Category Archives: Gastroenterology

Vedolizumab More Effective Than Adalimumab for Ulcerative Colitis

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Gastroendonews: Tea Leaves No More: Biologics Head-to-Head Produces a Winner

An excerpt:

In the first head-to-head trial of biologic treatments for inflammatory bowel disease, vedolizumab (Entyvio, Takeda) was nearly 50% more effective than adalimumab (Humira, AbbVie) in inducing clinical and mucosal remission in patients with moderate to severe ulcerative colitis…

They enrolled 771 patients with moderate to severe ulcerative colitis in the VARSITY study and randomly assigned them to receive 52 weeks of treatment with either vedolizumab or adalimumab…

They had failed other conventional therapies, including 25% in each group that had received an anti–tumor necrosis factor (TNF) agent…

  • 31.3% of vedolizumab recipients and 22.5% of those taking adalimumab were in clinical remission after 52 weeks (P=0.0061). Clinical remission was defined as a complete Mayo score of 2 or lower and no subscore greater than 1
  • Nearly 40% of patients who received vedolizumab achieved mucosal healing at 52 weeks, compared with 27.7% of adalimumab recipients (P=0.0005).

My take: This study provides a rationale for vedolizumab to be used as a first-line biologic agent for ulcerative colitis.

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What’s Going On in Patients with Reflux Who Fail Proton Pump Inhibitors

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A recent prospective study (J Abdallah et al. Clin Gastroenterol Hepatol 2019; 17: 1073-80) examined adults patients with documented reflux at baseline.  Patients who reported heartburn and/or regurgitation at least twice a week for 3 months (n=16) despite proton pump inhibitor (PPI) therapy were considered PPI failures. Those (n=13) who responded to standard dose PPI for at least 4 weeks were in the “PPI success” group.

Standard PPI dosing in this study:

  • Omeprazole 20 mg per day
  • Esomeprazole 40 mg per day
  • Pantoprazole 40 mg per day

Methods: Both groups (PPI Failure group, PPI Success group) underwent EGD and pH-MII studies. Abnormal acid exposure was considered if pH <4 was present for >4.2%.

Key findings:

  • 12 patients (75%) in the PPI failure group had either functional heartburn or reflux hypersensitivity
  • 4 patients in both groups had abnormal pH test result.
  • There was no statistically significant differences in the number of reflux events, acid exposure or nonacid reflux parameters between patients who failed or those who were successfully treated with PPIs.
  • In the PPI failure group: 25% had persistent GERD, 12.% had overlap with reflux hypersensitivity, and 62.5% had overlap with functional heartburn

My take: The difference between PPI failure and PPI success largely is due to the overlapping presence of functional esophageal disorders.

Related blog posts:

Royal Palace, Madrid

NAFLD Outcomes After Bariatric Surgery

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A recent systematic review and meta-analysis (Y Lee, et al. Clin Gastroenterol Hepatol 2019; 17: 1040-60) included 32 cohort studies with 3093 liver biopsy specimens from patients with nonalcoholic fatty liver disease (NAFLD).

Key findings:

  • Bariatric surgery resulted in a biopsy-confirmed resolution of steatosis in 66%, inflammation in 50%, ballooning degeneration in 76%, and fibrosis in 40%.
  • Bariatric surgery resulted in worsening features of NAFLD in 12%.
  • The authors note that Roux-en-Y Gastric Bypass (RYGB) “showed greater reduction of liver side effects and higher: resolution of NAFLD.”
  • Jejejnoileal bypass (JIB) and biliopancreatic diversion (BPD) “both have been associated with higher liver function morbidity.”
  • The overall GRADE quality of evidence was considered very low.

My take: Though better studies are needed, the majority of patients’ livers appear to benefit from bariatric surgery.

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Mucosal Eosinophilia –A Marker for Nonceliac Wheat Sensitivity?

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A recent prospective study (A Carrocio et al. Gastroenterol 2019; 17: 682-90) with 78 patients who were diagnosed with “nonceliac gluten or wheat sensitivity” (NCGWS) by double-blind challenge had duodenal and rectal biopsies collected and analyzed. More commonly NCGWS is referred to as NCGS.

Key findings:

  • Duodenal tissues from patients with NCGWS had hihger numbers of eosinophils than non-NCGWS controls as did rectal mucosa.  Other elevated markers included epithelial CD3+ T cells, and lamina proppria CD45+ cells.
  • Rectal mean eosinophil infiltrations was more than 2.5-fold the upper limit of normal and it was almost 2-fold increased in the duodenum.
  • Sensitivity and specificity of rectal eosionphilia, defined by >9 eos in the lamina propria) was 94% and 70% respectively.

My take: This study is intriguing but needs more confirmation. Overall, it appears that the frequency of NCGS is very low.

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Synagogue of Santa María la Blanca. Toledo Spain

Practice Tips for New IBD Therapies

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A recent review provides some helpful advice: “A Practical Guide to the Safety and Monitoring of New IBD Therapies” (B Click, M Regueiro. Inflamm Bowel Dis 209; 25: 831-42).

