Randomized controlled trial of mg in untreated chronic inflammatory demyelinating polyradiculoneuropathy

J. R. Mendell, R. J. Barohn, M. L. Freimer, J. T. Kissel, W. King, H. N. Nagaraja, R. Rice, W. W. Campbell, P. D. Donofrio, C. E. Jackson, R. A. Lewis, M. Shy, D. M. Simpson, G. J. Parry, M. H. Rivner, C. A. Thornton, M. B. Bromberg, R. Tandan, Y. Harati, M. J. Giuliani

Research output: Contribution to journalArticle

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Abstract

Objective: To determine the efficacy of IV immunoglobulin (IVIg) given patients with untreated chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Methods: A randomized, double-blind, multicenter, investigator-initiated study compared IVIg (Aventis Behring LLC, King of Prussia, PA) with placebo (5% albumin), On days 1, 2, and 21, IVIg (1 g/kg) or placebo was given. The primary outcome measure was the change in muscle strength from baseline to day 42, using the average muscle score (AMS). Secondary outcome measures included change from baseline AMS at days 10 and 21, the Hughes' functional disability scale, forced vital capacity (FVC), and nerve conduction studies (NCS) of four motor nerves (median, ulnar, peroneal, and tibial). Results: The patients (n = 33) were randomized. Of these, 30 (14 women, 16 men, aged 54 ± 20 years, range 13 to 82) received IVIg and 23 were given placebo (12 women, 11 men, aged 50 ± 18 years, range 23 to 73). Baseline AMS values of the groups were similar (Mg 7.06 ± 1.31 versus placebo 7.28 ± 1.18, p = 0.53). There were two dropouts in placebo group and one in the IVIg group. Mean AMS improved at day 42 comparing IVIg with placebo (0.63 versus -0.1, p = 0.006). Improved strength was seen by day 10. The placebo group lost strength over this same interval. In the IVIg, 11 subjects improved by the functional disability scale; none worsened. This differed (p = 0.019) from those in the placebo-treated group (two improved, two got worse, remainder unchanged). Forced vital capacity did not improve with IVIg treatment. IVIg improved ulnar motor distal latency (p = 0.005), tibial distal compound muscle amplitude (p = 0.003), and peroneal nerve conduction velocity (p = 0.03). Conclusions: IVIg improves strength in patients with untreated CIDP by day 10 with continued benefit through day 42; more than one third improve by at least a functional grade on a disability scale. This study provides data supporting Mg as the initial treatment for CIDP.

Original languageEnglish (US)
Pages (from-to)445-449
Number of pages5
JournalNeurology
Volume56
Issue number4
DOIs
StatePublished - Feb 27 2001

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Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Intravenous Immunoglobulins
Randomized Controlled Trials
Placebos
Muscles
Neural Conduction
Vital Capacity
Prussia
Outcome Assessment (Health Care)
Peroneal Nerve
Ulnar Nerve
Median Nerve
Muscle Strength
Albumins
Research Personnel

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Mendell, J. R., Barohn, R. J., Freimer, M. L., Kissel, J. T., King, W., Nagaraja, H. N., ... Giuliani, M. J. (2001). Randomized controlled trial of mg in untreated chronic inflammatory demyelinating polyradiculoneuropathy. Neurology, 56(4), 445-449. https://doi.org/10.1212/WNL.56.4.445

Randomized controlled trial of mg in untreated chronic inflammatory demyelinating polyradiculoneuropathy. / Mendell, J. R.; Barohn, R. J.; Freimer, M. L.; Kissel, J. T.; King, W.; Nagaraja, H. N.; Rice, R.; Campbell, W. W.; Donofrio, P. D.; Jackson, C. E.; Lewis, R. A.; Shy, M.; Simpson, D. M.; Parry, G. J.; Rivner, M. H.; Thornton, C. A.; Bromberg, M. B.; Tandan, R.; Harati, Y.; Giuliani, M. J.

In: Neurology, Vol. 56, No. 4, 27.02.2001, p. 445-449.

