Development of an Indigo Naturalis Suppository for Topical Induction Therapy in Patients with Ulcerative Colitis

Digestion ◽  
2019 ◽  
Vol 101 (4) ◽  
pp. 492-498 ◽  
Author(s):  
Yusuke Yoshimatsu ◽  
Makoto Naganuma ◽  
Shinya Sugimoto ◽  
Shun Tanemoto ◽  
Satoko Umeda ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Induction Therapy ◽  
Indigo Naturalis

scholarly journals A15 EFFICACY AND SAFETY OF FILGOTINIB AS INDUCTION THERAPY FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 2B/3 SELECTION STUDY

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 18-20
Author(s):  
B G Feagan ◽  
E V Loftus ◽  
S Danese ◽  
S Vermeire ◽  
W J Sandborn ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Active Ulcerative Colitis ◽  
Treatment Groups ◽  
Disease Characteristics ◽  
Serious Infections ◽  
Endoscopic Remission ◽  
Induction Study ◽  
Secondary Endpoints

Abstract Aims The SELECTION (NCT02914522) Induction Studies evaluated the efficacy/safety of filgotinib (FIL), a preferential JAK1 inhibitor, as induction therapy for patients (pts) with moderately to severely active ulcerative colitis (UC) who were biologic-naïve but failed conventional therapy (Induction Study A) or failed prior biologics (Induction Study B). Methods Pts were randomized 2:2:1 to once–daily FIL 200mg, FIL 100mg or placebo (PBO). The primary (clinical remission), key secondary (Mayo Clinic Score [MCS] remission, endoscopic remission, and histologic remission), and exploratory endpoints (MCS response and endoscopic improvement) were assessed at Week 10. Results In both studies, baseline demographics and disease characteristics were similar across treatment groups. In Study A, 659 pts were randomized and treated. Baseline mean MCS was 8.6 and 56% had a Mayo endoscopic subscore (ES)=3. A significantly higher proportion of biologic-naïve pts on FIL 200mg achieved clinical remission vs PBO and all key secondary endpoints (Table). In Study B, 689 pts were randomized and treated. Baseline mean MCS was 9.3 and 78% had ES=3. Prior treatment failures were: anti-TNF (86%), vedolizumab (52%) and both (dual-refractory; 43%). A significantly higher proportion of biologic-experienced pts on FIL 200mg achieved clinical remission vs PBO. In Studies A and B, a greater proportion of pts on FIL 200 mg achieved an MCS response and endoscopic improvement vs PBO. The rates of AEs, serious AEs and discontinuations due to AEs were similar across FIL and PBO groups during induction. In the PBO, FIL 100mg and FIL 200mg groups, serious infections occurred in 0.7%, 0.7% and 0.4% pts in Study A and 1.4%, 1.4% and 0.8% pts in Study B; H Zoster occurred in <1% in both groups for both cohorts. Conclusions SELECTION included a high proportion of dual-refractory pts, and pts with severe endoscopic disease. Both doses of FIL were well tolerated. Filgotinib 200mg was effective induction therapy for both biologic-naïve/-experienced pts with moderately to severely active UC. Funding Agencies None

scholarly journals P522 Cytapheresis as remission induction therapy in 154 ulcerative colitis patients: A five year experience

2014 ◽  
Vol 8 ◽  
pp. S285-S286
Author(s):  
O. Nomura ◽  
T. Shibuya ◽  
T. Osada ◽  
D. Ishikaw ◽  
N. Sakamoto ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Induction Therapy ◽  
Remission Induction

scholarly journals Model-Informed Precision Dosing during Infliximab Induction Therapy Reduces Variability in Exposure and Endoscopic Improvement between Patients with Ulcerative Colitis

Pharmaceutics ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1623
Author(s):  
Ruben Faelens ◽  
Zhigang Wang ◽  
Thomas Bouillon ◽  
Paul Declerck ◽  
Marc Ferrante ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Standard Deviation ◽  
Induction Therapy ◽  
Trough Concentration ◽  
Fat Free Mass ◽  
Average Dose ◽  
Time Curve ◽  
Concentration Time ◽  
Dosing Regimens ◽  
Median Area

Model-informed precision dosing (MIPD) may be a solution to therapeutic failure of infliximab for patients with ulcerative colitis (UC), as underexposure could be avoided, and the probability of endoscopic improvement (pEI; Mayo endoscopic subscore ≤1) could be optimized. To investigate in silico whether this claim has merit, four induction dosing regimens were simulated: 5 mg/kg (label dosing), 10 mg/kg, covariate-based MIPD (fat-free mass, corticosteroid use, and presence of extensive colitis at baseline), and concentration-based MIPD (based on the trough concentration at day 14). Covariate- and concentration-based MIPD were chosen to target the same median area under the infliximab concentration-time curve up to endoscopy at day 84 (AUCd84), as was predicted from 10 mg/kg dosing. Dosing at 5 mg/kg resulted in a mean ± standard deviation pEI of 55.7% ± 9.0%. Increasing the dose to 10 mg/kg was predicted to improve pEI to 65.1% ± 6.1%. Covariate-based MIPD reduced variability in exposure and pEI (65.1% ± 5.5%). Concentration-based MIPD decreased variability further (66.0% ± 3.9%) but did so at an increased average dose of 2293 mg per patient, as compared to 2168 mg for 10 mg/kg dosing. Mean pEI remained unchanged between 10 mg/kg dosing and MIPD, since the same median AUCd84 was targeted. In conclusion, quantitative simulations predict MIPD will reduce variability in exposure and pEI between patients with UC during infliximab induction therapy.

Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis – experiences from a single center

2015 ◽  
Vol 15 (9) ◽  
pp. 1257-1262 ◽  
Author(s):  
Klaudia Farkas ◽  
Mariann Rutka ◽  
Anita Bálint ◽  
Ferenc Nagy ◽  
Renáta Bor ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Induction Therapy ◽  
Single Center
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