 0.1 to 0.5 g/kg which may be given in divided doses up to a total maximum dose of 2g/Kg/4 week period. The aim should be to use the lowest dose possible that achieves the appropriate clinical outcome for each patient. Refer to the current product information sheet for further information on dose, administration and contraindications. Treatment or prevention of graft rejection where the use of conventional immunosuppressive therapies is contraindicated or poses a threat to the graft or patient Recurrent Dose (IVIg) - 0.1 to 0.5 g/kg which may be given in divided doses up to a total of 2g/Kg in a 4 week period. Single divided dose (IVIg) - Up to 2 g/kg as a single dose. Therapy should be reviewed and cessation considered if an improvement has not been achieved after two consecutive authorisations. The aim should be to use the lowest dose possible that achieves the appropriate clinical outcome for each patient. Refer to the current product information sheet for further information on dose, administration and contraindications.

Bibliography
Ahsan, N & Shah, KV 2002, ‘Polyomaviruses: an overview’, Graft, vol. 5, pp. S9–18. https://www.researchgate.net/publication/247903519_Polyomaviruses_An_Overview Berry, GJ, Angelini, A, Burke, MM et al 2011, ‘The ISHLT working formulation for pathologic diagnosis of antibody-mediated rejection in heart transplantation: Evolution and current status (2005-2011)’, The Journal of Heart and Lung Transplant, vol. 30, no. 6, pp. 601:611. http://www.jhltonline.org/article/S1053-2498(11)00796-0/abstract Biotext 2004, ‘Summary data on conditions and papers’ in A systematic literature review and report on the efficacy of intravenous immunoglobulin therapy and its risks, commissioned by the National Blood Authority on behalf of all Australian Governments: 86–87. Available from: https://www.blood.gov.au/system/files/A-systematic-literature-review-and-report-on-the-efficacy-of-IVIg-therapy-and-its-risks.pdf Casadei, DH, del C Rial, M, Opelz, G, et al 2001, ‘A randomised and prospective study comparing treatment with high-dose intravenous immunoglobulin with monoclonal antibodies for rescue of kidney grafts with steroid-resistant rejection’, Transplantation, vol. 71, no. 1, pp. 53–58. https://www.ncbi.nlm.nih.gov/pubmed/11211195 Choi, J, Jung, J, Shin, S, et al 2016, ‘The early outcomes of bortezomib therapy in patients with late antibody mediated rejection in renal transplantation’, Poster Abstracts. American Journal of Transplantation, vol. 16. pp. 405–798. http://onlinelibrary.wiley.com/doi/10.1111/ajt.13898/full Colvin, MM, Cook, JL, Chang, P, et al 2015, ‘Antibody mediated rejection in cardiac transplantation: emerging knowledge in diagnosis and management: a scientific statement from the American Heart Association’, Circulation, vol. 131, no. 18, pp. 1608-1639. https://www.ncbi.nlm.nih.gov/pubmed/25838326 Conti, DJ, Freed, BM, Gruber, SA, et al 1994, ‘Prophylaxis of primary cytomegalovirus disease in renal transplant recipients. A trial of ganciclovir vs. immunoglobulin’, Archives of Surgery, vol. 129, no. 4, pp. 443–447. https://www.ncbi.nlm.nih.gov/pubmed/8154971 Cooper, JE, Gralla, J, Klem, P, et al 2014, ‘High dose intravenous immunoglobulin therapy for donor-specific antibodies in kidney transplant recipients with acute and chronic graft dysfunction. Transplantation, vol. 97, no. 12, pp. 1253-9. https://www.ncbi.nlm.nih.gov/pubmed/24937199 Djamali, A, Kaufman, DB, Ellis, TM, et al 2014, ‘Diagnosis and management of anti-body mediated rejection: current status and novel approaches’, American Journal of Transplantation, vol. 14, no. 2, pp. 255-271. https://www.ncbi.nlm.nih.gov/pubmed/24401076 Einecke, G, Bräsen, J, Schwarz, A, et al 2016, ‘Treatment of Late Antibody-Mediated Rejection: Observations from Clinical Practice’, American Journal of Transplantation. Poster Abstracts. American Journal of Transplantation, vol. 16, pp. 609. http://onlinelibrary.wiley.com/doi/10.1111/ajt.13898/full Frommer, M & Madronio, C 2006, ‘The use of intravenous immunoglobulin in Australia. A report for the National Blood Authority’, Part B: systematic literature review. Sydney Health Projects Group, University of Sydney, Sydney, pp. 18–20. https://www.blood.gov.au/pubs/ivig/conditions-for-which-IVIg-has-an-established-therapeutic-role.html Gupta, G, Abu Jawdeh, BG, Racusen LC, et al 2014, ‘Late antibody-mediated rejection in renal allografts: outcome after conventional and novel therapies’, Transplantation, vol. 97, no. 12, pp. 1240-6. https://www.ncbi.nlm.nih.gov/pubmed/24937198 Haas, M, Sis, B, Racusen, LC, et al 2014, ‘Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions’, American Journal of Transplantation, vol. 14, no. 2, pp. 272-283. https://www.ncbi.nlm.nih.gov/pubmed/24472190 Jordan, SC, Tyan, D, Stablein, D, et al 2004, ‘Evaluation of intravenous immunoglobulin as an agent to lower allosensitisation and improve transplantation in highly sensitized adult patients