Myasthenia Gravis News - LARVOL Sigma

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|||||||||| Therapeutic Plasma Exchange and Double Filtration Plasmapheresis in neuroimmune diseases as the first treatment option (B1) - Apr 21, 2023 - Abstract #EAN2023EAN_2472;
Based on the results of our center, we conclude that plasmapheresis represents a first option in the treatment of autoimmune diseases, being a relatively safe procedure with mild complications and good clinical outcome.

|||||||||| Light sensitivity in myasthenia gravis: frequency, clinical characteristics and impact on the quality of life (B1) - Apr 21, 2023 - Abstract #EAN2023EAN_2467;
LS represents a frequent and disabling symptom of MG, it has an impact on the quality of life of patients. The cause of LS in MG warrants further investigation.

|||||||||| A family from Turkey with congenital myasthenia and hereditary polyneuropathy (A2) - Apr 21, 2023 - Abstract #EAN2023EAN_2453;
The co-occurrence of congenital myasthenia and polyneuropathy is probably an incidental finding in this family due to high frequency of consanguineous matings on one hand and the high ethnic heterogeneity of the population under investigation on the other hand. The presence of conduction blocks in familial polyneuropathy is an interesting finding.

|||||||||| Prevalence, incidence, and mortality of myasthenia gravis: a population-based study in Denmark, Finland, and Sweden (B6) - Apr 21, 2023 - Abstract #EAN2023EAN_2109;
Factors likely contributing to these findings may include increased MG awareness, improved diagnostic tools, and an aging population, but further studies are needed to clarify underlying causes in relevant sub- populations. An excess mortality represents a concern.

|||||||||| PERIPHERAL NERVOUS SYSTEM ADVERSE EVENTS ASSOCIATED WITH IMMUNE CHECKPOINT INHIBITORS (B1) - Apr 21, 2023 - Abstract #EAN2023EAN_2032;
In our large cohort of ICI-treated patients, 2.17% developed PNS-irAEs. Compared to patients with neuropathies, those with MG/myositis had a more aggressive clinical course, characterized by earlier onset, worse response to treatment, and higher mortality.

|||||||||| Soliris (eculizumab) / AstraZeneca
Real-world experience with eculizumab in Japanese patients with myasthenia gravis: Post-marketing surveillance data (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1997;
The observed reduction in concomitant oral corticosteroid use, also consistent with other real-world experiences, underlines the benefit of C5 inhibition in these patients. Table: MG-ADL responder rates at Weeks 12, 26, 52 and 104 after eculizumab initiation in the overall population and according to patient and disease characteristics (effectiveness analysis set).

|||||||||| A Study Examining The Concordance Between Patient And Physician Assessment Of The MG-ADL (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1996;
Excellent concordance of the assessment of MG symptoms with the MG-ADL was found between patients and neurologists. This evidence supports patient self-administration of the MG-ADL in MG-related clinical practice and research.

|||||||||| Rystiggo (rozanolixizumab) / UCB
Rozanolixizumab in muscle-specific kinase autoantibody-positive myasthenia gravis: Further analyses from MycarinG study (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1992;
P3
Rozanolixizumab lowered total and subclass IgG levels and improved MG-specific outcomes in MuSK+ gMG, consistent with the overall study population. Funding: UCB Pharma.

|||||||||| Efficacy of innovative therapies in Myasthenia Gravis: review and meta-analysis. (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1991;
Anti-complement and FcRn treatments proved to be both effective in MG patients, whereas Rituximab did not show benefit in AChr-Ab+ patients. With the limitations of this meta-analysis, including efficacy time-points, FcRN treatments showed a short-term higher effect on the qMG.

|||||||||| Soliris (eculizumab) / AstraZeneca, Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
A Real-life experience with Eculizumab and Efgartigimod in generalized Myasthenia Gravis patients. (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1990;
They reduced MG-ADL and qMG in difficult to treat gMG patients. Responder rate was higher than previously reported in phase III trials.

|||||||||| Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
Efgartigimod Demonstrates Consistent Improvements in Patients With gMG Regardless of Prior Treatment Failures (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1989;
Responder rate was higher than previously reported in phase III trials. Similar to results in AChR-Ab+ patients with gMG studied in ADAPT, efgartigimod demonstrated consistent and statistically significant improvements across outcome measures in patients with refractory gMG.

|||||||||| A case of late-onset Congenital Myasthenic Syndrome associated to PREPL heterozygotic mutation (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1939;
In almost all cases is caused by biallelic deletion/duplication in PREPL gene. However, the function of this gene remains unknown.

