Abstract
Objectives: Myasthenia gravis (MG) is an immune-mediated neuromuscular disorder responsive to immunomodulatory treatments. 10–20% of MGs are not responsive to conventional first-line therapies. Here, we sought to investigate the efficacy and safety of rituximab therapy in the treatment of patients with refractory MG.Methods: In a 48-week, multicenter, open-labeled, prospective cohort setting, 34 participants with refractory MG were assigned to receive infusions of Zytux, which is a rituximab biosimilar, according to a validated protocol. Clinical, functional, and quality of life (QoL) measurements were recorded at baseline, and seven further visits using the Myasthenia Gravis Foundation of America (MGFA), Myasthenia Gravis Composite (MGC), Myasthenia Gravis Activities of Daily Living profile (MG-ADL), and Myasthenia Gravis Quality of Life (MGQoL-15) scales. Besides, the post-infusion side effects were systematically assessed throughout the study.Results: The correlation analysis performed by generalized estimating equations analysis represented a significant reduction of MGC, MG-ADL, and MGQoL-15 scores across the trial period. The subgroup analysis based on the patients' clinical status indicated a significant effect for the interaction between time and MGFA subtypes on MG-ADL score, MGC score, and pyridostigmine prednisolone dose, reflecting that the worse clinical condition was associated with a better response to rituximab. Finally, no serious adverse event was documented.Conclusions: Rituximab therapy could improve clinical, functional, and QoL in patients with refractory MG in a safe setting. Further investigations with larger sample size and a more extended follow-up period are warranted to confirm this finding.Clinical Trial Registration: The study was registered by the Iranian Registry of Clinical Trials (IRCT) (Code No: IRCT20150303021315N18).
Highlights
Myasthenia gravis (MG) is a neuromuscular disorder that is caused by an antibody-mediated autoimmune reaction to post-synaptic proteins of the neuromuscular junction [1]
Functional, and quality of life (QoL) measurements were recorded at baseline, and seven further visits using the Myasthenia Gravis Foundation of America (MGFA), Myasthenia Gravis Composite (MGC), Myasthenia Gravis Activities of Daily Living profile (MG-ADL), and Myasthenia Gravis Quality of Life (MGQoL-15) scales
The correlation analysis performed by generalized estimating equations analysis represented a significant reduction of MGC, MG-ADL, and MGQoL-15 scores across the trial period
Summary
Myasthenia gravis (MG) is a neuromuscular disorder that is caused by an antibody-mediated autoimmune reaction to post-synaptic proteins of the neuromuscular junction [1]. It has been shown that 10–15% of the patients, so-called refractory MG, do not entirely respond to conventional treatments or experience severe side effects related to immunosuppressive medications, most likely attributable to a heterogeneous pattern of the disease pathophysiology leading to diverse disease courses [6, 7]. The suggested criteria include the following: failure of adequate response to conventional therapies with maximal possible safe doses of corticosteroids and at least one or more immunosuppressive drug at an adequate dose and period; inability to lessen immunosuppressive therapy without clinical relapse or a need for continuing rescue therapy such as intravenous immunoglobulin G (IVIg) or plasma exchange (PLEX); intolerable adverse effects from immunosuppressive therapy; comorbidity that confines the usage of conventional therapies; recurrent myasthenic crises even though the patient is on suitable therapy [4]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
