Dosing and individualized treatment - patient-centric treatment: changing practice guidelines

Patwa, Huned

doi:10.1111/cei.12503

Cited by 5 publications

(5 citation statements)

References 19 publications

(18 reference statements)

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“…This variation is likely to be caused by differences in IVIg catabolism between patients but may also be due to variations in disease activity (Kuitwaard et al, ) . A similar large variation in IVIg dosage level requirement and frequency has been reported in multifocal motor neuropathy (MMN) and primary immunodeficiencies (Patwa, ; Vlam et al, ) . Therefore, the optimum dosage and frequency of maintenance IVIg must be individually established for every CIDP patient (Koller et al, ; Rajabally et al, ; Vallat et al, ; Lunn et al, ) .…”

Section: Current Practice Of Ivig Maintenance Treatment In Cidpsupporting

confidence: 61%

“…Third, patients do not need a continuous increase in dosage with prolonged treatment with IVIg (Querol et al, ; Kuitwaard et al, ) . Investigation if IVIg treatment leads to treatment dependency is difficult because reasons why CIDP patients go into remission and predictors of remission are unfortunately still unknown (Patwa, ) . In our experience the median time on IVIg treatment before it successfully can be stopped is about 5 years.…”

Section: Current Practice Of Ivig Maintenance Treatment In Cidpmentioning

confidence: 99%

See 1 more Smart Citation

Maintenance IV immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy

Kuitwaard

Fokkink

Brusse

et al. 2017

J Peripheral Nervous Sys

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Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients treated with intravenous immunoglobulin (IVIg) usually start with a standard dosage of 2 g/kg bodyweight. Only a minority of patients has a sustained improvement, and most require ongoing maintenance treatment. Preferred IVIg regimens, however, vary considerably between doctors and at present it is unknown which is optimal. As there are also large differences in IVIg dosage and interval requirements between patients, optimal IVIg maintenance treatment of CIDP is even more complex. The lack of evidence-based guidelines on how IVIg maintenance treatment should be administered may potentially lead to under- or overtreatment of this expensive therapy. We provide an overview of published practical IVIg maintenance treatment regimens, IVIg maintenance schedules used in randomized controlled trials and one based upon our own long-term experience on how this treatment could be given in CIDP.

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Section: Current Practice Of Ivig Maintenance Treatment In Cidpsupporting

confidence: 61%

Section: Current Practice Of Ivig Maintenance Treatment In Cidpmentioning

confidence: 99%

Maintenance IV immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy

Kuitwaard

Fokkink

Brusse

et al. 2017

J Peripheral Nervous Sys

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“…The standard dosage of 2 g/kg body weight in 5 days for GBS is copied from the regimen used in paediatric patients with immune thrombocytopenia [ 48 ]. Dose-finding studies with IVIg have been sparsely conducted in GBS and it is unknown if the standard regimen is optimal for this disorder [ 15 , 49 ]. Whether a higher peak concentration and/or a larger area under the concentration–time curve has clinical significance remains to be unravelled.…”

Section: Discussionmentioning

confidence: 99%

Population Pharmacokinetic Modelling of Intravenous Immunoglobulin Treatment in Patients with Guillain–Barré Syndrome

et al. 2022

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Background and Objective Intravenous immunoglobulin (IVIg) at a standard dosage is the treatment of choice for Guillain-Barré syndrome. The pharmacokinetics, however, is highly variable between patients, and a rapid clearance of IVIg is associated with poor recovery. We aimed to develop a model to predict the pharmacokinetics of a standard 5-day IVIg course (0.4 g/kg/day) in patients with Guillain-Barré syndrome. Methods Non-linear mixed-effects modelling software (NONMEM ® ) was used to construct a pharmacokinetic model based on a model-building cohort of 177 patients with Guillain-Barré syndrome, with a total of 589 sequential serum samples tested for total immunoglobulin G (IgG) levels, and evaluated on an independent validation cohort that consisted of 177 patients with Guillain-Barré syndrome with 689 sequential serum samples. ResultsThe final two-compartment model accurately described the daily increment in serum IgG levels during a standard IVIg course; the initial rapid fall and then a gradual decline to steady-state levels thereafter. The covariates that increased IgG clearance were a more severe disease (as indicated by the Guillain-Barré syndrome disability score) and concomitant methylprednisolone treatment. When the current dosing regimen was simulated, the percentage of patients who reached a target ∆IgG > 7.3 g/L at 2 weeks decreased from 74% in mildly affected patients to only 33% in the most severely affected and mechanically ventilated patients (Guillain-Barré syndrome disability score of 5). Conclusions This is the first population-pharmacokinetic model for standard IVIg treatment in Guillain-Barré syndrome. The model provides a new tool to predict the pharmacokinetics of alternative regimens of IVIg in Guillain-Barré syndrome to design future trials and personalise treatment.Willem Jan R. Fokkink and Sander J. van Tilburg contributed equally to the article.

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“…In the off-label context, indications about the optimal dosage, duration, and frequency of immunomodulatory IVIG are usually contingent to expert opinions, varying among different centers; they are also on the basis of the equipe expertise, of the patients' preferences and comorbidity, and of the environmental affordability. In general, a HD-IVIG protocol ranges from 1000 to 3000 mg/kg of body weight, divided into 400 mg/day for generally 2-5 days [44,45].…”

Section: Introductionmentioning

confidence: 99%

Anti-Inflammatory and Immunomodulatory Effect of High-Dose Immunoglobulins in Children: From Approved Indications to Off-Label Use

Conti,

Moratti,

Leonardi

et al. 2023

Cells

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Background: The large-scale utilization of immunoglobulins in patients with inborn errors of immunity (IEIs) since 1952 prompted the discovery of their key role at high doses as immunomodulatory and anti-inflammatory therapy, in the treatment of IEI-related immune dysregulation disorders, according to labelled and off-label indications. Recent years have been dominated by a progressive imbalance between the gradual but constant increase in the use of immunoglobulins and their availability, exacerbated by the SARS-CoV-2 pandemic. Objectives: To provide pragmatic indications for a need-based application of high-dose immunoglobulins in the pediatric context. Sources: A literature search was performed using PubMed, from inception until 1st August 2023, including the following keywords: anti-inflammatory; children; high dose gammaglobulin; high dose immunoglobulin; immune dysregulation; immunomodulation; immunomodulatory; inflammation; intravenous gammaglobulin; intravenous immunoglobulin; off-label; pediatric; subcutaneous gammaglobulin; subcutaneous immunoglobulin. All article types were considered. Implications: In the light of the current imbalance between gammaglobulins’ demand and availability, this review advocates the urgency of a more conscious utilization of this medical product, giving indications about benefits, risks, cost-effectiveness, and administration routes of high-dose immunoglobulins in children with hematologic, neurologic, and inflammatory immune dysregulation disorders, prompting further research towards a responsible employment of gammaglobulins and improving the therapeutical decisional process.

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Dosing and individualized treatment - patient-centric treatment: changing practice guidelines

Cited by 5 publications

References 19 publications

Maintenance IV immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy

Maintenance IV immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy

Population Pharmacokinetic Modelling of Intravenous Immunoglobulin Treatment in Patients with Guillain–Barré Syndrome

Anti-Inflammatory and Immunomodulatory Effect of High-Dose Immunoglobulins in Children: From Approved Indications to Off-Label Use

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