Research output: Contribution to journalArticle

Mendell, JR, Barohn, RJ, Freimer, ML, Kissel, JT, King, W, Nagaraja, HN, Rice, R, Campbell, WW, Donofrio, PD, Jackson, CE, Lewis, RA, Shy, M, Simpson, DM, Parry, GJ, Rivner, MH, Thornton, CA, Bromberg, MB, Tandan, R, Harati, Y & Giuliani, MJ 2001, 'Randomized controlled trial of mg in untreated chronic inflammatory demyelinating polyradiculoneuropathy', Neurology, vol. 56, no. 4, pp. 445-449. https://doi.org/10.1212/WNL.56.4.445
Mendell JR, Barohn RJ, Freimer ML, Kissel JT, King W, Nagaraja HN et al. Randomized controlled trial of mg in untreated chronic inflammatory demyelinating polyradiculoneuropathy. Neurology. 2001 Feb 27;56(4):445-449. https://doi.org/10.1212/WNL.56.4.445
Mendell, J. R. ; Barohn, R. J. ; Freimer, M. L. ; Kissel, J. T. ; King, W. ; Nagaraja, H. N. ; Rice, R. ; Campbell, W. W. ; Donofrio, P. D. ; Jackson, C. E. ; Lewis, R. A. ; Shy, M. ; Simpson, D. M. ; Parry, G. J. ; Rivner, M. H. ; Thornton, C. A. ; Bromberg, M. B. ; Tandan, R. ; Harati, Y. ; Giuliani, M. J. / Randomized controlled trial of mg in untreated chronic inflammatory demyelinating polyradiculoneuropathy. In: Neurology. 2001 ; Vol. 56, No. 4. pp. 445-449.
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abstract = "Objective: To determine the efficacy of IV immunoglobulin (IVIg) given patients with untreated chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Methods: A randomized, double-blind, multicenter, investigator-initiated study compared IVIg (Aventis Behring LLC, King of Prussia, PA) with placebo (5{\%} albumin), On days 1, 2, and 21, IVIg (1 g/kg) or placebo was given. The primary outcome measure was the change in muscle strength from baseline to day 42, using the average muscle score (AMS). Secondary outcome measures included change from baseline AMS at days 10 and 21, the Hughes' functional disability scale, forced vital capacity (FVC), and nerve conduction studies (NCS) of four motor nerves (median, ulnar, peroneal, and tibial). Results: The patients (n = 33) were randomized. Of these, 30 (14 women, 16 men, aged 54 ± 20 years, range 13 to 82) received IVIg and 23 were given placebo (12 women, 11 men, aged 50 ± 18 years, range 23 to 73). Baseline AMS values of the groups were similar (Mg 7.06 ± 1.31 versus placebo 7.28 ± 1.18, p = 0.53). There were two dropouts in placebo group and one in the IVIg group. Mean AMS improved at day 42 comparing IVIg with placebo (0.63 versus -0.1, p = 0.006). Improved strength was seen by day 10. The placebo group lost strength over this same interval. In the IVIg, 11 subjects improved by the functional disability scale; none worsened. This differed (p = 0.019) from those in the placebo-treated group (two improved, two got worse, remainder unchanged). Forced vital capacity did not improve with IVIg treatment. IVIg improved ulnar motor distal latency (p = 0.005), tibial distal compound muscle amplitude (p = 0.003), and peroneal nerve conduction velocity (p = 0.03). Conclusions: IVIg improves strength in patients with untreated CIDP by day 10 with continued benefit through day 42; more than one third improve by at least a functional grade on a disability scale. This study provides data supporting Mg as the initial treatment for CIDP.",
author = "Mendell, {J. R.} and Barohn, {R. J.} and Freimer, {M. L.} and Kissel, {J. T.} and W. King and Nagaraja, {H. N.} and R. Rice and Campbell, {W. W.} and Donofrio, {P. D.} and Jackson, {C. E.} and Lewis, {R. A.} and M. Shy and Simpson, {D. M.} and Parry, {G. J.} and Rivner, {M. H.} and Thornton, {C. A.} and Bromberg, {M. B.} and R. Tandan and Y. Harati and Giuliani, {M. J.}",
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T1 - Randomized controlled trial of mg in untreated chronic inflammatory demyelinating polyradiculoneuropathy

AU - Mendell, J. R.

AU - Barohn, R. J.

AU - Freimer, M. L.

AU - Kissel, J. T.

AU - King, W.

AU - Nagaraja, H. N.

AU - Rice, R.

AU - Campbell, W. W.

