Sa1711 - Real World Comparative Risk of Serious Infection with Adalimumab, Vedolizumab, and Infliximab in Patients with Inflammatory Bowel Disease

Osterman, Mark T.; Long, Millie D.; Singh, Siddharth; Meyer, Nicole; Feng, Chaoling; Higgins, Kate; Hepp, Zsolt; Arikan, Dilek; Wang, Anthony; Feagan, Brian G.

doi:10.1016/s0016-5085(18)31535-x

Cited by 3 publications

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“…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: 82%

“…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%

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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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158

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

confidence: 82%

Section: Resultsmentioning

confidence: 99%

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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158

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“…A recent multicenter, propensity score analysis—published as abstract only 31 —showed a significantly lower rate of serious adverse events and a non‐significant trend toward a lower risk of serious infections in patients treated with VDZ compared with those treated with anti‐TNFs. Conversely, a retrospective study—again, available as abstract only 32 —showed that serious infections risk was not significantly different between IBD patients treated with IFX, ADA, and VDZ, even among older patients.…”

Section: Discussionmentioning

confidence: 94%

A propensity score weighted comparison of vedolizumab and adalimumab in Crohn's disease

Macaluso

Ventimiglia

Fries

et al. 2020

J of Gastro and Hepatol

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Background and AimThere are no head‐to‐head randomized controlled trials between biologics in Crohn's disease (CD). We aimed to perform a multicenter, real‐life comparison of the effectiveness of vedolizumab (VDZ) and adalimumab (ADA) in CD.MethodsData of consecutive patients with CD treated with VDZ and ADA from January 2016 to April 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. The effectiveness was evaluated at 12, 52 weeks, and as failure‐free survival at the end of follow up. Propensity score analysis was performed using the inverse probability of treatment weighting method.ResultsFive hundred eighty‐five treatments (VDZ: n = 277; ADA: n = 308) were included (median follow‐up: 56.0 weeks). After 12 weeks, a clinical response was achieved in 64.3% patients treated with VDZ and in 83.1% patients treated with ADA (odds ratio [OR] 0.65, 95% confidence interval [CI] 0.38–1.10, P = 0.107), while at 52 weeks, a clinical response was observed in 54.0% patients treated with VDZ and in 69.1% patients treated with ADA (OR 0.77, 95% CI 0.45–1.31, P = 0.336). Cox survival analysis weighted for propensity score showed no significant difference in the probability of failure‐free survival between the two drugs (hazard ratio = 1.20, 95% CI 0.83–1.74, P = 0.340). Post‐treatment endoscopic response and mucosal healing rates were similar between the two groups (endoscopic response: 35.3% for VDZ and 25.5% for ADA, P = 0.15; mucosal healing: 31.8% for VDZ and 33.8% for ADA, P = 0.85).ConclusionsIn the first study comparing VDZ and ADA in CD via propensity score analysis, the drugs showed comparable effectiveness and a similar safety profile.

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Comparative Risk of Serious Infection With Vedolizumab vs Anti-Tumor Necrosis Factor in Inflammatory Bowel Disease: Results From Nationwide Swedish Registers

Karlqvist,

Sachs,

Eriksson

et al. 2024

Am J Gastroenterol

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Objectives: We aimed to assess the risk of serious infection in inflammatory bowel disease (IBD) patients treated with vedolizumab, compared to those treated with anti-tumor necrosis factors (TNF) and the general population. Methods: In this Swedish cohort study, treatment episodes were identified from nationwide health registers. We used Cox regression with propensity score-matched cohorts to estimate hazard ratios (HRs) for incident serious infections, defined as infections requiring hospital admission. Results: During 1376 treatment-episodes in Crohn’s disease, the rate of serious infections per 100 person-years (PY) was 5.18 (95%CI=3.98-6.63) with vedolizumab vs 3.54 (95%CI=2.50-4.85) with anti-TNF; HR=1.72 (95%CI=1.12-2.65), partly explained by more gastrointestinal infections. Compared to the rate of 0.75/100 PYs (95%CI=0.59-0.92) in a matched general population cohort, vedolizumab demonstrated higher risk (HR=7.00; 95%CI=5.04-9.72). During 1294 treatment-episodes in ulcerative colitis, the corresponding rates were 3.74/100 PYs (95%CI=2.66-5.11) with vedolizumab vs 3.42/100 PYs (95%CI=2.31-4.89) with anti-TNF; HR=0.80 (95%CI=0.47-1.36) during the initial 1.1 years and HR=2.03 (95%CI=0.65-6.32) after 1.1 years (truncated due to non-proportional hazards). Pneumonia accounted for 40% of all infections among anti-TNF whereas no case was observed among vedolizumab episodes. Compared to the rate of 0.69/100 PYs (95%CI=0.53-0.87) in a matched general population cohort, vedolizumab showed an HR of 5.45 (95%CI=3.67-8.11). Conclusions: Vedolizumab was associated with increased risks of serious infections compared to anti-TNF in Crohn’s disease, but not in ulcerative colitis. Nonetheless, the panorama of serious infections seemed to differ between the drugs. Our findings underscore the importance of clinical awareness of infections and the safety profile of the two therapies.

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Sa1711 - Real World Comparative Risk of Serious Infection with Adalimumab, Vedolizumab, and Infliximab in Patients with Inflammatory Bowel Disease

Cited by 3 publications

References 0 publications

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

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

A propensity score weighted comparison of vedolizumab and adalimumab in Crohn's disease

Comparative Risk of Serious Infection With Vedolizumab vs Anti-Tumor Necrosis Factor in Inflammatory Bowel Disease: Results From Nationwide Swedish Registers

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