with end-stage renal disease: report of the NIH IG02 trial’, Journal of the American Society of Nephrology, vol. 15, no. 12, pp. 3256–62. https://www.ncbi.nlm.nih.gov/pubmed/15579530 Jordan, SC, Vo, A, Bunnapradist, S, et al 2003, ‘Intravenous immune globulin treatment inhibits crossmatch positivity and allows for successful transplantation of incompatible organs in living-donor and cadaver recipients’, Transplantation, vol. 76, no. 4, pp. 631–6. https://www.ncbi.nlm.nih.gov/pubmed/12973100 Jordan, SC, Vo, AA, Tyan, D, et al 2005, ‘Current approaches to treatment of antibody-mediated rejection’, Pediatric Transplantation, vol. 9, no. 3,pp. 408–15. https://www.ncbi.nlm.nih.gov/pubmed/15910400 Lee, CY, Lin, WC, Wu, MS, et al 2016, ‘Repeated cycles of high-dose intravenous immunoglobulin and plasmapheresis for treatment of late antibody-mediated rejection of renal transplants’, Journal of the Formosan Medical Association, vol. 115, no. 10, pp. 845-852. https://www.ncbi.nlm.nih.gov/pubmed/27542515 Lian, M, Chan, W, Slavin, M, et al 2006, ‘Miliary tuberculosis in a Caucasian male transplant recipient and the role of intravenous immunoglobulin as an immunosuppressive sparing agent’, Nephrology (Carlton), vol. 11, no. 2, pp. 156–8. https://www.ncbi.nlm.nih.gov/pubmed/16669980 Luke, PP, Scantlebury, VP, Jordan, ML, et al 2001, ‘Reversal of steroid- and anti-lymphocyte antibody-resistant rejection using intravenous immunoglobulin (IVIg) in renal transplant recipients’, Transplantation, vol. 72, no. 3, pp. 419–22. https://www.ncbi.nlm.nih.gov/pubmed/11502969 Moger, V, Ravishankar, M, Sakhuja, V, et al 2004, ‘Intravenous immunoglobulin: a safe option for treatment of steroid-resistant rejection in the presence of infection. Transplantation, vol. 77, no. 9, pp. 1455–6. https://www.ncbi.nlm.nih.gov/pubmed/15167606 Montgomery, RA, Lonze, BE, King, KE, et al 2011, ‘Desensitization in HLA-incompatible kidney recipients and survival’, New England Journal of Medicine, vol. 365, no. 4, pp. 318–326. https://www.ncbi.nlm.nih.gov/pubmed/21793744 Ontario Regional Blood Coordinating Network 2016. Ontario Intravenous Immune Globulin (IVIG) Utilization Management Guidelines, Version 3.0. [online]. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216671/dh_131107.pdf Orange, JS, Hossny, EM, Weiler, CR, et al 2006, ‘Use of intravenous immunoglobulin in human disease: A review of primary evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology’, Journal of Allergy and Clinical Immunology, vol. 117, no. 4, pp. S525–53. https://www.ncbi.nlm.nih.gov/pubmed/16580469 Peraldi, MN, Akposso, K, Haymann, JP, et al 1996, ‘Long-term benefit of intravenous immunoglobulins in cadaveric kidney retransplantation’, Transplantation, vol. 62, no. 11, pp. 1670–3. https://www.ncbi.nlm.nih.gov/pubmed/8970626 Puliyanda, D, Radha, RK, Amet, N, et al 2003, ‘IVIg contains antibodies reactive with polyoma BK virus and may represent a therapeutic option for BK nephropathy’, American Journal of Transplantation, vol. 3, no. 5, pp. 359. Sautenet, B, Blancho, G, Büchler, M, et al 2016, ‘One-year Results of the Effects of Rituximab on Acute Antibody-Mediated Rejection in Renal Transplantation’, Transplantation, vol. 100, no. 2, pp. 391-399. https://www.medscape.com/medline/abstract/26555944 Sonnenday, CJ, Warren, DS, Cooper, MC, et al 2004, ‘Plasmapheresis, CMV hyperimmune globulin, and anti-CD20 allow ABO-incompatible renal transplantation without splenectomy’, American Journal of Transplantation, vol. 4, no. 8, pp. 1315–22. https://www.ncbi.nlm.nih.gov/pubmed/15268734 Takemoto, SK, Zeevi, A, Feng, S, et al 2004, ‘National conference to assess antibody-mediated rejection in solid organ transplantation’, American Journal of Transplantation, vol. 4, no. 7, pp. 1033–41. https://www.ncbi.nlm.nih.gov/pubmed/15196059 Tydén, G, Kumlien, G, Genberg, H, et al 2005, ‘ABO incompatible kidney transplantations without splenectomy, using antigen-specific immunoadsorption and rituximab’, American Journal of Transplantation, vol. 5, no. 1, pp. 145–8. https://www.ncbi.nlm.nih.gov/pubmed/15636623 UK National Kidney Federation 2002 ‘Transplant’. Available from: https://www.kidney.org.uk/ [cited 7 Dec 2007]. Viglietti, D, Gosset, C, Loupy, A, et al 2016, ‘C1 Inhibitor in Acute Antibody-Mediated Rejection Nonresponsive to Conventional Therapy in Kidney Transplant Recipients: A Pilot Study’, American Journal of Transplantation, vol. 16, no. 5, pp. 1596-1603. https://www.ncbi.nlm.nih.gov/pubmed/26693703 Zarkhin, V, Li, L, Kambham, N, et al 2008, ‘A Randomized, Prospective Trial of Rituximab for Acute Rejection in Pediatric Renal Transplantation’, American Journal of Transplantation, vol. 8, no. 12, pp. 2607-2617. http://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2008.02411.x/full UK Department of Health 2011, ‘Clinical Guidelines for Immunoglobulin Use: Second Edition Update: Summary Poster’. Available from: http://igd.mdsas.com/clinical-info/

