P397 Effectiveness of vedolizumab (VDZ) for the induction of remission in inflammatory bowel disease (IBD): Results from the Spanish Eneida Registry

Chaparro, María; Garre, Ana; Alfaro, Ignacio; Iborra, Marisa; Mesonero, P; Mendoza, Isabel Vera; Rodríguez, A; Miquel-Cusachs, J O; Riestra, Sabino; Navarro, Pablo; Parga, L De Castro; González‐Muñoza, Carlos; Rivero, Montserrat; Mañosa, Míriam; Salazar, Luis Fernández; Jiménez, Nuria; Guardiola, Jordi; Cabriada, José Luis; Casbas, Ana Gutiérrez; Sicilia, B; Calle, José Lázaro Pérez; Piqueras, Marta; Algaba, Alicia; Roncero, Óscar; Bargalló, Ana; Sainz, Empar; Barrio, Jesús; Calvet, Xavier; García, A. Delgado; Barrio, Mónica Llorente; Poyatos, R Llorente; Almela, Pedro; Madrigal, R; Villarín, Alfredo José Lucendo; Pajares, Ramón; Domselaar, Manuel Van; Gil, Jerzy; Gisbert, Javier P.

doi:10.1093/ecco-jcc/jjx180.524

Journal of Crohn's and Colitis

2018

DOI: 10.1093/ecco-jcc/jjx180.524

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P397 Effectiveness of vedolizumab (VDZ) for the induction of remission in inflammatory bowel disease (IBD): Results from the Spanish Eneida Registry

María Chaparro

Ana Garre

Ignacio Alfaro

et al.

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“…In Scotland, 340 patients (203 CD and 137 UC) experienced lower hospitalization rates and steroid usage associated with vedolizumab treatment . In Spain, a study of 274 patients (144 CD and 130 UC) identified that vedolizumab was more likely to be effective in UC than CD, if the patients were anti‐tumor necrosis factor naïve and if they had mild or moderate disease, instead of severe disease . In Ireland, a study of 39 UC patients treated with vedolizumab resulted in clinical response rates of 47% at 3 months and 46% at 6 months .…”

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Real‐world evidence for vedolizumab: Understanding the landscape

Lawrance

Pulusu

2018

J of Gastro and Hepatol

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Vedolizumab is a monoclonal antibody that selectively inhibits the migration of α4-β7 positive inflammatory cells to the gastrointestinal tract. In the GEMINI 1 randomized double-blinded placebo-controlled trial of vedolizumab in ulcerative colitis (UC), the response rate was 47.1% at week six and, for patients receiving vedolizumab every 8 weeks, 56.6% at week 52. Of interest, however, is that despite a clinical remission rate of 16.9% at week six there was a mucosal healing rate of 40.9% at the same time point. Again, after 52 weeks of treatment, 41.8% of patients were in clinical remission, but 51.6% had complete mucosal healing. These findings suggest that symptoms of post-inflammatory irritability of the bowel may reduce the perceived clinical response rates. 1 In the GEMINI 2 randomized double-blind placebo-controlled trial of vedolizumab in Crohn's disease (CD), the remission rate was 14.5% at week six and 39% at week 52 with 8-weekly vedolizumab treatment. 2 Since the pivotal Phase III studies, there have been several publications from various centers that have collected real-life data for the management of UC and CD with vedolizumab. A systematic pooled analysis of nine studies that included 1565 (571 UC and 994 CD) adult patients with inflammatory bowel disease identified that in CD, vedolizumab achieved a 54% clinical response and 22% remission at week six and 49% responded and 32% were in remission by week 14. This was similar to the findings at week 52 where 45% of patients were responding and 32% were in clinical remission. In UC, vedolizumab achieved a 43% clinical response and 25% remission at week six and 51% responded and 30% were in remission by week 14. This was similar to the findings at week 52 where 48% of patients were responding and 39% were in clinical remission. 3 What appear to be better findings, however, were seen in a retrospective study of 27 centers from Finland that included 247 patients (139 UC and 108 CD), in which clinical remission was achieved at 6 months in 42% of treatment persistent patients with CD and 73% of treatment persistent patients with UC. 4 More recently, there have been numerous abstracts presented from many countries around the world. From the Netherlands, endoscopic response to vedolizumab therapy was observed in 8/15 (47%) patients with CD and 9/11 (82%) patients with UC, but the clinical remission rates were < 50% in both CD and UC. 5 In Scotland, 340 patients (203 CD and 137 UC) experienced lower hospitalization rates and steroid usage associated with vedolizumab treatment. 6 In Spain, a study of 274 patients (144 CD and 130 UC) identified that vedolizumab was more likely to be effective in UC than CD, if the patients were anti-tumor necrosis factor naïve and if they had mild or moderate disease, instead of severe disease. 7 In Ireland, a study of 39 UC patients treated with vedolizumab resulted in clinical response rates of 47% at 3 months and 46% at 6 months. 8 In Canada, endoscopic remission was 41% at 6 months and 48% at 12 months in UC, while clinical...

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confidence: 99%

Real‐world evidence for vedolizumab: Understanding the landscape

Lawrance

Pulusu

2018

J of Gastro and Hepatol

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P397 Effectiveness of vedolizumab (VDZ) for the induction of remission in inflammatory bowel disease (IBD): Results from the Spanish Eneida Registry

Cited by 1 publication

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Real‐world evidence for vedolizumab: Understanding the landscape

Real‐world evidence for vedolizumab: Understanding the landscape

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