|||||||||| Rystiggo (rozanolixizumab) / UCB
Rozanolixizumab responder and minimal symptom expression rates in generalised MG: Pooled Phase 3 and extension studies (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1937;
P3
Rozanolixizumab efficacy was maintained over symptom-driven cyclical treatment and multiple endpoints. Funding: UCB Pharma.

|||||||||| methimazole / Generic mfg., lacosamide / Generic mfg., carbamazepine / Generic mfg.
Ocular Neuromyotonia In Thyroid Eye Disease (B2) - Apr 21, 2023 - Abstract #EAN2023EAN_1892;
Despite its rarity, ONM should be considered in TED. Lack of response to voltage-gated sodium channel blockers in our case, suggests the presence of pathomechanism(s) other than ephaptic transmission.

|||||||||| CON03 What is the best therapeutic strategy for myasthenia gravis? (Room Paris) - Apr 21, 2023 - Abstract #EAN2023EAN_1752;
There is still no consensus concerning the place of new targeted treatment in the MG treatment landscape. The presenters will also rise some socioeconomic issues related to the increasing prices of these new therapies.

|||||||||| Ultomiris IV (ravulizumab-cwvz IV) / AstraZeneca
Ravulizumab in adults with generalised myasthenia gravis: Post hoc analysis of MG-ADL item score change in CHAMPION MG (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1653;
P3
The presenters will also rise some socioeconomic issues related to the increasing prices of these new therapies. In patients with AChR Ab+ gMG, ravulizumab provided greater treatment benefit in reducing symptom severity than placebo in 7/8 MG-ADL items, including ocular items, which had the highest proportions of patients with severe impairment at baseline.

|||||||||| Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
Long-Term Safety, Tolerability, And Efficacy of Efgartigimod In Patients With gMG: Final Analyses From The ADAPT+ Study (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1651;
These ADAPT+ analyses suggest long-term efgartigimod treatment is well tolerated and efficacious. Additional final data cut analyses will be presented at EAN 2023.

|||||||||| zilucoplan (RA101495) / UCB
Response to zilucoplan in the Phase 3 RAISE study in patients with generalised myasthenia gravis (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1650;
P3
Responder rates for MG-ADL continued to increase up to the study completion at 12 weeks, regardless of patient baseline disease characteristics. Funding: UCB Pharma.

|||||||||| Shared B cell receptor repertoire between thymus and peripheral blood in patients with myasthenia gravis (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1649;
Some clonotypes were shared between thymus from different MG patients. These clonotypes were more frequently found in peripheral blood of MG patients than of healthy controls.

|||||||||| Soliris (eculizumab) / AstraZeneca
Eculizumab in adolescents with refractory gMG: A sub-analysis of a phase 3 study by chronic IVIg use at study entry (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1648;
P3
These clonotypes were more frequently found in peripheral blood of MG patients than of healthy controls. Adolescents with refractory AChR Ab+ gMG treated with eculizumab achieved clinical improvement, irrespective of whether or not they were receiving chronic IVIg at baseline.

|||||||||| Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
Safety Profile Overview of Efgartigimod Clinical Trials in Participants With Diverse IgG-Mediated Autoimmune Diseases (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1646;
Efgartigimod was well tolerated across indications and doses studied. Most TEAEs, including infections, were mild or moderate in severity and did not increase in frequency with recurrent dosing.

|||||||||| Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
A real world experience with Efgartigimod in generalized Myasthenia Gravis in a national reference center (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1645;
A longer follow-up will be available at the time of the meeting. Our experience strengthens the role of FcRn inhibition as a new effective tool in the management of MG.

|||||||||| IgG as a biomarker of clinical efficacy in generalized myasthenia gravis: Model-based meta-analysis of FcRn inhibitors (B1) - Apr 21, 2023 - Abstract #EAN2023EAN_1573;
Since ?IgG explains a large proportion of anti- FcRn effect on ??MG-ADL, IgG could be used as a potential biomarker for clinical efficacy. This would increase the efficiency of clinical trials (size and duration) to reduce burden for patients in gMG.

|||||||||| Epidemiology of Antibody-positive Myasthenia Gravis in Sardinia, Italy (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1560;
This would increase the efficiency of clinical trials (size and duration) to reduce burden for patients in gMG. We report the highest incidence and prevalence of MG worldwide.

|||||||||| Correlation of disease activity and EQ-5D-3L-derived utility in myasthenia gravis patients in a Swedish national cohort. (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1558;
In this real-life dataset of MG patients, we observed considerably impaired health status in patients with active disease. This indicates an unmet medical need, especially in those with high disease activity, in turn warranting further improvements in MG treatment and care.

|||||||||| Prevalence study of Myasthenia Gravis in Lima (A5) - Apr 21, 2023 - Abstract #EAN2023EAN_1551;
Lima has a medium MG prevalence and is comparable to other series reported in the literature. The clinical characteristics of our patients are similar to other countries in the region.

