Limits...
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.


Related in: MedlinePlus

Individual mean dose reduction (g/kg).
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4281444&req=5

fig2: Individual mean dose reduction (g/kg).

Mentions: All 26 patients agreed on new administration protocol; one patient after two infusions expressed wish to continue with two-day administration (admission). Admission was therefore not needed in 96.1% of patients. If we would use recommended maintenance dose of IVIG (1 g/kg), monthly dose would be 2040 g. Intervals range between infusions was between 2 and 6 weeks and all doses were recalculated to monthly format. Thanks to frequent clinical reviews and appropriate staff training we were able to reduce amount of IVIG to mean dose 0.67 g/kg/month (range 0.3–2.5 g/kg, P < 0.0001). So at the end of the second phase (approximately after 12 months) cumulative monthly dose was reduced to 1298 g per month (−36.4% reduction, P < 0.000005). Majority of patients were not reporting any significant clinical progression during second phase (69.2% reported their condition as stable, 26.9% as better, and 3.9% as mildly worse) and this agreed with objective examination. 5 patients discontinued treatment at the end of titration period (second phase). Two patients with paraneoplastic polyneuropathy (anti-Hu positive) and one patient with paraprotein mediated polyneuropathy and one with myasthenia gravis discontinued treatment for infectivity (clinical progression or lack of improvement (nonresponders) despite escalation of treatment to maximal dose). One patient was reclassified from multifocal motor neuropathy to degenerative anterior horn cell degeneration/motor neuron disease on the basis of clinical picture and follow-up neurophysiology. Deescalation protocol clearly failed in one patient (CIDP patient) who remained on 2.5 g/kg every month (administered over two days) despite steroids added to treatment regimen. 21 patients entered final observational period and at the end of observation (after further 3 months) mean monthly dose was reduced further to 0.60 g/kg and cumulative monthly dose dropped to 991 gm/month (Figure 2).


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

Dolezal O - Autoimmune Dis (2014)

Individual mean dose reduction (g/kg).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig2: Individual mean dose reduction (g/kg).
Mentions: All 26 patients agreed on new administration protocol; one patient after two infusions expressed wish to continue with two-day administration (admission). Admission was therefore not needed in 96.1% of patients. If we would use recommended maintenance dose of IVIG (1 g/kg), monthly dose would be 2040 g. Intervals range between infusions was between 2 and 6 weeks and all doses were recalculated to monthly format. Thanks to frequent clinical reviews and appropriate staff training we were able to reduce amount of IVIG to mean dose 0.67 g/kg/month (range 0.3–2.5 g/kg, P < 0.0001). So at the end of the second phase (approximately after 12 months) cumulative monthly dose was reduced to 1298 g per month (−36.4% reduction, P < 0.000005). Majority of patients were not reporting any significant clinical progression during second phase (69.2% reported their condition as stable, 26.9% as better, and 3.9% as mildly worse) and this agreed with objective examination. 5 patients discontinued treatment at the end of titration period (second phase). Two patients with paraneoplastic polyneuropathy (anti-Hu positive) and one patient with paraprotein mediated polyneuropathy and one with myasthenia gravis discontinued treatment for infectivity (clinical progression or lack of improvement (nonresponders) despite escalation of treatment to maximal dose). One patient was reclassified from multifocal motor neuropathy to degenerative anterior horn cell degeneration/motor neuron disease on the basis of clinical picture and follow-up neurophysiology. Deescalation protocol clearly failed in one patient (CIDP patient) who remained on 2.5 g/kg every month (administered over two days) despite steroids added to treatment regimen. 21 patients entered final observational period and at the end of observation (after further 3 months) mean monthly dose was reduced further to 0.60 g/kg and cumulative monthly dose dropped to 991 gm/month (Figure 2).

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