The Real-World Effectiveness and Safety of Vedolizumab for Moderate–Severe Crohn’s Disease: Results From the US VICTORY Consortium

2016 ◽  
Vol 111 (8) ◽  
pp. 1147-1155 ◽  
Author(s):  
Parambir S Dulai ◽  
Siddharth Singh ◽  
Xiaoqian Jiang ◽  
Farhad Peerani ◽  
Neeraj Narula ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
The Real ◽  
The Us

scholarly journals P537 Real-world long-term effectiveness of ustekinumab in Crohn’s disease: Results from the ENEIDA registry

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S458-S460
Author(s):  
M I Iborra Colomino ◽  
B Beltrán ◽  
A Fernández-Clotet ◽  
E Iglesias Flores ◽  
P Navarro ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Clinical Remission ◽  
Poor Response ◽  
Faecal Calprotectin ◽  
The Real ◽  
Reactive Protein ◽  
Endoscopic Remission

Abstract Background There are limited data of long-term ustekinumab administered according to the doses recommended in the UNITI studies. The objective of this study was to assess the real-world, long-term effectiveness of ustekinumab in refractory Crohn’s disease (CD) (LONG-CROHNUSK Study). Methods Multicentre study of CD patients starting ustekinumab at the recommended dose based on weight ~6 mg/kg IV week 0, 90 mg SC week 8 and maintenance 90 mg SC every 8 or 12 weeks and with 1 year of follow-up. Values for Harvey-Bradshaw Index (HBI), endoscopic activity, C reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 26 and 52. Demographic and clinical data, previous treatments, adverse events (AEs), surgeries and hospitalisations were documented. Potential predictors of clinical and endoscopic remission were examined. Results Four hundred and seven patients were analysed (Table 1). For the maintenance dose, ustekinumab 90 mg was administered SC every 12, 8 and 4 weeks in 56 (14%), 318 (84.5%) and 7 (1.5%) patients, respectively. An interval reduction was applied for 118 patients (29%). Before 52 weeks, treatment discontinuation occurred in 71 patients (17%). At baseline, 295 (72%) had an HBI >4 points. Of these, 169 (57%) and 190 (64%) achieved clinical remission at weeks 26 and 52, respectively. FC levels returned to normal (<250 μg/g) in the 44% and 54% of the patients at weeks 26 and 52, respectively. CRP returned to normal (<3 mg/l) in 36% and 37% of the patients at weeks 26 and 52 respectively. HBI, FC, and CRP values over time are shown in Figure 1. Of the 159 patients with endoscopy at 52 weeks, 25 (16%) were in remission and 58 (36%) presented mild activity. Thirty-eight (9.3%) patients worsened extra-intestinal manifestations and 33 (8%) their perianal disease. AEs were recorded in 54 patients, 73 were hospitalised and 53 had surgery. An association was shown for fewer previous anti-TNF agents and ileal localisation with clinical remission, and for endoscopic severity at baseline with poor response. No factors correlated with endoscopic remission. Conclusion This is the first study to show the real-world long-term effectiveness, endoscopic improvement and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients.

S1040 Dosage Pattern of Adalimumab in Real-World Clinical Practice and Predictors of Dosage Increase in Patients with Crohn's Disease in the US

2009 ◽  
Vol 136 (5) ◽  
pp. A-175-A-176 ◽  
Author(s):  
Edward V. Loftus ◽  
Xiaoyun Pan ◽  
Pete Zurawski ◽  
Jingdong Chao ◽  
Parvez Mulani
Keyword(s):  
Crohn’S Disease ◽  
Clinical Practice ◽  
Crohn's Disease ◽  
Real World ◽  
Dosage Increase ◽  
The Us

611 THE REAL-WORLD EFFECTIVENESS OF USTEKINUMAB IN THE TREATMENT OF CROHN'S DISEASE

2021 ◽  
Vol 160 (6) ◽  
pp. S-121
Author(s):  
Amanda M. Johnson ◽  
Maria Barsky ◽  
Waseem Ahmed ◽  
Samantha Zullow ◽  
Jonathan S. Galati ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
The Real

22 REAL-WORLD EFFECTIVENESS OF FIRST-LINE BIOLOGIC VEDOLIZUMAB IN CROHN'S DISEASE: ANALYSIS OF HIGHER TREATMENT EFFECT SUBPOPULATION FROM THE EVOLVE STUDY

2021 ◽  
Vol 160 (6) ◽  
pp. S-4
Author(s):  
Andres Yarur ◽  
Brian Bressler ◽  
Song Wang ◽  
Shashi Adsul ◽  
Pravin Kamble ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Treatment Effect ◽  
First Line ◽  
Disease Analysis

