Our group shared data yesterday on variation in individual provider level outcomes with regard to diagnostic yield and colonoscopy. In addition, the poster highlights the likelihood of diagnostic yield based on indications.
Yesterday, I posted a blog that tried to summarize some of William Balistreri’s talk on Global Health. He gave a 2nd Excellent Lecture on Food Safety at the Georgia AAP Nutrition Symposium. One audience member suggested that this lecture was well-paired with the previous lecture as the awareness of food-borne illnesses might deter gluttony.
This lecture was packed with information regarding food safety; he highlighted the extensive and frequent food-borne illnesses.
- The problem of food-borne illness was put under a spotlight by Upton Sinclair in The Jungle (1906) which led to reforms in meat packing industry. However, more work is needed
- FSMA -Food Safety Modernization Act was signed into law in 2011; it’s aim is to create a proactive rather than reactive approach, Historic opportunity to increase food safety
- Food-borne illnesses: 1 in 10 persons worldwide will be sick every year & leads to 1/2 million deaths worldwide each year. 125,000 deaths in children
- Food-borne illnesses: 48 million cases in U.S. each year (CDC estimates) and 3000 deaths (MMWR 64:2, 2015)
- Besides significant mortality rates for food-borne illnesses, they also contribute to post-infectious irritable bowel syndrome (~13% of all cases) and these illnesses can be indefinite
- Social media, including “IwasPoisoned.com” and Yelp, will likely help identify outbreaks more quickly. Newer molecular technologies during food processing has the potential to improve food safety.
- For those who want to keep up food-borne illnesses, Dr. Balistreri recommended food safety news, which provides daily emails. Link to subscribe: Food Safety News
- Two books that were recommended: The Poison Squad by Deborah Blum and Outbreak by Timothy Lytton
- The CDC has plenty of advice and a useful pamphlet regarding the key 4 steps with food preparation: Clean, Separate, Cook, Chill. https://www.cdc.gov/foodsafety/keep-food-safe.html
- Another resource: FoodSafety.gov
Link to full talk slides PDF: FOOD SAFETY (10-10-19) I have placed about 20 slides below which summarize much of the information that he conveyed.
A recent study (LE Targownik, EI Benchimol, J Witt et al. Inflamm Bowel Dis 2019; 25: 1718-28) shows that direct health care costs are increased with anti-TNF therapy.
In this retrospective study using the Manitoba IBD Database, the authors examined the direct costs associated with anti-TNF therapy initiation in 928 patients (676 CD, 252 UC). Only 84 subjects were <18 years.
- The median costs for health care in the year of anti-TNF initiation increased compared to prior year. In year prior to initiation, median costs were $4698 for CD and $6364 for UC; in the first year of anti-TNF treatment, costs rose to $39,749 and $49,327 respectively.
- Costs remained elevated through 5 years of anti-TNF therapy for continuous users with total median of $210,956 and $245,260 respectively
- There were reductions in non-drug costs. Inpatient and outpatient costs decreased in the year after anti-TNF initiation by 12% and 7% respectively, when excluding the costs of anti-TNFs. These observed savings are considerably less than the medication expenditures.
- Costs for medications are likely to improve with the introduction of biosimilars. Currently these are being used mainly in persons with a new diagnosis due to reticence to switch from originator product in established patients.
- The authors note that costs were overall higher with infliximab (IFX) than adalimumab (ADA) though “it is possible that patients with higher-severity disease are channeled toward IFX over ADA.”
- Indirect costs like ability to go to work and achieve educational potential could offset some of the direct costs. In a prior study in the U.S., ADA treatment was estimated to reduce indirect costs of “nearly $11,000 per person treated.”
- Some costs were not measured in the study including emergency room visits, over the counter medications and alternative health care use.
- This was not a randomized study; thus, it is impossible to know what costs of persons with similar disease who were untreated would have been.
My take: This study shows that saving money is not the main reason to use anti-TNF therapies; rather, their effects on improved health and fewer complications.
Related blog posts:
- Do Anti-TNF Agents Reduce Surgeries and Hospitalizations?
- Top Anti-TNF for Ulcerative Colitis
- Gold Medal Winner: Infliximab (in the anti-TNF category) this post initially was during 2016 Olympics
- Comparing Biologics for Ulcerative Colitis | gutsandgrowth
- Head-to-Head: Nutritional Therapy versus Biological … – gutsandgrowth
- Adalimumab for children with Crohn’s disease | gutsandgrowth
- Should All Pediatric Patients with Crohn’s Disease … – gutsandgrowth
- What is Your Infliximab Adherence Rate? | gutsandgrowth
- Changes in the Use of IBD Biologic Therapy
D Piovani et al. Gastroenterol 2019; 157: 647-59. This study examined environmental risk factors for inflammatory bowel disease after extensive literature review and assessment of meta-analysis.
