Update on the use of immunoglobulin in human disease: A review of evidence

Perez, Elena E.; Orange, Jordan S.; Bonilla, Francisco A.; Chinen, Javier; Chinn, Iván K.; Dorsey, Morna J.; El-Gamal, Yehia; Harville, Terry; Hossny, Elham; Mazer, Bruce; Nelson, Robert P.; Secord, Elizabeth; Jordan, Stanley C.; Stiehm, E. Richard; Vo, Ashley; Ballow, Mark

doi:10.1016/j.jaci.2016.09.023

Cited by 480 publications

(473 citation statements)

References 620 publications

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“…These adverse effects require long term replacement with intravenous immunoglobulins (IVIGs). We recom mend intervention to maintain serum immunoglobulin levels above 400 µg/l with IVIGs as well as consideration of IVIG administration to provide specific immunity during active infection, irrespective of immuno globulin levels 63,125 . B cell aplasia has been associated with progressive multifocal leukoencephalopathy (PML) 126,127 ; thus, patients should be closely monitored for neurological signs and symptoms that are suggestive of PML (neuropsychological deficits, progressive demen tia, apraxia, or visual and motor deficits) 126 until the resolution of B cell aplasia.…”

Section: Long-term Follow-up Assessmentmentioning

confidence: 99%

Management guidelines for paediatric patients receiving chimeric antigen receptor T cell therapy

et al. 2018

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In 2017, an autologous chimeric antigen receptor (CAR) T cell therapy indicated for children and young adults with relapsed and/or refractory CD19 acute lymphoblastic leukaemia became the first gene therapy to be approved in the USA. This innovative form of cellular immunotherapy has been associated with remarkable response rates but is also associated with unique and often severe toxicities, which can lead to rapid cardiorespiratory and/or neurological deterioration. Multidisciplinary medical vigilance and the requisite health-care infrastructure are imperative to ensuring optimal patient outcomes, especially as these therapies transition from research protocols to standard care. Herein, authors representing the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network Hematopoietic Stem Cell Transplantation (HSCT) Subgroup and the MD Anderson Cancer Center CAR T Cell Therapy-Associated Toxicity (CARTOX) Program have collaborated to provide comprehensive consensus guidelines on the care of children receiving CAR T cell therapy.

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Section: Long-term Follow-up Assessmentmentioning

confidence: 99%

Management guidelines for paediatric patients receiving chimeric antigen receptor T cell therapy

et al. 2018

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“…Intravenous immunoglobulin (IVIG) is a polyspecific pooled immunoglobulin G preparation and one of the commonly used immunotherapeutics for the treatment of autoimmune diseases including those of neurological origin [1–4]. Various reports demonstrate that IVIG exerts beneficial effects through several mutually non-exclusive mechanisms including expansion of CD4 + Foxp3 + regulatory T cells (T reg cells) [5–10].…”

Section: Introductionmentioning

confidence: 99%

Regulatory T cell frequency, but not plasma IL-33 levels, represents potential immunological biomarker to predict clinical response to intravenous immunoglobulin therapy

Maddur

Stephen-Victor

Das

et al. 2017

J Neuroinflammation

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BackgroundIntravenous immunoglobulin (IVIG) is a polyspecific pooled immunoglobulin G preparation and one of the commonly used therapeutics for autoimmune diseases including those of neurological origin. A recent report in murine model proposed that IVIG expands regulatory T (Treg) cells via induction of interleukin 33 (IL-33). However, translational insight on these observations is lacking.MethodsTen newly diagnosed Guillain-Barré syndrome (GBS) patients were treated with IVIG at the rate of 0.4 g/kg for three to five consecutive days. Clinical evaluation for muscular weakness was performed by Medical Research Council (MRC) and modified Rankin scoring (MRS) system. Heparinized blood samples were collected before and 1, 2, and 4–5 weeks post-IVIG therapy. Peripheral blood mononuclear cells were stained for surface CD4 and intracellular Foxp3, IFN-γ, and tumor necrosis factor alpha (TNF-α) and were analyzed by flow cytometry. IL-33 and prostaglandin E2 in the plasma were measured by ELISA.ResultsThe fold changes in plasma IL-33 at week 1 showed no correlation with the MRC and MRS scores at weeks 1, 2, and ≥4 post-IVIG therapy. Clinical recovery following IVIG therapy appears to be associated with Treg cell response. Contrary to murine study, there was no association between the fold changes in IL-33 at week 1 and Treg cell frequency at weeks 1, 2, and ≥4 post-IVIG therapy. Treg cell-mediated clinical response to IVIG therapy in GBS patients was associated with reciprocal regulation of effector T cells-expressing TNF-α.ConclusionTreg cell expansion by IVIG in patients with autoimmune diseases lack correlation with IL-33. Treg cell frequency, but not plasma IL-33 levels, represents potential immunological biomarker to predict clinical response to IVIG therapy.

