Is Inflectra (infliximab-dyyb) 560 mg intravenous infusion every 8 weeks medically indicated for a patient with Crohn's Disease without a documented negative tuberculosis test result within the past 12 months?

Infliximab (Inflectra) is NOT Medically Indicated Without Recent TB Screening

This patient cannot receive infliximab-dyyb (Inflectra) without documented negative tuberculosis testing within the past 12 months, as TB screening is an absolute prerequisite before initiating or continuing anti-TNF therapy.

Critical Safety Requirement: Tuberculosis Screening

The FDA label for infliximab products explicitly mandates TB testing before treatment initiation, stating: "Perform test for latent TB; if positive, start treatment for TB prior to starting [infliximab]. Monitor all patients for active TB during treatment, even if initial latent TB test is negative." 1

• All patients must undergo tuberculosis screening before receiving any infliximab product, as there is increased risk of serious infections including tuberculosis reactivation, which can be fatal 1
• The American Gastroenterological Association specifically recommends that "patients undergo purified protein derivative skin testing before treatment with infliximab" due to the risk of reactivating latent tuberculosis 2
• Clinical practice guidelines emphasize that patients with evidence of active infection should not receive infliximab until the infection is adequately treated, and all patients must be screened for tuberculosis prior to initiating therapy 3

Why This Requirement Cannot Be Waived

The risk of TB reactivation with anti-TNF therapy is substantial and potentially life-threatening:

• Infliximab carries a boxed warning for "increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections and infections due to other opportunistic pathogens" 1
• Case reports document tuberculosis developing in patients on anti-TNF therapy despite initial negative screening, with complications including immune reconstitution inflammatory syndrome (IRIS) upon treatment withdrawal 4
• The FDA mandates discontinuation of infliximab if a patient develops a serious infection 1

Clinical Documentation Requirements Before Treatment

Prior to administering infliximab, patients must have documentation of:

• Tuberculosis screening results (PPD or interferon-gamma release assay) within 12 months 5, 1
• Hepatitis B status assessment 5, 1
• Absence of active infection 5, 1
• Recent clinical assessment of disease activity 5

Efficacy of Infliximab for Crohn's Disease (When Safely Administered)

While the medication itself is highly appropriate for this patient's Crohn's disease, the safety prerequisites must be met first:

• The Canadian Association of Gastroenterology strongly recommends anti-TNF therapy (infliximab, adalimumab) for moderate to severe Crohn's disease, with high-quality evidence supporting its use 2
• The ECCO guidelines provide a strong recommendation for infliximab maintenance therapy at 5 mg/kg every 8 weeks in patients who achieved remission with anti-TNF agents 2
• The dosing regimen of 560 mg (approximately 5-10 mg/kg for most adults) every 8 weeks aligns with standard maintenance dosing 5, 1

Required Action Before Next Infusion

The prescribing gastroenterologist must:

1. Order and document tuberculosis screening (PPD skin test or interferon-gamma release assay such as QuantiFERON-Gold) 1, 3
2. Obtain negative results before administering the next scheduled infusion 1
3. If TB screening is positive, initiate latent TB treatment before resuming infliximab 1
4. Document this screening in the medical record as part of ongoing safety monitoring 5

Treatment should be held until TB screening is completed and documented as negative. The risk of serious infection, including potentially fatal tuberculosis reactivation, outweighs any benefit of continuing therapy without proper screening 1, 4.