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Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis

Sandborn, William J; Feagan, Brian G; Wolf, Douglas C; D'Haens, Geert; Vermeire, Severine; Hanauer, Stephen B; Ghosh, Subrata; Smith, Heather; Cravets, Matthew; Frohna, Paul A; Aranda, Richard; Gujrathi, Sheila; Olson, Allan; [Katz, Seymour]
BACKGROUND: Ozanimod (RPC1063) is an oral agonist of the sphingosine-1-phosphate receptor subtypes 1 and 5 that induces peripheral lymphocyte sequestration, potentially decreasing the number of activated lymphocytes circulating to the gastrointestinal tract. METHODS: We conducted a double-blind, placebo-controlled phase 2 trial of ozanimod in 197 adults with moderate-to-severe ulcerative colitis. Patients were randomly assigned, in a 1:1:1 ratio, to receive ozanimod at a dose of 0.5 mg or 1 mg or placebo daily for up to 32 weeks. The Mayo Clinic score was used to measure disease activity on a scale from 0 to 12, with higher scores indicating more severe disease; subscores range from 0 to 3, with higher scores indicating more severe disease. The primary outcome was clinical remission (Mayo Clinic score 1) at 8 weeks. RESULTS: The primary outcome occurred in 16% of the patients who received 1 mg of ozanimod and in 14% of those who received 0.5 mg of ozanimod, as compared with 6% of those who received placebo (P=0.048 and P=0.14, respectively, for the comparison of the two doses of ozanimod with placebo). Differences in the primary outcome between the group that received 0.5 mg of ozanimod and the placebo group were not significant; therefore, the hierarchical testing plan deemed the analyses of secondary outcomes exploratory. Clinical response (decrease in Mayo Clinic score of >/=3 points and >/=30% and decrease in rectal-bleeding subscore of >/=1 point or a subscore
PMID: 27144850
ISSN: 1533-4406
CID: 2195832

How Relative Value Units Undervalue the Cognitive Physician Visit: A Focus on Inflammatory Bowel Disease

Katz, Seymour; Melmed, Gil
PMCID:4872854
PMID: 27231455
ISSN: 1554-7914
CID: 2115162

Fulminant Colitis Following Rituximab Therapy

Lipka, Seth; Katz, Seymour; Crawford, James M
PMCID:4865788
PMID: 27330506
ISSN: 1554-7914
CID: 2157992

Risk of New or Recurrent Cancer in Patients with Inflammatory Bowel Disease and Previous Cancer Exposed to Immunosuppressive and Anti-TNF Agents

Axelrad, Jordan; Bernheim, Oren; Colombel, Jean-Frederic; Malerba, Stefano; Ananthakrishnan, Ashwin; Yajnik, Vijay; Hoffman, Gila; Agrawal, Manasi; Lukin, Dana; Desai, Amit; Mceachern, Elisa; Bosworth, Brian; Scherl, Ellen; Reyes, Andre; Zaidi, Hina; Mudireddy, Prashant; DiCaprio, David; Sultan, Keith; Korelitz, Burton; Wang, Erwin; Williams, Renee; Chen, LeaAnn; Katz, Seymour; Itzkowitz, Steven
BACKGROUND AND AIMS: Our understanding of malignancy associated with immunosuppression in patients with inflammatory bowel disease (IBD) comes from studies of individuals with no history of cancer. We investigated whether patients with IBD and a history of cancer who were subsequently immunosuppressed have an increased risk of developing incident cancer. METHODS: We performed a retrospective analysis of data from 333 patients with IBD treated at 7 academic medical centers who developed cancer and subsequently received treatment with anti-tumor necrosis factor (TNF), anti-TNF with an anti-metabolite (thiopurines, methotrexate), anti-metabolites, or no subsequent exposure to immunosuppressive agents (controls). We collected data on their primary outcomes of incident cancers (new or recurrent). Hazard ratios (HRs) were calculated using Cox proportional hazards and Kaplan-Meier survival curves; study groups were compared using the Log-Rank test. RESULTS: During the follow-up period, 90 patients (27%) developed an incident cancer. Patient characteristics between groups differed, but matching was not possible due to the relatively small sample sizes. There was no difference in time to (p=0.14) or type of (p= 0.61) incident cancer among the 4 groups. After adjusting for recurrence risk for type of prior cancer, there was no difference in risk of incident cancer (HR for anti-TNF=0.32; 95% confidence interval [CI], 0.09-1.09; HR for anti-TNF with an anti-metabolite=0.64; 95% CI, 0.26-1.59; HR for an anti-metabolite=1.08; 95% CI, 0.54-2.15) or time to subsequent cancer between study arms (p=.22). CONCLUSION: Based on a retrospective study, in patients with IBD and a history of cancer, exposure to an anti-TNF agent or an anti-metabolite following cancer was not associated with an increased risk of incident cancer, compared to patients who did not receive immunosuppression. Larger, matched, prospective studies are needed to confirm these findings.
PMID: 26247164
ISSN: 1542-7714
CID: 1709242

