Is there any data to support dosing up to 4 g/kg of IVIG for myasthenia gravis exacerbation (divided over 2-5 days)?

Comment by InpharmD Researcher

There is a paucity of evidence supporting intravenous immunoglobulin (IVIG) doses above 2 g/kg for myasthenia gravis (MG) exacerbations. Randomized trials and guideline reviews support total doses of 1 to 2 g/kg, which improve clinical outcomes and show efficacy comparable to plasma exchange, with no controlled studies demonstrating benefit at higher doses. One review discussed the potential need for super-high IVIG dosing (3-4 g/kg per month) in select refractory patients based on pharmacogenomic and mechanistic considerations (eg, increased IgG catabolism related to neonatal Fc receptor [FcRn] polymorphisms), but it did not identify clinical trial data evaluating 4 g/kg for acute exacerbations. The authors emphasized that this higher-dose approach is theoretical and based on expert opinion, not direct evidence. Overall, IVIG doses up to 2 g/kg remains the evidence-supported standard, and dosing to 3-4 g/kg lacks clinical support for MG exacerbations.

Search strategy: myasthenia gravis exacerbations and Intravenous immunoglobulin, myasthenia gravis exacerbation and IVIG, worsening myasthenia gravis and IVIG, acute myasthenia gravis and immunomodulation, high-dose IVIG and myasthenia gravis

Background

A 2023 international guideline reviewed the role of intravenous immunoglobulin (IVIG) in the management of myasthenia gravis, including its use in acute exacerbations and myasthenic crisis. The guideline synthesized evidence from randomized trials, comparative studies, and expert consensus evaluating IVIG dosing strategies and clinical outcomes. Standard IVIG regimens for acute exacerbation were identified as 0.4 g/kg/day for 5 consecutive days or 1 g/kg/day for 2 days, corresponding to a total cumulative dose of 2 g/kg. Outcomes assessed included improvement in quantitative myasthenia gravis (QMG) scores, duration of myasthenic crisis, ventilatory requirements, and clinical stabilization, with IVIG demonstrating efficacy comparable to plasmapheresis in moderate to severe disease. The authors noted that in selected cases, lower cumulative doses (e.g., 1 g/kg total) may be sufficient, while IVIG has also been used off-label as maintenance therapy in specific clinical scenarios; however, no randomized or controlled data were identified supporting cumulative doses exceeding 2 g/kg. Based on the available evidence, the guideline concludes that IVIG doses up to 2 g/kg are supported for MG exacerbation and crisis, and there is no evidence within the reviewed literature to support dosing up to 4 g/kg, regardless of administration over 2-5 days. [1]

A 2022 review evaluated the immunomodulatory mechanisms and clinical use of IVIG in myasthenia gravis (MG), with a focus on its role in acute exacerbations and factors influencing treatment response. The review summarized clinical trial data demonstrating that IVIG administered at a total dose of 2 g/kg, typically divided over 2 consecutive days, produces clinically meaningful improvements in disease severity scores within days in patients with severe MG exacerbations. While no controlled clinical trials were identified that directly evaluated IVIG doses up to 4 g/kg for MG exacerbations, the authors discussed pharmacogenomic data indicating that polymorphisms in the neonatal Fc receptor (FcRn) receptor gene (VNTR2/3 genotype) are associated with increased IgG catabolism and reduced IVIG exposure. Based on these mechanistic and pharmacokinetic considerations, the authors noted that some patients with MG who respond inadequately to standard dosing are likely to require higher IVIg doses (such as super-high IVIg at 3-4 g/kg per month) or more frequent administrations if 2 g/kg is not effective. The authors concluded that while 2 g/kg remains the evidence-supported standard for acute MG exacerbations, higher cumulative doses may be biologically plausible in refractory patients, though this strategy is based on expert opinion and indirect evidence rather than direct clinical trial data and warrants further study. [2]

