A5035601572- Inflammatory Bowel Disease
- Microscopic Colitis
- Biosimilars and Bioanalytical Methods
- Eosinophilic Esophagitis
- Health Systems, Economic Evaluations, Quality of Life
- Liver Diseases and Immunity
- Chronic Lymphocytic Leukemia Research
- Autoimmune and Inflammatory Disorders
- Gastrointestinal disorders and treatments
- Diagnosis and treatment of tuberculosis
- Celiac Disease Research and Management
- Immunodeficiency and Autoimmune Disorders
- Acute Lymphoblastic Leukemia research
- Cancer Immunotherapy and Biomarkers
- Gallbladder and Bile Duct Disorders
- Bone and Dental Protein Studies
- Skin Diseases and Diabetes
- Mycobacterium research and diagnosis
- Intraperitoneal and Appendiceal Malignancies
- RNA modifications and cancer
- Colorectal Cancer Treatments and Studies
- Pancreatitis Pathology and Treatment
- Drug-Induced Hepatotoxicity and Protection
- Fibromyalgia and Chronic Fatigue Syndrome Research
- Cancer-related gene regulation
First Affiliated Hospital of Soochow University
2024-2025
Soochow University
2024-2025
Janssen (United States)
2016-2024
Mianyang Central Hospital
2024
Biostats (United States)
2020
Abstract Disruption of the intestinal epithelial barrier results in increased permeability and is a key factor onset progression Crohn's disease (CD). The protein SPARC primarily involved cell interaction migration, but its specific role remains unclear. This study demonstrates that significantly overexpressed both CD patients murine models colitis. Furthermore, mice deficient exhibits resistance to chemically induced colitis, phenomenon associated with modulation barrier‐associated...
Abstract Background The QUASAR Induction Study 1 (NCT04033445) is a phase 2b randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of guselkumab (GUS), an interleukin-23 p19 subunit antagonist, as induction therapy in patients with moderately severely active ulcerative colitis (UC) who had inadequate response or intolerance conventional (ie, thiopurines corticosteroids) advanced tumor necrosis factor alpha antagonists, vedolizumab, tofacitinib)....
Krüppel-like factor 4 (KLF4), a transcription factor, is involved in various biological processes. However, the role of KLF4 regulating intestinal epithelial barrier (IEB) inflammatory bowel disease (IBD) and its mechanism have not been extensively studied. expression IBD patients colitis mice was analyzed using Gene Expression Omnibus(GEO) database, immunohistochemistry (IHC) Western blot. The roles IEB symptoms were verified dextran sulfate sodium (DSS)-induced...
The study objective was to evaluate the safety and efficacy of SC ustekinumab (UST) as maintenance therapy in UC patients who were clinical response a single IV induction dose UST. This Ph3, double-blind, randomised withdrawal with moderate–severe active failed conventional or biologic (including anti-TNF and/or vedolizumab) 8 weeks after receiving UST dose. primary population included 523 1:1:1 placebo (PBO) SC, 90 mg q8w q12w at Week 0. Primary endpoint remission 44 (52 induction); key...
Abstract Background Fatigue is a common symptom in patients with ulcerative colitis (UC) that impairs health-related quality of life. The Phase 3 QUASAR Induction Study (NCT04033445) was randomized, double-blind, placebo-controlled, parallel-group, multicenter study guselkumab (GUS), an interleukin-23 p19 subunit antagonist, moderately to severely active UC. impact GUS IV induction on patient-reported symptoms fatigue reported here. Methods Patients were randomized 3:2 receive 200 mg or...
Clofazimine is mainly used for the treatment of neoplastic leprosy, and can also be in combination with other anti-tuberculosis drugs to treat multidrug-resistant tuberculosis.
Study objective was to evaluate safety and efficacy of SC ustekinumab (UST) as maintenance therapy in UC patients who were clinical response a single IV induction dose UST.
Abstract Background Ustekinumab (UST) is an interleukin12/23p40 antagonist approved for treatment of moderate to severe Ulcerative Colitis (UC). Here we report final clinical outcomes based on the Mayo score, including endoscopy subscore, from UNIFI long-term extension (LTE) study through 4 years UST treatment. Methods Overall, 523 intravenous induction responders were randomised subcutaneous maintenance therapy: 175 placebo (PBO); 172 90 mg every 12 weeks (q12w); 176 q8w. A total 284...
Ustekinumab (UST) is an effective therapy for moderate–severe UC; however, data regarding histological healing and the combination of endoscopic (also described as improvement in appearance mucosa) are unknown. We evaluated effects UST on activity UNIFI Ph3 induction study UC(n = 961). Two colonic biopsies were collected from distal colon at screening Wk8. Subjects not response to placebo (PBO) Wk8 received 6 mg/kg IV, those IV 90 mg SC; obtained Wk16. Endoscopic (EH; also a was defined Mayo...
Ustekinumab (UST), an IL12/23 blocker approved for Crohn's disease, was effective in Ph3 induction and maintenance of moderate–severe ulcerative colitis (UC). Efficacy biologic-failure (BF) non-biologic-failure (NBF) populations evaluated. Pts were randomised to a baseline IV UST dose (130 mg or weight-range based doses approximating 6 mg/kg (~6 mg/kg)), PBO. Responders entered SC 90 (q12wks q8wks), Primary endpoint wk8 wk44 clinical remission. Major secondary endpoints induction: endoscopic...
