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. 2020 Mar;27(3):506-513.
doi: 10.1111/ene.14096. Epub 2019 Nov 7.

Combined intravenous immunoglobulin and methylprednisolone as induction treatment in chronic inflammatory demyelinating polyneuropathy (OPTIC protocol): a prospective pilot study

M E Adrichem  1 , S R Bus  1 , L Wieske  1 , H Mohammed  2 , C Verhamme  1 , R Hadden  2 , I N van Schaik  1 , F Eftimov  1
Affiliations

Combined intravenous immunoglobulin and methylprednisolone as induction treatment in chronic inflammatory demyelinating polyneuropathy (OPTIC protocol): a prospective pilot study

M E Adrichem et al. Eur J Neurol. 2020 Mar.

Abstract

Background and purpose: We hypothesized that combining intravenous immunoglobulin (IVIg) and intravenous methylprednisolone (IVMP) leads to more frequent remission compared with IVIg alone while maintaining the fast efficacy of IVIg. In this uncontrolled pilot study, we evaluated remission, rate of improvement and safety in patients with chronic inflammatory demyelinating polyradiculoneuropathy receiving induction treatment with combined IVIg and IVMP.

Methods: Consecutive treatment-naive patients with chronic inflammatory demyelinating polyradiculoneuropathy were treated with IVIg infusions, consisting of a 2 g/kg loading dose and 1 g/kg maintenance treatment every 3 weeks, combined with 3-weekly 1-g IVMP infusions, for a total of 18 weeks. The cumulative steroid dose was 7 g. Primary outcome was remission at 1 year in patients who completed the treatment schedule. Remission was defined as improvement at 18 weeks without the need for further immune treatment between end of the treatment schedule and 1-year follow-up. Improvement was defined as a minimal clinically important difference on the Inflammatory Rasch-Built Overall Disability Scale and/or an increase of ≥8 kPa in grip strength between baseline and week 18.

Results: A total of 20 patients were included; 17 completed the treatment schedule. A total of 13 (76%) of these patients improved at 18 weeks after start of treatment and 10 (59%) patients were in remission at 1 year. Serious adverse events were found in four patients.

Conclusions: Short-term combined induction treatment with IVIg and IVMP induced remission in almost 60% of patients who completed the treatment schedule. Combined induction therapy was generally well tolerated. A randomized controlled trial is currently running to confirm efficacy and safety of IVMP as add-on treatment to IVIg.

Keywords: chronic inflammatory demyelinating polyradiculoneuropathy; corticosteroids; intravenous immunoglobulin.

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Conflict of interest statement

R. Hadden received personal and departmental payments from CSL Behring and Grifols. I.N. van Schaik reports departmental honoraria for serving on scientific advisory boards for CSL Behring and Baxter. He chaired a steering committee for CSL Behring. He is a member of the Scientific Board of the Kreuth III meeting. F. Eftimov reports grants from Prinses Beatrix Spierfonds, Netherlands Organization for Health Research and Development, and a consulting fee from CSL Behring, UCB Pharma and Aserta Pharma that was paid to the Institution, outside the submitted work. The other authors declare no financial or other conflicts of interest.

Figures

Figure 1
Figure 1
OPTIC treatment protocol. BL, baseline; IVIg, intravenous immunoglobulin; IVMP, intravenous methylprednisolone.
Figure 2
Figure 2
Protocol flowchart and outcome. One patient who did not complete protocol was in remission at 1 year. The one patient who was scored as a non‐responder due to slow improvement was also in remission at 1 year. IVIg, intravenous immunoglobulin.
Figure 3
Figure 3
Overview of the Inflammatory Rasch‐Built Overall Disability Scale (iRODS) and total grip strength over time in patients who completed all courses of intravenous methylprednisolone (n = 17). Upper graphs show iRODS scores (centile); lower graphs show (total) grip strength. Patients treated between week 18 and 52 (n = 2) did not classify as remission.
See this image and copyright information in PMC

References

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