The drug Infliximab can be used to improve quality of life for patients with IBD

Reference: Deboer, M.D., et al., Changes in Inflammation and QoL After a Single Dose of Infliximab During Ongoing IBD Treatment. J Pediatr Gastroenterol Nutr, 2012. 54(4): p. 486-90.

A study out of Virginia on the effect Inflixib on the effect of hormone growth and quality of life for patients with inflammatory bowel disease (IBD). 

Brief Summary: Infliximab is used in maintenance therapy for IBD. The main objective of this study was to investigate the drug’s effects on a number of outcome measures.  These outcome measures included the Pediatric Crohn's Disease Activity Index (PCDAI), High-sensitivity C-reactive protein (hsCRP), interleukin (IL)-6 (a hormone indicator), and quality of life (QoL) measured by a survey called the IMPACT 3.  The author’s recruited 24 subjects (ages 6 to 22) - 14 of those classified as symptotic (symptoms 4 days before the clinical visit) and 10 as asymptotic (no symptoms 4 days before clinical visit).  Measurements were taken on all the outcome variables at day 0 and day 14 of Infliximab treatment.

Results: Among those patients which were symptotic, a rapid decrease in levels of hsCRP after 2 days and an increase in quality of life scores resulted.  Particularly, for quality of life, emotional symptoms and social functioning were found to have a drastic benefit for the symptotic patients.   These results did not occur for patients which were asymptotic. 

Implications for Practice: For pediatric Chron’s patients who show a strong sign of symptoms (defined as presence of diarrhea, abdominal pain, or blood in stool), Infiximab can help with the maintenance of pediatric Chron’s patients.   This is particularly true for patients with high levels of hsCRP or showing impaired emotional symptoms or social functioning.   

Discussion: This is a good study showing the effects of Infliximab for pediatric patients.  It was interesting that the only quality of life indicators showing an improvement (for the symptotic patients) from day 0 to day 14 were emotional symptoms and social functioning, but the other quality of life indicators such as bowel symptoms, systematic symptoms, and body image did not show a significant improvement.   Particularly, I would be interested to see the direct effect of Infliximab on various clinical measurements from the bowel. 

Commentary on Statistics and Study Design: This is a prospective observational study.  As the author’s noted, an experimental study is really needed in order to elucidate precisely the cause and effect relationship between Infliximab and the various outcome measures.  However, this study can be a good lead-way into those experimental studies. 

Only 24 patients were recruited. However, this should be enough patients since only one variable is being measured on.  And for this purpose, the simple t-test statics utilized are ample to answer this question, since there does not seem to be any concern for any other extraneous or confounding variables which may also be correlated with the outcome measures. 

However, it would still be interesting to look at those extraneous or confounding variables. Particularly, I would be interested to see if there are any interaction effects at play here with Infliximab – especially with some of the symptomatic variables. For instance, it may be that the improvement for Infliximab is greater among patients with severe diarrhea vs. non-severe diarrhea.  To answer this question, you would need to setup an multi-variate regression model, and these are the types of interesting questions which could be exhausted in a study like this. 

A big thanks to our friends at UV for running this study.