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    Home > Medical News > Medical World News > Lilly and Johnson and Johnson announce the latest clinical results of IL-23 inhibitors for Crohn's disease!

    Lilly and Johnson and Johnson announce the latest clinical results of IL-23 inhibitors for Crohn's disease!

    • Last Update: 2020-10-23
    • Source: Internet
    • Author: User
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    The 28th European Digestive Disease Week 2020 (UEG Week 2020) Virtual Meeting was held from October 11-13.
    the conference, Lilly and Johnson and Johnson presented the latest results of two phase 2 clinical studies on the treatment of Crohn's disease (CD) by two IL-23 inhibitors, mirikizumab and Tremfya (Tenoya ®, common name: guselkumab, gusekumab.
    CD is an inflammatory bowel disease (IBD) that manifests it as abdominal pain, diarrhea, fever, weight loss, and leads to intestinal obstruction, fibrosis, and other complications.
    IL-23 is a cytokine that plays a key role in a variety of autoimmune diseases.
    Mirikizumab is a targeted humanized IgG4 monoantigenic combination of leukolytin 23 (IL-23) p19 sub-base and is currently being developed for the treatment of a variety of immunologic diseases, including CD, psoriasis, and ulcerative colitis.
    Tremfya, an all-human monoantigen targeted to bind to IL-23 p19 sub-base, was first approved in July 2017 and is the first regulatoryly approved option IL-23 inhibitor.
    in China, Tremfya was approved in Hong Kong in November 2018 and in mainland China in December 2019 to treat adult patients with moderate to severe plaque psoriasis suitable for systematic treatment.
    mirikizumab: Continuously improving symptoms and reducing intestinal inflammation The results from phase 2 SERENITY study showed that mirikizumab was treated for 52 weeks, resulting in continuous improvement of symptoms and significant reduction of inflammation of the intestinal mucosa in patients with moderate to severe active CD.
    this data enhances the ongoing evaluation of mirikizumab's treatment CD in key VIVID Phase 3 projects.
    SERENITY was a multi-center, randomized, parallel group, double-blind, placebo-controlled phase 2 study conducted in patients with moderate to severe active CD.
    study, which lasted 52 weeks and included a 12-week induction period and a 40-week maintenance period, is evaluating the safety and effectiveness of multiple dosage regimens and two dosing regimens (intravenous IV, subsothic injection SC).
    the induction period, patients were randomly divided into 4 treatment groups and treated with a placebo or 3 doses of mirikizumab (200 mg, 600 mg, 1000 mg) IV.
    week, patients with improved endoscopy were randomly classified as IV or SC mirikizumab.
    were randomly assigned IV mirikizumab treatment after the endoscopy did not improve or were randomly assigned to the placebo group at induction time.
    May 2019, Lilly reported the main endpoint results: in the 12th week of treatment, a higher proportion of patients in the mirikizumab treatment group achieved clinical response and clinical remission than those in the placebo group.
    New data released at the conference showed that the study reached several key secondary endpoints in week 52, including endoscopic response (defined as Crohn's disease simple endoscopic score (SES-CD) is at least 50% lower than baseline), patient reporting results (PRO) mitigation (defined as average daily detox ≤2.) 5 times, abdominal pain ≤1 time and no worse than the baseline condition), endoscopic remission (defined as: SES-CD score of colorectal disease <4 points, isolated colorectal disease SES-CD score <2 points, and no sub-score >1 point).
    , endoscopic response and PRO remission are two important therapeutic targets for CD.
    specific data are: (1) endoscopic response: nearly 60% of patients reached endoscopic response, random IV dosing group of 58.5%, SC dosing group of 58.7%.
    (2) PRO remission: more than 45% of patients achieved PRO remission, 46.3% in the IV dosage group and 45.6% in the SC dosing group.
    (3) subset analysis showed that in patients who reached endoscopic response in week 12, 69.6% and 66.7% of patients in group IV (n=23) and SC (n=24) were in the 52nd Endoscopic reactions were also expected during the week, and in patients who reached endoscopic remission at week 12, 50.0% and 64.3% of patients in group IV (n=6) and SC (n=14) had endoscopic remission at week 52, respectively.
