Keep the Stool Cool for More Reliable Calprotectin

A recent study (S-M Haisma et al. Arch Dis Child http://dx.doi.org/10.1136/archdischild-2018-316584) shows that stool calprotectin levels stored at room temperature dropped nearly 20% after one day and dropped further over several days compared to baseline values, whereas calprotectin values remained reliable over six days for stool specimens stored at 4 degrees Celsius.

The authors conclude: “Calprotectin is not stable at room temperature. Children with IBD and their caretakers may be falsely reassured by low calprotectin values. The best advisable standard for preanalytical calprotectin handling is refrigeration of the stool sample until delivery at the hospital laboratory.”

Full text (link from KT Park’s twitter feed): Calprotectin instability may lead to undertreatment in children with IBD

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Likelihood of Opioid Dependency If Opioid Given During an IBD Flare

According to a recent study (Full Link: MR Noureldn, PDR Higgins et al. Aliment Pharmacol Ther. 2019;49:74–83. Incidence and predictors of new persistent opioid use following inflammatory bowel disease flares treated with oral corticosteroids), and with the limitation of using an insurance database –Key Findings:

  • 5411 (35.8%) were opioid‐naïve patients (mean age 43.9 yrs) of which 35.0% developed persistent opioid use after the flare
  • Factors associated with new persistent opioid use include a history of depression (hazard ratio [HR] 1.29, 95% confidence interval [CI] 1.13‐1.47), substance abuse (HR 1.36, 95% CI 1.2‐1.54), chronic obstructive pulmonary disease (COPD) (HR 1.17, 95% CI 1.04‐1.3), as well as, Crohn’s disease (HR 1.26, 95% CI 1.14‐1.4) or indeterminate colitis (HR 1.6, 95% CI 1.36‐1.88)

My take: As noted in previous blog (Increased Narcotic Usage in Pediatric Patients with IBD), opioid usage is an issue with pediatric IBD patients as well, particularly in those with associated depression and/or anxiety.

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AntiTNF Therapy Associated with Reduced Surgical Resections

Full text: Increased prevalence of anti‐TNF therapy in paediatric inflammatory bowel disease is associated with a decline in surgical resections during childhood JJ Ashton et al. Alim Pham Ther 2019; https://doi.org/10.1111/apt.15094

From absract:

Design: All patients diagnosed with PIBD within Wessex from 1997 to 2017 were assessed. The prevalence of anti‐TNF‐therapy and yearly surgery rates (resection and perianal) during childhood (<18 years) were analysed

Results: Eight‐hundred‐and‐twenty‐five children were included (498 Crohn’s disease, 272 ulcerative colitis, 55 IBD‐unclassified), mean age at diagnosis 13.6 years (1.6‐17.6), 39.6% female. The prevalence of anti‐TNF‐treated patients increased from 5.1% to 27.1% (2007‐2017), P = 0.0001. Surgical resection‐rate fell (7.1%‐1.5%, P = 0.001), driven by a decrease in Crohn’s disease resections (8.9%‐2.3%, P = 0.001)…

Patients started on anti‐TNF‐therapy less than 3 years post‐diagnosis (11.6%) vs later (28.6%) had a reduction in resections, P = 0.047. Anti‐TNF‐therapy prevalence was the only significant predictor of resection‐rate using multivariate regression (P = 0.011).

Conclusion: The prevalence of anti‐TNF‐therapy increased significantly, alongside a decrease in surgical resection‐rate. Patients diagnosed at younger ages still underwent surgery during childhood. Anti‐TNF‐therapy may reduce the need for surgical intervention in childhood, thereby influencing the natural history of PIBD.

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FDA Approves Adalimumab Biosimilar -But Will Enter U.S. Market in 2023!

October 31, 2018: FDA Approves Sandoz’s Biosimilar Adalimumab, Hyrimoz

An excerpt:

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz). 

The drug has been approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis…

Despite today’s approval, US patients will have to continue to wait for access to Hyrimoz, as the biosimilar will not enter the US market until 2023. Earlier this month, Sandoz announced a global settlement of patent disputes with AbbVie over the drug. While the settlement allowed Sandoz to launch Hyrimoz in the European Union on October 16, 2018, it forestalled US market entry until September 30, 2023. 

My take: Why will this biosimilar be allowed in Europe but not U.$?

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Big Biosimilar Study

Briefly noted: A Meyer et al. Ann Intern Med. 2018. DOI: 10.7326/M18-1512

Abstract link: Effectiveness and Safety of Reference Infliximab and Biosimilar in Crohn Disease: A French Equivalence Study

In this study with 5050 patients, based on review of an administration database, the authors found the following:

  • In multivariable analysis of the primary outcome, CT-P13 (biosimilar) was equivalent to infliximab reference product (RP) (HR, 0.92 [95% CI, 0.85 to 0.99]). 1147 patients in the RP group and 952 patients in the CT-P13 group met the composite end point (including 838 and 719 hospitalizations, respectively).
  • No differences in safety outcomes were observed between the 2 groups: serious infections (HR, 0.82 [CI, 0.61 to 1.11]), tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]), and solid or hematologic cancer (HR, 0.66 [CI, 0.33 to 1.32]).

The authors conclude that “real-world data indicates that the effectiveness of CT-P13 is equivalent to that of RP for infliximab-naive patients with CD.”

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Another Reason For HPV Vaccine –Prevention of Anal Cancer

Briefly noted: A recent study (L Vuitton et al. Clin Gastroenterol Hepatol 2018; 16: 1768-76) document a high prevalence of anal canal high-risk human papillomavirus (HPV)  infection in all subjects (n=469, median age 54 years) and even higher rates in patients with Crohn’s disease (n=70).  The authors detected HPV DNA in anal tissues from 34% of the subjects and high risk (oncogenic) HPV in 18%.  In patients with Crohn’s disease, high risk HPV was detected in 30%.

My take: HPV infection predisposes to anal cancer which represent 3-4% of lower-digestive tract cancers. The high rate of HPV

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