FDA approves Jansen Pharmaceuticals STELARA ® (ustekinumab) for treatment of adult patients with ulcerative colitis
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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today, Johnson and Johnson's JanssenPharmaceutical(http://announced that itsproduct(http://STELARA ® (usinumab) has been approved by theFDA(http://for the treatment of adult patients with moderate to severe active ulcerative colitisCriticaltrial(http://includes an initial induction study (UNIFI-I), in which patients receive single dose of STELARA 6 mg/kg intravenous (IV) infusionAfter 8 weeks, a maintenance study (UNIFI-M) was conducted, in which patients received STELARA 90 mg subcutaneous (SC) injections every 8 weeks for 44 weeksbothstudies have demonstrated the safety and efficacy of STELARA as a treatment for patients with moderate to severe active ulcerative colitis, and the design and complete results were recently published in the New England Journal of MedicineIn the induction study, 19% of patients receiving STELARA achieved clinical remission in just 8 weeksSTELARA provides patients with symptoms of rapid remission, as 58% of patients receiving STELARA experience clinical responses in week 8In the maintenance study, 45 percent of patients receiving STELARA were remission after one yearSTELARA also helps patients achieve clinical remission without the need for corticosteroidsOne year later, 43% of patients treated with STELARA were in clinical remission and were not treated with steroids
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