I’m not going to go into too much detail here; a lot of this was quite technical.  But the major point is that you have to have standardized ways to assess whether or not a drug works for a disease.  When you have complicated multi-system diseases like RA, this can be especially complicated.  If you do a study of RA, should your primary outcome be whether a subject has fewer swollen joints?  Or feels better in general?  Should you ask the doctor if he/she thinks the subject looks better?  Should you look at whether the subject is more functional?  It’s hard, and in early RA trials investigators used all of these.  Unfortunately that makes it very hard to compare trials.  If one investigator uses one measure in one study, and one uses another in another study, which of the two drugs they’re studying is better?  Maybe it’s just the measure they used.

So for the past 10 years we’ve been using a measure known as the ACR20, which is basically a conglomerate of standardized measures that we can all use as a single primary outcome measure.  It’s been very successful and has actually been a model in many other disciplines of clinical medicine in how to standardize an outcome that can be used across clinical trials.

But it has its flaws.  I won’t go into them all, but the major thing is that it’s no longer powerful enough.  What I mean by this is that as RA drugs have gotten better, the measure hasn’t kept up.  So many drugs now get patients into an ACR20 state that’s it’s once again hard to compare studies.

So it’s being updated.  This is exciting. The ACR20 was a very important and successful model.  And now it’s being improved.  And it’s great fun to be here to see our field progress like this.  What once was an improvement is no longer good enough.  That’s a sign that we are being successful in finding better treatments for our patients.

The second presentation in this session was about the development of similar measures for inflammatory myopathies like polymyositis and dermatomyositis.  These are diseases of muscle where the muscles break down due to inflammation and people slowly lose strength until they no longer breath – very scary!   It’s been especially difficult to develop standardized definitions and response criteria because we rheumatologists are not the only ones who treat it – so do neurologists and dermatologists.  So it took some coordination to get everyone talking to each other.  But it’s happening.

Once again, a good session.  I watched it with my old mentor from the Semi-urban UMC.  It was kind of fun.  I’ve learned a lot about these kinds of studies and was actually able to teach him a little about this stuff!

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