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Eculizumab: A Review in Generalized Myasthenia Gravis
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Journal Article
Eculizumab: A Review in Generalized Myasthenia Gravis
2018
Overview
The humanized monoclonal antibody eculizumab (Soliris
®
) is a complement inhibitor indicated for use in anti-acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis (gMG) in the USA, refractory gMG in the EU, or gMG with symptoms that are difficult to control with high-dose IVIg therapy or PLEX in Japan. It is the first complement inhibitor to be approved for use in these patients. In the well-designed, 26-week REGAIN study in patients with anti-AChR-positive refractory gMG, although a statistically significant benefit of eculizumab over placebo in the prespecified primary endpoint analysis (change from baseline in MG-activities of daily living (ADL) score assessed by worst-rank ANCOVA) was not formally demonstrated, preplanned and post hoc sensitivity analyses of this outcome, as well as other secondary outcomes supported the efficacy of eculizumab. Overall, patients receiving eculizumab experienced significant improvements in the ADL, muscle strength and health-related quality of life (HR-QOL) parameters relative to patients receiving placebo. Moreover, an ongoing extension of REGAIN showed that treatment benefits with eculizumab were sustained during continued therapy for at least 52 weeks. Eculizumab was generally well tolerated in these studies, with a tolerability profile similar to that reported previously in other indications. Although several questions remain, such as duration of treatment, cost effectiveness and long-term efficacy and tolerability, current evidence indicates that eculizumab is a valuable emerging therapy for patients with refractory gMG.
Publisher
Springer International Publishing,Springer Nature B.V
Subject
/ Adults
/ Antibodies, Monoclonal, Humanized - administration & dosage
/ Antibodies, Monoclonal, Humanized - adverse effects
/ Antibodies, Monoclonal, Humanized - pharmacology
/ Antibodies, Monoclonal, Humanized - therapeutic use
/ Complement Inactivating Agents - administration & dosage
/ Complement Inactivating Agents - adverse effects
/ Complement Inactivating Agents - pharmacology
/ Complement Inactivating Agents - therapeutic use
/ Europe
/ Humans
/ Japan
/ Medicine
/ Myasthenia Gravis - drug therapy
/ Patients
/ Proteins
/ Receptors, Cholinergic - immunology
/ Studies
/ Therapy
