Randomized trial of intravenous immunoglobulin maintenance treatment regimens in chronic inflammatory demyelinating polyradiculoneuropathy
Kuitwaard, K.; Brusse, E.; Jacobs, B. C.; Vrancken, A. F.J.E.; Eftimov, F.; Notermans, N. C.; van der Kooi, A. J.; Fokkink, W. J.R.; Nieboer, D.; Lingsma, H. F.; Merkies, I. S.J.; van Doorn, P. A.
(2021) European Journal of Neurology, volume 28, issue 1, pp. 286 - 296
(Article)
Abstract
Background and purpose: High peak serum immunoglobulin G (IgG) levels may not be needed for maintenance intravenous immunoglobulin (IVIg) treatment in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and such high levels may cause side effects. More frequent lower dosing may lead to more stable IgG levels and higher trough levels, which
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might improve efficacy. The aim of this trial is to investigate whether high frequent low dosage IVIg treatment is more effective than low frequent high dosage IVIg treatment. Methods: In this randomized placebo-controlled crossover trial, we included patients with CIDP proven to be IVIg-dependent and receiving an individually established stable dose and interval of IVIg maintenance treatment. In the control arm, patients received their individual IVIg dose and interval followed by a placebo infusion at half the interval. In the intervention arm, patients received half their individual dose at half the interval. After a wash-out phase patients crossed over. The primary outcome measure was handgrip strength (assessed using a Martin Vigorimeter). Secondary outcome indicators were health-related quality of life (36-item Short-Form Health Survey), disability (Inflammatory Rasch-built Overall Disability Scale), fatigue (Rasch-built Fatigue Severity Scale) and side effects. Results: Twenty-five patients were included and were treated at baseline with individually adjusted dosages of IVIg ranging from 20 to 80 g and intervals ranging from 14 to 35 days. Three participants did not complete the trial; the main analysis was therefore based on the 22 patients completing both treatment periods. There was no significant difference in handgrip strength change from baseline between the two treatment regimens (coefficient −2.71, 95% CI −5.4, 0.01). Furthermore, there were no significant differences in any of the secondary outcomes or side effects. Conclusions: More frequent lower dosing does not further improve the efficacy of IVIg in stable IVIg-dependent CIDP and does not result in fewer side effects.
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Keywords: chronic inflammatory demyelinating, crossover studies, immunoglobulins, intravenous, polyradiculoneuropathy, Clinical Neurology, Neurology, Journal Article
ISSN: 1351-5101
Publisher: Wiley-Blackwell
Note: Funding Information: K.K. reports grants from Takeda, during the conduct of the study, grants from Grifols, and other from Sanquin, outside the submitted work. B.C.J. reports grants from Hansa Biopharma, Annexon, Grifols, CSL Behring, Prinses Beatrix Spierfonds, GBS‐CIDP Foundation International and EU Horizon 2020, outside the submitted work. F.E. reports grants from CSL Behring, Kedrion, Terumo BCT and Takeda Pharmaceutical Company, outside the submitted work. Grants were paid to the institution and are used for investigator‐initiated studies within INCbase, an international CIDP registry. Also, F.E. received a consultancy fee from UCB Pharma, paid to the institution, outside the submitted work. A.J.v.d.K. reports grants from Interlaken leadership Award, outside the submitted work. I.S.J.M. reports grants from the EU Commission, the Talecris Talents Program and GBS‐CIDP Foundation International, personal fees and other from the Octapharma CIDP study, and personal fees from the Novartis CIDP study, the LFB MMN study and the Talecris CIDP study during the conduct of the present study. P.A.v.D. reports grants from Takeda, during the conduct of the study, grants from Prinses Beatrix Spierfonds, Sanquin Blood Supply and Grifols, and other from Hansa, Annexon, Argenx, CSL and Octapharma, outside the submitted work. A.F.J.E.V., E.B., N.C.N., W.‐J.R.F., D.N. and H.F.L. have nothing to disclose. Funding Information: This investigator‐initiated trial was supported by a grant from Shire International GmbH, a Takeda company, ID #BT13‐20896. Publisher Copyright: © 2020 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology
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