A 2012 review evaluated randomized controlled trials assessing the efficacy and dosing of IVIG for MG exacerbation, worsening disease, and chronic stable disease. The review included seven RCTs comparing IVIG with placebo, plasma exchange, corticosteroids, or alternative IVIG dosing regimens, with outcomes primarily assessing changes in myasthenic muscle score (MMS) and QMG score within 7-15 days of treatment. Standard IVIG dosing across trials ranged from 1 g/kg total to 2 g/kg total, administered either as 0.4 g/kg/day over 3-5 days or 1 g/kg/day over 1-2 days. Importantly, the largest dose-comparison trial (N= 168) demonstrated no statistically significant superiority of 2 g/kg over 1 g/kg in clinical improvement, and the authors concluded that any potential benefit of higher dosing was small and not clinically meaningful. No trials evaluated cumulative IVIG doses exceeding 2 g/kg, and there is no evidence in this review to support IVIG dosing up to 4 g/kg for myasthenia gravis exacerbation or worsening. [3]

A 2023 review evaluated randomized controlled trials comparing IVIG and plasma exchange (PLEX) for the treatment of moderate-to-severe worsening myasthenia gravis, focusing on efficacy, safety, and speed of relapse control. Across the included trials, IVIG dosing regimens varied but were limited to conventional cumulative doses, including 2 g/kg administered as 1 g/kg/day over 2 days or 0.4 g/kg/day over 5 days, with no studies evaluating IVIG doses exceeding 2 g/kg per treatment course. The meta-analysis of 114 patients demonstrated no statistically significant difference in overall efficacy between IVIG and PLEX based on changes in QMG scores, although there was a nonsignificant trend toward faster improvement with PLEX within the first two weeks. Safety outcomes showed no significant difference in adverse event rates between IVIG and PLEX, though adverse event reporting carried a high risk of bias. Importantly, the authors highlighted heterogeneity in IVIG dosing across trials and emphasized that existing randomized evidence in MG relapse is confined to standard dosing strategies, providing no direct clinical data to support IVIG doses up to 4 g/kg for myasthenia gravis exacerbations. [4]

References: [1] Wiendl H, Abicht A, Chan A, et al. Guideline for the management of myasthenic syndromes. Ther Adv Neurol Disord. 2023;16:17562864231213240. Published 2023 Dec 26. doi:10.1177/17562864231213240
[2] Dalakas MC, Meisel A. Immunomodulatory effects and clinical benefits of intravenous immunoglobulin in myasthenia gravis. Expert Rev Neurother. 2022;22(4):313-318. doi:10.1080/14737175.2022.2057223
[3] Gajdos P, Chevret S, Toyka KV. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database Syst Rev. 2012;12(12):CD002277. Published 2012 Dec 12. doi:10.1002/14651858.CD002277.pub4
[4] Pavlekovics M, Engh MA, Lugosi K, et al. Plasma Exchange versus Intravenous Immunoglobulin in Worsening Myasthenia Gravis: A Systematic Review and Meta-Analysis with Special Attention to Faster Relapse Control. Biomedicines. 2023;11(12):3180. Published 2023 Nov 29. doi:10.3390/biomedicines11123180
Literature Review

A search of the published medical literature revealed 4 studies investigating the researchable question:

Is there any data to support dosing up to 4 g/kg of IVIG for myasthenia gravis exacerbation (divided over 2-5 days)?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-4 for your response.


 

Treatment of Myasthenia Gravis Exacerbation With Intravenous Immunoglobulin: A Randomized Double-blind Clinical Trial
Design

Randomized double-blind placebo-controlled multicenter trial

N= 173

Objective To determine the optimal dose of intravenous immunoglobulin (IVIG) for treating myasthenia gravis (MG) exacerbation
Study Groups

Group 1: 1 g/kg of IVIG on day 1 and placebo on day 2 (n= 81)

Group 2: 1 g/kg of IVIG on 2 consecutive days (n= 87)

