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Combined intravenous immunoglobulin and methylprednisolone as induction treatment in chronic inflammatory demyelinating polyneuropathy (OPTIC protocol): a prospective pilot study
Author(s) -
Adrichem M. E.,
Bus S. R.,
Wieske L.,
Mohammed H.,
Verhamme C.,
Hadden R.,
Schaik I. N.,
Eftimov F.
Publication year - 2020
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.14096
Subject(s) - medicine , methylprednisolone , polyradiculoneuropathy , adverse effect , chronic inflammatory demyelinating polyneuropathy , multifocal motor neuropathy , anesthesia , pediatrics , antibody , guillain barre syndrome , immunology , mismatch negativity , electroencephalography , psychiatry
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.