How am I doing? How are we doing? It all depends.
Notes from the Director
Frederick Wolfe, MD
If you have arthritis or some of the similar conditions we ask about, you know that these are chronic problems. Research doctors want to know how people with these conditions are doing – how well treatments work on average. But you and your doctor might be more interested in how you, yourself, are doing. A treatment might work well for most people, but not for you. This group vs. individual issue is the kind of problem that you see discussed in the media frequently when the FDA removes a drug from the market because it ‘doesn’t work. ’ Yet some people who take the treatment have good results and are unhappy with the FDA decision.
Recently I received an email from an NDB participant who was concerned that an NDB study found that biologic treatment of RA didn’t work as well in NDB participants as it appeared to work in clinical trials. She had had a superb response to one of the biologics, and wondered whether what we found could be true.
Her experience reflected the same group vs. individual problem: An individual may do better or worse than average.
But, how treatments work on average is a way to compare one treatment to the next.
In RA, one way to compare treatments is to study how well treatments lead to remission. Remission means the illness goes away, either permanently or temporarily. If a pharmaceutical company is testing a new treatment, then the percent of people who go into remission can be a good indication of how effective the treatment can be. And your doctor would certainly want to know if you are in remission – doing as well as possible. In some trials of biologic treatments remission has been noted in 50% of patients receiving the treatments. That’s an extraordinary result. In effect it means that half the people are cured. Is that too good to be true? Yes it is.
Physicians have come up with a variety of definitions for remission, and recently a committee of researchers from the US/Canada and Europe has proposed a new “official” definition – the ACR/EULAR definition. You are in remission from your RA if you have no more than one swollen joint, no more than one tender joint, you rate the overall severity of your RA 10 or less on a 0-100 visual analog scale (VAS - take a look at severity question in the
NDB questionnaire to get a better idea about the question), and your sedimentation rate blood test is low (below 30 for women and 20 for men). Before this definition became available there were a number of others.
We looked at remission using this definition in more than 1,400 people being treated by community rheumatologists (not in clinical trials or research settings). We found the
ACR/EULAR rate to be about 6%. That’s very different from the 50% quoted above. But in case you think we got it wrong, several researchers in different countries in
Europe found the same rate as we did. How could it be that there are such great differences? Well, it all depends on how you define remission. We found that when we tested with the widely used DAS criteria (Disease Activity Score) the remission rate was 27%, 4-5 times greater. More than that, the
ACR/EULAR criteria agreed with the DAS criteria in only 20% of cases. And when doctors were asked about remission they also agreed with the ACR/EULAR criteria in just 20% of the cases.
You might ask, with such discrepancy, does assessing remission make sense? Yes. We need an official definition to help understand how people with RA are doing. But remission criteria and how you are doing are not necessarily the same thing.
One of the problems with the ACR/EULAR assessment is your overall assessment of the severity of your RA. If you have pain in your back or difficulty moving because of damage to a joint, you may rate your overall severity as more than is allowed by the new criteria, even though your RA may be completely inactive. What kind of definition allows this type of contradiction? A definition that considers “groups of patients” rather than one patient. When assessing groups of patients, an average score of how they are doing is good enough because it doesn’t matter if there are a few mistakes. But it would be wrong to apply this definition to an individual person with RA. Insurance companies often make this mistake as they try to assess whether a drug works and should be continued.
We at the NDB are constantly working on the problem of determining how well people with rheumatic diseases are doing. We have developed several fibromyalgia scales now in wide use to assess severity. Some of the scales are just for groups, but the newest ones that are included in the Diagnostic Criteria for Fibromyalgia can be used in individuals. We also aided in development of scales for Lupus over the last two years. As always, thanks for your help and participation. You, the group of individuals, make it possible.