Chronic appendicitis: uncommon cause of chronic abdominal pain

Kothadia, Jiten P; Katz, Seymour; Ginzburg, Lev
PMCID:4416293
PMID: 25949528
ISSN: 1756-283x
CID: 1565742

Patients With Inflammatory Bowel Disease and a History of Cancer: The Risk of Cancer Following Exposure to Immunosuppression [Meeting Abstract]

Axelrad, Jordan E.; Bernheim, Oren; Colombel, Jean-Frederic; Malerba, Stefano; Ananthakrishnan, Ashwin N.; Yajnik, Vijay; Hoffman, Gila; Agrawal, Manasi; Lukin, Dana J.; Desai, Amit P.; McEachern, Elisa; Bosworth, Brian; Scherl, Ellen J.; Reyes, Andre; Zaidi, Hina; Mudireddy, Prashant R.; DiCaprio, David; Sultan, Keith; Korelitz, Burton I.; Wang, Erwin; Williams, Renee; Chen, Lea Ann; Katz, Seymour; Itzkowitz, Steven H.
ISI:000360115800112
ISSN: 0016-5085
CID: 3177942

Pathogenesis, diagnosis, and management of ulcerative proctitis, chronic radiation proctopathy, and diversion proctitis

Wu, Xian-Rui; Liu, Xiu-Li; Katz, Seymour; Shen, Bo
: Chronic proctitis refers to persistent or relapsing inflammation of the rectum, which results from a wide range of etiologies with various pathogenic mechanisms. The patients may share similar clinical presentations. Ulcerative proctitis, chronic radiation proctitis or proctopathy, and diversion proctitis are the 3 most common forms of chronic proctitis. Although the diagnosis of these disease entities may be straightforward in the most instances based on the clinical history, endoscopic, and histologic features, differential diagnosis may sometimes become problematic, especially when their etiologies and the disease processes overlap. The treatment for the 3 forms of chronic proctitis is different, which may shed some lights on their pathogenetic pathway. This article provides an overview of the latest data on the clinical features, etiologies, diagnosis, and management of ulcerative proctitis, chronic radiation proctopathy, and diversion proctitis.
PMID: 25687266
ISSN: 1078-0998
CID: 1466722

