Fourth indication in China! Summel approved for multi-joint infant ionic arthritis

Shumeile ® is currently the first chinese approved for the treatment of multi-joint infant isoarthritis monoclonal antibody monoclonal antibodiesin 2008, The ® was approved for treatment of pJIA patients aged 4 and over in the United States, and in 2014, the age range for the indication was extended to pJIA patients aged 2 and over, and orphan drug status (Orphan Care Pharmaceutical) was granted to pJIA patients aged 2-17 yearsIn the European Union, the ® was approved for treatment of 13-17-year-old pJIA patients in 2008, the age range for pJIA indications was extended to 4-17 years in 2011, and the age range for pJIA indications was further expanded to 2-17 years in 2013Sumerle®key clinical studies for the treatment of multi-joint infant iade stoidal arthritisAdamu mono-anti-joint or non-joint methotrexate to treat juvenile rheumatoid arthritis:this is a 16-week open label import period, 32-week double-blind suspension period and open label extension of randomized, double-blind, stratified, placebo control, multicenter, drug-removal studypatients aged 4 to 17 years of active rheumatoid arthritis who had previously been treated with nonsteroidal anti-inflammatory drugs were stratified according to the use of methotrexate, giving Adamu monoantigen (maximum dose of 40 mg) per body surface area (maximum dose of 40 mg) and injecting every other week for 16 weeksAt week 16, we will reach 30% of patients with reduced conditions at the American Society of Rheumatology Paediatric Standard (ACR Pedi 30), receiving adamamy monotonous or placebo sin-form in a double-blind manner every other week, up to 32 weeks74% of patients who did not receive methotrexate treatment (64 out of 86) and 94% of patients treated with methotrexate (80 out of 85 cases) met ACR-Pedi 30 remission at 16 weeks and met the conditions for double-blind treatmentOf the patients not treated with methotrexate, 43% of patients treated with Adamazole and 71% of those treated with placebo developed a disease attack (main result) (P-0.03)Of the patients treated with methotrexate, 37% of the patients treated with Adamu monoresist and 65% of those treated with a placebo developed a disease attack (P-0.02)At 48 weeks, the percentage of patients receiving adamation to ACR-Pedi 30, 50, 70, or 90 relief was significantly higher than in patients treated with a placebo, and for patients who were not treated with methotrexate, there was no significant difference between patients treated with methotrexate and those treated with placeboAfter 104 weeks of treatment, the remission rate remained the sameThere were no reports of death, malignant tumors, opportunistic infections, tuberculosis, demyelination disease or lupus-like syndrome during the study periodthe safety, efficacy and pharmacokinetics of multi-joint type isoarthritis in children aged 2-4 years: study was designed to assess the safety of moderate to severe active multi-joint juvenile isoarthritis (pJIA) in Adamu monoantigen treatment 2-4 years of age or over 4 years of age and over 15 kg, and also evaluated the clinical efficacy and pharmacokinetics of Adamu monoantigen This is an international, multi-center, open label, phase 3b study, 32 active JIA patients enrolled in the group These patients were given Adamu monoantigen 24 mg/m2 (maximum dose of 20 mg/dose) every other week, lasting up to 120 weeks, combined or not combined with methotrexate Summary of Adverse Events (AE) for completed visits The end pointof of efficacy includes the American Society of Rheumatology Paediatric Standard (PedACR) 30/50/70/90 remission and JIA core variables In one patient, the concentration of Adamu mono-anti-serovalley was measured centrally Of these patients, 88 per cent were women Baseline average age, weight and JIA duration were 3 years, 13 kg and 12 months, respectively; The incidence of AE includes any AE (29/32,91%), severe AE (5/32,16%), infectious AE (25/32,78%) and severe infection (3/32,9%) No deaths, malignancies, or opportunistic infections are reported Growth is not adversely affected At 96 weeks, 92% of patients reached PedACR30 and 77% reached PedACR70 The improvement of the core variables of JIA was observed The average steady-state serum Adamu mono-valley concentration in weeks 12 and 24 was 7-8 ?g/mL Jia patients aged 2 to 4 years or 4 years of age weighing 15 kg have a good tolerance for Adamu mono-resistance The efficacy and pharmacokinetics of Adamu monoantigen are similar to those in older JIA patients concluded: "
in this very young population, Adamu mono-anti-combination or non-joint methotrexate treatment is safe and well tolerated, the results are similar to the older JIA patients treated with Adamu monoantigen." After 96 weeks of Adamu monoantigen treatment, the activity parameters of core JIA disease continued to improve, and the efficacy was remarkable these new data represent the first systematic clinical study of Adamu monoantigen therapy in this very young JIA population( with great and unmet medical needs) efficacy, pharmacokinetics and safety in pediatric patients with juvenile isoarthritis in Japan: study aims to evaluate the efficacy, pharmacokinetics and safety of Adamu disantion in the treatment of japanese multi-joint type of juvenile iade arthritis (pJIA) The single-group, open-label, multi-center Adamu monoantigen study included patients between the ages of 4 and 17 Patients weighing 30 kg have a dose of 