Lupus: Bellevue single against PK Tattisip, who can win?

Systemic lupus is a complex systemic autoimmune disease with diverse clinical manifestations, including large-scale red rash, fever, pain, often leading to multi-organ, multi-system damage, is a major life-threatening disease, most lying in women of childbearing age between 15 and 45 years old, the ratio of men to women is about 1:9China's epidemiological survey report shows that the prevalence of systemic lupus is 70 per 100,000 people, China has about 1 million patients, the world has about 5 million patientsAt present, the drugs used in the clinical treatment of systemic lupus mainly include glucocorticoids (pernitson, hydrocortisone, pentamipine), immunosuppressants (cyclophosphamide), antimalarial drugs (hydroxychloroquine) and biologicsThese drugs are often accompanied by adverse reactions, especially the long-term use of commonly used glucocorticoids in clinical practice is very harmful to the human bodysystemic lupus has a huge clinical demand for new therapeutic drugs, but the development of new drugs in this area is extremely difficult, in recent years, the international Phase III project has largely failed (see figure below)Bellevue: The first new lupus drug in 60 years
In July 2019, GlaxoSmithKline announced that Bellevue monoantigen (commodity name: Piriten) was officially approved in China for use in combination with conventional treatment for adult patients with active, autoantibodies-positive systemic lupus (SLE) patients who are still active and autoanti-positive on the basis of conventional treatmentThe approval of this drug also gives Chinese SLE patients access to the most internationally recognized target B-cell biologics todayBellevue monosytade is the world's first approved bio-target preparation for the treatment of systemic lupus erythematosus, and the first new drug approved for the treatment of SLE in nearly 60 years, with a Guide A recommendation in Europethe 2017 annual meeting of the European Society of Rheumatology (EULAR), GSK published the results of a 10-year clinical study of active systemic lupus in Bellevue monoantigen therapythis study is a multicenter, open label, ongoing clinical study (BEL 112626; NCT00583362) to assess the long-term efficacy and safety of beliho monoantigen 10 mg/kg dose combined standard careThe patients in the group had previously completed a double-blind, placebo-controlled, 52-week treatment period (Belliu monoantigen dose 1, 4, 10 mg/kg), 24-week expansion period (placebo to 10 mg/kg; Bellevue monoantigen same dose or 10 mg/kg) Phase II study, with a total of 298 patients enrolled in a long-term and continuous study10 years, 131 patients (44%) were still in the study, with a total remission rate of 65.2%In terms of security, the (severe) incidence of adverse events has also remained relatively stable over time and is consistent with the known security of Bellevue MonoantigenBEL113750 was a multicenter, randomized, double-blind, placebo control study for SLE patients in Northeast Asia (China, Korea, Japan) and received 10 mg/kg beliho monoantigen combined routine treatment and placebo combined routine treatment in groupsA total of 677 subjects were finally analyzed, with 76.4% of Chinese patients Beliho monoantigen reduced the risk of relapse of severe SFI (SLE disease activity index) by 50% from week 12, the rate of SRIs in the Bellevue monoantigen group was higher than that of the placebo group and continued into the 52nd week, with a significant improvement in disease activity of the affected organs; Beliau monoantigen group had a 50% lower risk of severe recurrence than the placebo group, and the cumulative hormone dose was significantly lower (4190mg and 4758.1mg of accumulated hormones at 52 weeks); Belieu monoantigen group had a similar incidence of adverse events compared to the placebo group, with the majority of adverse events being mild to moderate Teitasip: Chinese-made double-target lupus innovation drug teitathip (RC18, telitacicept), a product called Tai ai, the drug is an innovative product developed by Rongchang Bio, this drug is fusion protein drug, recombinant human B lymphocytic stimulator receptor (trans activatand CAMLll, TACI) BLyS and APRIL are the key factors for the differentiation and maturation of B lymphocytes, and the overexpression of this factor is an important cause of various B lymphocytic-related autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, and so on On July 12, 2019, Rongchang Bio announced the results of a key phase II/III clinical study of the new drug Tetasip (RC18) for the treatment of systemic lupus (SLE), showing that the 48-week sRRS (Systemic Lupus Response Index) in the high-dose group of Tataxip was significantly higher than that of the placebo control group (79.2% vs 32.0) Baseline for Patients with Systemic Lupus: : System Lupus Response Index
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secondary endpoints for : Pregnancy time: br br/br/clinical data show: br/br/1.titasep vs placebo, SRI-4 significantly increased, Statistics were statistically significant to reach the primary endpoint of clinical trials, 2 Secondary endpoints such as serum indicators were consistent with effectiveness results, and 3 Tatasip also had good safety and tolerance Tetisip vs Bailey Wood monoantigen: the effect is more significant
Although the pathogenesis of systemic lupus is not fully clear, but the mainstream view is that this is a B-cell hyperplasia caused by the autoimmune disease Stimulated by the interaction of genetic factors, environmental factors, estrogen levels and other factors, B cells overgrow, produce a large number of autoantibodies, and the corresponding autoantigens in the body to form the corresponding immune complex, deposited in the skin, joints, small blood vessels, glomerular balls and other parts, and then in the participation of the complement, causing acute and chronic inflammation and tissue necrosis Or antibodies act directly with tissue cell antigens, causing cell damage, resulting in multi-system damage to the body the target point of Bailey wood monoantigen is BLyS, Chinese B lymphocytic stimulator, so it is not difficult to understand the mechanism of effect of Bailey wood monoantigen By specifically binding to soluble BLyS in the serum, Bailey wood monoantigen can block the binding of BLyS to the receptors on B cells, inhibit the proliferation of B cells and the differentiation of B cells to plasma cells, thereby reducing the autoantibodies produced by B cells in the serum, to achieve the purpose of treating SLE a global, randomized, placebo-controlled Phase III clinical study (NCT00410384) published in The Journal of Arthritis Rheum in December 2011 included 819 patients, with 52 weeks of SRI with Bailey wood monoantigen significantly better than the placebo group (43.2 percent vs 33.5 percent) a randomized, placebo-controlled Phase III study (NCT01345253) in the March 2018 issue of Ann Rheum Dis in ann Rheum Dis journal was in groups of 677 patients, with 52 weeks of SRIs significantly better than the placebo group (53.8 percent vs 40.1 percent) when compared with clinical data published by Rongchang Bio, it was found that terasop improved significantly better on SRI than placebo (79.2 percent vs 32.0%) than placebo (79.2 percent vs 32.0 percent) This clinical result is not only a milestone in the field of systemic lupus disease, but also a sign of the improvement of the development of innovative drugs in China unlike The Pelicans, which are only for BLyS, tatisep inhibits both BLyS and APRIL cytokines Both BLyS and APRIL are key factors for the differentiation and maturation of Blyolcell differentiation, and inhibiting BLyS/APRIL can more effectively reduce the body's immune response and achieve the goal of treating autoimmune diseases Tetaxipu has the characteristics of new targets, new structures and new mechanisms, and the invention patents have been authorized by China, the United States, Europe, Russia, South Korea, Japan and so on The Taitasip project has also received major special support for science and technology during the "11th Five-Year Plan", "12th Five-Year Plan" and "13th Five-Year Plan" period At present, Tatasip has the conditions to list! SLE to see the battle between the two male, may start here! (Note: Reference to Pharmaceutical Rubik's Cube, Web, etc.) author: MedSci Source: MedSci Original highlights: day 2020-3-26 comment: good learning opportunities (from: MedSci Medical app )