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In a phase 2b/3 clinical trial (NCT02848326), adults treated with atogepant (Allergan, Madison, NJ) had greater reduction from baseline in monthly migraine days (MMD) on average, compared with those treated with placebo. No serious adverse events related to treatment occurred. Of those treated with atogepant, the frequency of treatment-emergent adverse events ranged from 57% to 66% across the treatment arms vs 49.5% for those who took placebo. Elevated ALT or AST (>3x the upper limit of normal) occurred in 10 participants (1.8%), balanced across the 6 treatment arms, including...
Results from multiple trials of SMN1gene-replacement therapy (Zolgensma; Avexis, Bannockburn, IL) show promise for single-dose treatment of spinal muscular atrophy (SMA). In the STRIVE phase 3 study for treatment of spinal muscular atrophy, 22 infants under age 6 months, diagnosed genetically (biallelic SMN1 mutations/deletions, 2 SMN2 copies), were treated. Of the 15 babies treated more than 13.6 months or who discontinued the study before then, 13 (87%) survived without needing permanent ventilation, in contrast to the 25-50% survival rate for children with SMA when untreated....
Treatment with inebilizumab (VielaBio, Gaithersburg, MD) reduced relapses of neuromyelitis optica spectrum disorder (NMOSD) by 77% after 28 weeks of treatment. Response to treatment with inebilizumab for NMOSD was safe and effective such that the trial was terminated early as it was deemed unethical not to treat participants in the placebo arm of a phase 3 trial (NCT02200770). After this judgement was made, all participants in the placebo arm began receiving inebilizumab on an open-label extension basis. Treatment with inebilizumab also reduced worsening from baseline score on...
Niushen Zhang, MD
Saif A. Bushnaq, MD; and Sunil A. Sheth, MD
Ronald Devere, MD, FAAN