A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of @entity9381 in Adolescents with Primary XXXX .

@entity1 @entity1119 @entity9381
OBJECTIVE: To evaluate the efficacy and safety of @entity9381 in adolescents with primary @entity1119 . METHODS: This 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary @entity1119 . @entity1 could receive up to six treatments with @entity9381 (50  U per axilla), with re-treatment occurring no sooner than 8  weeks after the prior treatment cycle and no later than 44  weeks after the initial treatment cycle. The primary efficacy measure was treatment response, based on self-assessed @entity1119 severity following the first two treatments using the 4-point @entity1119 Severity Scale (HDSS). Other efficacy measures included spontaneous resting sweat production and health outcomes. RESULTS: Fifty-six (38.9%) @entity1 underwent one treatment, 59 (41.0%) underwent two, 20 (13.9%) underwent three, 6 (4.2%) underwent four, and 3 (2.1%) underwent five. @entity9381 significantly improved HDSS scores and decreased sweat production compared with treatment cycle baselines. Seventy-nine @entity1 (54.9%) responded to treatment based on HDSS criteria. From 56.6% to 72.3% of @entity1 experienced a two-grade or more improvement at 4 and 8  weeks after each of the first two treatments. The majority (79.4%-93.2%) had a 75% or greater reduction in sweat production at week 4 (treatments 1-3). The median duration of effect for responders ranged from 134 to 152  days. Using quality of life measures, health outcomes improved markedly. Eight @entity1 (5.6%) had mild or moderate treatment-related adverse events. No unexpected safety signals were observed in this study. Neutralizing antibodies to @entity9381 did not develop. CONCLUSION: @entity9381 injections provided beneficial effects in adolescents with primary @entity1119 .
