The real-world effectiveness of vedolizumab on intestinal and articular outcomes in inflammatory bowel diseases

Macaluso, Fabio Salvatore; Orlando, R.; Fries, Walter; Scolaro, M; Magnano, Antonio; Pluchino, Dario; Cappello, Maria; Morreale, Gaetano Cristian; Siringo, S.; Privitera, Antonino Carlo; Ferracane, Concetta; Belluardo, Nunzio; Alberghina, Nadia; Ventimiglia, Marco; Rizzuto, G.; Renna, Sara; Cottone, Mario; Orlando, Ambrogio

doi:10.1016/j.dld.2018.02.013

Cited by 40 publications

(33 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Some studies have shown better treatment outcomes in biologic‐naive patients . In our analysis, being naive or experienced with anti‐TNF was not a significant predictor of response, and this has also been reported in other real‐life settings …”

Section: Discussionsupporting

confidence: 82%

“…The same results were shown by Kopylov et al with similar rates of response and remission both for CD and UC. Other authors found no difference in CD and UC cohorts after the induction phase, while in one study a higher clinical benefit in patients with UC was seen, with a cumulative clinical remission plus response rate after 14 weeks of 91.2% in UC and 78.5% in CD ( P = 0.02). Again, at 52 weeks the trend of the response in our study was favorable to CD patients despite a lack of statistical significance; in other real‐life studies, the two groups were comparable or there were higher response rates in UC .…”

Section: Discussionmentioning

confidence: 90%

“…Considering the highly selective character of trial enrollment, it is always fundamental to observe whether real‐life settings support the initially reported results of a new drug . Real‐world publications on this field are accumulating, with some conflicting results, but only a few of them include long‐term evaluation at 1 year with endoscopic assessment . Therefore, we presented an Italian single‐center study on VDZ long‐standing effectiveness and tolerability in patients with UC and CD at a tertiary referral setting.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Dragoni

Bagnoli

Grazie

et al. 2019

J of Digest Diseases

View full text Add to dashboard Cite

Objective: The study aimed to evaluate the long-term efficacy and safety of vedolizumab in a real-life cohort of patients with inflammatory bowel diseases enrolled at a tertiary referral center.The primary outcomes were clinical response and remission at 14, 24, and 52 weeks, and steroid-free remission rate (SFRR) at 52 weeks. Endoscopic response and remission rates at 52 weeks were the secondary outcomes. Results: Altogether 49 patients (22 with ulcerating colitis [UC] and 27 with Crohn'sDisease [CD]) were enrolled. The clinical response rate gradually dropped from 85% and 50% in CD and UC, respectively, at week 14 to 59% and 25% at week 52, with significantly a higher response in CD at week 14. The endoscopic response at week 52 was 55% in CD and 25% in UC (P = 0.21). CD group had a higher SFRR than UC group (41% vs 20%) at 52 weeks, although the difference was not statistically significant. Similar clinical and endoscopic rates were observed in biologic-naive and -experienced patients. We reported no discontinuation due to adverse drug reactions, and only mild to moderate events.Conclusions: In our cohort the clinical response in the induction phase was similar to those of registered trials, despite surprising better results for CD. During the maintenance phase we observed an higher drop out than in the reported literatures. Of note, its good safety profile makes vedolizumab a reliable choice in patients with contraindications to anti-tumor necrosis factor agents. K E Y W O R D Sadverse event, anti-integrin, endoscopic remission, inflammatory bowel diseases, maintenance, swap therapy

show abstract

Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 90%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Dragoni

Bagnoli

Grazie

et al. 2019

J of Digest Diseases

View full text Add to dashboard Cite

show abstract

“…Very recently, real-world data on the effectiveness of vedolizumab on gut and articular symptoms in 163 patients with IBD were reported by an Italian group[ 22 ] (Table 2 ). Steroid-free remission was observed in 71 (43.6%; UC: 45.6%, CD: 41.7%) and 29 (40.8%; UC: 40.0 %, CD: 41.7%) patients at weeks 10 and 22, respectively.…”

Section: Effectiveness Of Vedolizumab In Patients With Ibd From Real-mentioning

confidence: 99%

Vedolizumab for inflammatory bowel disease: From randomized controlled trials to real-life evidence

Scribano

2018

WJG

View full text Add to dashboard Cite

The biologic antitumor necrosis factor alpha (anti-TNFα) agents have revolutionised the treatment of inflammatory bowel disease (IBD). However, some patients experience primary nonresponse, loss of response, or intolerance. Therefore, introducing a newer class of therapy with a mechanism of action that acts on different inflammatory pathways involved in IBD pathogenesis is appealing. Vedolizumab is a fully humanised monoclonal antibody that selectively targets α4β7 integrin. Based on the results of the pivotal clinical GEMINI trials, vedolizumab was approved for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) refractory or intolerant to either conventional therapy or TNFα inhibitors. This review describes the efficacy, safety, and tolerability of vedolizumab reported in both randomized, controlled, clinical trials and from real-world experience in patients with UC and CD in order to identify its place in treatment algorithms for IBD.

show abstract

“…In contrast, similar to our data, a recent Italian real-life study from Macaluso et al . 14 described a similar percentage of clinical benefit: 64.3% and 68.4% at week 10, and 55.6% and 54.3% at week 22 in CD and UC, respectively. Our results, in terms of endoscopy response, were higher than those of two recent prospective studies evaluating the efficacy of VDZ in CD.…”

Section: Discussionmentioning

confidence: 68%

Good efficacy and safety of vedolizumab in Crohn’s disease and ulcerative colitis in a real-world scenario

Zingone

Barberio

Compostella

et al. 2020

Therap Adv Gastroenterol

View full text Add to dashboard Cite

Background: Data on vedolizumab (VDZ) use in inflammatory bowel disease (IBD) patients are still limited. We aimed to assess the effectiveness and tolerability of VDZ in a real-life clinical scenario. Methods: We retrospectively collected data of all consecutive IBD patients who started VDZ from September 2016 to December 2018 at our IBD Unit of the University Hospital of Padua and strictly followed them for 1 year. Clinical benefit (rate of clinical steroid-free remission plus clinical response), endoscopic and histological responses were evaluated over 1 year. Results: A total of 117 patients who started VDZ for Crohn’s disease (CD) and ulcerative colitis (UC) were included in the main analysis (69 CD patients, 48 UC patients). We obtained a clinical benefit in 68.1%, 68.1% and 59.4% of CD patients and in 68.7%, 54.2% and 54.1% of UC patients after induction, and at 30 weeks and 52 weeks, respectively. After 1 year, endoscopy response was observed in 47% of CD and 38.2% of UC patients, while the histological response was 19.6% and 23.5%, respectively. Finally, we found that 20.5% of patients needed treatment optimization, with 33.3% of them failing to respond despite this action. No deaths or serious adverse events requiring hospitalization were observed. The main cause of VDZ interruption was drug inefficacy. During the study, two patients developed new spondylarthritis, and two had a worsening of pre-existing arthralgia. Conclusion: Vedolizumab resulted in being effective and safe in CD as well as in UC patients.

show abstract

The real-world effectiveness of vedolizumab on intestinal and articular outcomes in inflammatory bowel diseases

Cited by 40 publications

References 20 publications

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Vedolizumab for inflammatory bowel disease: From randomized controlled trials to real-life evidence

Good efficacy and safety of vedolizumab in Crohn’s disease and ulcerative colitis in a real-world scenario

Contact Info

Product

Resources

About