Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort

Bamias, Giorgos; Kokkotis, Georgios; Gizis, Michalis; Kapizioni, Christina; Karmiris, Konstantinos; Koureta, Evgenia; Kyriakos, Nikolaos; Leonidakis, Georgios; Makris, Konstantinos; Markopoulos, Panagiotis; Michalopoulos, Georgios; Michopoulos, Spyridon; Papaconstantinou, Ioannis; Polymeros, Dimitrios; Siakavellas, Spyros I.; Triantafyllou, Konstantinos; Tsironi, Eftychia; Tsoukali, Emmanouela; Tzouvala, Maria; Viazis, Nikos; Xourafas, V.; Zacharopoulou, Eirini; Zampeli, Evanthia; Zografos, Konstantinos G.; Papatheodoridis, George; Mantzaris, Gerasimos

doi:10.1007/s10620-021-06907-5

Cited by 8 publications

(6 citation statements)

References 31 publications

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“…Furthermore, an association of elevated inflammatory markers with lower rates of clinical response and remission has also been described[ 13 - 15 , 24 - 26 ]. A post-hoc analysis of the GEMINI trials reported higher rates of rates of induction and maintenance of clinical remission among TNF antagonist naïve patients[ 27 , 28 ] which has been confirmed by real world trials[ 17 , 21 , 23 , 26 , 29 - 32 ]. Patients who achieve early response to vedolizumab also appear to be more likely to have a long-term response[ 15 , 16 , 30 , 33 , 34 ].…”

Section: Resultsmentioning

confidence: 81%

Approach to loss of response to advanced therapies in inflammatory bowel disease

Vootukuru,

Vasudevan

2024

World J Gastroenterol

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BACKGROUND Remarkable progress over the last decade has equipped clinicians with many options in the treatment of inflammatory bowel disease. Clinicians now have the unique opportunity to provide individualized treatment that can achieve and sustain remission in many patients. However, issues of primary non-response (PNR) and secondary loss of response (SLOR) to non-tumour necrosis factor inhibitor (TNFi) therapies remains a common problem. Specific issues include the choice of optimization of therapy, identifying when dose optimization will recapture response, establishing optimal dose for escalation and when to switch therapy. AIM To explores the issues of PNR and SLOR to non-TNFi therapies. METHODS This review explores the current evidence and literature to elucidate management options in cases of PNR/SLOR. It will also explore potential predictors for response following SLOR/PNR to therapies including the role of therapeutic drug monitoring (TDM). RESULTS In the setting of PNR and loss of response to alpha-beta7-integrin inhibitors and interleukin (IL)-12 and IL-23 inhibitors dose optimization is a reasonable option to capture response. For Janus kinase inhibitors dose optimization can be utilized to recapture response with loss of response. CONCLUSION The role of TDM in the setting of advanced non-TNFi therapies to identify patients who require dose optimization and as a predictor for clinical remission is not yet established and this remains an area that should be addressed in the future.

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Section: Resultsmentioning

confidence: 81%

Approach to loss of response to advanced therapies in inflammatory bowel disease

Vootukuru,

Vasudevan

2024

World J Gastroenterol

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“…Among the 63 publications, 10‐72 58 were journal articles and 5 were international conference abstracts. Two conference abstracts 71,72 were replaced by subsequent published articles found in our search.…”

