INTRODUCTION Following inadequate response, loss of response, or intolerance to a first-line biologic, patients with Crohn’s disease (CD) may switch treatment to a second-line biologic therapy. Data on the clinical outcomes of patients receiving two or more lines of biologic therapy are limited. We assessed the adverse clinical outcomes of patients with CD receiving different biologic treatment sequences. METHODS ROTARY (Real-wOrld ouTcomes Across tReatment sequences in inflammatorY bowel disease patients) part B used data from the Optum Clinical Database and included adult patients diagnosed with CD who received at least two biologics successively between January 1, 2013 and February 29, 2020. This retrospective cohort study measured adverse clinical outcomes, including the incidences of inflammatory bowel disease (IBD)-related hospitalization, IBD-related surgery, dysplasia, colorectal cancer (CRC), and infection during each line of therapy individually and for both lines of treatment overall. The start of the first line of therapy (LOT1) was defined as the date of first prescription or infusion of a biologic therapy. The start of the second line of therapy (LOT2) was defined as the first date of prescription or infusion of a second-line biologic therapy. LOT1 biologics included in the analysis were adalimumab (ADA), infliximab (IFX), ustekinumab (UST) and vedolizumab (VDZ). LOT2 biologics included were IFX and ADA. RESULTS Among all treatment sequences UST to IFX had the highest overall incidences of hospitalization, surgery, CRC, and infection. The overall incidences of hospitalization, surgery, and CRC were lowest for the VDZ to ADA treatment sequence. The overall incidences of infection and dysplasia were lowest for UST to ADA and UST to IFX, respectively; the second-lowest overall incidences for these outcomes were for VDZ to ADA (Figure 1). When comparing adverse clinical outcomes during LOT2, there were similar incidences of hospitalization, surgery, dysplasia, and infection with ADA following either VDZ or UST. In comparison, UST to IFX had higher incidences of hospitalization, surgery, and infection compared with VDZ to IFX (Table 1). DISCUSSION We identified that the VDZ to ADA biologic treatment sequence had the lowest real-world incidences of adverse clinical outcomes in patients with CD. In patients who were unsuccessfully treated with either VDZ or UST during LOT1, ADA was associated with a lower incidence of adverse clinical outcomes during LOT2 than IFX. The adverse clinical outcomes for sequences including two anti-tumor necrosis factor therapies (ADA to IFX, IFX to ADA) were similar during LOT1, LOT2, and overall. These results, although they may be influenced by selection bias, provide potential guidance to clinicians choosing sequences of biologic treatments in patients with CD.
case reports and signal detection studies showed that enoxaparin was suspected of liver injury after arthroplasty. The objective of this study was to compare enoxaparin and rivaroxaban in their safety (liver injury and bleeding) and efficacy (DVT, PE, and mortality) by performing a meta-analysis of randomized controlled trials that focused in patients after total knee or hip arthroplasty. Methods: A comprehensive search was performed using PubMed, Embase, and Cochrane to retrieve studies that compared enoxaparin and rivaroxaban after arthroplasty. Relative risk (RR) and 95% confidence intervals using Mantel-haenszel approach were reported. Beta-Binomial model was applied to perform sensitivity analysis. The primary endpoints are liver injury and bleeding and the secondary endpoints are incidences of DVT, PE, and mortality. Results: Ten studies were included in the meta-analysis. Compared to rivaroxaban, enoxaparin had a higher risk of liver injury [RR= 1.77; 95% CI: 1.29,2.44]. Use of enoxaparin resulted in a nearly two-fold risk for DVT compared to rivaroxaban and was statistically significant. The pooled estimate for proximal DVT, distal DVT and any DVT were [RR=3.04; 95% CI: 1.34,6.88], [RR=1.72; 95% CI: 1.29,2.29], [RR=2.09; 95% CI :1.48,2.97] respectively. However, there was no statistically significant difference in the rate of symptomatic and asymptomatic DVT, PE, mortality, and bleeding between the two drugs. Conclusions: Enoxaparin was associated with a higher risk for liver injury and rivaroxaban was associated with lower rates of distal DVT, proximal DVT, and any DVT. However, no difference was observed in the risk of bleeding, PE, and mortality. Overall, enoxaparin is less effective and more risky compared to rivaroxaban for people undergoing total knee or hip arthroplasty.
Table 1. (continued) Placebo (N561) GUS 200 mg IV q4w à100 mg SC q8w (N561) GUS 600 mg IV q4w à200 mg SC q4w (N563) GUS 1200 mg IV q4w à 200 mg SC q4w (N561) UST ;6 mg/kg IV à90 mg SC q8w (N563) Wk 12 Wk 48 -0.73 (8.872), N556 -4.63 (8.869),* N558 -5.66 (10.437), N556 -3.43 (9.178),* N561 -4.85 (8.831), N558 -6.78 (7.805),** N557 -6.34 (10.188), N549 -3.86 (7.908), N563 -5.09 (6.624), N559
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