Inclusion Criteria Patients aged 15 to 85 years with acute exacerbation of myasthenia gravis
Exclusion Criteria Corticosteroid treatment initiated or modified within the last month, plasma exchange within the last 6 weeks or IVIG within the last 3 months, known allergy to IVIG, serum creatinine level greater than 1.4 mg/dL, body weight greater than 100 kg, pregnancy, age younger than 15 years
Methods Participants were randomly assigned to receive 1 g/kg of IVIG on day 1 and placebo on day 2 (group 1) vs 1 g/kg of IVIG on 2 consecutive days (group 2). The IVIG and placebo were prepared and dispensed in identical bottles. Anticholinesterase drugs were given as necessary. Measurements included myasthenic muscular score (MMS), forced vital capacity, serum creatinine level, and others
Duration November 13, 1996, to October 26, 2002
Outcome Measures

Primary: Improvement in the myasthenic muscular score after 2 weeks

Secondary: Time course of MMS increase, response rate, forced vital capacity change, anti-AChR ab level change, need for mechanical ventilatory assistance or nasogastric tube

Baseline Characteristics   Group 1 (n = 81) Group 2 (n = 87)
Age, y 55 (43-71) 55 (37-71)
Male sex 31 (38.3%) 35 (40.2%)
Disease duration, y 1 (0-6) 2 (1-7)
Previous MG exacerbations 1 (0-2) 1 (0-2)
Anti-AChR ab–positive 67 (82.7%) 68 (78.2%)
Thymoma 23 (28.4%) 23/86 (26.7%)
Thymectomy 32 (39.5%) 34 (39.1%)

Functional stage before exacerbation

1

2

3

4

5

 

15 (18.5%)

27 (33.3%)

31 (38.3%)

8 (9.9%)

 

9 (10.3%)

26 (29.9%)

39 (44.8%)

13 (14.9%)

Prednisone or immunosuppressants, and no previous exacerbation or crisis 24 (29.6%) 28 (32.2%)
Severe muscle weakness 65 (80.3%) 66 (75.9%)
Impaired swallowing 61 (75.3%) 68 (78.2%)
Acute respiratory distress 14 (17.3%) 16 (18.4%)
Myasthenic muscular score, points 50 (41-61) 50 (37-62)
Mechanical ventilation 11 (13.6%) 11 (12.6%)
Nasogastric tube 20 (24.7%) 27 (31.0%)
Forced vital capacity, % predicted 74 (57-99) 82 (60-96)
Anti-AChR ab level, nmol/L 12 (2-29) 10 (2-23)
Results   Group 1 Group 2 Effect Size (95% CI) p-value
Primary end point of myasthenic muscular score change from day 0 to day 15, points 15.49 ± 15.40 19.33 ± 16.48 3.84 (−1.03 to 8.71) 0.12
Cumulative incidence of responders on day 15 55.00 ± 5.56 60.64 ± 5.30 1.45 (0.77 to 1.71) 0.48
Forced vital capacity change from day 0 to day 15, absolute difference, % predicted 6.22 ± 18.93 8.48 ± 15.80 2.26 (−3.84 to 8.36) 0.34
Cumulative incidence of patients who required mechanical ventilatory assistance on day 15 18.52 ± 4.32 19.54 ± 4.25 1.05 (0.53 to 2.11) 0.87
Cumulative incidence of patients with nasogastric tube on day 15 30.86 ± 5.13 37.93 ± 5.20 1.25 (0.43 to 2.10) 0.34
Anti-AChR ab level change from day 0 to day 15, absolute difference, nmol/L −0.79 ± 14.02 −0.65 ± 15.07 0.14 (−4.85 to 5.13) 0.89
Adverse Events Most adverse events were mild and self-limited. Headaches were more common in group 2. Elevation of serum creatinine level occurred in both groups, slightly more common with the higher dose, but levels returned to normal by day 15 in 70% of cases. 
Study Author Conclusions The trial found no significant superiority of 2 g/kg over 1 g/kg of IVIG in the treatment of myasthenia gravis exacerbation. Therefore, 1 g/kg may be the best dose for general clinical practice, which may have implications on the cost of IVIG infusion for acute exacerbation of MG. 
Critique The study was well-designed as a randomized double-blind placebo-controlled trial, which strengthens the validity of the findings. However, the lack of significant difference between the two dosing regimens may be due to the sample size or the inherent variability in patient response. Additionally, the study did not explore the long-term outcomes of the different dosing strategies, which could be a limitation in understanding the full impact of the treatment regimens. 

