Abstract

BackgroundInternational guidelines recommend either intravenous immunoglobulin (IVIg) or corticosteroids as first-line treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). IVIg treatment usually leads to rapid improvement and is generally safe, but does not seem to lead to long-term remissions. Corticosteroids act more slowly and are associated with more side effects, but may induce long-term remissions. The hypothesis of this study is that combined IVIg and corticosteroid induction treatment will lead to more frequent long-term remissions than IVIg treatment alone.MethodsAn international, randomised, double-blind, placebo-controlled trial, in adults with ‘probable’ or ‘definite’ CIDP according to the EFNS/PNS 2010 criteria. Three groups of patients are included: (1) treatment naïve, (2) known CIDP patients with a relapse after > 1 year without treatment, and (3) patients with CIDP who improved within 3 months after a single course of IVIg, who subsequently deteriorate at any interval without having received additional treatment. Patients are randomised to receive 7 courses of IVIg and 1000 mg intravenous methylprednisolone (IVMP) (in sodium chloride 0.9%) or IVIg and placebo (sodium chloride 0.9%), every 3 weeks for 18 weeks. IVIg treatment consists of a loading dose of 2 g/kg (over 3–5 days) followed by 6 courses of IVIg 1/g/kg (over 1–2 days). The primary outcome is remission at 1 year, defined as improvement in disability from baseline, sustained between week 18 and week 52 without further treatment. Secondary outcomes include changes in disability, impairment, pain, fatigue, quality of life, care use and costs and (long-term) safety.DiscussionIn case of superiority of the combined treatment, patients will experience the advantages of two proven efficacious treatments, namely rapid improvement due to IVIg and long-term remission due to corticosteroids. Long-term remission would reduce the need for maintenance IVIg treatment and may decrease health care costs. Additionally, we expect that the combined treatment leads to a higher proportion of patients with improvement as some patients who do not respond to IVIg will respond to corticosteroids. Risks of short and long-term additional adverse events of the combined treatment need to be assessed.Trial registrationISRCTN registry ISRCTN15893334. Prospectively registered on 12 February 2018.

Highlights

  • Background and rationale {6a} Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated neuropathy affecting the arms and legs [1, 2]

  • We expect that the combined treatment leads to a higher proportion of patients with improvement as some patients who do not respond to intravenous immunoglobulin (IVIg) will respond to corticosteroids

  • The OPTIC trial is a randomised controlled trial aiming to determine whether combined induction treatment of IVIg and intravenous methylprednisolone (IVMP) leads to more remissions than IVIg treatment alone

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Summary

Introduction

Background and rationale {6a} Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated neuropathy affecting the arms and legs [1, 2]. An important advantage of corticosteroids compared to IVIg is that they may lead to long-term remissions, defined as a stable condition without the need for continued treatment [8, 9]. In a recent open-label non-controlled pilot study, 20 CIDP patients were treated with a combination of IVIg and intravenous methylprednisolone (IVMP) over 4 months after which treatment was stopped. We hypothesise that combining IVIg and pulsed IVMP as induction treatment will lead to more long-term remissions than IVIg monotherapy in patients with CIDP. International guidelines recommend either intravenous immunoglobulin (IVIg) or corticosteroids as first-line treatment for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The hypothesis of this study is that combined IVIg and corticosteroid induction treatment will lead to more frequent long-term remissions than IVIg treatment alone

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