|||||||||| Long-term follow up of generalized Myasthenia Gravis patients during 1998-2020 in a Spanish referral Unit. (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1549;
The clinical characteristics of our patients are similar to other countries in the region. Some patients with gMG experience a high burden of disease despite treatment, due to persistent symptoms, exacerbations and drug side effects that can lead to treatment discontinuation.

|||||||||| Generalized myasthenia gravis (gMG) diagnostic journey and treatment: real-world physician and patient perspectives (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1547;
In this international survey, patients with gMG were diagnosed 10 months following symptom onset and initiated treatment 3 months following diagnosis. Optimizing the diagnosis and treatment pathways may improve health outcomes among patients with gMG.

|||||||||| A comprehensive assessment of the impact of generalised myasthenia gravis (gMG): Insights from patients and caregivers (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1546;
This study indicates that the impact of gMG on patients and caregivers is broader than previously reported. In the future, it is necessary to consider both patient and caregiver experiences in each of the reported domains when assessing the impact of rare diseases such as gMG.

|||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
A single center experience with neuromuscular immune-related adverse events of immune checkpoint inhibitors. (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1544;
Although ICI neurological adverse events are not very frequent, they are potentially fatal. More studies are needed to clarify the management of these complications but probably early recognition and treatment with intensive immunotherapy may be the key.

|||||||||| Ultomiris IV (ravulizumab-cwvz IV) / AstraZeneca, Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
Matching-adjusted indirect comparison of ravulizumab/efgartigimod in generalised myasthenia gravis: Timepoint challenges (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1543;
Outcomes from indirect comparisons of the effects of efgartigimod and ravulizumab on symptom control in patients with gMG can vary depending on the chosen timepoints and matching methodology. The consistency of symptom control achievable over a prolonged period should be considered, alongside efficacy and tolerability, when assessing treatment options for patients with gMG.

|||||||||| Evidence-based expert consensus guidance for ongoing assessment of generalised myasthenia gravis (gMG) (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1541;
The consistency of symptom control achievable over a prolonged period should be considered, alongside efficacy and tolerability, when assessing treatment options for patients with gMG. This process provides evidence- and expert consensus-based guidance for use of objective and subjective assessment tools across gMG care to improve outcomes for patients.

|||||||||| The Burden MG patients Experience in Fatigue, Sleep, and Mental Health Compared to the General Population (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1539;
This process provides evidence- and expert consensus-based guidance for use of objective and subjective assessment tools across gMG care to improve outcomes for patients. A considerable burden in MG patients was found in this direct comparison of mental health, sleep and fatigue with the general population, using data from two international studies and published population norms.

|||||||||| Longitudinal MGFA-PIS evaluation in a large Italian cohort of patients with Myasthenia Gravis (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1538;
A considerable burden in MG patients was found in this direct comparison of mental health, sleep and fatigue with the general population, using data from two international studies and published population norms. Chance to achieve the CSR did not vary significantly from literature, but our data showed that its modification over time may change in specific MG-subgroups.

|||||||||| zilucoplan (RA101495) / UCB
Long-term safety, efficacy & self-injection satisfaction with zilucoplan in myasthenia gravis: RAISE-XT interim analysis (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1537;
P2, P3
High satisfaction rates with self-injection were reported. Funding: UCB Pharma.

|||||||||| Camillo Golgi Lecture: Autoimmune synaptic diseases: The basics and the latest (Main Auditorium) - Apr 21, 2023 - Abstract #EAN2023EAN_1376;
There are now in vitro and animal models of passive transfer of patients' IgG, CSF, or monoclonal antibodies, and models of active immunization that provide new insights into the immunopathogenesis. Even though most AE respond to treatment, improvement is usually slow or incomplete, and current efforts are aimed to improve our understanding of the recovery process and develop better therapies.

|||||||||| Smoking and alcohol associated to the risk of developing Myasthenia gravis in a Swedish nationwide prevalent cohort (Room Helsinki) - Apr 21, 2023 - Abstract #EAN2023EAN_1288;
Alcohol use might be a negative confounder for smoking. Current smoking is associated with an increased risk of MG, and the association is stronger when controlling for alcohol consumption.

|||||||||| Is Virtual Reality an effective educational tool to enhance patient-physician dialogue? ENGAGE learning intervention. (B2) - Apr 21, 2023 - Abstract #EAN2023EAN_1188;
Current smoking is associated with an increased risk of MG, and the association is stronger when controlling for alcohol consumption. ENGAGE aspires to better understand what drives current behaviour and to evaluate immersive learning as an educational tool for neurologists to improve patient- physician dialogue and SDM in MG.

