Vaccination and Inflammatory Bowel Disease -Resources Targeted for Adult Patients

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From a recent Gastroenterology & Hepatology –Full Link:

Gastroenterology & Hepatology  July 2017 – Volume 13, Issue 7; Vaccination of Patients With Inflammatory Bowel Disease.  Francis A. Farraye, MD, MSc

Thanks to John Pohl’s twitter feed for this link that provides recommendations for Adults with IBD.

An excerpt:

G&H  What specific resources for vaccinations are available to help gastroenterologists?

FF  It is helpful for providers to keep a copy of the Crohn’s and Colitis Foundation’s health maintenance recommendations posted in their office. This 1-page checklist (available at http://www.crohnscolitisfoundation.org/science-and-professionals/programs-materials/ccfa-health-maintenance.pdf) includes all recommended vaccines and also comments on other important health maintenance items, such as screening for cervical and skin cancer, depression, and osteoporosis. In addition, Cornerstones Health has a vaccination checklist (available at http://www.cornerstoneshealth.org/wp-content/uploads/2017/06/Monitoring-and-Prevention-3.10.2017.pdf) that can be downloaded, printed, and placed in each examination room to reinforce the importance of vaccination. Primary care providers as well as gastroenterologists can use these checklists as reminders in their busy practices.

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Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Two Viewpoints: Anti-TNF Therapy Shortly After Crohn’s Disease Surgery

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A recent AGA perspectives issue provides two viewpoints on when to start/resume anti-TNF therapy after Crohn’s disease surgery:

Dr. Bressler states that he considers anti-TNF therapy for patients with ongoing immune dysfunction after surgery who are at high risk for recurrence.  Attributes of high risk disease include the following:

  • younger age (<30 years)
  • smoker
  • two or more surgeries for penetrating disease.

His commentary indicates that a “‘wait and see’ approach is appropriate for most patients. He frequently will measure a calprotectin three months postoperatively and every three months and perform a colonoscopy typically 6-9 months postoperatively. Those with endoscopic recurrence will be placed on anti-TNF therapy.

Dr. Requiero states:

  • The most effective way to prevent recurrence is to initiate an anti-TNF within four weeks of surgery. It has been my practice that patients at high risk for postoperative Crohn’s disease recurrence initiate anti-TNF shortly after they are discharged from the hospital.
  • If a patient had been on an anti-TNF prior to the surgery, I will usually resume the same anti-TNF after the surgery. In these patients, I do not give a re-induction course unless they had not received the anti-TNF for more than three months prior to surgery.
  • Concomitant therapy: “In the majority of patients, I treat with an anti-TNF, I will use a concomitant immunomodulator…One year after surgery, if there is no disease recurrence, I will decrease and often stop the immunomodulator. With the advent of therapeutic drug monitoring, I have a number of postoperative anti-TNF patients on monotherapy without an immunomodulator.
  • [In] patients at moderate risk for postoperative recurrence… I perform an ileocolonoscopy six months postoperatively and, if there is evidence of endoscopic recurrence, I add an anti-TNF agent. After finding a high rate of recurrence in these patients, I am beginning to shift my practice to initiating anti-TNFs in this moderate-risk group as well.

My take: I tend to favor Dr. Reguieiro’s approach in my patient population.

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What Happens to Picky Eaters

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“Little belly-achers grow up to be big belly-achers and big belly-achers beget little belly-achers” –John Apley

John Apley’s monographThe Child with Abdominal Pains indicates that children with recurrent abdominal pain often grow up to be adults with abdominal pains.  A recent study indicates the same type of phenomenon with picky eaters.

A summary of this study in Research Digest: The first study to see if fussy-eating children grow into fussy-eating adults (Thanks to Bonney Reed-Knight for this link.)

An excerpt:

60 per cent of fussy eating children in the study were also fussy eaters at age 23, but fussy eating young adults were no more likely to report signs of eating disorder than their non-fussy peers.

The researchers led by Meredith Van Tine at Stanford University School of Medicine managed to catch up with 61 individuals, now aged 23, who’d participated as children in a long-running study in which their eating habits had been scored by their parents at ages 2, 7, 9.5 and 11, including any signs of fussy eating (being a “selective eater”, having strong likes and dislikes, and only eating a limited variety of foods etc). The participants were now asked to rate themselves on whether they were selective or fussy eaters, and they answered questions about whether they engaged in behaviours related to eating disorders.