Bibliography

Ahsan, N & Shah, KV 2002, ‘Polyomaviruses: an overview’, Graft, vol. 5, pp. S9–18. https://www.researchgate.net/publication/247903519_Polyomaviruses_An_Overview

Berry, GJ, Angelini, A, Burke, MM et al 2011, ‘The ISHLT working formulation for pathologic diagnosis of antibody-mediated rejection in heart transplantation: Evolution and current status (2005-2011)’, The Journal of Heart and Lung Transplant, vol. 30, no. 6, pp. 601:611. http://www.jhltonline.org/article/S1053-2498(11)00796-0/abstract

Biotext 2004, ‘Summary data on conditions and papers’ in A systematic literature review and report on the efficacy of intravenous immunoglobulin therapy and its risks, commissioned by the National Blood Authority on behalf of all Australian Governments: 86–87. Available from: https://www.blood.gov.au/system/files/A-systematic-literature-review-and-report-on-the-efficacy-of-IVIg-therapy-and-its-risks.pdf

Casadei, DH, del C Rial, M, Opelz, G, et al 2001, ‘A randomised and prospective study comparing treatment with high-dose intravenous immunoglobulin with monoclonal antibodies for rescue of kidney grafts with steroid-resistant rejection’, Transplantation, vol. 71, no. 1, pp. 53–58. https://www.ncbi.nlm.nih.gov/pubmed/11211195

Choi, J, Jung, J, Shin, S, et al 2016, ‘The early outcomes of bortezomib therapy in patients with late antibody mediated rejection in renal transplantation’, Poster Abstracts. American Journal of Transplantation, vol. 16. pp. 405–798. http://onlinelibrary.wiley.com/doi/10.1111/ajt.13898/full

Colvin, MM, Cook, JL, Chang, P, et al 2015, ‘Antibody mediated rejection in cardiac transplantation: emerging knowledge in diagnosis and management: a scientific statement from the American Heart Association’, Circulation, vol. 131, no. 18, pp. 1608-1639. https://www.ncbi.nlm.nih.gov/pubmed/25838326

