Is J2327 medically indicated for a patient with Crohn's disease of the large intestine without complications switching from Infliximab?

Medical Indication for J2327 (Infliximab) in Crohn's Disease of Large Intestine

Yes, J2327 (infliximab) is medically indicated for this patient with Crohn's disease of the large intestine (K50.10) who is switching from infliximab, though the clinical rationale for switching from infliximab to infliximab requires clarification—if this represents a switch to a biosimilar infliximab, it is supported by guidelines; if switching between different anti-TNF agents is intended, alternative biologics would be more appropriate.

Clinical Context and Indication

The scenario appears to involve either:

1. Switching to biosimilar infliximab (most likely interpretation)
2. Continuing infliximab therapy after prior exposure
3. Potential coding/documentation clarification needed

If Switching to Biosimilar Infliximab

The British Society of Gastroenterology strongly recommends that patients already on originator infliximab can be switched to biosimilar infliximab if in stable response or remission (strong recommendation, moderate-quality evidence) 1. This switching should remain a clinical decision made by the physician and patient on an individual basis supported by scientific evidence 1.

• The NOR-SWITCH trial demonstrated non-inferiority of biosimilar infliximab (CT-P13) over 52 weeks, with 26% experiencing disease worsening with originator infliximab versus 30% with biosimilar 1
• Automatic substitution is inappropriate—all changes must be made with full agreement and supervision of the prescribing physician 1
• The confidence interval was close to inferiority for CT-P13 specifically in Crohn's disease, though overall non-inferiority was maintained 1

If Continuing Infliximab After Prior Exposure

Infliximab is strongly recommended for moderate to severe Crohn's disease, including colonic disease, in patients who have not responded to conventional therapy 1. The Canadian Association of Gastroenterology provides a strong recommendation for anti-TNF therapy (infliximab, adalimumab) as first-line therapy in patients with moderate to severe luminal Crohn's disease with risk factors of poor prognosis (strong recommendation, moderate-quality evidence) 1.

• In patients with Crohn's disease who have achieved symptomatic response with anti-TNF induction therapy, continued anti-TNF therapy is strongly recommended to achieve and maintain complete remission (strong recommendation, high-quality evidence) 1
• The standard induction regimen is infliximab 5 mg/kg intravenously at weeks 0,2, and 6 1, 2

Critical Considerations for This Case

Assessment of Prior Infliximab Response

If the patient previously lost response to infliximab, switching within the anti-TNF class is generally not recommended 3. The guidelines suggest:

• For secondary loss of response or intolerance to infliximab, switching to ustekinumab or vedolizumab is strongly recommended rather than another anti-TNF agent 3
• Switching within the anti-TNF class is not appropriate for paradoxical reactions, requiring a mechanism switch instead 3
• The British Society of Gastroenterology suggests against switching between anti-TNF therapies in patients who are doing well on anti-TNF therapy (conditional recommendation, low-quality evidence) 1

If Patient Had Adequate Response Previously

Patients in clinical remission under infliximab who require treatment modification should preferentially continue infliximab or switch to biosimilar rather than discontinue 4. The SPARE trial demonstrated:

• 2-year relapse rates were 14% in patients continuing combination therapy versus 36% in those withdrawing infliximab 4
• Withdrawal of infliximab resulted in significantly higher relapse rates (HR 3.45,95% CI 1.56-7.69, p=0.003) 4
• Of patients who relapsed after infliximab withdrawal and were retreated, 22 of 23 achieved remission again 4

Combination Therapy Considerations

The European Crohn's and Colitis Organisation provides a strong recommendation for combination therapy with thiopurines when starting infliximab (strong recommendation, moderate-quality evidence) 1, 2.

• Infliximab combined with purine analogues is probably more effective than purine analogues alone for clinical remission at weeks 24-26 (RR 1.92,95% CI 1.59-2.32; moderate-certainty evidence) 5
• The American Gastroenterological Association suggests combination therapy with thiopurines when starting anti-TNF therapy to induce complete remission (conditional recommendation, low-quality evidence) 1
• Combination therapy reduces antibody formation, acute infusion reactions, and delayed hypersensitivity-like reactions 6, 7

Response Assessment Requirements

All IBD patients should be reviewed 2-4 weeks after completing loading doses of anti-TNF therapy to assess response and optimize maintenance dosing 1. Assessment should include:

• Clinical response evaluation between weeks 8-12 after initiating induction therapy 1, 2
• Serum drug and anti-drug antibody concentrations 1
• Blood inflammatory markers (CRP) and fecal biomarkers (calprotectin) 1, 3
• Endoscopy if uncertainty exists about disease activity 3

Common Pitfalls to Avoid

• Do not automatically substitute biosimilar without physician and patient agreement 1
• Do not switch to another anti-TNF agent if the patient had paradoxical reactions or true treatment failure to infliximab—switch to a different mechanism (ustekinumab or vedolizumab) instead 3
• Do not delay combination therapy—starting thiopurines concurrently with infliximab is more effective than adding them later 2
• Do not continue infliximab without objective assessment of disease activity if the reason for switching is unclear 1

Documentation Requirements

For medical necessity, documentation should clearly indicate:

• Reason for switching (biosimilar conversion vs. treatment optimization vs. other)
• Prior response to infliximab (if applicable)
• Current disease activity status
• Presence or absence of complications
• Whether patient is in remission or has active disease requiring induction therapy

The medical indication is supported provided the switch represents either biosimilar conversion in a stable patient or continuation/reinitiation of infliximab in a patient with appropriate clinical indication and no contraindications to anti-TNF therapy 1.