HPE 101 – July 2022 | Page 35

GETTY X2 concurrent use of anti-psychotics . The NIBS were used over the left dorsolateral prefrontal cortex .
There were over 20 different NIBS procedures used including high-definition transcranial random noise stimulation , intermittent theta-burst stimulation , anodal transcranial direct current stimulation and high-frequency repetitive transcranial magnetic stimulation . When compared with sham treatment , all produced a significantly larger improvement in negative symptoms . Moreover , acceptability of the intervention did not differ between groups .
The authors concluded that excitatory stimulation over the left dorsolateral prefrontal cortex was associated with alleviation of the severity of negative symptoms in schizophrenia . They added how these findings should serve as a basis for future large-scale randomised trials .
References 1 Correll CU , Schooler NR . Negative Symptoms in Schizophrenia : A Review and Clinical Guide for Recognition , Assessment , and Treatment . Neuropsychiatr Dis Treat 2020 ; 16:519 – 34 . 2 Carbon M , Correll CU . Thinking and acting beyond the positive : the role of the cognitive and negative symptoms in schizophrenia . CNS Spectr 2014 ; 19 Suppl 1:38 – 52 . 3 Yang F et al . Effects and potential mechanisms of transcranial direct current stimulation ( tDCS ) on auditory hallucinations : A meta-analysis . Psychiatry Res 2019 ; 273:343 – 9 . 4 Valiengo LDCL et al . Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia : A Randomized Clinical Trial . JAMA Psychiatry 2020 ; 77 ( 2 ): 121 – 9 . 5 Rosenberg O et al . Deep transcranial magnetic stimulation add-on for the treatment of auditory hallucinations : a doubleblind study Ann Gen Psychiatry 2012 ; 11:13 . 6 Tseng PT et al . Assessment of Noninvasive Brain Stimulation Interventions for Negative Symptoms of Schizophrenia : A Systematic Review and Network Meta-analysis . JAMA Psychiatry 2022 doi : 10.1001 / jamapsychiatry . 2022.1513
Ustekinumab and adalimumab equivalent for clinical remission in moderate – severe Crohn ’ s disease
Crohn ’ s disease is a chronic , inflammatory disease of the gastrointestinal tract that gives rise to symptoms including diarrhoea and abdominal pain together with the presence of mucosal ulceration . Patients are typically initiated on corticosteroids and immunomodulators such as methotrexate or azathioprine although in cases where these treatments are ineffective , patients progress to biologic therapy . Both ustekinumab and adalimumab are monoclonal antibodies approved for use in Crohn ’ s disease . In fact , data suggest that ustekinumab can induce and maintain remission in patients with moderate to severe disease 1 as adalimumab . 2
While a 2018 network meta-analysis concluded that adalimumab might be a preferred first-line agent and ustekinumab a preferred second-line agent for the induction of remission in patients with moderate – severe Crohn ’ s , it did acknowledge that head-to-head trials were warranted . 3 Consequently , for the present trial , 4 researchers set out to assess the relative safety and efficacy of monotherapy with either ustekinumab or adalimumab , in biologically-naïve patients with moderate to severe Crohn ’ s disease .
The researchers undertook a randomised , active comparator Phase III trial among biologic-naïve adult patients with a Crohn ’ s disease activity index ( CDAI ) score of 220 – 450 ( which represents moderate – severe disease ) and who were either intolerant or who had failed to respond adequately to conventional therapy . Patients received either ustekinumab ( 6mg / kg initially and then 90mg subcutaneously once every 8 weeks ) or adalimumab ( 160mg initially then 80mg at two weeks , then 40mg once every 2 weeks through to week 56 ). The primary endpoint was the proportion of patients in clinical remission ( defined by a CDAI score < 150 ) at week 52 . A major secondary outcome was corticosteroid-free remission ( CDAI score < 150 ) and no corticosteroids for at least the past 30 days at week 52 .
A total of 386 patients with a mean age of 37.2 years ( 48 % male ) were randomised to ustekinumab ( 191 ) or adalimumab . The median baseline CDAI score was 287 ( ustekinumab ) and 291 ( adalimumab ).
After 52 weeks of therapy , 65 % of those receiving ustekinumab and 61 % of those using adalimumab achieved the primary outcome ( between-group difference = 4 %, 95 % CI -6 to 14 , p = 0.42 ). For the secondary outcome , 61 % of those given ustekinumab and 57 % of patients using adalimumab had corticosteroidfree clinical remission .
With respect to safety , serious infections occurred in 2 % ( ustekinumab ) and 3 % ( adalimumab ) and there were no reported deaths .
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