Conti, DJ, Freed, BM, Gruber, SA, et al 1994, ‘Prophylaxis of primary cytomegalovirus disease in renal transplant recipients. A trial of ganciclovir vs. immunoglobulin’, Archives of Surgery, vol. 129, no. 4, pp. 443–447. https://www.ncbi.nlm.nih.gov/pubmed/8154971

Cooper, JE, Gralla, J, Klem, P, et al 2014, ‘High dose intravenous immunoglobulin therapy for donor-specific antibodies in kidney transplant recipients with acute and chronic graft dysfunction. Transplantation, vol. 97, no. 12, pp. 1253-9. https://www.ncbi.nlm.nih.gov/pubmed/24937199

Djamali, A, Kaufman, DB, Ellis, TM, et al 2014, ‘Diagnosis and management of anti-body mediated rejection: current status and novel approaches’, American Journal of Transplantation, vol. 14, no. 2, pp. 255-271. https://www.ncbi.nlm.nih.gov/pubmed/24401076

Einecke, G, Bräsen, J, Schwarz, A, et al 2016, ‘Treatment of Late Antibody-Mediated Rejection: Observations from Clinical Practice’, American Journal of Transplantation. Poster Abstracts. American Journal of Transplantation, vol. 16, pp. 609. http://onlinelibrary.wiley.com/doi/10.1111/ajt.13898/full

Frommer, M & Madronio, C 2006, ‘The use of intravenous immunoglobulin in Australia. A report for the National Blood Authority’, Part B: systematic literature review. Sydney Health Projects Group, University of Sydney, Sydney, pp. 18–20. https://www.blood.gov.au/pubs/ivig/conditions-for-which-IVIg-has-an-established-therapeutic-role.html

Gupta, G, Abu Jawdeh, BG, Racusen LC, et al 2014, ‘Late antibody-mediated rejection in renal allografts: outcome after conventional and novel therapies’, Transplantation, vol. 97, no. 12, pp. 1240-6. https://www.ncbi.nlm.nih.gov/pubmed/24937198

Haas, M, Sis, B, Racusen, LC, et al 2014, ‘Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions’, American Journal of Transplantation, vol. 14, no. 2, pp. 272-283. https://www.ncbi.nlm.nih.gov/pubmed/24472190

Jordan, SC, Tyan, D, Stablein, D, et al 2004, ‘Evaluation of intravenous immunoglobulin as an agent to lower allosensitisation and improve transplantation in highly sensitized adult patients with end-stage renal disease: report of the NIH IG02 trial’, Journal of the American Society of Nephrology, vol. 15, no. 12, pp. 3256–62. https://www.ncbi.nlm.nih.gov/pubmed/15579530

Jordan, SC, Vo, A, Bunnapradist, S, et al 2003, ‘Intravenous immune globulin treatment inhibits crossmatch positivity and allows for successful transplantation of incompatible organs in living-donor and cadaver recipients’, Transplantation, vol. 76, no. 4, pp. 631–6. https://www.ncbi.nlm.nih.gov/pubmed/12973100

Jordan, SC, Vo, AA, Tyan, D, et al 2005, ‘Current approaches to treatment of antibody-mediated rejection’, Pediatric Transplantation, vol. 9, no. 3,pp. 408–15. https://www.ncbi.nlm.nih.gov/pubmed/15910400

Lee, CY, Lin, WC, Wu, MS, et al 2016, ‘Repeated cycles of high-dose intravenous immunoglobulin and plasmapheresis for treatment of late antibody-mediated rejection of renal transplants’, Journal of the Formosan Medical Association, vol. 115, no. 10, pp. 845-852. https://www.ncbi.nlm.nih.gov/pubmed/27542515

Lian, M, Chan, W, Slavin, M, et al 2006, ‘Miliary tuberculosis in a Caucasian male transplant recipient and the role of intravenous immunoglobulin as an immunosuppressive sparing agent’, Nephrology (Carlton), vol. 11, no. 2, pp. 156–8. https://www.ncbi.nlm.nih.gov/pubmed/16669980

Luke, PP, Scantlebury, VP, Jordan, ML, et al 2001, ‘Reversal of steroid- and anti-lymphocyte antibody-resistant rejection using intravenous immunoglobulin (IVIg) in renal transplant recipients’, Transplantation, vol. 72, no. 3, pp. 419–22. https://www.ncbi.nlm.nih.gov/pubmed/11502969

