Continuation of Infliximab (Remicade) for Crohn's Disease in Remission
Yes, continuation of infliximab therapy is medically necessary for this patient with Crohn's disease who has achieved quiescent disease status. The Canadian Association of Gastroenterology provides strong recommendation with high-quality evidence that patients who have achieved symptomatic response with anti-TNF induction therapy should continue anti-TNF therapy to achieve and maintain complete remission 1.
Primary Justification for Continuation
The most recent and highest quality guideline evidence strongly supports maintaining infliximab therapy in patients who have achieved remission. The 2025 British Society of Gastroenterology guidelines explicitly state that routine withdrawal of infliximab therapy is not suggested after 1 year of stable remission in Crohn's disease, as discontinuation is associated with an elevated risk of relapse of approximately one in three patients in the first 1-2 years 1.
Key Clinical Evidence Supporting Continuation
This patient demonstrates excellent disease control: no abdominal pain, normal bowel habits (2-3 formed stools/day), MR enterography showing no evidence of active IBD, normal inflammatory markers (hemoglobin 15, sedimentation rate 18), therapeutic infliximab levels (22.9 μg/mL with no antibodies), and fecal calprotectin of 10 1
The physician's global assessment confirms quiescent disease status, which meets the Aetna criteria for continuation: the patient has achieved and is maintaining remission with improvement in abdominal pain, diarrhea, hematocrit, and mucosal appearance on MRE 1
FDA labeling supports maintenance therapy: Infliximab is indicated for "inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease," with recommended dosing of 5 mg/kg every 8 weeks for maintenance 2
Evidence Against Discontinuation
Stopping infliximab in patients with remission carries significant risk. The British Society of Gastroenterology guidelines report that even with at least 6 months corticosteroid-free clinical remission and with biochemical and endoscopic remission, anti-TNF withdrawal is associated with relapse in approximately 33% of patients within 1-2 years 1.
Additional Risks of Discontinuation
Loss of response upon re-treatment: While re-treatment with infliximab after relapse is usually successful, treatment failure may be higher, and antibody formation can occur 1
This patient has penetrating Crohn's disease phenotype, which represents more aggressive disease requiring sustained therapy to prevent complications 1
Dosing Appropriateness
The requested regimen of 5 doses every 8 weeks is standard evidence-based maintenance therapy. The landmark ACCENT I trial established that infliximab 5 mg/kg every 8 weeks maintains remission more effectively than placebo, with median time to loss of response of 38 weeks versus 19 weeks 3. The Canadian Association of Gastroenterology recommends against switching between anti-TNF therapies in patients who are doing well on current therapy 1.
Therapeutic Drug Monitoring Supports Current Dosing
The patient's infliximab trough level of 22.9 μg/mL is well above the therapeutic target of 3-7 μg/mL for maintenance therapy, with no antibodies detected 4
No dose adjustment is indicated as the patient maintains complete remission on standard 8-week dosing 1
Medical Necessity Determination
All Aetna continuation criteria are clearly met:
- Patient is using infliximab for moderately to severely active Crohn's disease (penetrating phenotype) and has achieved remission 1
- Improvement from baseline in abdominal pain (resolved severe pain), diarrhea (stable normal bowel habits), hematocrit (normal at 42.5), and mucosal appearance on MRE (no evidence of active IBD) 1
The concern about receiving the same office visit note should not preclude approval when the clinical documentation clearly demonstrates sustained remission with objective evidence including recent imaging (MRE from recent date), laboratory values, therapeutic drug levels, and physician assessment of quiescent disease 1.
Common Pitfalls to Avoid
Do not discontinue therapy based solely on achieving remission: This contradicts high-quality guideline evidence showing increased relapse risk 1
Do not require biosimilar switching in stable patients: Guidelines recommend against switching biologics in patients doing well on current therapy 1, 4
Do not interpret "quiescent disease" as indication to stop therapy: Quiescent disease is the therapeutic goal that maintenance therapy aims to sustain 1