An overview of a presentation by Associate Professor Gert van Assche from Leuven University Hospital, Belgium, at the Raising Expectations in Gastroenterology symposium, 2010.

Clinical benefit of infliximab

Data from a cohort of 614 patients at the Leuven University Hospital has provided insight into long-term outcomes and practical issues in the management of patients with Crohn's disease. The data was collected at a time when episodic treatment in response to symptomatic relapse was more common than regular, scheduled maintenance treatment.
The primary response rate to infliximab was 89%. The annual risk of not responding or not tolerating therapy was approximately 6%.1

In a cohort of 183 initial responders to infliximab therapy, complete mucosal healing (MH) was observed in 45.4% and partial healing in 22.4% of patients. In addition:2

  • MH was more common in those treated with scheduled vs episodic infliximab (76.9% vs 61.0%, p= 0.0222)
  • MH was associated with a significantly reduced need for major abdominal surgery vs no MH (14.1% vs 38.4%, p<0.0001)
  • Scheduled treatment was associated with reduced requirement for surgery vs episodic treatment (9.3% vs 22.4%, p=0.040)
  • Concomitant treatment with corticosteroids reduced the healing rate vs no corticosteroid treatment (37.9% vs 63.2%, p=0.021)

Long-term infliximab was shown to be "very efficacious" and changed disease outcomes by decreasing the rate of hospitalisation and surgery. Almost two-thirds of patients maintained clinical benefit 60 months after therapy was commenced. However, there was an overall decline in the proportion of patients that maintained clinical benefit over time.1

Antibody formation

The immunogenicity of biological therapy is an important issue in treatment. It should be noted that antibody formation is not limited to infliximab – immunogenicity was likely to be a significant factor in the declining response rate observed in a Leuven patient cohort treated with adalimumab.3 In this study, 58% of patients had a sustained clinical response at 60 weeks without the need for a dose escalation, declining to 20% at 120 weeks. Drug discontinuation was associated with low adalimumab trough serum concentrations, which were observed more frequently in patients who developed antibodies against adalimumab.3

Safety profiles

The long-term safety of infliximab in IBD was evaluated in a comparison of 734 Leuven patients treated with infliximab and 666 control patients not treated with infliximab. No significant difference was observed between the infliximab and control groups in the rates of severe adverse events (p=0.45), mortality, malignancy or infection. Concomitant treatment with corticosteroids was an independent risk factor for infections in patients receiving infliximab (odds ratio 2.69, p=0.018).4

Summary

  • Long-term anti-TNF therapy is efficacious and can change disease outcomes
  • Immunogenicity is a practical issue that is common to anti-TNF biologic therapies
  • Infliximab has a good long-term safety profile

Please note, the views expressed in this article are not necessarily those of the sponsor.

References

  1. Schnitzler F et al. Long-term outcome of treatment with infliximab in 614 patients with Crohn's disease: results from a single-centre cohort. Gut 2009; 58: 492–500.
  2. Schnitzler F et al. Mucosal healing predicts long-term outcome of maintenance therapy with infliximab in Crohn's disease. Inflammatory Bowel Diseases 2009; 15: 1295–1301.
  3. Karmiris K et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology 2009; 137: 1628–1640.
  4. Fidder H et al. Long-term safety of infliximab for the treatment of inflammatory bowel disease: a single-centre cohort study. Gut 2009; 58: 501–508.

REMICADE® (infliximab) PBS INFORMATION. Crohn's disease: This is listed as a Section 100 item.

Acute Severe Ulcerative Colitis: This is listed as a Section 100 item [Public Hospital Authority Required (Streamlined); Private Hospital Authority Required]. Please refer to PBS Schedule for full authority information.

Chronic Refractory Ulcerative Colitis: Not listed on the PBS.

Please refer to Product Information before prescribing. Full product Information is available here. Further information is available on request from Janssen-Cilag.

®Registered Trademark of Janssen-Cilag Pty Ltd. ABN 47 000 129 975. 1–5 Khartoum Road, Macquarie Park NSW 2113. Tel: 1800 226 334. AU-REM0178. McCann Health REM0165. Date prepared: April 2014.

PBS information: This product is listed as a Section 100 item for Crohn’s disease and ulcerative colitis. Refer to PBS Schedule for full authority information.

Please refer to Product Information before prescribing. Full product Information is available here. Further information is available on request from Janssen-Cilag.

®Registered Trademark of Janssen-Cilag Pty Ltd. ABN 47 000 129 975. 1–5 Khartoum Road, Macquarie Park NSW 2113. Tel: 1800 226 334. AU-REM0178. McCann Health REM0165. Date prepared: April 2014. Updated: September 2015.