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“…IVIG is known for its anti-inflammatory and immunomodulatory effects with a wide clinical use in numerous autoimmune and inflammatory conditions like antiphospholipid-antibody syndrome, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, and Crohn’s disease [22–24]. Our rationale for using high dose IVIG in this patient was the potential binding of IVIG to the neonatal Fc receptors (FcRn) [23,25] which are responsible for recycling of antibodies, including pathological antibodies such as anti-rhGAA thus blocking rhGAA antibodies from being recycled and leading to their destruction. Saturating the FcRn receptor with high dose IVIG may prevent such recycling so that anti-rhGAA IgG antibody titers decrease over time as they are directed towards the degradation pathway [26].…”

Section: Discussionmentioning

confidence: 99%

High dose IVIG successfully reduces high rhGAA IgG antibody titers in a CRIM-negative infantile Pompe disease patient

Rairikar

Kazi

Desai

et al. 2017

Molecular Genetics and Metabolism

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Alglucosidase alfa (rhGAA) has altered the course of an otherwise fatal outcome in classic infantile Pompe disease (IPD), which presents with cardiomyopathy and severe musculoskeletal involvement. However, the response to therapy is determined by several factors including the development of high and sustained antibody titers (HSAT) to rhGAA. Cross-reactive immunologic material (CRIM) negative patients are at the highest risk for development of HSAT. Immune tolerance induction (ITI) with methotrexate, rituximab, and intravenous immunoglobulin (IVIG) has been largely successful in preventing the immune response and in achieving tolerance when done in conjunction with enzyme replacement therapy (ERT) initiation. Reducing antibody titers in cases with an entrenched immune response remains a challenge in the field despite the use of multiple immunomodulatory agents. Success has been shown with addition of bortezomib to the ITI regimen, yet the prolonged course and potential risks with the use of such agents’ demands caution. We present here a 7-year-old CRIM-negative IPD patient who was not successfully tolerized by an ITI regimen with rituximab, methotrexate, and IVIG due to intolerability to the regimen and recurrent infections. She went on to develop HSAT, with significant clinical decline, loss of all motor abilities, and a fragile medical state, which made it challenging to institute the bortezomib based regimen to reduce HSAT. She had severe developmental delay, respiratory failure with invasive ventilation and tracheostomy, persistent hypotonia, ptosis of eyelids, diffuse severe osteopenia, contractures, and was completely G-tube fed. As a rescue mechanism, we treated her with high dose and high frequency IVIG in an attempt to reduce rhGAA IgG antibody titers (antibody titers; titers). Her titers saw a steady decline on weekly IVIG doses at 1 g/kg for 20 weeks. Subsequently when the IVIG regimen was altered to 1 g/kg every month, rising titers were detected and therefore the regimen was changed to a biweekly regimen. High dose IVIG resulted in an eightfold decrease in antibody titers. Clinically, she showed improvement with partial recovery of previously lost motor abilities, especially hand movements and better head and neck control than before. The regimen was safely tolerated with no hospitalizations. The effectiveness of IVIG as a single agent, in this case with multiple comorbidities and fragile clinical status, was lifesaving and may represent an effective, perhaps lifesaving rescue approach to reduce antibody titers.

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Update on the use of immunoglobulin in human disease: A review of evidence

Cited by 480 publications

References 620 publications

Management guidelines for paediatric patients receiving chimeric antigen receptor T cell therapy

Management guidelines for paediatric patients receiving chimeric antigen receptor T cell therapy

Regulatory T cell frequency, but not plasma IL-33 levels, represents potential immunological biomarker to predict clinical response to intravenous immunoglobulin therapy

High dose IVIG successfully reduces high rhGAA IgG antibody titers in a CRIM-negative infantile Pompe disease patient

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