Section: Resultsmentioning

confidence: 99%

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

Yiu,

Ko,

Pudipeddi

et al. 2024

Aliment Pharmacol Ther

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SummaryBackgroundThe expanding options in advanced therapies for ulcerative colitis (UC) and Crohn's disease (CD) present challenges in treatment selection. Persistence analysis assesses drug durability in real‐world settings, acting as a surrogate marker for medication efficacy and tolerance. Unlike traditional comparative studies, persistence analysis provides insights extending beyond the initial year of treatment.AimTo provide real‐world evidence on treatment effectiveness, tolerability and preferences of physicians and patients regarding various advanced therapies for IBD.MethodsWe conducted a systematic review of observational studies up to March 2023 assessing advanced therapies' persistence in UC and CD. Advanced therapies under examination included infliximab, adalimumab, vedolizumab, ustekinumab, golimumab, certolizumab and tofacitinib. We pooled the persistence of each agent and conducted a meta‐analysis to compare the persistence of newer agents with traditional TNF inhibitors (TNFi)—specifically infliximab and adalimumab.ResultsAmong 63 observational studies, vedolizumab had the highest 1‐year persistence in UC (73.8%, 95% CI: 70.0%–77.6%) and ustekinumab in CD (77.5%, 95% CI: 72.9%–82.1%). Compared to TNFi, vedolizumab demonstrated increased persistence with a relative risk (RR) of 1.30 (95% CI: 1.19–1.41) for UC and 1.14 (95% CI: 1.09–1.20) for CD at 1 year, while ustekinumab demonstrated a RR of 1.15 (95% CI: 1.07–1.23) for CD at 1 year. Vedolizumab exhibited sustained increased persistence in UC over 2 years compared to TNFi (RR: 1.33, 95% CI 1.14–1.54).ConclusionThis meta‐analysis highlights the superior persistence of ustekinumab and vedolizumab over TNFi, and offers valuable insights for clinicians navigating the challenging landscape of UC and CD therapeutic choices.

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“…[1][2][3] VDZ may be another alternative therapy for patients with moderate-to-severe UC, including those who have lost response to conventional drugs or anti-TNF agents. [9] Six studies [22][23][24][25][26][27] in non-Asian countries evaluated the efficacy of VDZ at 6 to 14 weeks, with clinical response proportions of 58% to 75% and clinical remission proportions of 31% to 56%. With regard to long-term efficacy, the proportions of clinical response were 52% to 75% and clinical remission were 38% to 61% at 6 to 12 months.…”

Section: Discussionmentioning

confidence: 99%

“…With regard to long-term efficacy, the proportions of clinical response were 52% to 75% and clinical remission were 38% to 61% at 6 to 12 months. [22][23][24][25]27] However, the genetic profile of Asian UC patients is different from that of Western populations. [13] Only a few studies from Asian countries have reported the efficacy and safety of VDZ in the real-world.…”

Section: Discussionmentioning

confidence: 99%

Real-life effectiveness and safety of vedolizumab in moderate-to-severe ulcerative colitis: A single-center experience in Northern China

Yan,

Ding,

et al. 2024

Medicine

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Vedolizumab (VDZ), a monoclonal antibody to α4β7 integrin, is available for patients with moderate-to-severe ulcerative colitis (UC). This study planned to assess the real-world effectiveness and safety of VDZ for UC patients in Northern China. We enrolled patients with moderate-to-severe UC who underwent VDZ induction therapy from March 2021 to November 2022 at the Affiliated Hospital of Qingdao University. The primary outcome was clinical remission at weeks 14 and 52 after the initial VDZ therapy. Overall adverse events and risk factors associated with loss of response (LOR) were also evaluated. Seventy-three UC patients receiving VDZ therapy were included in this study. The rates of clinical response, clinical remission, and steroid-free clinical remission were 69.9%, 39.7%, and 34.2% at week 14 and 90.5%, 66.7%, and 64.4% at week 52, respectively. The mucosal remission rates were 37.5% (18/48) at week 14 ± 8 and 27.3% (9/33) at week 52 ± 16, while only 2 and 3 patients achieved mucosal healing at weeks 14 ± 8 and 52 ± 16, respectively. Of the UC patients, 23.3% experienced adverse events associated with VDZ, most of which were mild and self-limiting. Until the last follow-up, 37 of 73 UC patients experienced LOR during the maintenance period. Patients with a higher ulcerative colitis endoscopic severity index (UCEIS), partial Mayo scores (PMS), or hemoglobin below 120 g/L at baseline were more likely to experience LOR after VDZ induction therapy. VDZ is an effective and safe agent for patients with moderate-to-severe UC in Northern China. A high baseline UCEIS, PMS, or hemoglobin < 120 g/L may be an independent risk factor for LOR during the maintenance period.

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Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort

Cited by 8 publications

References 31 publications

Approach to loss of response to advanced therapies in inflammatory bowel disease

Approach to loss of response to advanced therapies in inflammatory bowel disease

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

Real-life effectiveness and safety of vedolizumab in moderate-to-severe ulcerative colitis: A single-center experience in Northern China

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