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Abstract
Objective: To investigate the efficacy, tolerability, and safety of subcutaneous immunoglobulin (SCIg) in patients with mild to moderate myasthenia gravis (MG) exacerbation.
Methods: We performed a prospective, open-label, phase 3 trial in patients with MG aged 18 years or older and mild to moderate worsening (transition from Myasthenia Gravis Foundation of America class I to II/III or class II to III), treated with SCIg (2 g/kg), self-administered over 4 weeks. The primary endpoint was change in quantitative MG (QMG) score from baseline to study end at 6 weeks. Secondary endpoints included change in manual muscle testing (MMT), MG activities of daily living (MG-ADL), and MG composite (MGC) scores, as well as occurrence of adverse events, and tolerability as assessed via Treatment Satisfaction Questionnaire for Medication (TSQM).
Results: Twenty-two of 23 patients completed the study. QMG score decreased from 14.9 ± 4.1 to 9.8 ± 5.6 (p < 0.0001), MMT score decreased from 16.8 ± 9.5 to 5.2 ± 4.5 (p < 0.0001), MG-ADL score decreased from 9.5 ± 3.0 to 4.6 ± 3.0 (p < 0.0001), and MGC score decreased from 17.4 ± 5.0 to 5.6 ± 4.5 (p < 0.0001). Satisfaction by TSQM was high (79.6 ± 15.6%). Common adverse events included headache and injection site reactions. No serious adverse events occurred.
Conclusions: SCIg is well-tolerated, safe, and effective in mild to moderate MG exacerbation. Comparative safety and efficacy must be established with randomized controlled trials.
Classification of evidence: This study provides Class IV evidence that in patients with mild to moderate MG exacerbation, SCIg is safe and effective in reducing MG disability measures.
GLOSSARY
- AChR=
- acetylcholine receptor;
- IgA=
- immunoglobulin A;
- IgG=
- immunoglobulin G;
- IVIg=
- IV immunoglobulin;
- MG=
- myasthenia gravis;
- MG-ADL=
- myasthenia gravis activities of daily living;
- MGC=
- myasthenia gravis composite;
- MGFA=
- Myasthenia Gravis Foundation of America;
- MMT=
- manual muscle testing;
- MuSK=
- muscle-specific tyrosine kinase;
- PLEX=
- plasma exchange;
- QMG=
- quantitative myasthenia gravis;
- SCIg=
- subcutaneous immunoglobulin;
- TSQM=
- Treatment Satisfaction Questionnaire for Medication
Footnotes
↵* These authors contributed equally to this work.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
- Received April 6, 2017.
- Accepted in final form June 21, 2017.
- © 2017 American Academy of Neurology
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