20 mg every other week (eow) and a dose of 40 mg eow for patients weighing 30 kg The combined use of methotrexate (MTX) is allowed (10 mg/m2 per week) The main outcome was the percentage of patients with a 30-relief (ACR Pedi 30) at the American Society of Rheumatology Pediatric Standard 30 at week 16 Analysis of JIA core variables, serum Adamu monoantigen concentration and anti-Adamu monoantibodies (AAA) Adverse events (AE) were monitored A total of 25 patients were enrolled (20 combined MTX at baseline time, 5 cases not combined with MTX drugs): 24 cases completed 16 weeks of treatment and 22 completed 60 weeks of treatment At week 16, 90% of patients with combined MTX and 100% of patients without combined MTX reached ACR Pedi 30, and at week 60, the remission rates remained the same for 94% and 80% of patients, respectively Over time, each JIA core variable improves Six patients tested positive for AAA (2 each at 8, 16 and 60 weeks), some of which were temporary All six AAA-positive patients reached ACR-Pedi 30 at week 16 and 4 patients remained ACR-pedi 30 at week 60 In 6 cases (all combined with MTX), 9 patients had severe AE (JIA, fever, joint pain, pneumonia, hepatitis B virus infection, pharyngitis, dehydration, sore throat, pneumonia) The safety data of Adamu monoantigen treatment in japanese patients with multi-joint type of juvenile iade arthritis are similar to those in Western studies, and no new adverse event signals were observed, and adamumono is safe and effective in reducing disease activity for up to 60 weeks Safety and Effectiveness of Adamu monoantigen in the course of multi-joint infant isoarthritis: STRIVE Registration 7 mid-year results the purpose of this study was to assess the safety and efficacy of Adamu mono-resistance (ADA) in multi-joint infant iapathic arthritis (pcJIA) in THE STRIVE registration (NCT00783510) the group of pcJIA patients were divided into two groups on the basis of individual treatment with methotrexate (MTX) or ADA-combined/non-combined MTX (ADA-MTX) treatment The registered group analyzed adverse events (AE) for every 100 patient years (PY) observation time Patients who were registered within 4 weeks of starting to use MTX or ADA-MTX (defined as a new user) were assessed for changes in disease activity by a 27-joint juvenile arthritis disease activity score (JADAS27CRP) based on C-reactive protein data for 838 patients is available on the 7-year deadline (June 1, 2016) (MTX group, N-301; ADA-MTX group, N-537) The most common AEs in the MTX group were nausea (10.3%), sinusitis (4.7%), vomiting (4.3%), and the most common AE in the ADA-MTX group was arthritis (3.9%), upper respiratory tract infections (3.5%), sinusitis, tonsillitis, and injection site pain (3.0% each) The mTX group had a severe infection rate of 1.5 cases/100PY, and the ADA-MTX group had 2.0 cases/100PY The incidence of AE and severe AE in patients who received ADA combined with non-joint MTX treatment was similar No deaths, active TB events, or tumors were reported Compared to new users in the MTX group in the first year of STRIVE, the average JADAS27CRP of the new users in the ADA-MTX group showed a lower trend The 7-year mid-year results of STRIVE registration support that most children have a good tolerance for ADA-MTX The registered median (quart spacing) ADA was exposed to 2.47 (1.0-3.6) years, of which 42% continued to receive ADA treatment by the 7-year deadline in China, Shumeile ® was listed in 2010 and has been approved for four indications: rheumatoid arthritis indication synod in 2010, strong straight syllitis indication in 2013, medium-severe plaque psoriasis indication in 2017, and multiple-joint type of juvenile idiopathic arthritis indication in 2019 In 2018, NMPA approved the change of the adult psoriasis ® to "adult patients with severe and severe chronic plaque dandruff patients who need systematic treatment" and changed the drug from clinical second-line system therapy to clinical first-line system therapy At the same time, NMPA also approved the results of a clinical trial of silver chip A to be added to the Chinese ® at present, the ® of Shumeile has been included in the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalog, which can cover the indications including rheumatoid arthritis, hyperthyroidism and moderate tosevere plaque psoriasis In the future, the ® of Sumeral (Adamu mono-resistant injection) is expected to continue to develop new indications The ® treatment of non-infectious intermediate vitis, post-vactia and whole viticulture has been included in the second batch of clinically urgent overseas new drugs list as a child drug and has obvious clinical advantages, the application for pJIA indications of the Xiumel ® has been approved by the Drug Review Center (CDE) of the State Drug Administration for the granting of China's registered clinical trials and priority review and approval qualifications reference source: 1, Hashkes PJ, et al JAMA 2005 Oct 5;294 (13): 1671-84 s.2.2 Clin Rheumatol 1998;17(6):505-10 Wallace CA Arthritis Rheum 1998 Mar;41 (3):381-91 Lovell DJ, et al N Engl J Med 2008 Aug 21;359 (8):810-20.
Kingsbury DJ, et al Clin Rheumatol 2014;33(10):1433-41 Imagawa T, et al Clin Rheumatol 2012 Dec; 31 (12): 1713-213 7, Brunner HI , et al Arthritis Care Res.2019 Aug 17 doi: 10.1002/acr.24044 .8 The National Drug Administration's Drug Review Center is listed on the list of preferred varieties, from http://
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