AU - Donofrio, P. D.

AU - Jackson, C. E.

AU - Lewis, R. A.

AU - Shy, M.

AU - Simpson, D. M.

AU - Parry, G. J.

AU - Rivner, M. H.

AU - Thornton, C. A.

AU - Bromberg, M. B.

AU - Tandan, R.

AU - Harati, Y.

AU - Giuliani, M. J.

PY - 2001/2/27

Y1 - 2001/2/27

N2 - Objective: To determine the efficacy of IV immunoglobulin (IVIg) given patients with untreated chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Methods: A randomized, double-blind, multicenter, investigator-initiated study compared IVIg (Aventis Behring LLC, King of Prussia, PA) with placebo (5% albumin), On days 1, 2, and 21, IVIg (1 g/kg) or placebo was given. The primary outcome measure was the change in muscle strength from baseline to day 42, using the average muscle score (AMS). Secondary outcome measures included change from baseline AMS at days 10 and 21, the Hughes' functional disability scale, forced vital capacity (FVC), and nerve conduction studies (NCS) of four motor nerves (median, ulnar, peroneal, and tibial). Results: The patients (n = 33) were randomized. Of these, 30 (14 women, 16 men, aged 54 ± 20 years, range 13 to 82) received IVIg and 23 were given placebo (12 women, 11 men, aged 50 ± 18 years, range 23 to 73). Baseline AMS values of the groups were similar (Mg 7.06 ± 1.31 versus placebo 7.28 ± 1.18, p = 0.53). There were two dropouts in placebo group and one in the IVIg group. Mean AMS improved at day 42 comparing IVIg with placebo (0.63 versus -0.1, p = 0.006). Improved strength was seen by day 10. The placebo group lost strength over this same interval. In the IVIg, 11 subjects improved by the functional disability scale; none worsened. This differed (p = 0.019) from those in the placebo-treated group (two improved, two got worse, remainder unchanged). Forced vital capacity did not improve with IVIg treatment. IVIg improved ulnar motor distal latency (p = 0.005), tibial distal compound muscle amplitude (p = 0.003), and peroneal nerve conduction velocity (p = 0.03). Conclusions: IVIg improves strength in patients with untreated CIDP by day 10 with continued benefit through day 42; more than one third improve by at least a functional grade on a disability scale. This study provides data supporting Mg as the initial treatment for CIDP.

AB - Objective: To determine the efficacy of IV immunoglobulin (IVIg) given patients with untreated chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Methods: A randomized, double-blind, multicenter, investigator-initiated study compared IVIg (Aventis Behring LLC, King of Prussia, PA) with placebo (5% albumin), On days 1, 2, and 21, IVIg (1 g/kg) or placebo was given. The primary outcome measure was the change in muscle strength from baseline to day 42, using the average muscle score (AMS). Secondary outcome measures included change from baseline AMS at days 10 and 21, the Hughes' functional disability scale, forced vital capacity (FVC), and nerve conduction studies (NCS) of four motor nerves (median, ulnar, peroneal, and tibial). Results: The patients (n = 33) were randomized. Of these, 30 (14 women, 16 men, aged 54 ± 20 years, range 13 to 82) received IVIg and 23 were given placebo (12 women, 11 men, aged 50 ± 18 years, range 23 to 73). Baseline AMS values of the groups were similar (Mg 7.06 ± 1.31 versus placebo 7.28 ± 1.18, p = 0.53). There were two dropouts in placebo group and one in the IVIg group. Mean AMS improved at day 42 comparing IVIg with placebo (0.63 versus -0.1, p = 0.006). Improved strength was seen by day 10. The placebo group lost strength over this same interval. In the IVIg, 11 subjects improved by the functional disability scale; none worsened. This differed (p = 0.019) from those in the placebo-treated group (two improved, two got worse, remainder unchanged). Forced vital capacity did not improve with IVIg treatment. IVIg improved ulnar motor distal latency (p = 0.005), tibial distal compound muscle amplitude (p = 0.003), and peroneal nerve conduction velocity (p = 0.03). Conclusions: IVIg improves strength in patients with untreated CIDP by day 10 with continued benefit through day 42; more than one third improve by at least a functional grade on a disability scale. This study provides data supporting Mg as the initial treatment for CIDP.

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