Sarcopenia as a Predictor of Anti-TNF Non-Response in Crohn’s Disease
| Nik Ding
© Nik Ding
Aim of Research
- To demonstrate that sarcopenia, myopenia and body composition parameters are associated with lower anti-TNF drug levels and primary non-response in patients with moderate to severe Crohn’s Disease who are anti-TNF naive.
- To demonstrate that sarcopenia is a biomarker of primary non-response (PNR) and secondary loss of response (SLR) to anti-TNF therapy.
- To demonstrate that sarcopenia/myopenia is a biomarker of primary non-response (PNR) to anti-TNF therapy due to inadequate anti-TNF dosing by use of therapeutic drug monitoring.
- To demonstrate that improvement of sarcopenia/myopenia increases anti-TNF drug levels and clinical response to anti-TNF drugs.
The hypothesis is that sarcopenia is predictive of low anti-TNF drug levels and possible primary non-response to anti-TNF therapy, and, in addition, that sarcopenia is a predictor for primary non-response and loss of response to anti-TNF therapy which correlates with anti-TNF levels at weeks 4 and 12.
There will be two arms of this study:
- Prospective cohort study (80 patients) – to validate findings that myopenia is associated with primary non-response to anti-TNF therapy due to associations with anti-TNF levels through MRI, DEXA and assessment of hand-grip strength. We will measure anti-TNF levels at weeks 4 and 12 to determine whether there is a correlation between myopenia or other body composition parameters and anti-TNF level as well as clinical response.
- A sub-cohort (10 patients) who are identified as sarcopenic will undergo strengthening exercises via the physiotherapy department and dietitian support with imaging before and after these measures to assess body composition and impacts on anti-TNF drug level as well as clinical response.
All patients within the study will be identified from the St Vincent’s Hospital Crohn’s database. Sarcopenia will be assessed from initial CT and MRI scans and the results correlated with prospectively collected data.
This study will be completed within 12–24 months to allow for study data collection and analysis.