Abstract Background The Phase 3 QUASAR induction study evaluated efficacy and safety of guselkumab (GUS), an IL-23p19 subunit antagonist, in pts with moderately to severely active UC. At Week (Wk) 12, GUS 200mg IV was more effective than placebo (PBO) inducing clinical remission response.1 Pts not response at Wk 12 received through 24. Here, we report cumulative safety. Methods a modified Mayo score 5-9 centrally reviewed endoscopy subscore ≥2 baseline (BL) were randomized 3:2 receive or PBO...
Abstract Background Patients (pts) with ulcerative colitis (UC) suffer from symptoms that impair health-related quality of life (HRQoL). The Phase 3 QUASAR induction study (NCT04033445) evaluated the efficacy and safety guselkumab (GUS), an IL-23 p19 subunit antagonist, in pts moderately to severely active UC who had demonstrated inadequate response, loss or intolerance conventional and/or advanced therapies (ie, tumor necrosis factor-alpha antagonists, integrin receptor Janus kinase...
Abstract Background Abdominal pain and bowel urgency are prevalent, burdensome symptoms experienced by patients (pts) with ulcerative colitis (UC) that impact daily life, including social activities. In this study, we use data from the Phase 3 QUASAR Induction Study to assess efficacy of guselkumab (GUS) on abdominal pain, urgency, pts’ lives. Methods Pts were randomized 3:2 receive IV GUS 200mg or placebo (PBO) at Weeks (Wks) 0, 4, 8. evaluated baseline Wk12 using items Inflammatory Bowel...
Abstract Background The UNIFI randomised-withdrawal maintenance study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) in patients (patients) with moderately to severely active ulcerative colitis (UC) who had responded intravenous (IV) UST during induction. We dose adjustment long-term extension (LTE). Methods At Week (Week) 0 44 weeks study, 523 IV induction were randomly assigned a 1:1:1 ratio placebo (PBO) SC, SC 90 mg q12w, or q8w. Patients completed eligible...
The UNIFI studies evaluated the safety and efficacy of ustekinumab (UST) intravenous (IV) induction subcutaneous (SC) maintenance in patients with moderately to severely active ulcerative colitis (UC). Here, we present patient-reported outcomes from Inflammatory Bowel Disease Questionnaire (IBDQ). In study, eligible were randomised a single IV dose placebo (PBO, n = 319), UST 130 mg (n 320), or ~6 mg/kg 322). Patients who clinical response 8 weeks after receiving for study SC PBO 175), 90...
Ustekinumab (UST) is an effective therapy for moderate-to-severe ulcerative colitis (UC), however data regarding histologic healing and the combination of endoscopic are unknown.
Abstract Background The UNIFI randomized-withdrawal maintenance study and long-term extension (LTE) evaluated the safety efficacy of subcutaneous (SC) ustekinumab (UST) in patients with moderately to severely active ulcerative colitis (UC) who had responded intravenous (IV) UST during induction. We dose adjustment through Week (Wk) 152 (LTE). Methods 523 induction responders were randomized SC therapy (SC placebo [PBO], n=175; 90mg every 12 weeks [q12w], n=172; or q8w, n=176). 284 completed...
Pharmacokinetic (PK) and exposure–response (ER) data for ustekinumab (UST) from the UNIFI study in ulcerative colitis (UC)1 were evaluated. PK, efficacy, safety obtained this Phase 3, double-blind, placebo-controlled induction trial which enrolled 961 patients with moderate–severe UC. Pts who previously failed biologics (1 or more TNF-blockers vedolizumab) conventional therapy (corticosteroid and/or 6-MP/AZA) included. randomised 1:1:1 to receive an IV dose of UST 130 mg a weight-range based...
The UNIFI randomised-withdrawal maintenance study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab in patients with moderately to severely active ulcerative colitis (UC) who had responded intravenous (IV) during induction. In this analysis, we describe durability remission through Week 44. At 0 study, 523 IV induction were randomly assigned a 1:1:1 ratio placebo SC, SC 90 mg q12w, or q8w. Although clinical at 44 was major secondary endpoint (reported elsewhere), partial...
Ustekinumab (UST) was effective in Ph3 induction & maintenance of moderate-severe UC. Efficacy biologic-failure (BF) and nonbiologic-failure (NBF) populations evaluated.
Abstract Background Ustekinumab (UST) is an IL12/23 blocker approved for Crohn’s disease and ulcerative colitis (UC). In the UNIFI maintenance study of patients with moderate–severe UC, >90% who achieved clinical response or remission at week 44 were able to eliminate corticosteroids, important goal therapy. this analysis, we describe corticosteroid (CS) sparing effects UST treatment through 92 among treated in long-term extension (LTE). Methods Responders 8 weeks after IV induction...
Abstract Background Ustekinumab (UST) is an effective therapy for moderate-to-severe ulcerative colitis (UC). Histological and endoscopic improvement of mucosa after induction are associated with clinical remission steroid-free at maintenance Week 44. The association histological-endoscopic mucosal healing UST or 2-year outcomes in UC not known. Methods In the UNIFI study UC, was defined as achieving both (Mayo endoscopy subscore ≤1) histological (i.e., neutrophil infiltration <5%...
Abstract Background Ustekinumab (UST) is a mAb to IL-12/23p40 that approved for moderate-to-severe ulcerative colitis (UC). The UNIFI maintenance study evaluated SC UST through 1 year in patients who responded IV induction. Patients completed the could enter long-term extension (LTE) 220weeks. Here, we report efficacy of 92weeks randomised study. Methods were clinical response 8weeks after induction PBO (n = 175), 90mg q12w 172), or q8w 176). All Week 44 eligible and continue LTE at...