Checklist to start biological therapy in IBD

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Patients with a IBD (Inflammatory Bowel Disease) moderate to severe phenotype and/or with risk factors for a worse prognosis, once elected for advanced therapy with biologics, should undergo preparation for the start of treatment safely.

This stage involves the evaluation of 3 pillars:

  • Check if there is a relative or absolute contraindication to the use of such medications;
  • Screening for active or latent infections;
  • Updating vaccination status

Regarding contraindications or signs of greater attention to the use of biologics, we have:

  • Severe ongoing infection, including perianal abscess;
  • Untreated latent tuberculosis (a period from the start of treatment should be awaited to start the biologic, preferably a non-anti-TNF);
  • Decompensated CHF or EF ? 35% (absolute contraindication to anti-TNF);
  • History of severe previous infusion reaction to biologics;
  • Multiple sclerosis or other demyelinating diseases; optic neuritis; previous lymphoma (in these conditions anti-TNF has an absolute contraindication, the others weigh risk x benefit);
  • Current malignancy;
  • Decompensated liver disease (cirrhosis Child B or C);
  • Untreated chronic infection by the hepatitis B virus;
  • Uncontrolled HIV infection;
  • History of melanoma (absolute contraindication to anti-TNF) or recurrent cervical dysplasia (relative contraindication to anti-TNF)

The next step is to carry out the infectious screening, which includes:

  • Chest X-ray;
  • PPD and/or IGRA (interferon gamma release test);
  • Serologies for hepatitis B, C and HIV (also consider adding screening for measles, CMV, varicella zoster and Epstein-Barr – note that primary EBV infection in immunosuppressed patients increases the risk of lymphoproliferative diseases, in this scenario caution should be exercised when prescribing associated thiopurines);
  • In the presence of diarrhea, exclude the presence of Clostridium difficile as a mimicking agent;
  • In the female population, colpocytology is also recommended for HPV infection screening.

The screening for latent TB should be renewed annually while the patient is using the biologic, especially if it is of the anti-TNF class, as we know how much TNF-alpha is crucial for granuloma stability.

In the case of patients with PPD ? 5mm, or IGRA + or sequelae on chest X-ray suggestive, first the treatment of latent TB should be started and only start the biologic after 30 days from the start of treatment.

Patients with HBsAg + or with isolated anti-HBc + should receive antiviral therapy during the use of biologics or oral immunosuppressants. In the first case, the treatment time will be guided by liver disease. In the second case (hidden infection), for at least 6 months after the end of treatment (if applicable).

Vaccination status

Regarding the vaccination schedule, inactivated vaccines are extremely safe and indicated for all patients with IBD, and ideally should be administered at least 2 weeks before the biologic, so as not to compromise the vaccine response. The attenuated vaccines are contraindicated for patients who are already using immunosuppressants or biologics, or who are planning to start such medications in the next 4 to 6 weeks. They can only use attenuated vaccines after 3 months of suspension of such medications (if applicable).

The inactivated vaccines to be considered in patients with IBD are: Influenza, Pneumococcal, Tetanus/Diphtheria (Adult Double), Meningococcal, Hepatitis A, Hepatitis B (including possibly making 4 double doses aiming for anti-HBs >10), HPV, COVID-19. Recently, the recombinant inactivated herpes zoster vaccine was also launched, allowing use to patients in immunosuppression or planning to start biologics, unlike the vaccine available until then which was attenuated virus.

Reinforcing, the attenuated vaccines that should not be done in the scenario of immunosuppressed patients are: MMR (measles, mumps and rubella), varicella, yellow fever and the older version of the herpes zoster vaccine composed of live attenuated virus.

References:

  1. T. Kucharzik et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. Journal of Crohn’s and Colitis, 2021, 879–913
  2. Chebli JMF et al. Preparing Patients With Inflammatory Bowel Diseases For Biological Therapies In Clinical Practice. Journal of Gastroenterology and Hepatology Research 2018; 7(2): 2535-2554
  3. Beaugerie et al. Predicting, Preventing, and Managing Treatment-Related Complications in Patients With Inflammatory Bowel Diseases. Clinical Gastroenterology and Hepatology 2020;18:1324–1335
  4. S. Riestra et al. Recommendations of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU) on screening and treatment of tuberculosis infection in patients with inflammatory bowel disease. Gastroenterología y Hepatología 44 2021 51—66
  5. R. Ferreiro-Iglesias et al. Recommendations of the Spanish Group on Crohn’s Disease and Ulcerative Colitis on the importance, screening and vaccination in inflammatory bowel disease patients. Gastroenterología y Hepatología 45 (2022) 805—818

How to cite this article

Vilela PBM, Check-list to start biological therapy in IBD Gastropedia 2023, Vol 2. Available at: gastropedia.com.br/sem-categoria/check-list-para-iniciar-terapia-biologica-na-dii/