P089 REAL-WORLD EXPERIENCE: CLINICAL AND ENDOSCOPIC EFFECTIVENESS OF STANDARD VEDOLIZUMAB DOSING AND MODIFIED MAINTENANCE DOSING IN PATIENTS WITH MODERATE-SEVERE CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S75-S75
Author(s):  
Scott D Lee ◽  
Anand Singla ◽  
Caitlin Kerwin ◽  
Kindra Clark-Snustad
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Real World ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Clinical Disease ◽  
Endoscopic Remission ◽  
Starting Dose

Abstract Background Vedolizumab (VDZ) is an effective treatment for Crohn’s disease (CD); however, inadequate and loss of response is common. Pivotal VDZ trials evaluated alternative dosing intervals, demonstrating numeric but not statistical superiority in efficacy as compared to FDA-approved dosing. The safety and effectiveness of FDA-approved and modified-dosing schedules in a real-world population are unknown. We aimed to evaluate clinical and endoscopic effectiveness & safety of standard and modified maintenance VDZ dosing in a real world cohort. Methods We retrospectively reviewed CD patients (pts) treated with >3 months VDZ, assessing Harvey Bradshaw Index (HBI), Simple Endoscopic Score for Crohn’s disease (SESCD), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), C-reactive protein (CRP), albumin and hematocrit prior to and following standard VDZ dosing, and prior to and following modified VDZ maintenance dosing. We measured duration on therapy and adverse events. Results We identified 226 eligible pts, mean age 41.5 years, 55.3% female, median disease duration 10 years, 88.9% with prior biologic exposure. Mean duration on VDZ was 28.3 months. Standard VDZ dosing: 61.5% of pts with active clinical disease and adequate follow up data achieved clinical response after 3–12 months; 41.0% had clinical remission. 51.9% of pts with active endoscopic disease and adequate follow up data achieved mucosal improvement; 42.3% had endoscopic remission; 26.0% had mucosal healing after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized CRP after 3–12 months. Modified maintenance dosing: 72 non-remitters to standard VDZ dosing received modified VDZ maintenance dosing. 51.5% of pts with active clinical disease prior to starting dose modification and adequate follow up data achieved clinical response after 3–12 months of modified maintenance dosing; 42.4% had clinical remission. 22.2% of pts with SESCD ≥3 prior to starting dose modification achieved mucosal improvement after 3–24 months; 22.2% had mucosal healing. 26.7% of pts with SESCD ≥4 prior to starting modified dosing had endoscopic remission after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized their CRP after 3–12 months. Safety: 82.7% of pts reported ≥1 adverse events, most commonly infection and worsening CD symptoms. Discussion Standard VDZ dosing resulted in clinical and endoscopic improvement in pts with moderate-severe CD, with prior exposure to multiple advanced therapies. For non-remitters to standard dosing, modified VDZ maintenance dosing improved clinical disease activity in ∼50% of pts and improved endoscopic disease activity in ∼20% of pts, suggesting that for pts who did not achieve remission with standard VDZ dosing, modified VDZ dosing may result in clinical and endoscopic improvement.

scholarly journals P130 Efficacy and safety of ustekinumab in Crohn’s disease: a real-world study from the west midlands

2021 ◽  
Author(s):  
Ella Mozdiak ◽  
Muhammad Junaid Aleem ◽  
Noor Alhamamy ◽  
Harkaran Kalkat ◽  
Saskia Port ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Efficacy And Safety ◽  
The West ◽  
West Midlands

scholarly journals Exploring the Real-World Profile of Refractory and Non-Refractory Chronic Idiopathic Urticaria Patients in the US

2016 ◽  
Vol 137 (2) ◽  
pp. AB242
Author(s):  
Susan Gabriel ◽  
Meryl Mendelson ◽  
Alexander J. Gillespie ◽  
Ben Hoskin
Keyword(s):  
Real World ◽  
Chronic Idiopathic Urticaria ◽  
The Real ◽  
The Us

A real-world study focused on the effectiveness and safety of adalimumab as first-line anti-TNF treatment for paediatric Crohn's disease

2018 ◽  
Vol 88 (2) ◽  
pp. 89-99 ◽  
Author(s):  
Víctor Manuel Navas-López ◽  
Gemma Pujol-Muncunill ◽  
Enrique Llerena ◽  
María Navalón Rubio ◽  
David Gil-Ortega ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
First Line ◽  
Paediatric Crohn’S Disease
Sign in / Sign up

Export Citation Format

Share Document