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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

A Rare Disease Mimicking Crohn's Disease [Meeting Abstract]

Shen, Huafeng; Cave, David; Katz, Seymour
ISI:000344383101707
ISSN: 1572-0241
CID: 1443802

An Analysis of Older Patients With Inflammatory Bowel Disease on 6-Mercaptopurine: A Community Practice Experience [Meeting Abstract]

Shen, Huafeng; Lipka, Seth; Alexander, Cibi; Kendes, Ante; Katz, Seymour
ISI:000344383102088
ISSN: 1572-0241
CID: 1443822

A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease

Sandborn, William J; Ghosh, Subrata; Panes, Julian; Vranic, Ivana; Wang, Wenjin; Niezychowski, Wojciech; Katz, Seymour
BACKGROUND & AIMS: Tofacitinib, an orally administered Janus kinase inhibitor, blocks signaling through gamma-chain-containing cytokines (interleukins 2, 4, 7, 9, 15, and 21). We performed a phase 2 trial to measure its efficacy in patients with moderate-to-severe active Crohn's disease. METHODS: Patients (N = 139; age, >/=18 y) with moderate-to-severe active Crohn's disease were assigned randomly to groups given 1 mg (n = 36), 5 mg (n = 34), or 15 mg (n = 35) tofacitinib or placebo (n = 34), twice daily for 4 weeks, at 48 centers in 12 countries. The primary end point was the proportion of clinical responders at week 4 (decrease from baseline in the Crohn's Disease Activity Index score of >/=70 points [Response-70]). Secondary end points included clinical remission (Crohn's Disease Activity Index score of <150 points) at week 4. RESULTS: A clinical response was observed in 36% (P = .467), 58% (P = .466), and 46% (P >/= .999) of patients given the 1-, 5-, and 15-mg doses of tofacitinib, compared with 47% of patients given placebo. Clinical remission was observed in 31% (P = .417), 24% (P = .776), and 14% (P = .540) of patients given the 1-, 5-, and 15-mg doses of tofacitinib, compared with 21% of patients given placebo. The 15-mg dose of tofacitinib reduced levels of C-reactive protein and fecal calprotectin from baseline. Adverse and serious adverse events were similar among groups. Dose-dependent increases in low- and high-density lipoprotein cholesterol were observed in patients given the 5- or 15-mg doses of tofacitinib. CONCLUSIONS: There were no significant differences in the percentage of patients with moderate-to-severe active Crohn's disease who achieved clinical responses (Response-70) or clinical remission after 4 weeks' administration of tofacitinib (1, 5, or 15 mg) or placebo twice daily. However, a large percentage of patients given placebo achieved Response-70 or remission. Reductions in C-reactive protein and fecal calprotectin levels among patients given the 15-mg dose of tofacitinib indicate its biologic activity. ClinicalTrials.gov number: NCT00615199.
PMID: 24480677
ISSN: 1542-3565
CID: 1446862

Increased hospitalizations in elderly with inflammatory bowel disease on anti-tumor necrosis factor therapy but not increased infections: A community practice experience [Letter]

Shen, Huafeng; Lipka, Seth; Katz, Seymour
PMID: 24434182
ISSN: 1873-9946
CID: 789642

Appendiceal adenocarcinoma in a patient with chronic ulcerative colitis: What is the appropriate surgical procedure? [Letter]

Shen, Huafeng; Lipka, Seth; Katz, Seymour
PMID: 24275203
ISSN: 1873-9946
CID: 789652

Hepatobiliary Disease and Inflammatory Bowel Disease : Inflammatory Bowel Disease: A Practical Approach, Series #88

Schonfeld, Emily; Park, James S; Katz, Seymour
ORIGINAL:0009416
ISSN: 0277-4208
CID: 1446892

Endoscopy in the elderly: risks, benefits, and yield of common endoscopic procedures

Razavi, Farid; Gross, Seth; Katz, Seymour
There has been limited research examining the risks, benefits, and use of common endoscopic procedures in the elderly. Furthermore, gastroenterology training programs do not routinely incorporate elderly concerns when dealing with common gastrointestinal issues. There exists a broad array of endoscopic procedures with varying inherent risks that must be weighed with each elderly patient in mind. This article discusses the benefits and drawbacks of the most common procedures and indications for endoscopy including upper endoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, percutaneous endoscopic gastrostomy, and deep enteroscopy.
PMID: 24267608
ISSN: 0749-0690
CID: 652462