Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists

Feagan, Brian G.; Rubin, David T.; Danese, Silvio; Vermeire, Séverine; Abhyankar, Brihad; Sankoh, Serap; James, Alexandra; Smyth, Michael

doi:10.1016/j.cgh.2016.08.044

Cited by 179 publications

(171 citation statements)

References 37 publications

(41 reference statements)

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“…They consistently showed benefit from vedolizumab treatment in the induction and maintenance of clinical response and remission in both anti‐TNF failure and anti‐TNF naïve patients, in comparison with placebo. Authors observed that the rates of response and remission were higher in CD patients not exposed to anti‐TNF agents than in patients who had anti‐TNF failure . These higher rates persisted at week 52.…”

Section: Discussionmentioning

confidence: 99%

“…A question arises about the impact of previous exposure to anti‐TNF drugs on vedolizumab efficacy. Two post hoc analyses from the GEMINI studies evaluated the efficacy of vedolizumab in CD and UC based on prior anti‐TNF exposure . They consistently showed benefit from vedolizumab treatment in the induction and maintenance of clinical response and remission in both anti‐TNF failure and anti‐TNF naïve patients, in comparison with placebo.…”

Section: Discussionmentioning

confidence: 99%

“…Authors observed that the rates of response and remission were higher in CD patients not exposed to anti-TNF agents than in patients who had anti-TNF failure. 25 These higher rates persisted at week 52. The same results were found in UC: patients naïve to anti-TNF had higher rates of response (absolute difference: 15.5%), compared to placebo at week 6, than patients with anti-TNF failure (absolute difference: 7%), whereas during maintenance treatment, the absolute differences with placebo were the same in both groups.…”

Section: Safetymentioning

confidence: 94%

“…Two post hoc analyses from the GEMINI studies evaluated the efficacy of vedolizumab in CD and UC based on prior anti-TNF exposure. 7,25 They consistently showed benefit from vedolizumab treatment in the induction and maintenance of clinical response and remission in both anti-TNF failure and anti-TNF naïve patients, in comparison with placebo. Authors observed that the rates of response and remission were higher in CD patients not exposed to anti-TNF agents than in patients who had anti-TNF failure.…”

Section: Safetymentioning

confidence: 97%

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Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Chaparro¹,

Garre²,

Ricart³

et al. 2018

Aliment Pharmacol Ther

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Summary Background Effectiveness of vedolizumab in real world clinical practice is unknown. Aim To evaluate the short and long‐term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). Methods Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey‐Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short‐term response was assessed at week 14. Variables associated with short‐term remission were identified by logistic regression analysis. The Kaplan‐Meier method was used to evaluate the long‐term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response. Results 521 patients were included (median follow‐up 10 months [interquartile range 5‐18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient‐year of follow‐up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent. Conclusions Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short‐ and long‐term response. Vedolizumab seems to be safe in clinical practice.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Safetymentioning

confidence: 94%

Section: Safetymentioning

confidence: 97%

See 2 more Smart Citations

Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Chaparro¹,

Garre²,

Ricart³

et al. 2018

Aliment Pharmacol Ther

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“…In the subanalysis focusing on the type of IMM, the median TLs were not influenced, irrespective of the IMM, methotrexate or thiopurin. At week 2, the median TLs were measured at 29 (24.5-37) and 30 (24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36) µg/ml with thiopurin and methotrexate, respectively (P = 0.6). At week 6, the median TLs were measured at 27 (17.5-38.5) and 22 (16.3-37.5) µg/ml with thiopurin and methotrexate, respectively (P = 0.6).…”

Section: Impact Of Immunomodulator On Vedolizumab Trough Level At Indmentioning

confidence: 99%

Early vedolizumab trough levels at induction in inflammatory bowel disease patients with treatment failure during maintenance

