This study is an open label, single center, prospective, 26 weeks study with descriptive analysis where IVIG is replaced by efgartigimod therapy. MG-ADL and MGQOL evaluations will occur weekly throughout the study to week 26.
Objectives: To determine if efgartigimod is equivalent or non-inferior in efficacy to IVIG in the treatment of stable, acetylcholine receptor antibody positive, IVIG dependent myasthenia gravis patients. To determine patient treatment preference between IVIG and efgartigimod in stable, IVIG dependent acetylcholine receptor antibody positive myasthenia gravis patients. To determine the safety and tolerability of efgartigimod administered in a fixed regular dosing regimen over 6 months in stable IVIG dependent acetylcholine receptor antibody positive myasthenia gravis patients. IVIG will be discontinued one week prior to the baseline visit (week 0) while other concurrent medications (non-steroidal immunosuppressive therapies (NSISTs), acetylcholinesterase (AChE) inhibitors or corticosteroids) for myasthenia will be kept unchanged for the duration of the study. The dose and frequency of efgartigimod treatment will be 10mg/kg (max of 1200mg) administered as a one-hour intravenous infusion every week x 4 infusions followed by a four-week break and repeated for a total four treatment cycles till week 24 and then followed by a two-week observation with an end of study visit at week 26.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
efgartigimod infusion
Clinique Neuro-Outaouais
Gatineau, Quebec, Canada
RECRUITINGMG-ADL
The percentage of patients who do not experience, at any time during the study, a 2 or more-point deterioration from their averaged baseline MG-ADL score that is sustained for a period of 4 or more consecutive weeks. (stable or improved patients)
Time frame: a sustained decrease persistent for at least 4 consecutive weeks over the 26 week period
QMG
The percentage of patients who do not experience, at any time during the study, a 3 or more-point deterioration from their baseline QMG score that is sustained for a period of 4 or more consecutive weeks. (stable or improved patients)
Time frame: those who experience a sustained decrease for 4 consecutive weeks during the 26 week period
MGQOL
The change in group, mean MGQOL score from the averaged baseline to the week 26 end of study visit.
Time frame: during the whole study period of 26 weeks
incidence of patients who are still receiving efgartigimod by the end of the 26 weeks
incidence of patients who are still receiving efgartigimod by the end of the 26 weeks
Time frame: for the duration of the 26 week study
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