277 - Comparative Safety Profile of Vedolizumab and Tumor Necrosis Factor-Antagonist Therapy for Inflammatory Bowel Disease: A Multicenter Consortium Propensity Score-Matched Analysis

Lukin, Dana J.; Weiss, Aaron; Aniwan, Satimai; Kadire, Siri; Tran, Gloria; Rahal, Mahmoud; Faleck, David; Winters, Adam C.; Chablaney, Shreya; Meserve, Joseph; Kochhar, Gursimran; Shashi, Preeti; Koliani-Pace, Jenna L.; Bohm, Matthew; Sagi, Sashivar; Fischer, Monika; Boland, Brigid S.; Singh, Siddharth; Hirten, Robert; Shmidt, Eugenia; Hudesman, David; Chang, Shannon; Simfukwe, Keith; Swaminath, Arun; Gupta, Nitin; Kane, Sunanda V.; Loftus, Edward V.; Shen, Bo; Sands, Bruce E.; Sandborn, William J.; Colombel, Jean Fréd́eric; Siegel, Corey A.; Dulai, Parambir S.

doi:10.1016/s0016-5085(18)30684-x

Cited by 10 publications

(17 citation statements)

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“…Comparative safety of the two classes of therapy have been examined mostly in the post‐operative setting where there may be a modest but inconsistent increase in risk of post‐operative infections with VDZ . In an analysis of the US multi‐centre VICTORY consortium that included 872 patients (436 on VDZ), VDZ‐treated patients had a numerical but statistically insignificant lower rate of serious infections (6.9% vs 10.1%) . Our findings of similar safety at 1 year between both therapeutic classes in elderly IBD patients provide reassurance to clinicians considering use of either anti‐TNF or VDZ for the treatment of IBD.…”

Section: Discussionmentioning

confidence: 56%

Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study

Adar

Faleck

Sasidharan

et al. 2019

Aliment Pharmacol Ther

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Background:The older patient group with inflammatory bowel diseases (IBD) is particularly vulnerable to consequences of disease and therapy-related side effects but little is known about the best treatment options in this population. Aim:To compare safety and efficacy of tumor necrosis factor α antagonist (anti-TNF) or vedolizumab (VDZ) in patients with IBD >60 years of age.Methods: This retrospective study included patients with Crohn's disease (CD) or ulcerative colitis (UC) initiating anti-TNF or VDZ therapy ≥60 years of age at three study sites. We examined occurrence of infection or malignancy within 1 year after therapy as our primary outcome. Our efficacy outcomes included clinical remission at 3, 6 and 12 months. Multivariable logistic regression models adjusting for relevant confounders estimated odds ratios (OR) and 95% confidence intervals. Results:The study included 131 anti-TNF and 103 VDZ initiated patients (age range 60-88 years). Approximately half had CD. At 1 year, there were no significant differences in safety profile between the two therapeutic classes. Infections were observed in 20% of anti-TNF-treated and 17% of VDZ-treated patients (P = 0.54).Pneumonia was the most common infection in both groups. While more anti-TNFtreated CD patients were in remission at 3 months compared to VDZ (OR 2.82, 95% CI 1.18-6.76), this difference was not maintained at 6 and 12 months suggesting similar efficacy of both classes. Conclusions:Both anti-TNF and VDZ therapy were similarly effective and safe in elderly IBD patients.

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Section: Discussionmentioning

confidence: 56%

Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study

Adar

Faleck

Sasidharan

et al. 2019

Aliment Pharmacol Ther

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“…From 11,947 unique studies identified using our search strategy, the full text of 115 studies were reviewed in detail, and eventually 15 studies were included in the quantitative analysis [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] ; in addition, 3 studies comparing TNFi-based therapy vs chronic corticosteroids and non-TNFi biologics vs TNFi-based therapy were evaluated qualitatively. [30][31][32] Figure 1 shows the study selection flowsheet. Of these 15 studies, 9 used administrative claims databases (using a collaborative multidatabase study including Medicaid Analytic Extract linked to Medicare, Tennessee Medicaid, 2 US states' Medicare, Kaiser Permanente, nationwide populationbased cohorts from France and Denmark, regional population-based cohorts from British Columbia and Lazio [Italy], and claims analyses from OptumLabs (Eden Prairie, MN) data warehouse).…”

