Predictors and Management of Loss of Response to Vedolizumab in Inflammatory Bowel Disease

Shmidt, Eugenia; Kochhar, Gursimran; Hartke, Justin; Chilukuri, Prianka; Meserve, Joseph; Chaudrey, Khadija; Koliani-Pace, Jenna L.; Hirten, Robert; Faleck, David; Barocas, Morris; Luo, Michelle; Lasch, Karen; Boland, Brigid S.; Singh, Siddharth; Casteele, Niels Vande; Sagi, S V; Fischer, Monika; Chang, Shannon; Bohm, Matthew; Lukin, Dana J.; Sultan, Keith; Swaminath, Arun; Hudesman, David; Gupta, Nitin; Kane, Sunanda V.; Loftus, Edward V.; Sandborn, William J.; Siegel, Corey A.; Sands, Bruce E.; Colombel, Jean Fréd́eric; Shen, Bo; Dulai, Parambir S.

doi:10.1093/ibd/izy171

Cited by 54 publications

(40 citation statements)

References 20 publications

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“…Moreover, at the time of our analysis it was not possible to measure the VDZ trough level; consequently, dose intensification was based only on its clinical efficacy. In the future, the possibility of therapeutic drug monitoring will help the optimization of treatment and the more precise management of a loss of response …”

Section: Discussionmentioning

confidence: 99%

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

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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

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Section: Discussionmentioning

confidence: 99%

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

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“…Recent data from a systematic review showed estimated pooled incidence rates of LOR to VDZ of 47.9 and 39.8 per 100 person‐years of follow‐up (95% CI, 26.3‐87.0) in patients with CD and UC, respectively . This fact appears to be progressive during the maintenance phase, with cumulative rates of 20% and 35% at 6 and 12 months, respectively, showing slightly lower rates in CD than in UC (15% vs 18% at 6 months and 30% vs 39% at 12 months, respectively; P = .03) . In this setting, the strategy of VDZ intensification may restore the response to the drug, but only in around half (54%) of secondary nonresponders .…”

Section: Discussionmentioning

confidence: 99%

“…4 This fact appears to be progressive during the maintenance phase, with cumulative rates of 20% and 35% at 6 and 12 months, respectively, showing slightly lower rates in CD than in UC (15% vs 18% at 6 months and 30% vs 39% at 12 months, respectively; P = .03). 3 In this setting, the strategy of VDZ intensification may restore the response to the drug, but only in around half (54%) of secondary nonresponders. 4 This clinical scenario raises an important question concerning the medical options for patients with UC refractory to anti-integrin therapy.…”

Section: Discussionmentioning

confidence: 99%

“…It has shown to be effective in ulcerative colitis (UC) in randomized controlled trials and real‐world studies . Nevertheless, 20% to 35% of patients receiving VDZ can lose response (LOR) during the first 12 months of treatment . The intensification of VDZ can restore the response in some cases, but this strategy is only effective in approximately 54% of secondary nonresponders .…”

Section: Introductionmentioning

confidence: 99%

“…1,2 Nevertheless, 20% to 35% of patients receiving VDZ can lose response (LOR) during the first 12 months of treatment. 3 The intensification of VDZ can restore the response in some cases, but this strategy is only effective in approximately 54% of secondary nonresponders. 4 These results show that a relevant proportion of patients failing anti-integrin therapy still need alternative treatment options.…”

Section: Introductionmentioning

confidence: 99%

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The combination of granulocyte‐monocyte apheresis and vedolizumab: A new treatment option for ulcerative colitis?

Rodríguez‐Lago

Benítez

Sempere

et al. 2019

J of Clinical Apheresis

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Objectives To assess the effectiveness and safety of combining granulocyte‐monocyte apheresis (GMA) and vedolizumab (VDZ) in patients with refractory ulcerative colitis (UC). Methods This retrospective, multicentre pilot study included all UC patients receiving both GMA and VDZ. We recorded data on GMA sessions, demographic characteristics, and clinical response. Effectiveness was assessed 1 and 6 months after finishing the GMA using the partial Mayo score, C‐reactive protein, and fecal calprotectin levels. Data were also compiled on VDZ intensification, use of new immunomodulators and colectomy during follow‐up. Results Eight patients were included (mean age 46 years; 63% female; mean disease duration, 132 months; 50% E3). GMA was started after a loss of response to VDZ in all cases (25% primary nonresponse and 75% secondary loss of response). All had previously received anti‐TNF agents. VDZ was prescribed as the second‐, third‐, or fourth‐line biologic in 37%, 50%, and 13% of cases, respectively. Patients had a mean baseline partial Mayo score of 7.5 (SD 2.1) and received a median of 15 GMA sessions (range 5‐38). After a median follow‐up of 7.5 months (IQR 5‐12), partial Mayo score decreased after 1 and 6 months (P = .01 and .06, respectively). Three patients (38%) achieved steroid‐free clinical remission and five (63%) withdrew VDZ. Colectomy rate was 38%. No adverse events were observed during the combination therapy. Conclusions This small case series suggests that combining GMA with VDZ could be a treatment option in selected cases of UC with an inadequate response to this biologic agent.

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Clinical response of vedolizumab at week 6 predicted endoscopic remission at week 24 in ulcerative colitis

et al. 2021

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Background and Aim Vedolizumab is a humanized monoclonal antibody that selectively inhibits the migration of gut‐homing memory T cells into the intestinal submucosa by antagonizing the interaction of α 4 β 7 integrin with MAdCAM‐1. Vedolizumab is employed for ulcerative colitis with moderate to severe activity; however, predictors of its clinical efficacy have not been established in real‐world clinical practice. We investigated the clinical characteristics predicting vedolizumab efficacy. Methods This was a single‐center, retrospective, observational study that enrolled patients with ulcerative colitis at Kyorin University Hospital. Fifty‐two consecutive patients who started vedolizumab induction therapy and were tracked for minimum 14 weeks between August 2018 and February 2021 were included. Clinical and endoscopic disease activities were scored at baseline and at weeks 2, 6, and 14 with the Lichtiger index and at baseline and week 24 with the Mayo endoscopic subscore, respectively. Clinical remission, clinical response, and endoscopic remission were defined as Lichtiger index of ≤3, Lichtiger index of ≤10 with a reduction of minimum 3 points from baseline, and Mayo endoscopic subscore of ≤1, respectively. Results In these cases, clinical response/remission rates at weeks 2, 6, and 14 were 26.9%/15.3%, 50.0%/46.3%, and 57.6%/50.0%, respectively. The endoscopic remission rate at week 24 was 60%. The clinical response at week 6 was significantly associated with endoscopic remission at week 24 after starting vedolizumab. Conclusions In vedolizumab treatment for ulcerative colitis, the clinical response at week 6 can be a predictor for endoscopic remission at week 24.

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Predictors and Management of Loss of Response to Vedolizumab in Inflammatory Bowel Disease

Abstract: LOR to a TNF antagonist before VDZ use and higher baseline C-reactive protein are important predictors of VDZ LOR. Treatment response can be recaptured in almost half of these patients with VDZ infusion interval shortening.

Cited by 54 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

The combination of granulocyte‐monocyte apheresis and vedolizumab: A new treatment option for ulcerative colitis?

Clinical response of vedolizumab at week 6 predicted endoscopic remission at week 24 in ulcerative colitis

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