checklist

Vaccination and systematic work-up to consider before introducing immunomodulators or biologic therapy

1.1. Detailed interview

Ideally the medical history should cover:

  • History of bacterial infections (especially urinary tract infection)
  • History of fungal infections
  • Risk of latent or active tuberculosis:
    • date of the last BCG vaccination
    • potential contact with patients having tuberculosis
    • country of origin, or prolonged stay in an area endemic for tuberculosis
    • history of treatment for latent or active tuberculosis
  • History of varicella-zoster virus infection (chickenpox/ shingles)
  • History of herpes simplex virus infection
  • Immunisation status for hepatitis B
  • History of travel and/or living in tropical area or countries with endemic infections
  • Future plans to travel abroad to endemic areas.

1.2. Physical examination

General physical examination best includes a search for features that often pass without comment, because they are of minor significance in people who are generally healthy, but which may have substantial implications when immunosuppressed:

  • Systemic or local signs of active infection (including gingivitis, oral or vaginal candidiasis, or intertrigo as features of fungal infection)
  • Cervical smear.

1.3. Laboratory tests

Many opportunistic infections are preventable and the potential for severe infection during immunosuppression can be ameliorated if thought is given to identifying risks before starting immunomodulator therapy. Ideally, baseline tests, potentially performed at diagnosis, should include:

  • Neutrophil and lymphocyte cell count
  • C-reactive protein
  • Urine analysis in patients with prior history of UTI or urinary symptoms
  • Varicella zoster virus (VZV) serology in patients without a reliable h/o of varicella immunisation
  • Hepatitis B virus serology
  • Human immunodeficiency virus (HIV) serology after appropriate counselling
  • Eosinophil cell count, stool examination and strongyloidiasis serology (for returning travellers).

1.4. Screening for tuberculosis

Screening for tuberculosis should be considered before using high dose corticosteroids or immunomodulators other than anti-TNF therapy, although it is considered mandatory for the latter group.

  1. Clinical context of risk (gathered from a detailed history, above)
  2. Chest radiograph within 3 months of starting therapy
  3. Interferon gamma release assay.

If any of the above 1, 2 or 3 is positive, the patient should be referred for assessment  to a specialist with an interest in TB. If IGRA is indeterminate or equivocal, it could be repeated after 2-3 weeks and if still indeterminate or equivocal- the patient should be referred for assessment to a specialist with an interest in Tb

1.5. Vaccination

Vaccines are best given before introduction of immunomodulators therapy. Consideration could reasonably be given to a vaccination programme at diagnosis of IBD, since around 80% of patients will be treated with corticosteroids, 40% with thiopurines and 20% with anti-TNF therapy.

As in the general population, the immunisation status of patients with inflammatory bowel disease should be checked and vaccination considered for routinely administered vaccines: tetanus, diphtheria, poliomyelitis. In addition, every patient with IBD should be considered for the five following vaccines, ideally at diagnosis for the reasons above:

  • VZV varicella vaccine (if there is no medical history of chickenpox, shingles, or VZV vaccination and VZV serology is negative
  • Human papilloma virus
  • Influenza (trivalent inactivated vaccine) once a year
  • Pneumococcal polysaccharide vaccine
  • Hepatitis B vaccine in all HBV seronegative patients.

Vaccines for patients on immunomodulators travelling in developing countries or frequently travelling around the world should be discussed with an appropriate specialist.

1.6 Other precautions

  • Exclude Pregnancy
  • Contraception during and 5 months (for Humira) after stopping the treatment- if pregnant need to report to Manufacturer’s registry.
  • Not to breast feed (breast feeding is a contraindication for biologics)
  • Monitor FBC/LFT/Urea electrolytes every week for a month, then twice monthly and then monthly
  • Previous history of neurological disease (caution should be exercised when using biologics for patients with h/o CNS demyelinating disorders)
  • Previous history of cancer
  • H/o Cardiac failure (biologics are contraindicated in moderate to severe heart failure, exercise caution with mild heart failure)

Ref:

http://www.ecco-ibd.eu/images/stories/docs/guidelines/oi_eccoconsensus.pdf

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