Section: Resultsmentioning

confidence: 99%

“…42 However, there has been limited real-world comparative safety assessment with other biologics and immunosuppressive agents. In a preliminary study using the Vedolizumab for Health Outcomes in Inflammatory Bowel Diseases consortium, Lukin et al 31 observed a trend toward a lower risk of serious infections with vedolizumab vs TNFi, this benefit was most apparent in patients treated with monotherapy; combination therapy, particularly with addition of corticosteroids, seemed to mitigate any potential safety benefit of vedolizumab over TNFi. In a network meta-analysis of clinical trials of biologic agents, Bonovas et al 7 did not observe any significant difference in risk of serious infections between anti-integrin agents and TNFi on indirect comparison.…”

Section: Discussionmentioning

confidence: 99%

“…We did not identify any full-text articles comparing the risk of serious infections between patients treated with TNFi vs non-TNFi biologic agents. In a multicenter consortium, Lukin et al 31 reported a trend toward a lower risk of serious infections in patients treated with vedolizumab-based therapy vs TNFi-based therapy (6.9% vs 10.1%; OR, 0.67; 95% CI, 0.41-1.07), particularly among patients treated with monotherapy (4.1% vs 10.1%; OR, 0.37; 95% CI, 0.13-1.02), but not among patients treated with biologic therapy in combination with IS and corticosteroids (11.5% vs 13.9%; OR, 0.81; 95% CI, 0.31-2.07). In contrast, in an administrative claims-based analysis, Osterman et al 32 did not find any significant difference in the risk of serious infections in adalimumab-vs vedolizumab-treated patients after adjusting for covariates (incidence rate ratio, 0.82; 95% CI, 0.49-1.37).…”

Section: Tumor Necrosis Factor Inhibitors Vs Other Non-tumor Necrosismentioning

confidence: 99%

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Comparative Risk of Serious Infections With Biologic and/or Immunosuppressive Therapy in Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis

Singh

Facciorusso

Dulai

et al. 2020

Clinical Gastroenterology and Hepatology

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159

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This article has an accompanying continuing medical education activity, also eligible for MOC credit, on page e7. Learning Objective-Upon completion of this activity, successful learners will be able to list the relative risk of serious infection with various treatment strategies in patients with inflammatory bowel disease; and in addition to biologic and immunomodulator therapies, list risk factors for serious infections in patients with inflammatory bowel diseases. BACKGROUND & AIMS: We performed a systematic review and meta-analysis to evaluate the comparative risk of serious infections with tumor necrosis factor (TNF) antagonists, non-TNF targeted biologics, tofacitinib, and immunosuppressive agents in patients with inflammatory bowel diseases (IBDs). METHODS: In a systematic search of publications, through March 18, 2018, we identified 15 observational studies (>500 person-years) of patients with IBD treated with TNF antagonists, non-TNF targeted biologics, tofacitinib, and/or immunosuppressive agents (thiopurines, methotrexate) that reported risk of serious infections. Only studies with active comparators were included, to allow appropriate comparative synthesis. We performed random-effects meta-analysis and estimated relative risk (RR) and 95% CIs. RESULTS: Compared with anti-TNF monotherapy, risk of serious infection increased with the combination of anti-TNF and an immunosuppressive agent (in 6 cohorts: RR, 1.19; 95% CI, 1.03-1.37), with anti-TNF and a corticosteroid (in 4 cohorts: RR, 1.64; 95% CI, 1.33-2.03), or with all 3 drugs (in 2 cohorts: RR, 1.35; 95% CI, 1.04-1.77); there was minimal heterogeneity among studies. In contrast, monotherapy with an immunosuppressive agent was associated with a lower risk of serious infections than monotherapy with a TNF antagonist (7 cohorts: RR, 0.61; 95% CI 0.44-0.84) or a TNF antagonist with an immunosuppressive agent (2 cohorts: RR, 0.56; 95% CI, 0.39-0.81). Infliximab-based therapy was associated with a lower risk of serious infections compared with adalimumab-based therapy in patients with ulcerative colitis (4 cohorts: RR, 0.57; 95% CI, 0.33-0.97), but not Crohn's disease (4 cohorts: RR, 0.91; 95% CI, 0.49-1.70). Few data were available on the comparative safety of biologic agents that do not inhibit TNF and tofacitinib. CONCLUSIONS: Combination therapies for IBD that include TNF antagonists, especially with corticosteroids, are associated with a higher risk of serious infection, whereas monotherapy with an immunosuppressive agent is associated with a lower risk, compared with monotherapy with a TNF antagonist. Studies are needed to evaluate the comparative safety of non-TNF targeted biologics and small molecules for treatment of IBD.

