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Intravenous immunoglobulin treatment in chronic neurological diseases: do we have maintenance dose right?

Dolezal O - Autoimmune Dis (2014)

Bottom Line: Conclusion.Individual dose titration leads to significant maintenance IVIG dose reduction with preserved clinical efficacy.Maintenance dose below 1 g/kg (in our study around 0.7 g/kg) has acceptable risk/benefit ratio.

View Article: PubMed Central - PubMed

Affiliation: NHS Scotland, Dumfries and Galloway Royal Infirmary, Bankend Road, Dumfries DG14AP, UK.

ABSTRACT
Objectives. We tried to define, on individual basis, minimal effective maintenance dose of intravenous immunoglobulins (IVIG) in 26 patients with chronic neurological conditions requiring long-term IVIG treatment. Methods. Clinical criteria were reviewed in individual cases (Phase 1) followed by titration phase (Phase 2, 12 months) and posttitration/follow-up phase (Phase 3, 3 months). Objective neurological examination and patient self-reports were used for clinical follow-up. Results. 69.2% of patients reported condition as stable, 26.9% as better, and 3.9% as mildly worse. Original mean monthly dose was 1 g/kg; over the period of 12 months we reduced dose of IVIG to mean dose 0.67 g/kg (range 0.3-2.5 g/kg, P < 0.0001) which meant reduction by 36.4%. We identified 4 nonresponders and diagnosis in one case was reclassified to degenerative disease. In follow-up phase we reduced dose further to 0.60 g/kg. Cumulative monthly dose dropped from 2040 g to 1298 g and to 991 g, respectively. Financial expenses were reduced significantly (by -36.4% during titration phase and by -51.4% during follow-up phase) (comparing with baseline) (P < 0.0001). Conclusion. Individual dose titration leads to significant maintenance IVIG dose reduction with preserved clinical efficacy. Maintenance dose below 1 g/kg (in our study around 0.7 g/kg) has acceptable risk/benefit ratio.

No MeSH data available.


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Study design (number of patients, phases).
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fig1: Study design (number of patients, phases).

Mentions: In our study we observed group of patients (N = 26) with various neurological conditions (see Table 1) for 15 months. They were treated by IVIG for more than 3 months at the beginning of observation (range 3–58 months). They all provided oral agreement with IVIG treatment. Patients were on no concomitant immunosuppressive treatment. Aim of our study was to establish minimal effective dose and lowest tolerable infusion frequency without compromising clinical efficacy. At the beginning of our study maintenance dose used in patients was 1 g/kg administered every 4 weeks (as per guidelines of joint task force of the European Federation of Neurological Societies (EFNS) and Peripheral Nerve Society (PNS)) [22–24], and infusion was administered over two consecutive days. That required member of junior medical staff (clerking connected with admission) and there were additional expenses connected with admission. Our study was divided into three separate phases (see Figure 1). In the first phase (Phase 1) general review of currently treated patients was performed; diagnosis and diagnostic criteria (including available test results, lumbar puncture, nerve conduction studies (NCS), etc.) were reviewed as well. All patients were offered to switch to “one-day” infusion (preventing hospital admission). At that point monthly dose never dropped under minimal recommended dose of 0.6 g/kg. This dose allowed us to prevent two-day administration and avoid admission (maximal daily dose administered in one day was 50 g). Intervals were set to 2–6 weeks (on the basis of individual patient experience). Second phase lasted for 12 months and during that period dose and intervals between infusions were changed according to clinical need (titration period). Patients were instructed to report any changes in clinical condition to trained staff and dose was readjusted when needed (month-to-month basis). Infusion room staff (two staff nurses) regularly took part in specialised clinic alongside neurology consultant to provide them with appropriate clinical training. Third phase (lasted 3 months) included another detailed clinical review and further dose adjustments; if clinical condition deteriorated introducing of steroid treatment was considered. Nonresponders were identified. For clinical evaluation subjective information from patients (quality of life, severity of sensory and motor symptoms, etc.) and detailed neurological examination (muscle strength, reflexes, etc.) were used. No serum biomarkers were monitored. Electrophysiology and other diagnostic tests were repeated only if diagnostic doubts were present. For statistical analysis we used Statistica software (StatSoft Inc.) to obtain descriptive statistics and to establish level of significance; t-test was used.