 

References:
[1] Gajdos P, Tranchant C, Clair B, et al; Myasthenia Gravis Clinical Study Group. Treatment of myasthenia gravis exacerbation with intravenous immunoglobulin: a randomized double-blind clinical trial. Arch Neurol. 2005;62(11):1689-1693.

 

IV immunoglobulin in patients with myasthenia gravis: A randomized controlled trial
Design

Randomized, placebo-controlled, double-masked study

N= 51

Objective To determine the effectiveness of IV immunoglobulin (IVIG) in the treatment of patients with myasthenia gravis (MG) and worsening weakness
Study Groups

IVIG group (n= 24)

Placebo group (n= 27)

Inclusion Criteria Patients age 18 or older with a diagnosis of MG and worsening weakness
Exclusion Criteria Respiratory distress requiring ICU admission, vital capacity <1 L, severe swallowing difficulties, change in corticosteroid dosage in the 2 weeks prior to screening, other disorders causing weakness or fatigue, known IgA deficiency, active renal or hepatic insufficiency, clinically significant cardiac disease, known hyperviscosity or hypercoagulable state, pregnancy or breastfeeding, concurrent infections or medications causing weakness
Methods Patients were randomized to receive either 2 g/kg IVIG or an equivalent volume of IV dextrose 5% in water over 2 days. The QMG Score for Disease Severity was calculated at baseline, day 14, and day 28 by a masked observer. Electrodiagnostic testing and antibody levels were assessed. No changes in cholinesterase inhibitors or other immunomodulators were made until day 14
Duration March 2004 to May 2005
Outcome Measures

Primary: Change in QMG Score for Disease Severity from baseline to day 14

Secondary: Change in QMG Score from day 1 to day 28, changes in SFEMG and RNS results, Post-Intervention Status on days 14 and 28

Baseline Characteristics   IVIG (n= 24) Placebo (n= 27)
Male 10 (41.7%) 10 (37%)
Age, mean years 56 ±17.20 55 ±17.12

Type of MG

Ocular

Generalized

 

7 (29.2%)

17 (70.8%)

 

10 (37%)

17 (63%)

Baseline QMG Score, mean 12.3 ±4.89 12.5 ±5.49
Cholinesterase inhibitors 16 (66.7%) 13 (48.1%)
Corticosteroids 5 (20.8%) 7 (25.9%)
Azathioprine 6 (25%) 3 (11.1%)
Cyclophosphamide 2 (7.4%)
Presence of thymoma 2 (8.3%) 7 (25.9%)
Results   IVIG (n= 24) Placebo (n= 27) p-value
Baseline QMG Score (mean) 12.3 ± 4.9 12.5 ± 5.5 0.897
ΔQMG Day 0–14 -2.54 -0.89 0.047
ΔQMG Day 0–28 -3.00 -1.19 0.055
ΔQMG Day 14–28 -0.46 -0.30 0.823
Adverse Events No serious adverse events occurred. Headache was the most frequent side effect, occurring in 75% of the IVIG group compared to 19% in the placebo group.
Study Author Conclusions IVIG is effective in patients with MG and worsening weakness, providing a rapid improvement in symptoms, particularly in those with moderate to severe disease. It can be a useful adjunctive therapy while awaiting the response to immunosuppressive medications.
Critique The study provides strong evidence for the effectiveness of IVIG in MG patients with worsening weakness, especially in those with severe symptoms. However, the improvement was relatively small for the entire cohort, and the study did not address long-term outcomes or compare IVIG with other treatments like plasma exchange. The sample size was limited, and the study was not powered to investigate the association between IVIG and other variables such as age, sex, and antibody status. 

