Rozanolixizumab in generalized myasthenia gravis: a profile of its use.

Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®), a humanized IgG4 monoclonal antibody with a high affinity and specificity for human neonatal Fc receptor (FcRn; which plays a vital role in the transport, distribution and persistence of IgG), is an effective and generally well tolerated treatment option in adults with acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) autoantibody-positive generalized myasthenia gravis (gMG). Administered subcutaneously once weekly for 6 weeks, with subsequent treatment cycles based on clinical evaluation, it is approved for the treatment of adults with gMG in the EU, Japan and the USA. In the pivotal, multinational, phase 3 MycarinG study, one 6-week cycle of rozanolixizumab ≈ 7 mg/kg or ≈ 10 mg/kg improved multiple disease-related outcomes versus placebo, with the benefits sustained following repeated treatment cycles according to a pooled analysis of data from the phase 3 study and two phase 3 extension studies. While increased infection susceptibility could be a consequence of the transient reduction in IgG levels with rozanolixizumab therapy, no severe or serious infections were reported in either rozanolixizumab group in the pivotal study. Plain Language Summary: Myasthenia gravis (MG) is a disease in which an individual's own IgG antibodies damage the communication between nerves and voluntary muscles, thereby weakening the muscles. Eye movements, speech, swallowing, breathing and use of the limbs are affected. A cure is not yet available, with treatment (based on changing or suppressing the immune system) aimed at easing symptoms and improving well-being. Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®) is an IgG4 antibody that targets a receptor that plays a vital role in the transport, distribution and persistence of IgG. It is administered under the skin once weekly for 6 weeks, with further treatment based on the initial response to rozanolixizumab. In adults with generalized MG, the administration of rozanolixizumab once weekly for 6 weeks improved various disease-related outcomes versus placebo, with the benefits sustained following repeated treatment. Rozanolixizumab was generally well tolerated by these patients, with repeated treatment associated with an acceptable safety profile. Headache was the most frequently reported treatment-emergent adverse event. Thus, rozanolixizumab is an effective and generally well tolerated treatment option in adults with generalized MG. [ABSTRACT FROM AUTHOR]