New anti-inflammatory drugs! Positive data were obtained in the phase IIIB study of Johnson and Johnson's stelara Crohn's disease treatment up to standard. The clinical remission rate of two doses was 67%

February 15, 2020 / bioun / -- Janssen Pharmaceutical, a subsidiary of JNJ, recently released the interim data of stellara (commonly known as ustekinumab) in the phase IIIB Stardust study on Crohn's disease (CD) at the 15th European Crohn's disease and colitis Organization (Ecco) conference in Vienna, Austria This is a randomized, international, multicenter, interventional study involving 500 adults with moderate to severe active CD who have not previously received biologics (primary treatment) or have previously received no more than one biologics In the study, patients received intravenous (IV) infusion of stellara 6mg / kg, and then subcutaneous (SC) injection of stellara 90mg at the 8th week At the 16th week, patients with decreased or more than 70 CADI scores (CADI 70 responders) were randomly assigned to the treatment to target group and the standard of care group for stellara maintenance treatment, and were followed up to the end of the study (48 weeks) In the study, endoscopic ultrasound (IUS) responses were evaluated, as early as week 4 The primary end point was the proportion of patients with simplified endoscopy score (ses-cd) of Crohn's disease who decreased by more than 50% from baseline It is worth mentioning that the Stardust study is the first study to use endoscopic response to guide dose adjustment therapy CD to explore a standard treatment strategy Treatment reaching standard is an active treatment strategy, which often monitors the results, such as endoscopic response, biomarkers and clinical symptoms, to guide the use of drugs According to the published interim data, 79% of the patients achieved clinical response and 67% of the patients were in clinical remission at the 16th week after the treatment of stellara with one dose of 6mg / kg iv infusion and one dose of 90mg SC injection Among 220 cdai70 responders randomly assigned to the standard treatment group, 37% achieved endoscopic response at the 16th week During the 16 week period, stelara's safety was consistent with that observed in phase III inflammatory bowel disease (IBD) clinical trials and in other indications Endoscopic ultrasonography (IUS) is a complementary method to assess CD disease activity, based on measurements of transmural intestinal characteristics, such as intestinal wall thickness and the presence of vascular hyperplasia The Stardust study was the first to use IUS to monitor CD patients in an interventional setting Future studies will need to determine whether early IUS response at week 4 can predict long-term (i.e., weeks 16 to 48) clinical and endoscopic outcomes in CD patients "Patients with Crohn's disease (CD) may respond to treatment while continuing to experience internal inflammation that can cause irreversible damage," said Professor Silvio danesei, lead researcher of the study and director of the inflammatory bowel disease center at the humanitas research hospital in Milan, Italy These patients may benefit from more aggressive, robust treatment and less invasive monitoring I am encouraged by these data, which demonstrate the potential clinical utility of noninvasive IUS methods in helping guide CD therapy, and look forward to the coming data, which may help us better understand the potential benefits of reaching treatment strategies " "The Stardust study represents an important milestone in our commitment to helping patients with Crohn's disease and their therapists," said Dr Jan wehkamp, vice president, Gastroenterology, Janssen R & D The data of this study can provide us with key clinical insights and reference for our future treatment strategies " Selara is the world's first biologics that can selectively target IL-12 and IL-23 at the same time IL-12 and IL-23 are two natural cytokines, which are believed to play a key role in immune-mediated inflammatory diseases, including UC, plaque psoriasis, psoriatic arthritis, Crohn's disease, etc Stelara inhibits these two proinflammatory cytokines by binding to P40 subunits shared by IL-12 and IL-23 and preventing their binding to cell surface receptor IL-12 β 1 Stelara was launched on the market in September 2009 At present, the approved indications include: (1) young people (≥ 6 years old) with moderate and severe plaque psoriasis and adult patients; (2) adult patients with active psoriatic arthritis; (3) adult patients with moderate and severe Crohn's disease (CD); and (4) adult patients with moderate and severe active ulcerative colitis (UC) In China, stelara (sidano ®) was launched in June 2019 It is a biological preparation with an innovative drug delivery mode - subcutaneous injection once every three months for the maintenance period, which is used to treat adult patients with moderate and severe plaque psoriasis who are not responsive, contraindicated or intolerable to other systems such as cyclosporine, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) Stellara is a core product of Johnson & Johnson's entry into the field of autoimmune diseases In 2019, the drug generated $6.361 billion in sales, an increase of 23.4% over 2018 Recently, an article published in the top international journal Nature (top product forecasts for 2020) pointed out that with the continuous increase of indications, the continuous expansion and penetration of the market, stelara's sales volume in 2020 is expected to reach 7.241 billion US dollars, ranking 7th in the world's best selling top 10 drugs in 2020 Original source: new phase 3B interior data from Stardust study show two things of patients with moderation to severe active Crohn's disease achieved clinical permission after two does of stellara ® (ustekinumab)