Smoking and early infliximab response in Crohn's disease: a meta-analysis

Inamdar, Sumant; Volfson, Ariy; Rosen, Lisa; Sunday, Suzanne; Katz, Seymour; Sultan, Keith
BACKGROUND: Infliximab is used to treat moderate to severe Crohn's disease (CD), but its efficacy varies. Although cigarette smoking worsens CD, its impact on the infliximab response is unknown. We conducted a systematic review and meta-analysis of clinical trials to determine the effect of smoking on the induction response to infliximab. METHODS: A systematic search was performed of MEDLINE, EMBASE, CINAHL, the Cochrane central register of controlled trials, the Cochrane IBD Group Specialized Trials Register for publications, and abstracts from major conferences from January 1996 to December 2010. Random effects meta-analysis using the Mantel-Haenszel method was conducted. Heterogeneity across studies was assessed using the Q statistic, the I2 statistic, and tau2. RESULTS: We identified 12 articles; four were excluded due to use of non-validated scoring systems.The remaining eight included a total of 1658 patients, with 649 active smokers. Luminal response was assessed by the Crohn's Disease Activity Index in four studies (three of which included fistula response) and the Harvey-Bradshaw index in two (both including fistula response), and two studies examined only the fistula response. The relative risk for response to infliximab among smokers was 0.99 (95% CI 0.88-1.11) (tau2 = 0.0143). Analyses of the five studies examining both inflammatory and fistulizing CD were similar to the analysis of all eight studies. The pooled relative risk was 0.92 (95% CI 0.80-1.06) (tau2 = 0.0154). CONCLUSION: Though smoking worsens CD, this meta-analysis does not show a negative effect of smoking on initial response to infliximab. This must be viewed in the proper context, as long-term maintenance of response may yet be influenced by smoking status.
PMID: 25518060
ISSN: 1876-4479
CID: 2610992

Comparison of Cardiovascular Events in Elderly and Younger Crohn's Disease Patients Treated With Certolizumab Pegol: Results From a Pooled Safety Analysis [Meeting Abstract]

Ha, Christina; Choi, Jennifer; Katz, Seymour; Kosutic, Gordana; Spearman, Marshall; Coarse, Jason; Hasan, Iram; Loftus, Edward V., Jr
ISI:000363715903445
ISSN: 1572-0241
CID: 1854642

A randomized study of lubiprostone for opioid-induced constipation in patients with chronic noncancer pain

Cryer, Byron; Katz, Seymour; Vallejo, Ricardo; Popescu, Anca; Ueno, Ryuji
OBJECTIVE: To evaluate the efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain. DESIGN: Prospective, randomized, double-blind, placebo-controlled trial. SETTING: Seventy-nine US and Canadian centers. SUBJECTS: Patients aged >/= 18 years with OIC, defined as <3 spontaneous bowel movements (SBMs) per week. METHODS: Patients received lubiprostone 24 mcg or placebo twice daily for 12 weeks. The primary endpoint was change from baseline in SBM frequency at week 8. RESULTS: Among randomized patients (N=418; lubiprostone, N=210; placebo, N=208), most completed the study (lubiprostone, 67.1%; placebo, 69.7%). The safety and efficacy (intent-to-treat) populations included 414 (lubiprostone, N=208; placebo, N=206) and 413 (lubiprostone, N=209; placebo, N=204) patients, respectively. The mean (standard deviation) age was 50.4 (10.9) years; most patients were female (64.4%) and white (77.7%). Changes from baseline in SBM frequency rates were significantly higher at week 8 (P=0.005) and overall (P=0.004) in patients treated with lubiprostone compared with placebo. Pairwise comparisons showed significantly greater overall improvement for abdominal discomfort (P=0.047), straining (P<0.001), constipation severity (P=0.007), and stool consistency (P<0.001) with lubiprostone compared with placebo. Moreover, patients rated the effectiveness of lubiprostone as significantly (P<0.05) better than placebo for 11 of 12 weeks. The most common treatment-related adverse events (AEs) with lubiprostone and placebo were nausea (16.8% vs 5.8%, respectively), diarrhea (9.6% vs 2.9%), and abdominal distention (8.2% vs 2.4%). No lubiprostone-related serious AEs occurred. CONCLUSION: Lubiprostone effectively relieved OIC and associated signs and symptoms and was well tolerated in patients with chronic noncancer pain (http://clinicaltrials.gov/ct2/show/NCT00595946).
PMCID:4282321
PMID: 24716835
ISSN: 1526-2375
CID: 1446172