    (4) safety data showed that in patients who showed endoscopic improvement in week 12, 1 in each group stopped treatment due to adverse events (AE).
    the frequency of adverse events (TEAEs) and severe adverse events (SAEs) occurred during treatment in the IV and SC groups.
    most common TAAEs were rhinitis (4.9 per cent in GROUP IV, 13 per cent in group SC), headache (7.3 per cent in group IV, 8.7 per cent in group SC), and joint pain (7.3 per cent in group IV, 13 per cent in group SC).
    Tremfya: Effectively induced clinical and endoscopic improvement Interim analysis data from phase 2 GALAXI 1 studies show that in patients with moderate to severe active CD, Tremfya showed significant improvements in key clinical and endoscopic outcome indicators compared to placebos in week 12 of treatment, consistent with approved adaptations.
    , Tremfya has not been approved for treatment of CD.
    data also represent the first data to assess moderate to severe active CD in Tremfya treatment.
    Although CD has made substantial progress in clinical treatment, some patients still benefit from any drugs currently approved that target the mechanism of action of CD symptoms, and the first data confirm that the three doses of Tremfya have produced significant responses in key clinical and endoscopic outcome measurements.
    GALAXI 1 is a double-blind, placebo-controlled, multi-center phase 2 dose range study that is evaluating the efficacy and safety of Tremfya therapy in patients with moderate to severe active CD patients who are underreacting to conventional treatments (corticosteroids, immunosuppressants) and/or biological agents (TNF antagonists).
    study, patients will receive up to three years of treatment.
    study included a positive control group treated with Stelara (Sidano, generic name: ustekinumab, ussnu monoanti).
    is the world's first biological agent to selectively target IL-12 and IL-23 simultaneously and has been approved for the treatment of adult CD patients.
    -term analysis reported 12 weeks of treatment for the first 250 patients.
    About 50 percent of these patients failed in previous biotherapy treatments, and baseline disease characteristics were consistent with moderate to severe active CD (CD Activity Index (CDAI), with an average score of 306.6; SEC-CD, median 11.0).
    study, patients were randomly divided into 5 treatment groups, including: 3 doses of Tremfya treatment group (doses: 200, 600, 1200 mg; 0, 4, 8 weeks, intravenous injection of IV), Stelara treatment group (week 0 6mg/kg IV, week 8 90mg SC), placebo group.
    results showed a significant reduction in CDAI per Tremfya dose group (200, 600, 1200 mg IV) compared to the placebo group at week 12 (minimum The method averages are -154.1, -144.3, -149.5, the placebo group -36.0, and all p.lt;0.001).
    compared to the placebo group, there was a significant increase in the proportion of patients in the Tremfya dose group who received clinical remission (CDAI-lt;150): 54.0%, 56.0%, 50.0%, respectively, and 15.7% in the placebo group (p.lt;0.001).
    patients who failed in routine treatment, 61.6 percent in the Tremfya combined treatment group and 18.5 percent in the placebo group achieved clinical remission at the 12th week.
    in patients who had previously failed biotherapy, Tremfya combined treatment group had 45.5 percent and placebo group 12.5 percent had clinical remission at week 12.
    In addition, in week 12, a significantly higher proportion of patients treated with Tremfya received clinical responses (p-lt;0.001), patient reporting results (PRO)-2 remission (p-lt;0.001), clinical biomarker responses (p<0.001), endoscopic responses (p<0.001).
    endoscopic healing was an important result of long-term disease control; 37.3 percent of patients in the Tremfya combined treatment group received endoscopic response after 12 weeks of induction therapy, while 11.8 percent of the placebo group received an endoscopic response( p.lt;0.001).
    the safety of Tremfya is consistent with the adaptations previously identified through clinical trials.
    12 weeks of treatment, adverse events (AEs) were observed to be similar between the treatment group and the placebo group.
    in Tremfya and placebo groups, the rates of severe adverse events were 4%, 4%, 2% and 4%, respectively, and serious infections were 2%, 0%, 0% and 0%, respectively.
    reported no deaths, no active tuberculosis, severe allergic reactions or malignant tumors in patients treated with Tremfya.
    source: 1. Mirikizumab Shows Continued Symptoms And Reduction of Intestinal In Patients with Crohn's Disease in 52-Week Phase 2 Trial2.TREMFYA (guselkumab) Induces and Clinical Endoscopic In Patients with Moderately to Severe Active Crohn's Disease on In Results from Phase 2 Study.
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