Moger, V, Ravishankar, M, Sakhuja, V, et al 2004, ‘Intravenous immunoglobulin: a safe option for treatment of steroid-resistant rejection in the presence of infection. Transplantation, vol. 77, no. 9, pp. 1455–6. https://www.ncbi.nlm.nih.gov/pubmed/15167606

Montgomery, RA, Lonze, BE, King, KE, et al 2011, ‘Desensitization in HLA-incompatible kidney recipients and survival’, New England Journal of Medicine, vol. 365, no. 4, pp. 318–326. https://www.ncbi.nlm.nih.gov/pubmed/21793744

Ontario Regional Blood Coordinating Network 2016. Ontario Intravenous Immune Globulin (IVIG) Utilization Management Guidelines, Version 3.0. [online]. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216671/dh_131107.pdf

Orange, JS, Hossny, EM, Weiler, CR, et al 2006, ‘Use of intravenous immunoglobulin in human disease: A review of primary evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology’, Journal of Allergy and Clinical Immunology, vol. 117, no. 4, pp. S525–53. https://www.ncbi.nlm.nih.gov/pubmed/16580469

Peraldi, MN, Akposso, K, Haymann, JP, et al 1996, ‘Long-term benefit of intravenous immunoglobulins in cadaveric kidney retransplantation’, Transplantation, vol. 62, no. 11, pp. 1670–3. https://www.ncbi.nlm.nih.gov/pubmed/8970626

Puliyanda, D, Radha, RK, Amet, N, et al 2003, ‘IVIg contains antibodies reactive with polyoma BK virus and may represent a therapeutic option for BK nephropathy’, American Journal of Transplantation, vol. 3, no. 5, pp. 359.

Sautenet, B, Blancho, G, Büchler, M, et al 2016, ‘One-year Results of the Effects of Rituximab on Acute Antibody-Mediated Rejection in Renal Transplantation’, Transplantation, vol. 100, no. 2, pp. 391-399. https://www.medscape.com/medline/abstract/26555944

Sonnenday, CJ, Warren, DS, Cooper, MC, et al 2004, ‘Plasmapheresis, CMV hyperimmune globulin, and anti-CD20 allow ABO-incompatible renal transplantation without splenectomy’, American Journal of Transplantation, vol. 4, no. 8, pp. 1315–22. https://www.ncbi.nlm.nih.gov/pubmed/15268734

Takemoto, SK, Zeevi, A, Feng, S, et al 2004, ‘National conference to assess antibody-mediated rejection in solid organ transplantation’, American Journal of Transplantation, vol. 4, no. 7, pp. 1033–41. https://www.ncbi.nlm.nih.gov/pubmed/15196059

Tydén, G, Kumlien, G, Genberg, H, et al 2005, ‘ABO incompatible kidney transplantations without splenectomy, using antigen-specific immunoadsorption and rituximab’, American Journal of Transplantation, vol. 5, no. 1, pp. 145–8. https://www.ncbi.nlm.nih.gov/pubmed/15636623

UK National Kidney Federation 2002 ‘Transplant’. Available from: https://www.kidney.org.uk/ [cited 7 Dec 2007].

Viglietti, D, Gosset, C, Loupy, A, et al 2016, ‘C1 Inhibitor in Acute Antibody-Mediated Rejection Nonresponsive to Conventional Therapy in Kidney Transplant Recipients: A Pilot Study’, American Journal of Transplantation, vol. 16, no. 5, pp. 1596-1603. https://www.ncbi.nlm.nih.gov/pubmed/26693703

Zarkhin, V, Li, L, Kambham, N, et al 2008, ‘A Randomized, Prospective Trial of Rituximab for Acute Rejection in Pediatric Renal Transplantation’, American Journal of Transplantation, vol. 8, no. 12, pp. 2607-2617. http://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2008.02411.x/full

UK Department of Health 2011, ‘Clinical Guidelines for Immunoglobulin Use: Second Edition Update: Summary Poster’. Available from: http://igd.mdsas.com/clinical-info/

Solid organ transplantation Version: 3.0 Published: 20 October 2018 Condition for which Ig has an emerging therapeutic role.

Solid organ transplantation
Version: 3.0
Published: 20 October 2018
Condition for which Ig has an emerging therapeutic role.