Browsing by Author "Swaminath, Arun"

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    Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis
    (Elsevier, 2022) Lukin, Dana; Faleck, David; Xu, Ronghui; Zhang, Yiran; Weiss, Aaron; Aniwan, Satimai; Kadire, Siri; Tran, Gloria; Rahal, Mahmoud; Winters, Adam; Chablaney, Shreya; Koliani-Pace, Jenna L.; Meserve, Joseph; Campbell, James P.; Kochhar, Gursimran; Bohm, Matthew; Varma, Sashidhar; Fischer, Monika; Boland, Brigid; Singh, Siddharth; Hirten, Robert; Ungaro, Ryan; Lasch, Karen; Shmidt, Eugenia; Jairath, Vipul; Hudesman, David; Chang, Shannon; Swaminath, Arun; Shen, Bo; Kane, Sunanda; Loftus, Edward V., Jr.; Sands, Bruce E.; Colombel, Jean-Frederic; Siegel, Corey A.; Sandborn, William J.; Dulai, Parambir S.; Medicine, School of Medicine
    Background & aims: We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. Methods: A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist-naïve and -exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. Results: A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumab-treated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist-naïve and -exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist-treated patients. However, in TNF-antagonist-naïve patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). Conclusions: Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist-naïve patients.
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    A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults with Crohn’s Disease
    (Science Direct, 2021-09-01) Lewis, James D.; Sandler, Robert; Brotherton, Carol; Brensinger, Colleen; Li, Hongzhe; Kappelman, Michael D.; Daniel, Scott G.; Bittinger, Kyle; Albenberg, Lindsey; Valentine, John F.; Hanson, John; Suskind, David; Meyer, Andrea; Compher, Charlene W.; Bewtra, Meenakshi; Saxena, Akriti; Dobes, Angela; Cohen, Benjamin; Flynn, Ann D.; Fischer, Monika; Saha, Sumona; Swaminath, Arun; Yacyshyn, Bruce; Scherl, Ellen; Horst, Sara; Curtis, Jeffrey R.; Braly, Kimberly; Nessel, Lisa; McCauley, Maureen; Herfarth, Hans; Medicine, School of Medicine
    Background & Aims This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean Diet (MD) as treatment for Crohn’s disease (CD) with mild to moderate symptoms. Methods Adult patients with CD and with mild-moderate symptoms were randomly assigned 1:1 to consume the MD or SCD for 12 weeks. For the first 6-weeks, participants received prepared meals and snacks according to their assigned diet. After 6-weeks, participants were instructed to follow the diet independently. The primary outcome was symptomatic remission at week 6. Key secondary outcomes at week 6 included: fecal calprotectin (FC) response (FC <250 μg/g and reduction by >50% among those with baseline FC >250 μg/g) and C-Reactive Protein (CRP) response (high-sensitivity CRP (hsCRP) <5 mg/L and >50% reduction from baseline among those with hsCRP >5mg/L). Results 194 patients were randomized, and 191 were included in the efficacy analyses. The percentage of participants who achieved symptomatic remission at week 6 was not superior with SCD (SCD 46.5%, MD 43.5%; P = .77). FC response was achieved in 8/23 participants (34.8%) with SCD and 4/13 participants (30.8%) with MD (P = .83). CRP response was achieved in 2/37 participants (5.4%) with SCD and 1/28 participant (3.6%) with MD (P = .68). Conclusions SCD was not superior to MD to achieve symptomatic remission, FC response and CRP response. CRP response was uncommon. Given these results, the greater ease of following the MD, and other health benefits associated with MD, the MD may be preferred to the SCD for most patients with CD with mild to moderate symptoms.