Translating Results from VARSITY to Real World: Adalimumab vs Vedolizumab as First-line Biological in Moderate to Severe IBD

2021 ◽  
Author(s):  
Annick Moens ◽  
Bram Verstockt ◽  
Dahham Alsoud ◽  
João Sabino ◽  
Marc Ferrante ◽  
...  
Keyword(s):  
Real World ◽  
Severe Disease ◽  
First Line ◽  
Treatment Persistence ◽  
First Line Therapy ◽  
Mayo Score ◽  
Therapy Initiation ◽  
Real World Setting ◽  
Line Therapy ◽  
Endoscopic Remission

Abstract Background Selecting a first-line therapy remains challenging in IBD. Adalimumab (ADM) and vedolizumab (VDZ) effectively lead to endoscopic remission in moderate to severe IBD. The VARSITY trial showed superiority of VDZ over ADM in ulcerative colitis (UC) regarding clinical remission and endoscopic improvement at week 52. We explored these results in a real-world setting of UC and Crohn’s disease (CD). Methods This retrospective study followed a cohort of biologic-naïve patients starting ADM or VDZ from 2015-2019. Patients had moderate to severe disease (endoscopic Mayo score ≥2 for UC, presence of ulcerations for CD) prior to therapy initiation. For UC, endoscopic remission (endoscopic Mayo score 0) and improvement (endoscopic Mayo score ≤1) at week 52 were assessed. For CD, endoscopic remission (absence of ulcerations) and improvement (markedly better endoscopy despite ulcerations) at weeks 26-52 were studied. Treatment persistence was also evaluated. Results In total, 195 biologic-naïve patients (109 UC; 86 CD) were included. In UC, VDZ was superior to ADM regarding endoscopic remission (29% vs 11%, P = .03), endoscopic improvement (51% vs 26%, P = .01) at week 52, and treatment persistence (P = .04). In CD, no differences in endoscopic remission (VDZ 48% vs ADM 60%; P=0.37), improvement (VDZ 76% vs ADM 77%; P = 1.00), or treatment persistence (P=0.43) at weeks 26-52 were seen. Safety profiles were similar in UC and CD. Conclusions This real-world cohort study of biologic-naïve IBD patients found VDZ to be superior to ADM as first-line treatment for patients with UC—but not CD—regarding endoscopic remission at week 52 and treatment persistence.

scholarly journals P309 Are results from VARSITY applicable to real world? Adalimumab versus vedolizumab as first line biological in moderate-to-severe IBD

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S336-S337
Author(s):  
A Moens ◽  
B Verstockt ◽  
D Alsoud ◽  
J Sabino ◽  
M Ferrante ◽  
...  
Keyword(s):  
Real World ◽  
Missing Values ◽  
Severe Disease ◽  
Binary Outcomes ◽  
First Line ◽  
Treatment Persistence ◽  
Treatment Groups ◽  
First Line Therapy ◽  
Endoscopic Remission

Abstract Background Therapeutic options in IBD are rapidly growing, causing new challenges including choice of first line therapy. Both adalimumab (ADM) and vedolizumab (VDZ) are effective at inducing and maintaining endoscopic remission in moderate-to-severe IBD. The VARSITY trial (Sands et al NEJM 2019) showed superiority of VDZ over ADM in achieving clinical remission and endoscopic improvement at W52 in UC patients. Our aim was to explore if these results withstand in a real world setting of UC patients, and if they are also valid in CD. Methods This retrospective cohort study included adult, biological-naive IBD patients starting ADM or VDZ between 2015-2019 in our referral IBD centre. Patients had moderate-to-severe disease (endoscopic Mayo sub score ≥ 2 for UC, presence of ulcerations for CD) prior to start of therapy. For UC, we assessed endoscopic remission (endoscopic Mayo sub score 0) and improvement (endoscopic Mayo sub score ≤ 1) at W52. For CD, we assessed endoscopic remission (absence of ulcerations) and improvement (markedly better endoscopy despite still presence of ulcerations) at weeks 26-52. Missing values were imputed as nonresponses for binary outcomes, and last-observation carried-forward was used for continuous outcomes. Results A total of 109 UC and 86 CD patients were included (Table 1). Endoscopic remission at W52 was significantly better for VDZ than ADM in UC (35% vs 15%, p=0.03), and also endoscopic improvement was numerically, yet not significantly, better for VDZ than ADM (56% vs 37%, p=0.08). At baseline, 23 UC patients (50%) in the ADM group and 40 (63%) in the VDZ group were on steroids. By W52, 83% and 78% (p=0.75) of UC patients respectively could discontinue steroids and steroid-free endoscopic remission was not different between groups (ADM: 22% vs VDZ: 23%, p=1.00). For CD patients, similar endoscopic remission (60% vs 48%, p=0.37) and improvement (77% vs 79%, p=1.00) rates at weeks 26-52 were seen between ADM and VDZ. Twenty-five (47%) CD patients in the ADM and 16 (48%) in the VDZ group were on steroids at baseline, and 88% of them in both groups could successfully stop steroids by W52. Again, no difference in steroid-free endoscopic remission was seen between ADM (56%) and VDZ (31%) treated CD patients (p=0.20). At the end of follow-up [81 (27-157) weeks], the rates of treatment persistence were significantly different between ADM and VDZ treatment groups in UC patients, though not in CD patients (Figure 1). Conclusion In a real-world cohort of bio-naive UC patients, VDZ was superior to ADM in achieving endoscopic remission at W52, while in bio-naive CD patients VDZ and ADM resulted in similar endoscopic outcomes.

