Clinical Scorecard: Thresholds for Subcutaneous Infliximab in Inflammatory Bowel Disease Patients: Insights from the ENEIDA Registry
At a Glance
Category
Detail
Condition
Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis)
Key Mechanisms
Switching from intravenous infliximab (IV-IFX) to subcutaneous infliximab (SC-IFX) increases drug trough levels and maintains clinical remission
Target Population
IBD patients in clinical remission for at least 24 weeks on stable IV-IFX therapy
Care Setting
Multicenter IBD referral centers with outpatient follow-up
Key Highlights
Switching from IV-IFX to SC-IFX safely maintains long-term remission with 92% drug persistence at 52 weeks.
Optimal SC-IFX trough concentration thresholds associated with remission are approximately 12–13 μg/mL at Weeks 12 and 52.
Higher body mass index is associated with increased SC-IFX trough levels; immunomodulators and perianal disease do not affect trough levels.
Guideline-Based Recommendations
Diagnosis
Assess clinical remission using Harvey-Bradshaw Index (CD) and Partial Mayo Score (UC).
Monitor serum C-reactive protein and fecal calprotectin as biochemical markers.
Measure infliximab trough levels and anti-infliximab antibodies before switching and during follow-up.
Management
Switch from IV-IFX to SC-IFX at a dose of 120 mg every other week after IV induction.
Consider switching to SC-IFX to reduce hospital visits, improve patient convenience, and optimize pharmacokinetics.
Maintain SC-IFX trough levels above 12–13 μg/mL to support clinical and biochemical remission.
Monitoring & Follow-up
Evaluate clinical activity, CRP, fecal calprotectin, and IFX trough levels at baseline, Week 12, Week 24, and Week 52 post-switch.
Monitor for loss of response and adjust therapy accordingly.
Assess safety profile regularly; SC-IFX has demonstrated a good safety profile.
Risks
Potential loss of response if SC-IFX trough levels fall below 12 μg/mL.
No significant impact of immunomodulatory therapy or perianal disease on IFX levels, but consider BMI influence.
Patient & Prescribing Data
IBD patients (Crohn’s disease and ulcerative colitis) in clinical remission on IV-IFX
Switching to SC-IFX increases drug trough levels, maintains remission, and offers convenience with a favorable safety profile and high treatment persistence.
Clinical Best Practices
Ensure patients are in stable clinical remission for at least 24 weeks before switching from IV-IFX to SC-IFX.
Use standardized clinical indices (HBI, PMS) and biomarkers (CRP, fecal calprotectin) to monitor disease activity.
Target SC-IFX trough levels of approximately 12–13 μg/mL to optimize remission maintenance.
Consider patient BMI when interpreting IFX trough levels.
Educate patients on self-administration to reduce hospital visits and improve adherence.
by Marisa Iborra, Berta Caballol, Alejandro Garrido, José María Huguet, Francisco Mesonero, Ángel Ponferrada, Lara Arias García, Marta Maia Boscá Watts, Samuel J Fernández Prada, Eduard Brunet Mas, Ana Gutiérrez Casbas, Elena Cerrillo, Ingrid Ordás, Lucía Ruiz, Irene García de la Filia, Jaime Escobar Ortiz, Beatriz Sicilia, Elena Ricart, Eugeni Domènech, Pilar Nos
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