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Randomized Controlled Trial
. 2021 Jan;132(1):226-231.
doi: 10.1016/j.clinph.2020.09.001. Epub 2020 Sep 14.

Electrophysiological testing in chronic inflammatory demyelinating polyneuropathy patients treated with subcutaneous immunoglobulin: The Polyneuropathy And Treatment with Hizentra (PATH) study

Vera Bril  1 , Hans-Peter Hartung  2 , John-Philip Lawo  3 , Billie L Durn  4 , Orell Mielke  3
Affiliations
Free article
Randomized Controlled Trial

Electrophysiological testing in chronic inflammatory demyelinating polyneuropathy patients treated with subcutaneous immunoglobulin: The Polyneuropathy And Treatment with Hizentra (PATH) study

Vera Bril et al. Clin Neurophysiol. 2021 Jan.
Free article

Abstract

Objective: To assess electrophysiology parameters that can reflect patients' clinical status and show changes in nerve function with treatment, in a study of subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy.

Methods: Nerve conduction studies (latency, conduction velocity, conduction block and compound muscle action potential [CMAP] on upper limb median, ulnar, and lower limb peroneal motor nerves) were conducted in the placebo-controlled PATH (Polyneuropathy And Treatment with Hizentra) study of two doses of maintenance subcutaneous immunoglobulin (SCIG) IgPro20 in CIDP.

Results: Averaged proximal latency substantially increased with placebo (+1.1 ms) indicating electrophysiologic deterioration but remained stable with IgPro20 (0.2 g/kg bodyweight [bw]: +0.1 ms; 0.4 g/kg bw: -0.1 ms). Distal latencies were also more prolonged with placebo versus IgPro20. Averaged motor nerve conduction velocity substantially decreased with placebo (-1.6 m/s) versus increasing in both IgPro20 groups (+0.2 m/s and +1.0 m/s, respectively). Conduction block and CMAP amplitudes did not change substantially.

Conclusion: These findings support the effectiveness of maintenance IgPro20, as nerve function changed in the direction of increasing nerve dysfunction with placebo but remained stable with ongoing IgPro20 therapy.

Significance: Electrophysiology testing can support assessment of clinical status in CIDP to determine treatment efficacy.

Keywords: Chronic inflammatory demyelinating polyneuropathy; Electrophysiology; IgPro20; Nerve conduction studies; Subcutaneous immunoglobulin.

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Conflict of interest statement

Declaration of Competing Interest VB is a consultant to CSL Behring, Grifols, Union Chimique Belge, Takeda, Alylam, Alexion and ArgenX. She serves on international scientific advisory boards for the Myasthenia Gravis Foundation of America and Guillain-Barré Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy (CIDP/GBS) Foundation International, and has received research support from CSL Behring, Grifols, Union Chimique Belge, and ArgenX. H-PH received fees for consulting or serving on steering committees or advertisement boards from Baxter, Bayer Healthcare, Biogen, CSL Behring, Geneuro, Kedrion, Laboratoire francais du Fractionnement et des Biotechnologies, MedImmune, Merck, Novartis, Octapharma, Receptos Celgene, Roche, Sanofi Genzyme, and Teva, with approval by the Rector of Heinrich-Heine-University Düsseldorf. J-PL is a CSL employee and biostatistician for this study. BLD was a CSL Behring employee during this study.

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