9 factors that were associated with increased risk of IBD:
- smoking (CD)
- urban living (CD & IBD)
- appendectomy (CD)
- tonsillectomy (CD)
- antibiotic exposure (IBD)
- oral contraceptive use (IBD)
- consumption of soft drinks (UC)
- vitamin D deficiency (IBD)
- Heliobacter species (non-Helicobacter pylori-like) (IBD)
7 factors that associated with reduced risk of IBD:
- physical activity (CD)
- breatfeeding (IBD)
- bed sharing (CD)
- tea consumption (UC)
- high folate levels (IBD)
- high vitamin D levels (CD)
- H pylori infection (CD, UC, and IBD)
EL Barnes et al. Inflamm Bowel Dis 2019; 1474-80. In this review which identified 12 studies and 4843 with an IPAA ( ileal pouch-anal anastomosis) for ulcerative colitis, 10.3% were ultimately diagnosed with Crohn’s disease. Link to full text and video explanation: The Incidence and Definition of Crohn’s Disease of the Pouch: A Systematic Review and Meta-analysis
EV Loftus et al. Inflamm Bowel Dis 2019; 1522-31. In this study with 2057 adalimumab-naive patients, “the proportion of patients in HBI remission increased from 29% (573 of 1969; baseline) to 68% (900 of 1331; year 1) and 75% (625 of 831; year 6). Patients stratified by baseline immunomodulator use had similar HBI remission rates.” Full text: Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn’s Disease: Results of the PYRAMID Registry
The following study was summarized in previous blog: Oral Antibiotics For Refractory Inflammatory Bowel Disease Full text link: Efficacy of Combination Antibiotic Therapy for Refractory Pediatric Inflammatory Bowel Disease
Briefly noted: NE Burr et al. Clin Gastroenterol Hepatol 2019; 17: 2042-49.
In a retrospective cohort (1994-2013) using a primary care database from England, the authors identified decreasing risk of surgeries with Crohn’s diseae (CD).
- From 1994-2003, the risk of first surgery dropped from 44% to 21%.
- The risk of a second resection dropped as well, from 40% in 1994 to 17% in 2003 (with 10-year followup)
The reasons for this reduction are not certain but could include better clinical care or reduction in other risk factors (like smoking).
A recent study (MR Khan et al. JPGN 2019; 69: 438-42) examined the rates of autoimmune disorders (AD) among patients with celiac disease (CD) (n=249) compared to a control group (n=498) over an 18 year period (1997-2015). The authors utilized the a database of medical records via the Rochester Epidemiology Project (Mayo Clinic/Olmstead County).
- Five years after the index date, 5.0% of CD patients and 1.3% of controls had a de novo AD diagnosis
- In the pediatric age group, there was an increased risk of AD: 5/83 (7.3%) of CD patients and 0/179 (0%) developed a AD diagnosis at the 5-year mark
- The authors note that they observed a lower rate of Hashimoto thyroiditis after the diagnosis of CD, likely indicating a protective role of a gluten-free diet
- Thyroid disorders, type 1 DM, psoriasis/psoriatic arthritis and rheumatoid arthritis were the most common AD identified in patients with CD
- Retrospective study
- Adherence with GFD was not assessed
My take: Screening for AD periodically is worthwhile in patients with CD, particularly thyroid disorders and type 1 diabetes which accounted for ~80% of the autoimmune conditions identified.
Briefly noted: R Ahawat et al. JPGN 2019; 69: 449-54. In this study with 38 newly-diagnosed CD, the authors found a high prevalence of low vitamin D (25OHD) levels (65.8%) -defined as <30 ng/mL; however, the control population had a higher rate of 79.3%. While the authors advocate checking vitamin D levels due to the risk of bone disease, it is noted that bone mineral density and vitamin deficiencies frequently improve with a gluten-free diet (Related post: Celiac studies)
A previous blog post (Vedolizumab More Effective Than Adalimumb for Ulcerative Colitis) highlighted a preliminary report on the “VARSITY” study. The full report has now been published (BE Sands et al NEJM 2019; 381: 1215-26) and a little nuance is needed.
This double-blind, double-dummy randomized trial included 769 patients who underwent randomization to receive at least one dose of one of the study medications.
- At week 52, clinical remission was higher in the vedolizumab group: 31.3% compared to 22.5% for adalimumab
- Endoscopic improvement was better for vedolizumab: 39.7% compared to 27.7%
- Corticosteroid-free remission was better for adalimumab: 21.8% compared to 12.6% for vedolizumab
- dose escalation was not allowed during the study –this limitation likely favors vedolizumab compared to adalimumab
- previous exposure to an anti-TNF agent was allowed in up to 25% of patients
My take: In two of three key measures, vedolizumab outperformed adalimumab. This study provides a rationale for vedolizumab to be considered a first-line agent. That being said, in my clinical experience, infliximab is a much more frequently used anti-TNF agent in moderate-to-severe ulcerative colitis. So a head-to-head study with infliximab would be of interest.
The image below shows histologic remission differences at week 52