Steffen Moritz, Chantal Dietl, Jan Felix Kersten, Frederick Aardema, Kieron O'Connor
Evaluation of Inference-Based Therapy (Doubt Therapy) as a Self-Help Tool for Obsessive-Compulsive Disorder
Journal of cognitive psychotherapy
patients hidradenitis suppurativa substantial unmet clinical needs scarce therapeutic options aimed assess efficacy safety bimekizumab monoclonal igg1 antibody selectively inhibits interleukin il17f il17a patients moderatetosevere hidradenitis suppurativa heard ii two identically designed 48week randomised doubleblind placebocontrolled multicentre phase 3 trials patients aged 18 years older moderatetosevere hidradenitis suppurativa randomly assigned 2221 using interactive response technology stratified worst hurley stage baseline baseline systemic antibiotic use receive subcutaneous bimekizumab 320 mg every 2 weeks bimekizumab 320 mg every 2 weeks week 16 every 4 weeks week 48 bimekizumab 320 mg every 4 weeks week 48 placebo week 16 bimekizumab 320 mg every 2 weeks primary outcome hidradenitis suppurativa clinical response least 50 defined reduction total abscess inflammatory nodule count least 50 baseline increase baseline abscess draining tunnel count hiscr50 week 16 efficacy analyses included randomly assigned study patients intentiontotreat population safety analyses included patients received least one full partial dose study treatment safety set bimekizumab activemedication set trials registered clinicaltrialsgov nct04242446 nct04242498 completed patients heard recruited feb 19 2020 oct 27 2021 505 patients enrolled randomly assigned patients heard ii recruited march 2 2020 july 28 2021 509 patients enrolled randomly assigned primary outcome week 16 met group received bimekizumab every 2 weeks using modified nonresponder imputation higher responder rates observed bimekizumab versus placebo trials 138 48 289 patients versus 21 29 72 patients heard odds ratio 223 975 ci 116431 p00060 151 52 291 patients versus 24 32 74 patients heard ii 229 122429 p00032 heard ii hiscr50 also met group administered bimekizumab every 4 weeks 77 54 144 vs 24 32 74 placebo 242 122480 p00038 responses maintained increased week 48 serious treatmentemergent adverse events reported 40 8 patients heard 24 5 patients heard ii treated bimekizumab 48 weeks frequently reported treatmentemergent adverse events week 48 hidradenitis trials addition coronavirus infection diarrhoea heard oral candidiasis headache heard ii one death reported across two trials due congestive heart failure patient substantial cardiovascular history treated bimekizumab every 2 weeks heard considered unrelated bimekizumab treatment investigator new safety signals observed bimekizumab well tolerated patients hidradenitis suppurativa produced rapid deep clinically meaningful responses maintained 48 weeks data two trials support use bimekizumab treatment patients moderatetosevere hidradenitis suppurativa ucb pharma