Rozanolixizumab Treatment Improves Symptoms and Ability to Perform Activities of Daily Living in Myasthenia Gravis

In the phase 3 MycarinG study (NCT03971422), participants with generalized myasthenia gravis (gMG), who were treated with 1 of 2 doses of rozanolixizumab (UCB7665; Creative Biolabs, Shirley, NY) had improvements on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale. 

The mean improvement on the MG-ADL with rozanolixizumab 7 or 10 mg/kg (n=66, 67), respectively, was 2.586 and 2.619 more than placebo (n=67; P<.001). Patient reported outcomes of gMG symptom improvements, including muscle weakness fatigability, physical fatigue, and bulbar muscle weakness were also significantly greater with rozanolixizumab vs placebo.

“The one constant in gMG is unpredictability. People living with this disease experience symptoms that are nebulous, fluctuating, and which vary from one day to the next. For this reason, there is an urgent need for more effective, targeted, and convenient treatments that reduce the burden of disease on patients’ daily lives. The results from the MycarinG study are extremely encouraging, and demonstrate the potential of rozanolixizumab as a new, effective and flexible treatment option to help ease the day-to-day burden of this challenging disease and improve treatment outcomes for patients,” said professor Vera Bril, professor of Medicine (Neurology), University of Toronto, director of the Neuromuscular Section, Division of Neurology, University of Toronto and University Health Network, Toronto, and lead investigator of the MycarinG study.

Participants in this study had gMG with positivity for autoantibodies to the acetylcholine receptor (antiAChR+) or to muscle-specific tyrosine kinase (antiMuSK+). The IgG levels in the participants treated with rozanolixizumab had a mean maximum reduction of more than 70%, and antiAChR autoantibody levels also decreased.

Adverse events occurred more frequently with rozanolixizumab than with placebo (81.3% and 82.6% with 7 or mg/kg rozanolixizumab vs 67.2% with placebo). The most common adverse event observed in those treated with rozanolixizumab was headaches of mild-to-moderate intensity. Other adverse events found were diarrhea, pyrexia, and nausea.