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“…Real-World-Daten liefern auch zur Verträglichkeit einen wichtigen Beitrag: In der umfangreichen Metaanalyse von Schreiber et al ergaben sich keine neuen oder unerwarteten Sicherheitssignale [1]. Die Auswertung der Daten aus dem US-Konsortium mittels Propensity-Score-Matching bestätigte ebenfalls das günstige Sicherheitsprofil unter Alltagsbedingungen [27].…”

Section: Schwerpunktunclassified

Vedolizumab - Über 4 Jahre klinische Praxis: Langzeitwirksamkeit und -sicherheit bei Morbus Crohn und Colitis ulcerosa (Sponsor: Takeda Pharma)

2019

TDR

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ZusammenfassungVedolizumab (Entyvio®) hat sich seit der Zulassung im Behandlungsalltag bewährt und wird in aktuellen Leitlinien zu Morbus Crohn und Colitis ulcerosa frühzeitig empfohlen, neben anderen Biologika. Neue Daten untermauern das therapeutische Potenzial des überwiegend darmselektiven Integrin-Antagonisten und bereichern um praxisrelevante Aspekte wie Langzeit-Remission, Mukosaheilung und Therapieretention. Dass Vedolizumab insbes. für Anti-TNFα-naive Patienten eine effektive und gut verträgliche Therapie bieten kann, haben aktuelle Studien aus dem Versorgungsalltag und Metaanalysen verdeutlicht. Vedolizumab kann eine langfristige Krankheitskontrolle mit hoher Therapiepersistenz ermöglichen. Real-World-Daten haben zudem Hinweise auf eine mögliche Überlegenheit von Vedolizumab gegenüber TNFα-Inhibitoren gegeben, was bspw. das Erreichen einer endoskopischen bzw. steroidfreien Remission und die Verträglichkeit betrifft. Mit Blick auf die meist erforderliche Langzeittherapie, hat die langfristige Sicherheit eine besonders hohe Relevanz – die detaillierte Analyse zu Vedolizumab basiert auf Daten über die Therapie bis zu 5 Jahre und bekräftigt das günstige Sicherheitsprofil des Integrin-Antagonisten Vedolizumab.

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277 - Comparative Safety Profile of Vedolizumab and Tumor Necrosis Factor-Antagonist Therapy for Inflammatory Bowel Disease: A Multicenter Consortium Propensity Score-Matched Analysis

Cited by 10 publications

References 0 publications

Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study

Comparative safety and effectiveness of tumor necrosis factor α antagonists and vedolizumab in elderly IBD patients: a multicentre study

Comparative Risk of Serious Infections With Biologic and/or Immunosuppressive Therapy in Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis

Vedolizumab - Über 4 Jahre klinische Praxis: Langzeitwirksamkeit und -sicherheit bei Morbus Crohn und Colitis ulcerosa (Sponsor: Takeda Pharma)

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