Jansen's innovative drug Stelara (ustekinumab) achieved positive results in Phase 3 clinical trials treating UC adult patients
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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UC and Crohn's disease (CD) are two of the most common inflammatory bowel disease (IBD), both chronic, recurrent, and self-relieving inflammatory progressive digestive tract (GI) diseasetoday, Janssen Pharmaceutical, a subsidiary of Johnson and Johnson, announced positive results in the trialof the 3st Stage Clinicaltrial (ustekinumab), a new drugfor the treatment of inflammatory
diseasesabout Ustekinumab
Ustekinumab is a selective target of leukocyte interleukinIL-12 and IL-23 humanoid monoantigenIL-23 and IL-12 are naturally occurring cytokines that are involved in inflammation and immune responses such as the activation of natural killer cells and the differentiation and activation of CD4-T cellsUstekinumab can disrupt IL-23 and IL-12 mediated signalconduction and cytokine cascade reactionsPreviously, thedrug(has been approved in the European Union for treatment of severe plaque psoriasis, as well as moderate to severe active CD patientsUstekinumab can also be used as a single therapy or in combination with methotrexate to treat active psoriasis arthritisthe UNIFI trialPhase 3 UNIFI trial to assess the induction and maintenance dose of ustekinumab, the effectiveness and safety of moderate to severe UC patientsthese patients were not adequately or intolerant of conventional therapies (corticosteroid hormones, immunomodulators) or biotherapy (TNF alpha antagonists or vedolizumab) Patients with clinical remission during the induced dose study period of at least 8 weeks, during which time clinical remission can continue for 44 weeks, up to 3 years of follow-up studies Patients were treated at different doses of ustekinumab, one group received 130 mg of ustekinumab and the other group received ustekinumab at 6 mg/kg body weight induced dose study results showed that at 8 weeks, the rate of clinical remission in UC patients significantly increased (15.6% in the 130 mg ustekinumab group; 15.5% in the 6 mg/kg ustekinumab group; 5.3% in the placebo group, p 0.001) Other critical secondary endpoints were also significantly improved, including clinical patient response ratios, endoscopic cure rates, and to health (associated quality of life score)
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