I think that whatever article you were looking at (you didn't post a link or say the name so I can't comment on that article specifically) does not accurately represent what we know NOW in 2011 about
these risks. The following information is a summary of info that can be found at www.ibdwg.org. This is a website for physicians treating patients with IBD by the IBD Working Group. The IBD Working Group is a group of top researchers from around the world although most are from North America.
From 1998 - 2006 world wide 843,000+ patients (all patients including those with RA for example) are known to have received biologic infusions.
This is 2,565,567 patient years of data.
In the US 137,000+ adult IBD patients had received biologic treatment
13,500+ pediatric patients
27,000+ young adults (18 - 30)
The TREAT registry was created to prospectively track risks associated with use of biologics in IBD. It includes patients who are and are not receiving biologics.
Based on results of 20,000+ infusions the rate of serious infections is 4.6% which overall is 2% higher than in the placebo group groups.
The highest rates of infections were pneumonia (1.2%) and abscess (1%)
The TREAT registry has (to date) identified 3 factors associated with increased risk of infection. In order of increased risk these are:
Concommitant use of Steroids
Concommitant use of Narcotics
However, in 20,000 patient years of follow up there has been no statistically significant increase in mortality due to serious infections.
Per 100 patient years there is no statistically significant increased risk in mortality when you compare IBDers who are and are not on biologics.
There is a statistically significant increased risk in mortality associated with steroids and narcotic use.
There is NO increased risk associated with length of Remicade treatment.
There is no evidence that Remicade reactivates latent viruses.
The TREAT reigstry has found NO statistically significant increase in cancer so far in patients taking biologics.
A meta-analysis of large clinical trials found that the only statistically increased risk of death in IBD patients taking biologics is associated with the use of ..................
There is uncertainty and insufficient data about the degree of increased risk of a specific, extremely rare cancer in young men on Remicade. This cancer, HSTCL (a cancer that was only identified in 1990 and has had barely more than 100 cases diagnosed worldwide) is a virulent, hard to diagnose cancer. The "sense" as the IBD researchers put it, is that there is "something" going on here given how rare this form of cancer is. However, there is too little data available to figure out what is really going on and whether there is in fact an increased risk due to peds IBD, biologics or some other factor like what they eat or where they live or ???
These risks must be viewed in the context of the risks associated with untreated IBD and IBD treated at a less than optimal level.
These risks are very difficult to quantify because most patients whose IBD has been diagnosed are in fact receiving some level of treatment and whether that treatment is optimal is anybody's guess in a given case at a given point in time.
What can be said is that, in research published before the advent of biologics - that is published through 1989 - estimates of the rate of mortality among CD patients was twice that of the general population. More recent estimates have placed the risk of mortality to be around 1.4 that of the general population.
At this time, researchers have found NO increased risk of death among IBD patients who are using biologics. This would appear (please note I said "appear") to suggest that, in fact, biologics have REDUCED the risk of death among IBD patients who are using biologics.
It is true that we do not know the truly long term (20+ years) effects of the use of biologics for various lengths of time in various disease presentations. But the evidence so far does not suggest that there is any hugely increased risk of cancer, mortality or infection.
I personally am nervous about whether there will be long term effects among pediatric patients. We won't know that for a very long time and in the meanwhile we parents are faced with very hard choices.
I hope this information is helpful to you.
son now 15, dx CD age 10; current meds: MTX and omeprazole; previous tmts: pred, 6-MP, Humira, entocort, GMCS, exclusive enteral feeds, pentasa, mesalamine enemas, cipro, flagyl, many topical treatments for perianal disease
sister, late 40's, short bowel syndrome, TPN w/lipids and vits, severe malabsorption, poor fluid retention, severe complications from malabsorption including retinal damage.
Post Edited (rlsnights) : 1/31/2011 11:11:54 AM (GMT-7)