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Diagnosis and Misdiagnosis of Constipation

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A personal pet peeve is having to explain to so many parents that their child is not constipated.  The typical scenario is that their child went to the ER for abdominal pain and had an abdominal radiograph (AXR); then, the parents are informed that their child is constipated based on ‘fecal loading’ noted on the AXR.  In this scenario, it is common for the child to have the following:

  • regular bowel movements
  • lack of a rectal exam
  • lack of improvement with laxatives (though some do improve, perhaps due to the fact that symptoms often have regression to the mean)
  • often a normal AXR when interpreted by radiologist rather than ED physician (it is normal to have some stool in the colon)

So, I like to see publications that support my viewpoint that this approach is misguided. Two recent studies provide some insight into this topic:

  • SB Freedman et al. J Pediatr 2017; 186: 87-94
  • CC Ferguson et al. Pediatrics 2017; 140 (1):e20162290 (thanks to Ben Gold for this reference)

Freedman et al performed a retrospective cohort study (children <18 yrs) who were diagnosed with constipation at 23 EDs from 2004-2015. This study used the PHIS database. Key findings:

  • 185,439 of 282,225 had AXR at index ED visit
  • Revisits to ED occurred in 3.7%
  • 0.28% returned with a clinically important alternate diagnosis, most commonly appendicitis (34% in this category)
  • Children who had AXR were more likely to have a 3-day revisit with a clinically important alternate diagnosis (0.33% vs. 0.17%)

Recognizing that AXRs are “unnecessary and potentially misleading,” Ferguson et al aimed to decrease AXR utilization in low-acuity patients who were suspected of having constipation. Using quality tools, the authors performed four plan-do-study-act cycles which included holding grand rounds, sharing best practices, metrics reporting, and academic detailing. Key finding:

  • Over 12 months, we observed a significant and sustained decrease from a mean rate of 62% to a mean rate of 24% in the utilizaiton of AXRs in the ED for patients suspected of having constipation.

My take: These studies support my view that routine use of AXR in the diagnosis of constipation is a mistake and can be misleading.

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How Good is Your Probiotic for Antibiotic-Associated Diarrhea?

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The enthusiasm for probiotics is generally greater than expected based on the data available to support their use for many indications.  This has been discussed several times on this blog (see below).  The reasons why probiotics are sometimes not effective can be related to being poorly regulated/lack rigorous production standards; even in conditions in which there is some effectiveness (eg. antibiotic-associated diarrhea [AAD]), the number of persons needed to treat for one person to benefit is fairly high. Furthermore, as a recent study (A Olek et al. J Pediatr 2017; 186: 82-6) shows, even in conditions like AAD in which probiotics have proven efficacy, the effects may be strain-specific and/or dose-related.

Olek et al showed that Lactobacillus planatarum DSM9843 (LP299V) was NOT beneficial compared to placebo in reducing the incidence of loose/watery stools or mean number of stools among 438 children receiving outpatient antibiotic therapy.

Specifics: This was a prospective, double-blind, randomized, placebo-controlled parallel-group study.  The treatment group received LP299V during antibiotic therapy and for 1 week afterwards.  In addition to monitoring the number of stools, the authors determined the frequency of AAD which they defined according to WHO guidelines (>3 loose/watery stools/24 hours after initiation of antibiotics).  In this study, AAD was confined to study duration rather than over 2 months.

  • Overall, 44.5% of children developed loose/watery stools among placebo group and 39% among probiotic group
  • 4.1% developed AAD among placebo group and 2.8% among LP299V
  • LP299V showed no significant beneficial effects in reducing AAD or loose/watery stools

The authors note that LP299V has been effective in studies involving adult hospitalized patients.  They question whether healthy children, therefore, may be less likely to benefit from probiotics and whether a higher dose could have been more effective.

My take: “Data from clinical studies on probiotics are conflicting” for many conditions, including antibiotic-associated diarrhea.

Lovers Leap, near Ashville (Appalachian Trail)

 

 

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FDA Warning for Obesity Devices: Intragastric Balloons

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FDA Warning: Five Die While Using Obesity Devices (Intragastric Balloons)

An excerpt:

At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.

The FDA says it doesn’t know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.

Related blog post: In the News: Weight Loss Intragastric Balloons

Pediatric Views on Biosimilars and Interchangeability

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A recent commmentary (D Patel, KT Park. JPGN 2017; 134-6) explains the topic of interchangeability and its relationship to biosimlars. While biosimilars are expected to reduce the cost of biologic therapy, there are concerns regarding immunogenicity and whether switching to these products could reduce therapeutic sustainability.

The authors explain that some products are truly interchangeable and produce the same clinical result.  An interchangeable medicine (eg. typical generic) does not increase safety risk and switching from originator drug can be done by pharmacists or government payers without intervention of the prescribing health provider.

CT-P13 (Inflectra) has been approved as a biosimilar but has not been deemed an interchangeable product.  This is important.  Biosimilars “could have clinical consequences and repeated switches may increase immunogenicity.” Also, biosimilar products are much more complicated products than typical generic drugs.

Other key points:

  • The assumption that CT-P13 is interchangeable in pediatric IBD is “highly debatable.” Biosimilars undergo fewer studies than originator products.  CT-P13 has data from PLANETRA and PLANETAS trials “which may not be applicable for IBD, particularly pediatric IBD, given the inherent differences in disease pathophysiology.”
  • “No long-term, multiple-switch (eg. originator to biosimilar to originator) studies in pediatric or adult patients have been performed.”
  • “It is premature and possibly risky to assume that interchangeability will not cause differences in immunogenicity without long-term evidence in the pediatric population.” Pediatric patients likely have a “higher probability of developing autoantiantibodies” and need effective therapy for a longer duration.

My take: We still have a lot to learn.  Until more studies are available, switching stable patients could increase risk of losing response.

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