 

References:
[1] Zinman L, Ng E, Bril V. IV immunoglobulin in patients with myasthenia gravis: a randomized controlled trial. Neurology. 2007;68(11):837-841. doi:10.1212/01.wnl.0000256698.69121.45

 

 

Randomized, Controlled Trial of Intravenous Immunoglobulin in Myasthenia Gravis
Design

Randomized, double-blinded, placebo-controlled trial

N= 15

Objective To evaluate the efficacy of intravenous immunoglobulin (IVIG) treatment in myasthenia gravis (MG) by measuring changes in the quantitative MG Score (QMG) at day 42
Study Groups

IVIG (n= 6)

Placebo (n= 9)

Inclusion Criteria Age >15 years, elevated acetylcholine receptor antibody levels, Grade 2 (mild) or Grade 3 (moderate) generalized MG using the Texas Clinical Classification System
Exclusion Criteria Other disorders causing weakness or fatigue, active thyroid dysfunction, IgA deficiency, pregnancy or breastfeeding, evidence of thymoma, thymectomy in the prior 3 months, plasma exchange in the prior 2 months, active renal or hepatic insufficiency, forced vital capacity <50% predicted, high risk of aspiration, weight >80% above ideal body weight
Methods Patients received IVIG 2 gm/kg at induction and 1 gm/kg after 3 weeks vs. 5% albumin placebo. The primary efficacy measurement was the change in the quantitative MG Score (QMG) at day 42. Secondary outcomes included repetitive nerve stimulation (RS) and single-fiber electromyography (SFEMG)
Duration

Randomized study: Day 0 to Day 42

Open-label study: Day 42 to Day 84

Outcome Measures

Primary: Change in quantitative MG Score (QMG) from baseline to day 42

Secondary: Percent decrement on 2–3 HZ repetitive nerve stimulation (RS), mean consecutive difference on single-fiber electromyography (SFEMG), MG–activities of daily living profile (MG-ADL)

Baseline Characteristics   IVIG (n= 6) Placebo (n= 9)
Mean age, years 46 37.8
Ethnic and sex distributions Similar Similar
Patients had generalized myasthenia gravis of mild to moderate severity (Texas Clinical Classification Grade 2–3), with comparable baseline characteristics between treatment groups. The mean age was 46.0 years in the IVIG group and 37.8 years in the placebo group, with similar sex and ethnic distributions. Baseline disease severity measures were not significantly different, including Quantitative Myasthenia Gravis (QMG) scores (8.5 ± 1.8 vs 11.3 ± 5.6), MG-ADL scores (5.3 ± 3.8 vs 6 ± 3.8), repetitive nerve stimulation decrement (12.2 ± 9.8% vs 18 ± 16.9%), and single-fiber EMG mean consecutive difference (66.9 ± 21 vs 115 ± 84.2 µs) for IVIG and placebo, respectively.
Results   IVIG (n= 6) Placebo (n= 9) p-value
QMG Day 0 to 42 0 ± 3.8 -1.6 ± 2.7 0.53
MG-ADL Day 0 to 42 -0.3 ± 2 -2.6 ± 2.4 0.11
RS Day 0 to 42 -2.0 ± 9.5 -3.4 ± 5.7 0.78
SFEMG Day 0 to 42 -10.3 ± 17.5 -20.9 ± 102 0.44
Adverse Events Two patients randomized to IVIG developed severe headaches and did not receive the 1 gm/kg infusion on day 22. Otherwise, IVIG was tolerated well with no renal impairment observed.
Study Author Conclusions The randomized study was underpowered to determine the efficacy of IVIG in MG due to early termination. Positive trends were observed in the open-label study, but data from the randomized trial cannot support or refute a role for IVIG in MG. 
Critique The study was limited by its early termination and small sample size, which resulted in insufficient power to detect significant differences. The open-label segment showed positive trends, but the lack of a larger, controlled study limits the ability to draw definitive conclusions about the efficacy of IVIG in MG. 

