Two key phase III studies of Pfizer oral JAK inhibitor tofacitinib ulcerative colitis have been successful
March 25, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];March 22, 2016 / Bio Valley BIOON / -- US pharmaceutical giant Pfizer recently announced oral JAK inhibitors at the 2016 European Scientific Meeting on Crohn's Disease and Colitis (ECCO) in Amsterdam, the Netherlands Detailed data on the first two phase III studies (OCTAVE Induction 2) of the tofacitinib (tofatinib) Phase III OCTAVE clinical project. The two studies were performed in adult patients with moderate to severe active ulcerative colitis (UC) and evaluated the efficacy of tofacitinib 10 mg twice daily (BID) in inducing disease remission.
The data show that tofacitinib reduces the symptoms of moderate to severe UC and induces disease remission. More importantly, tofacitinib showed therapeutic benefit in a population of patients who had previously been treated with tumor necrosis factor inhibitor (TNFis) and a group of patients who had not previously received TNFis. Moreover, tofacitinib showed improvement in the symptoms of the disease as early as the second week (the first evaluation time point of the two studies).
Both OCTAVE Induction 1 and OCTAVE Induction 2 met the primary endpoint of the study. In the OCTAVE Induction 1 study, at the 8th week, a significantly higher proportion of patients in the tofacitinib 10 mg BID treatment group achieved remission (18.5% (n=88) vs 8.2% (n=10)) compared with the placebo group. The OCTAVE Induction 2 study was consistent with the OCTAVE Induction 1 study. In the 8th week, a significantly higher proportion of patients in the tofacitinib 10 mg BID treatment group achieved remission compared with the placebo group (16.6% (n=71) vs 3.6% ( n=4)). Remission was defined as a Mayo score of ≤ 2, a single sub-score of no more than 1, and a rectal bleeding score of 0.
In addition, at week 8, a significantly higher proportion of patients in the tofacitinib 10 mg BID treatment group achieved mucosal healing compared with the placebo group, reaching a key secondary endpoint for both studies. In the OCTAVE Induction 1 study, at the 8th week of treatment, 31.3% (n = 149) of the tofacitinib 10 mg BID treatment group achieved mucosal healing, compared with 15.6% in the placebo group (n = 19). In the OCTAVE Induction 2 study, at the 8th week of treatment, 28.4% (n=122) of the tofacitinib 10 mg BID treatment group achieved mucosal healing, compared with 11.6% in the placebo group (n=13). Mucosal healing is defined as a Mayo endoscopic score of 0 or 1.
2 In this study, the safety of tofacitinib was similar to other tofacitinib experimental clinical studies.
The OCTAVE Global Clinical Development Program includes three key Phase III studies (OCTAVE Induction 1, OCTAVE Induction 2, OCTAVE Sustain) and a Long Term Extension Study (OCTAVE Open). Among them, OCTAVE Induction 1 and OCTAVE Induction 2 were placebo-controlled studies evaluating the efficacy of oral tofacitinib 10 mg BID in inducing remission in adults with moderate to severe active ulcerative colitis (UC). OCTAVE Sustain is a placebo-controlled study evaluating the efficacy of oral tofacitinib 10 mg BID and 5 mg BID as maintenance therapy in the treatment of moderate to severe UC adult patients. The study is expected to receive data at the end of 2016. OCTAVE Open is an open-label extension study designed to evaluate tofacitinib 10mg BID and 5mg BID in patients who have completed treatment or treatment failure (in the OCTAVE Sustain study) or after treatment without remission (OCTAVE Induction 1 study or OCTAVE Induction 2) The safety and tolerability of the study).
Ulcerative colitis (UC) is a chronic, inflammatory bowel inflammatory disease affecting millions of people around the world. The disease is a complex interaction between multiple factors (including environmental, genetic susceptibility, immune response, colon or small intestinal gut microbiota) that can cause abdominal pain, fever, weight loss, chronic diarrhea, and bleeding. UC affects the work, family, and social activities of patients. In one-third of patients with UC, incomplete treatment or complications may occur. In this case, surgical removal of the colon can be considered. However, even after surgery, some symptoms of UC may still exist. Therefore, there is still far-reaching medical demand in this field.
About tofacitinib (Xeljanz/Xeljanz XR):
Tofacitinib is a novel oral Janus kinase (JAK) inhibitor currently being investigated for the treatment of a variety of immune diseases. Discovered and developed by Pfizer's in-house scientists, the drug has a novel mechanism of action aimed at inhibiting the JAK pathway, which is thought to play a key role in a variety of chronic inflammatory diseases. By inhibiting these JAK pathways, tofacitinib is able to reduce cytokine signaling, cytokine-induced gene expression, and cell activation.
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