scholarly journals Is There Still a Role for Endocrine Therapy Alone in HR+/HER2– Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies

Breast Care ◽  
2019 ◽  
Vol 15 (1) ◽  
pp. 30-37
Author(s):  
Marina Elena Cazzaniga ◽  
Claudio Verusio ◽  
Mariangela Ciccarese ◽  
Alberto Fumagalli ◽  
Donata Sartori ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Median Duration ◽  
Real World ◽  
Advanced Breast ◽  
Data Sets ◽  
First Line ◽  
First Line Therapy ◽  
Real World Setting ◽  
Line Therapy

Background: Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting. Methods: For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies). Results: Eighty-one and 91 patients have been identified from the two data sets. The median age was 63 years (range 35–82) for the EVA and 57.8 years (range 35.0–82.3) for the AMBRA patients. ORRs were 23.5 and 24.3% in the whole population, 26.9% in the patients with bone only, and 21.8 and 21.4% in those with visceral metastases. The median duration of HD-FUL was 11.6 months (range 1–48) and 12.4 months (range 2.9–70.0) in the two data sets, respectively. Conclusion: These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients.

Overall survival and treatment patterns among real-world patients with locally advanced or metastatic urothelial carcinoma treated with first-line therapy.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 464-464
Author(s):  
Jason C Simeone ◽  
Beth L Nordstrom ◽  
Ketan Patel ◽  
Alyssa B Klein ◽  
Laura Horne
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Locally Advanced ◽  
First Line ◽  
First Line Therapy ◽  
Real World Setting ◽  
Line Therapy ◽  
Platinum Based Chemotherapy ◽  
Metastatic Urothelial Carcinoma

464 Background: Although platinum-based chemotherapy has been the standard of care for the treatment of locally advanced or metastatic urothelial carcinoma (UC), overall survival (OS) remains poor. Real world data on the treatment patterns for UC and effectiveness of these treatments are limited. Methods: Patients with locally advanced or metastatic UC who received first line therapy were identified from the Flatiron Oncology electronic medical record database from 2011–2016; patients who previously received immunotherapy treatment were excluded. Treatment characteristics included the most frequently administered first-line regimens in the study cohort and the time from advanced/metastatic diagnosis to start of first-line therapy. Median OS from the start of first-line therapy was calculated using Kaplan-Meier curves and 95% confidence intervals (CI) are presented. Results: Of 1,811 included patients who met study inclusion and exclusion criteria, the mean age was 70.4 ± 9.5 years, and 73.2% were male. Fewer than 3% of patients were tested for PD-L1 during follow-up. Platinum-based chemotherapy was the most commonly prescribed first-line treatment and immunotherapy was used in 1.3% of first-line regimens (Table 1); patients received a median of one treatment line during follow-up. The median OS was 12.7 months (95% CI: 11.8–13.5) from initiation of first-line therapy. Conclusions: Overall survival among locally advanced/metastatic UC patients who received first-line therapy in a real-world setting was approximately one year. As immunotherapy treatment for UC becomes more common, the impact on OS in the real world setting remains to be seen. [Table: see text]

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