What do professional GI (Gastrointestinal) society guidelines recommend regarding non-medical switching of biologics for Inflammatory Bowel Disease (IBD) after a patient achieves clinical remission?

Professional GI Society Guidelines on Non-Medical Switching of Biologics for IBD in Clinical Remission

Professional gastroenterology society guidelines recommend against non-medical switching of biologics for IBD patients who have achieved clinical remission, particularly emphasizing that enforced intravenous to subcutaneous switching is not recommended. 1

Current Guideline Recommendations

British Society of Gastroenterology (BSG) Guidelines

The BSG provides clear guidance regarding non-medical switching of biologics:

• Enforced intravenous to subcutaneous switching is explicitly not recommended 1
• Non-medical switching from originator to biosimilar should remain a clinical decision made by the physician and patient on an individual basis 1
• Automatic substitution is deemed inappropriate, as all changes should be made with full agreement and supervision of the prescribing physician 1

Switching Considerations in Clinical Practice

When considering any switch in biologic therapy for IBD patients in remission, guidelines suggest:

1. Annual review of biologic therapy: NICE technology appraisals recommend annual review of patients on biologics to assess safety and efficacy of long-term treatment 1

2. Medical vs. Non-medical switching:

   • Medical switching may be appropriate for addressing tolerability issues, adverse events, or patient convenience 1
   • Non-medical switching (when a clinically stable patient is switched for cost reasons) requires careful consideration 1

3. Biosimilar switching:

   • Scientific evidence is lacking for multiple switching and cross-switching between biosimilars 1
   • The effect on safety, efficacy, and immunogenicity with multiple switches is not well established 1

Monitoring After Any Switch

If a switch does occur (whether medically indicated or not), guidelines recommend:

• Assessment 2-4 weeks after switching to evaluate response 1
• Monitoring through serum drug and anti-drug antibody concentrations 1
• Evaluation of inflammatory markers, fecal biomarkers, or endoscopy 1

Special Considerations

Italian Group for IBD and Italian Society of Rheumatology Recommendations

For patients with IBD and associated spondyloarthritis:

• In case of secondary non-response or intolerance to one anti-TNF, consider dose escalation or switching to another anti-TNF 1
• JAK inhibitors can also be considered in appropriate cases 1

Common Pitfalls to Avoid

1. Ignoring immunogenicity risks:

   • Patients who form antibodies to one biologic may be more prone to forming them to a second 1
   • Consider combining the second biologic with immunomodulator therapy to reduce antibody formation risk 1

2. Failing to measure drug levels before switching:

   • Many studies on switching measure drug and anti-drug antibody concentrations before switching 1
   • This identifies patients with low drug levels and/or antibodies who probably should not switch 1

3. Nocebo effect:

   • Up to 90% of symptoms attributed to biosimilar switching resolve after switching back to originator, suggesting nocebo effects rather than true clinical differences 1

4. Overlooking persistence data:

   • Recent data shows significant differences in persistence rates between different biologics, which should be considered when making switching decisions 2

By adhering to these guidelines, clinicians can make appropriate decisions regarding non-medical switching of biologics in IBD patients who have achieved clinical remission, prioritizing patient outcomes and minimizing risks of disease relapse.