Continuation of Renflexis (Infliximab) for Ulcerative Colitis with Rectal Bleeding
Yes, continuation of Renflexis (infliximab) is medically necessary for this patient with ulcerative colitis and rectal bleeding, particularly given the dose intensification from Q8 to Q4 weeks, which indicates inadequate disease control requiring optimization of anti-TNF therapy. 1, 2
Rationale for Continuation
Evidence Supporting Maintenance Therapy
Long-term maintenance treatment is recommended for almost all patients with ulcerative colitis to maintain steroid-free remission. 1
The ACT 1 study demonstrated that at Week 54, sustained response rate was 39% (versus 14% placebo) and sustained remission rate was 20% (versus 6% placebo) with infliximab 5 mg/kg maintenance therapy. 1
Discontinuing infliximab while continuing immunomodulators results in significantly higher relapse rates (31.5% versus 11.2% with combination therapy), with a relative risk of 2.35 for relapse. 1
The goal of maintenance therapy is to maintain steroid-free remission, defined both clinically and endoscopically. 1
Addressing the Clinical Uncertainty
The patient's uncertainty about whether improvement is due to infliximab or steroids actually supports continuing infliximab, as:
Steroid-free remission rates in patients receiving corticosteroids at baseline were modest but statistically significant: 24% at Week 54 with infliximab versus 10% with placebo. 1
The primary therapeutic goal is achieving steroid-free remission, not determining which agent caused initial improvement. 1
Patients responding to infliximab should continue infliximab therapy with or without thiopurines to maintain remission. 1
Dose Intensification from Q8 to Q4 Weeks
The change from Q8 to Q4 weeks dosing is clinically appropriate and supported by guidelines:
For patients with incomplete response, consideration may be given to treating as often as every 4 weeks, though risk of serious infections increases at higher doses. 2
The British Society of Gastroenterology 2025 guidelines support dose escalation guided by lack of optimal response and/or therapeutic drug monitoring, which is embedded in routine clinical practice. 1
Accelerated dosing regimens are beneficial in patients not responding adequately to standard dosing, particularly in steroid-refractory disease. 1, 3
Impact of Missed Infusion
The missed infusion does not negate the need for continuation; rather, it emphasizes the importance of consistent maintenance therapy. 1
Interruption of infliximab therapy can lead to loss of response and increased risk of infusion reactions upon re-treatment, particularly without concomitant immunosuppressant therapy. 2
Re-treatment following disease flare carries higher risk of serious infusion reactions (4% versus <1% with continuous maintenance). 2
Critical Considerations
Concomitant Steroid Therapy
Steroids should be progressively tapered and discontinued once clinical response to infliximab is achieved. 1, 4
The presence of rectal bleeding indicates ongoing active disease requiring continued biologic therapy. 1, 5
Long-duration corticosteroid use (>30 days) without infliximab is associated with increased infection risk compared to short-duration steroid plus infliximab. 1
Monitoring Requirements
Therapeutic drug monitoring should be considered to optimize infliximab dosing, particularly given the dose intensification. 1, 3
Stool inflammatory markers (calprotectin) provide quantitative measures of inflammation and can guide treatment duration. 1, 5
Endoscopic evaluation may be necessary to assess mucosal healing, as endoscopic remission correlates with improved clinical outcomes and longer duration of remission. 1
Safety Considerations
Prior to continuing infliximab, patients should be evaluated for active tuberculosis and tested for latent infection. 2
The risk of serious infections is present but must be balanced against the risk of uncontrolled disease and potential colectomy. 1, 2
Approximately 3% of patients discontinued infliximab due to infusion reactions in clinical trials. 2
Common Pitfalls to Avoid
Do not discontinue infliximab prematurely based on uncertainty about which medication caused improvement; the goal is steroid-free remission. 1
Do not maintain patients on long-term steroids while questioning the efficacy of infliximab; this increases infection risk without addressing underlying disease. 1
Do not delay dose optimization in patients with inadequate response; the Q4 week dosing change indicates appropriate clinical management. 1, 2
Avoid sequential therapy with multiple rescue agents (e.g., adding cyclosporin after infliximab) as this carries profound immunosuppression risks. 1