This review discusses infection risk, malignancy risk, immunologic issues and other complications.

In terms of infection risk assessment, the authors describe a pyramid in which they stratify the risks of medications.  The safest to least safe in their assessment: vedolizumab –>ustekinumab–>anti-TNF monotherapy–>thiopurine or tofacintinib–>thiopurine/anti-TNF combination–>steroids.

Their Tables:

  • Table 1 lists potential infections and vaccination recommendations
  • Table 2 suggests management of active infections by IBD Medication Class
    • For anti-TNF agents and for IL12/23 agents: the authors recommend continuation of agent if viral (eg EBV, VZV, HSV) or bacterial (eg. Strep/Staph)/C difficile infections (unless severe) but holding for opportunistic infections.
    • For integrin agents, the authors recommend continuation of medications in the face of infections except “consider holding dose” during active C difficile infection
    • For JAK agents, the authors recommend stopping during viral infections and with opportunistic infections.  They recommend continuing with bacterial infections (hold if severe) and continuing with C difficile infection
  • Table 3 suggests management in the setting of active malignancy
    • Table 4 lists recommendations in the setting of immunologic complications.  Theses categories include antidrug antibodies,lupus-like reactions, demyelinating conditions, and psoriasis.
    • One of the points alluding to in this chart is that addition of methotrexate may help in patients receiving anti-TNF therapy with psoriasis.
    • No psoriatic reactions have been reported with vedolizumab, ustekinumab or tofacitinib; ustekinumab is FDA-approved for use in psoriasis and tofacitinib is FDA-approved for psoriatic arthritis.
  • Table 5 suggests recommendations in the setting of altered liver enzymes and altered lipids/creatine kinase

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Antidepressants for Patients with IBD and Their (Beneficial) Affect on Bowel Disease Activity

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A recent population-based cohort study (MS Kristensen et al. Inflamm Bowel Dis 2019; 25: 886-93) indicates that antidepressants are likely to be beneficial for patients with inflammatory bowel disease and could lower disease activity in addition to improving mood.

This study population, n=42,890, with prospectively collected data comprised all patients in the Danish National Patient Registry from 2000-2017 with ICD diagnoses of ulcerative colitis (UC, 69.5%) or Crohn’s disease (CD, 30.5%).  Outcome measures included markers of disease relapse:

  • hospitalizations with IBD as primary diagnosis
  • surgery with IBD as primary operation code
  • step-up medications with corticosteroids or anti-TNF treatment

Key findings:

  • After adjusting for confounders, lower incidence rate of disease activity was found among antidepressant users than nonusers.
    • For CD, the incidence rate ratio was 0.75 (CI 0.68-0.82).
    • For UC, the incidence rate ratio was 0.90 (CI 0.84-0.95).
    • For CD patients without prior use of antidepressants before diagnosis of CD, there was markedly lower incidence rate ratio of 0.51 (CI 0.43-0.62).
  • 28% of the study population redeemed at least 1 prescription for an antidepressant at some point.  This is similar to a Finnish study in which antidepressant use in IBD was 28% compared to 19% in general population

The authors note that anti-depressants may affect the level of pro-inflammatory cytokines which are involved in the pathogenesis of IBD.  This study did not assess potential adverse effects of using anti-depressants.

My take: This study is intriguing and suggests that antidepressants may improve the disease course in IBD. Whether this is related to more favorable brain-gut interaction or whether this is related to drug effects on inflammatory agents is unclear.

Related blog post: Psychosocial Problems in Adolescents with IBD

Park Guell -Fantastic Park in Barcelona (need to buy a pass to get to some parts)

Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications/diets (along with potential adverse effects) should be confirmed by prescribing physician/nutritionist.  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.

 

Getting In the Shower for Emetic Symptoms

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A recent study (I Aziz et al. Clin Gastroenterol Hepatol 2019; 17: 878-86) examined the epidemiology and clinical characteristics of Rome IV functional nausea and vomiting disorders (FNVDs) in adults.  The study used internet cross-sectional health surveys from 5931 adults in 2015.

Key findings:

  • 2.2% of the population (n=131) fulfilled criteria for Rome IV FNVDs
  • Hot water bathing, which has been reported in cannaboid hyperemesis syndrome, was also noted  in patients with cyclic vomiting syndrome (CVS) in 44%.  “This behavior was independent of cannabis but augmented by its use.”

My take: FNVDs are common and hot water bathing is not pathognomonic for cannaboid hyperemesis syndrome.

Related references:

  1. Moon AM, Buckley SA, Mark NM. Successful treatment of cannabinoid hyperemesis syndrome with topical capsaicin. ACG Case Rep J. 2018 Jan 3;5:e3.
  2. Graham J, Barberio M, Wang GS. Capsaicin cream for treatment of cannabinoid hyperemesis syndrome in adolescents: A case series. 2017 Dec;140(6): e20163795.

Hotel in Barcelona