Intravenous immunoglobulin treatment in chronic neurological diseases: do we have maintenance dose right?

Dolezal O - Autoimmune Dis (2014)

Study design (number of patients, phases).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4281444&req=5

fig1: Study design (number of patients, phases).
Mentions: In our study we observed group of patients (N = 26) with various neurological conditions (see Table 1) for 15 months. They were treated by IVIG for more than 3 months at the beginning of observation (range 3–58 months). They all provided oral agreement with IVIG treatment. Patients were on no concomitant immunosuppressive treatment. Aim of our study was to establish minimal effective dose and lowest tolerable infusion frequency without compromising clinical efficacy. At the beginning of our study maintenance dose used in patients was 1 g/kg administered every 4 weeks (as per guidelines of joint task force of the European Federation of Neurological Societies (EFNS) and Peripheral Nerve Society (PNS)) [22–24], and infusion was administered over two consecutive days. That required member of junior medical staff (clerking connected with admission) and there were additional expenses connected with admission. Our study was divided into three separate phases (see Figure 1). In the first phase (Phase 1) general review of currently treated patients was performed; diagnosis and diagnostic criteria (including available test results, lumbar puncture, nerve conduction studies (NCS), etc.) were reviewed as well. All patients were offered to switch to “one-day” infusion (preventing hospital admission). At that point monthly dose never dropped under minimal recommended dose of 0.6 g/kg. This dose allowed us to prevent two-day administration and avoid admission (maximal daily dose administered in one day was 50 g). Intervals were set to 2–6 weeks (on the basis of individual patient experience). Second phase lasted for 12 months and during that period dose and intervals between infusions were changed according to clinical need (titration period). Patients were instructed to report any changes in clinical condition to trained staff and dose was readjusted when needed (month-to-month basis). Infusion room staff (two staff nurses) regularly took part in specialised clinic alongside neurology consultant to provide them with appropriate clinical training. Third phase (lasted 3 months) included another detailed clinical review and further dose adjustments; if clinical condition deteriorated introducing of steroid treatment was considered. Nonresponders were identified. For clinical evaluation subjective information from patients (quality of life, severity of sensory and motor symptoms, etc.) and detailed neurological examination (muscle strength, reflexes, etc.) were used. No serum biomarkers were monitored. Electrophysiology and other diagnostic tests were repeated only if diagnostic doubts were present. For statistical analysis we used Statistica software (StatSoft Inc.) to obtain descriptive statistics and to establish level of significance; t-test was used.

Bottom Line: Conclusion.Individual dose titration leads to significant maintenance IVIG dose reduction with preserved clinical efficacy.Maintenance dose below 1 g/kg (in our study around 0.7 g/kg) has acceptable risk/benefit ratio.

View Article: PubMed Central - PubMed

Affiliation: NHS Scotland, Dumfries and Galloway Royal Infirmary, Bankend Road, Dumfries DG14AP, UK.

ABSTRACT
Objectives. We tried to define, on individual basis, minimal effective maintenance dose of intravenous immunoglobulins (IVIG) in 26 patients with chronic neurological conditions requiring long-term IVIG treatment. Methods. Clinical criteria were reviewed in individual cases (Phase 1) followed by titration phase (Phase 2, 12 months) and posttitration/follow-up phase (Phase 3, 3 months). Objective neurological examination and patient self-reports were used for clinical follow-up. Results. 69.2% of patients reported condition as stable, 26.9% as better, and 3.9% as mildly worse. Original mean monthly dose was 1 g/kg; over the period of 12 months we reduced dose of IVIG to mean dose 0.67 g/kg (range 0.3-2.5 g/kg, P < 0.0001) which meant reduction by 36.4%. We identified 4 nonresponders and diagnosis in one case was reclassified to degenerative disease. In follow-up phase we reduced dose further to 0.60 g/kg. Cumulative monthly dose dropped from 2040 g to 1298 g and to 991 g, respectively. Financial expenses were reduced significantly (by -36.4% during titration phase and by -51.4% during follow-up phase) (comparing with baseline) (P < 0.0001). Conclusion. Individual dose titration leads to significant maintenance IVIG dose reduction with preserved clinical efficacy. Maintenance dose below 1 g/kg (in our study around 0.7 g/kg) has acceptable risk/benefit ratio.

No MeSH data available.


Related in: MedlinePlus