Rashid Maqbool, Ifeanyi Echezona Amaechi
A systematic managerial perspective on the environmentally sustainable construction practices of UK
Environmental science and pollution research international
inebilizumab anticd19 bcelldepleting antibody demonstrated safety efficacy neuromyelitis optica spectrum disorder randomised controlled period nmomentum trial endofstudy data including randomised controlled period openlabel extension period reported doubleblind randomised placebocontrolled phase 23 nmomentum trial adults aged 18 years older neuromyelitis optica spectrum disorder diagnosis expanded disability status scale score 80 less history either least one acute inflammatory attack requiring rescue therapy past year two attacks requiring rescue therapy past 2 years recruited 81 outpatient specialty clinics hospitals 24 countries eligible participants randomly assigned 31 using central interactive voice system interactive web response system permuted block randomisation scheme block size 4 receive intravenous inebilizumab 300 mg identical placebo days 1 15 randomised period lasted 197 days participants study staff masked treatment assignment primary endpoint randomised period trial time onset adjudicated neuromyelitis optica spectrum disorder attack day 197 participants randomised controlled period adjudicated attack completed 197 days study randomised controlled period enrolment stopped could voluntarily enter openlabel period openlabel period participants either initiated inebilizumab assigned placebo receiving 300 mg days 1 15 openlabel period continued treatment assigned inebilizumab receiving 300 mg day 1 placebo day 15 maintain bcell depletion masking randomised controlled period participants subsequently received inebilizumab 300 mg every 6 months minimum 2 years endofstudy analysis endpoints time adjudicated attack annualised attack rate assessed participants received inebilizumab point randomised controlled period openlabel period inebilizumab population aquaporin4 aqp4igg seropositive subgroup inebilizumabaqp4igg seropositive population safety outcomes participants exposed inebilizumab analysed astreated study registered clinicaltrialsgov nct02200770 complete jan 6 2015 sept 24 2018 467 individuals screened 231 randomly assigned 230 received least one dose inebilizumab n174 placebo n56 may 19 2015 nov 8 2018 165 95 174 participants inebilizumab group 51 91 56 placebo group entered openlabel period mean age 429 years sd 124 197 91 216 female 19 9 male 115 53 white 45 21 asian 19 9 american indian alaskan native 19 9 black african american data cutoff end study analysis dec 18 2020 median exposure 1178 days iqr 8561538 total exposure 730 personyears 225 participants formed inebilizumab population 208 92 participants aqp4igg seropositive overall 63 adjudicated neuromyelitis optica spectrum disorder attacks occurred 47 21 225 treated participants 60 attacks occurred 44 21 208 aqp4igg seropositive subgroup 40 63 63 attacks occurred 34 15 225 treated participants first year treatment individuals adjudicated attack receiving inebilizumab 36 77 47 subsequently attackfree end 4 years annualised attack rates decreased yearonyear endofstudy adjusted annualised attack rates similar inebilizumabaqp4igg seropositive subgroup 0097 95 ci 0070014 inebilizumab populations 0092 0067013 overall 208 92 225 participants received inebilizumab least one treatmentemergent adverse event frequent urinary tract infection 59 26 nasopharyngitis 47 21 arthralgia 39 17 infection rates increase 4 years three 1 225 participants inebilizumab population died openlabel period one due cns event unknown cause pneumonia respiratory insufficiency resulting neuromyelitis optica spectrum disorder attack viral pneumonia related covid19 deemed unrelated treatment data endofstudy analysis nmomentum trial showed continued sustained clinical benefits longterm inebilizumab treatment individuals neuromyelitis optica spectrum disorder supports role inebilizumab cd19 bcelldepleting therapy neuromyelitis optica spectrum disorder medimmune viela biohorizon therapeutics part amgen