Liefferinckx

Minsart

Cremer

et al. 2019

European Journal of Gastroenterology &Amp; Hepatology

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Background Vedolizumab (VDZ) is effective as an induction and maintenance treatment for Crohn's disease and ulcerative colitis, but, as observed with antitumour necrosis factor-α (anti-TNFα) agents, some patients are nonetheless experiencing loss of response.Objective The aim of this study was to investigate the impact of the pharmacokinetics of VDZ during induction on long-term treatment response. Patients and methods This study focused on a single cohort of 103 inflammatory bowel disease patients treated with VDZ. VDZ trough levels (TLs) were measured by enzyme-linked immunosorbent assay (n = 536 samples), and thereafter correlated to clinical, biological, endoscopic and serological data. For patients exposed previously to infliximab, antibodies to infliximab were measured at baseline. On the basis of the outcome at the end of follow-up, patients were then categorized into long-term response, optimized and treatment failure groups. Results During VDZ induction, at week 6, inflammatory bowel disease patients with long-term response had higher TLs compared with patients in the treatment failure group (33 vs. 24 µg/ml, P = 0.02). A cut-off TL of 28 µg/ml predicted a sustained response in the follow-up with an area under curve of 0.723 (95% confidence interval = 0.567-0.878, P = 0.02). Patients with mucosal healing in maintenance had higher TLs at week 6 (41.65 µg/ml) compared with patients with mild (26 µg/ml) or severe endoscopic activity (20.8 µg/ml), P = 0.009. Positive perinuclear antineutrophil cytoplasmic antibody serology was associated with lower TLs. Patients previously exposed to anti-TNFα had lower TLs than naive patients (22.5 vs. 36 µg/ml, P = 0.03) without any impact of detectable antibodies to infliximab. Finally, the presence of an immunomodulator at induction did not impact on VDZ TLs at induction. Conclusion We confirmed that a drug exposure-efficacy association was found early on at induction. This study emphasizes that previous exposure to anti-TNFα and positive perinuclear antineutrophil cytoplasmic antibody serology are important factors influencing VDZ TLs at induction. Eur J Gastroenterol Hepatol 31:478-485

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Risankizumab for Ulcerative Colitis

Louis,

Schreiber,

Panaccione

et al. 2024

JAMA

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ImportanceThe clinical effects of risankizumab (a monoclonal antibody that selectively targets the p19 subunit of IL-23) for the treatment of ulcerative colitis are unknown.ObjectiveTo evaluate the efficacy and safety of risankizumab when administered as an induction and a maintenance therapy for patients with ulcerative colitis.Design, Setting, and ParticipantsTwo phase 3 randomized clinical trials were conducted. The induction trial was conducted at 261 clinical centers (in 41 countries) and enrolled 977 patients from November 5, 2020, to August 4, 2022 (final follow-up on May 16, 2023). The maintenance trial was conducted at 238 clinical centers (in 37 countries) and enrolled 754 patients from August 28, 2018, to March 30, 2022 (final follow-up on April 11, 2023). Eligible patients had moderately to severely active ulcerative colitis; a history of intolerance or inadequate response to 1 or more conventional therapies, advanced therapies, or both types of therapies; and no prior exposure to risankizumab.InterventionsFor the induction trial, patients were randomized 2:1 to receive 1200 mg of risankizumab or placebo administered intravenously at weeks 0, 4, and 8. For the maintenance trial, patients with a clinical response (determined using the adapted Mayo score) after intravenous treatment with risankizumab were randomized 1:1:1 to receive subcutaneous treatment with 180 mg or 360 mg of risankizumab or placebo (no longer receiving risankizumab) every 8 weeks for 52 weeks.Main Outcomes and MeasuresThe primary outcome was clinical remission (stool frequency score ≤1 and not greater than baseline, rectal bleeding score of 0, and endoscopic subscore ≤1 without friability) at week 12 for the induction trial and at week 52 for the maintenance trial.ResultsAmong the 975 patients analyzed in the induction trial (aged 42.1 [SD, 13.8] years; 586/973 [60.1%] were male; and 677 [69.6%] were White), the clinical remission rates at week 12 were 132/650 (20.3%) for 1200 mg of risankizumab and 20/325 (6.2%) for placebo (adjusted between-group difference, 14.0% [95% CI, 10.0%-18.0%], P &lt; .001). Among the 548 patients analyzed in the maintenance trial (aged 40.9 [SD, 14.0] years; 313 [57.1%] were male; and 407 [74.3%] were White), the clinical remission rates at week 52 were 72/179 (40.2%) for 180 mg of risankizumab, 70/186 (37.6%) for 360 mg of risankizumab, and 46/183 (25.1%) for placebo (adjusted between-group difference for 180 mg of risankizumab vs placebo, 16.3% [97.5% CI, 6.1%-26.6%], P &lt; .001; adjusted between-group difference for 360 mg of risankizumab vs placebo, 14.2% [97.5% CI, 4.0%-24.5%], P = .002). No adverse event signals were detected in the treatment groups.Conclusion and RelevanceCompared with placebo, risankizumab improved clinical remission rates in an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis. Further study is needed to identify benefits beyond the 52-week follow-up.Trial RegistrationClinicalTrials.gov Identifiers: NCT03398148 and NCT03398135

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Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists

Cited by 179 publications

References 37 publications

Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Early vedolizumab trough levels at induction in inflammatory bowel disease patients with treatment failure during maintenance

Risankizumab for Ulcerative Colitis

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