Beecher G, et al. – This prospective, open-label, phase 3 trial was conducted to examine the efficacy, tolerability, and safety of subcutaneous immunoglobulin (SCIg) in patients with mild to moderate myasthenia gravis (MG) exacerbation. In mild to moderate MG exacerbation, SCIg was well–tolerated, safe, and effective. Comparative safety and efficacy needed to be established with randomized controlled trials.

• The clinicians enrolled 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.
• Change in quantitative MG (QMG) score from baseline to study end at 6 weeks was the primary endpoint.
• 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) were included as secondary endpoints.

• Out of 23 patients, 22 completed the study.
• In this 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 was high (79.6 ± 15.6%) by TSQM.
• Headache and injection site reactions were common adverse events.
• There were no serious adverse events.