|||||||||| Retrospective Study of Select Adverse Events of Special Interest Associated With Corticosteroid Use in Myasthenia Gravis (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1109;
OCS exposure was associated with significantly increased hazard of AESIs in MG patients. Steroid-sparing immunotherapies for the underlying disease are needed in this population.

|||||||||| Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
Gender-specific analysis of efgartigimod efficacy in patients with gMG: Subanalysis of the randomised phase3 ADAPT trial (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1108;
P3
Steroid-sparing immunotherapies for the underlying disease are needed in this population. These analyses suggest efgartigimod results in consistent improvement across gMG-specific measures, regardless of patient gender.

|||||||||| Vyvgart (efgartigimod alfa-fcab) / argenx, Broteio
Efgartigimod Demonstrates Consistent Magnitude of Response Across Subgroups of Patients With gMG (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1107;
These analyses suggest efgartigimod results in consistent improvement across gMG-specific measures, regardless of patient gender. The proportion of responders and magnitude of response for patients treated with efgartigimod was consistent regardless of above defined subgroups, providing support for efgartigimod efficacy across a broad population of patients with gMG.

|||||||||| Thymectomy in Thymomatous and Nonthymomatous Myasthenia Gravis: a 10-year follow-up cohort (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1105;
Thymectomy led to a sustained clinical improvement in our cohort, allowing for a reduced need for medication. A shorter time to surgery seems to have a positive influence on long-term prognosis.

|||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Cancer frequency in muscle-specific tyrosine kinase (MuSK) myasthenia gravis (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1104;
Onco-hematological diseases, particularly mediastinal lymphoma (N=3/5, 60%), were the most common malignancy detected in MuSK-MG patients. We did not find a higher frequency of cancer occurrence in patients on long-term immunosuppression.

|||||||||| Keytruda (pembrolizumab) / Merck (MSD)
MYOTONIC DYSTROPHY TYPE II UNMASKED BY IMMUNE CHECKPOINT INHIBITOR (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1102;
The most commonly reported irAEs are myositis, myasthenia gravis and neuropathy with several cases resulting in a fatal outcome. Due to the susceptibility of the skeletal muscle,

|||||||||| Early-onset generalised myasthenia gravis in women aged 18-50: results from a real-world study in 5 European countries (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1101;
Due to the susceptibility of the skeletal muscle, The study shows that although EOF patients are earlier in their disease journey, the number of thymectomies, myasthenic crises and hospitalizations trend higher in EOF patients than in the general gMG population, potentially indicating that the unmet treatment needs of EOF patients.

|||||||||| Fatigue among generalised myasthenia gravis: real-world data from physicians and patients across 5 European countries (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1100;
Fatigue in gMG patients was reported in a significant number of patients, often correlated with markers of greater disease severity. Lower physician- reported, than patient-reported, fatigue may indicate a higher level of attention to fatigue is needed to understand the burden of fatigue on gMG patients.

|||||||||| Higher Need for Medical Resources in Moderate-To-Severe MG Patients: A Comparison With The General Population (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1099;
Lower physician- reported, than patient-reported, fatigue may indicate a higher level of attention to fatigue is needed to understand the burden of fatigue on gMG patients. Suffering from msMG was associated with a considerable impact on MRU compared to the general population, likely resulting in substantially higher health care costs.

|||||||||| Anxiety and depression in generalised myasthenia gravis in Europe, Middle East and Africa: A systematic review (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1097;
Although statistically significant differences in the extent of anxiety and depression are reported in patients with gMG compared with relevant populations and subgroups, these findings need to be confirmed in large cohorts administering consistent, validated questionnaires. Table 1: Studies reporting anxiety and depression patient reported outcome data in patients with gMG against relevant comparators or within gMG subgroups Figure 1: Proportion of patients with clinically relevant anxiety (Panel A) and depression (Panel B) by disease stage

|||||||||| Treatments, Healthcare Utilization and Costs in Newly Diagnosed and Pre-existing Myasthenia Gravis Patients in Sweden (A4) - Apr 21, 2023 - Abstract #EAN2023EAN_1095;
MG patients incurred substantially higher economic burden in the first year compared to later years. Future research should aim to better understand potential factors (e.g., delayed diagnosis and/or treatment) associated with the increased burden.

|||||||||| Comorbidities among myasthenia gravis patients: a population-based observational study in Denmark, Finland, and Sweden (B5) - Apr 21, 2023 - Abstract #EAN2023EAN_1069;
MG is associated with a wide range of comorbidities in a substantial proportion of patients. This highlights the complex management needs of MG patients, to limit comorbidity burden and exacerbation of existing conditions.



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