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Eculizumab: A Review in Generalized Myasthenia Gravis
#MMPMID29435915
Dhillon S
Drugs
2018[Mar]; 78
(3
): 367-376
PMID29435915
show ga
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.
|Antibodies, Monoclonal, Humanized/administration & dosage/adverse
effects/pharmacology/*therapeutic use
[MESH]
|Complement Inactivating Agents/administration & dosage/adverse
effects/pharmacology/*therapeutic use
[MESH]
free
free
free