 

References:
[1] Wolfe GI, Barohn RJ, Foster BM, et al. Randomized, controlled trial of intravenous immunoglobulin in myasthenia gravis. Muscle Nerve. 2002;26(4):549-552. doi:10.1002/mus.10224

 

 

Comparison of IVIg and PLEX in patients with myasthenia gravis
Design

Randomized, evaluator-masked study

N= 84

Objective To determine whether IV immunoglobulin (IVIg) is comparable to plasma exchange (PLEX) in efficacy for treating patients with moderate to severe myasthenia gravis
Study Groups

IVIg (n= 41)

PLEX (n= 43)

Inclusion Criteria Patients aged 18 years or older with moderate to severe MG, defined as Quantitative Myasthenia Gravis Score for disease severity (QMGS) ≥10.5, and worsening weakness requiring a change in treatment modality
Exclusion Criteria MG worsening due to concurrent medications or infection, change in corticosteroid dosage in the 2 weeks prior, other disorders causing weakness, known IgA deficiency, active renal or hepatic disease, significant cardiac disease, known hyperviscosity or hypercoagulable state, history of anaphylaxis to IVIg or albumin, known refractory status to previous IVIg or PLEX, poorly controlled hypertension, pregnancy, or breastfeeding
Methods Patients were randomized to receive either IVIg 1 g/kg/day for 2 consecutive days or PLEX 1.0 plasma volume exchanges for 5 exchanges. Evaluations were conducted at day 14 for primary efficacy parameter of change in QMGS and secondary clinical and electrophysiologic parameters. Follow-up was for 60 days
Duration Study conducted from 2007 to 2010 with follow-up for 60 days
Outcome Measures

Primary: Change in QMGS from baseline to day 14

Secondary: Change in QMGS from baseline to days 21 and 28, change in single-fiber EMG testing (SFEMG) jitter, abnormal pairs, blocking pairs, % decrement in repetitive nerve stimulation (RNS), postintervention status, change in acetylcholine receptor antibodies (AChRAb) titers, need for intensive care unit (ICU) admission, positive pressure ventilation, hospitalization, additional therapy for MG

Baseline Characteristics   IVIg (n= 41) PLEX (n= 43)  
Age, years 57 ± 18 58 ± 17  
Female 24 (58%) 24 (55%)  
MG duration, months 71 ± 90 64 ± 89  
Current pyridostigmine 32 (78%) 32 (74%)  
Current prednisone 14 (34%) 21 (48%)  
Baseline QMGS 14.26 ± 4.0 14.44 ± 3.8  

MGFA Classification 

Grade 2

Grade 3 

Grade 4

 

22 (53%)

17 (41%)

0

 

26 (60%)

15 (34%)

1 (2.3%)

 
Results   IVIg (n= 41) PLEX (n= 43) p-value
Baseline QMGS (mean ± SD) 14.2 ± 4 14.4 ± 3.8 0.83
Change in QMGS at day 14 3.2 ± 4.1 4.7 ± 4.9 0.13
Responders (≥3.5 unit change in QMGS) 51% 57% 0.50
Improved at day 14 69% 65% 0.74
Worsened at day 14 17.5% 2% 0.10
Stable at day 14 10% 31% 0.07
Adverse Events Adverse effects with IVIg included allergic reaction, nausea and vomiting, headache, chills, fever, hemolytic anemia, and hypertension. PLEX-related adverse effects included citrate reaction, poor venous access, vasospasm, and vasovagal reaction. One patient in the IVIg group had pneumonia requiring intubation, and one in the PLEX group had congestive heart failure and myocardial infarction possibly related to treatment. 
Study Author Conclusions IVIg has comparable efficacy to PLEX in the treatment of patients with moderate to severe MG. Both treatments are well-tolerated, and the duration of effect is comparable. Either treatment may be offered to patients depending on availability of resources. 
Critique The study provides strong evidence for the comparable efficacy of IVIg and PLEX in treating MG, with a well-designed randomized, evaluator-masked approach. However, the single-center design and potential for selection bias due to the exclusion criteria may limit generalizability. The study's strength lies in its rigorous methodology and comprehensive assessment of both clinical and electrophysiologic outcomes. 

 

References:
[1] Barth D, Nabavi Nouri M, Ng E, Nwe P, Bril V. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurology. 2011;76(23):2017-2023. doi:10.1212/WNL.0b013e31821e5505