Criteria to Determine Treatment Efficacy in RA

Nehad Soloman, MD: Thank you Joy, for those insights. Certainly, we know if we continue along the path of ineffective, or only partially effective treatments, that could lead to organ damage; we don’t want to see that. Do you feel like during everything you must navigate, whether it’s from the pairs or from the patient, their compliance or noncompliance or perhaps even limitation by the tools that we have to measure disease activity? Do you feel like there’s more risk in continuing these therapies and that disease progression that could happen if we don’t take on a higher stance? I remember when I trained over 20 years ago, we didn’t measure CDAIs [Clinical Disease Activity Index] yet; it wasn’t a thing to do, it was based on a gestalt. Do you think a lot of our colleagues are using that gestalt? Or do you think many have now sort of progressed? This is for either one of you—progressed to using more defined tools to measure?

Robert Levine, MD: I’ll take this one. I think the uptake on measuring something has increased but by no means is it universal at this point. We see big variability in some sticking with not measuring everything, anything and going with gestalt. That really becomes a problem when the patient has lots of complaints and yet their joint count is 0 and they have a comorbidity of fibromyalgia, for example. Their own pain scores might be quite high, but our assessment of the patient is their treatment is working and it’s effective. We have to really look at the objective measures to try to help us sort through. It doesn’t sort through all of that because there are patient-reported outcomes in our composite scores. I think that we need to look at all these factors in terms of patients and how our assessments match. I know that I measure a CDAI, I do a Rapid3. We have lots of PROs that we measure. We actually have a way that we can visually show those over time to our patients and so in helping to get them onboard in terms of agreeing to change therapy. If you show them that their scores are going up, that can help when you’ve decided that and getting them onboard to agree to change their therapy. One other comment, a couple other comments. I think that the formulary constructions don’t follow the science. That’s a problem that we face, and we really need to address. I think it’s pretty clear that the science says, if a patient has failed due to lack of efficacy of a certain mechanism of action [MOA], especially if it’s a primary lack of efficacy where they never got anything out of it, that going to a second of the same mechanism of action is just a waste of time and we shouldn’t be doing that. If it’s a secondary lack of efficacy—maybe it was antibody production or immune degradation that the patient’s immune system—maybe changing to a second of the same MOA, such as a TNF, might make sense. Then there’s the adverse event of failures, as well. That’s obvious if you don’t change the mechanism of action, you may not get the same adverse event. You might be able to use your same MOA to get effectiveness. The formulary constructions are not based on science. They’re based on economics and that is profit. How much profit can the PBM [pharmacy benefit manager] get from a certain medication that is preferred? I think that’s a driver in a lot of our frustration and our patient frustration in being able to get access to the right medication at the right time. Getting the best outcome possible.

Nehad Soloman, MD: I agree.

Joy Schechtman, DO: I would agree, too.

Nehad Soloman, MD: I think one of the things that a wise man once said: You can’t effectively manage anything unless you measure something, and how you’re doing it. Hopefully, many of our colleagues are jumping on the bandwagon and measuring something. It may not be uniform; at least measuring something consistently.

Robert Levine, MD: I think we’re seeing that. I think there have been growing numbers of us who are measuring something and who are using those measurements to make treatment decisions and change therapies. Instituting this has allowed me to have something more objective to hang my hat on and decide this patient isn’t responding right and we need to move on.

Joy Schechtman, DO: I think the patients appreciate it when we’re measuring something, as well. They know that we’re using sort of objective criteria. By using some of those objective criteria, it helps them to see the validity of what they’re doing. They’re living inside their bodies, and they can’t always see what we see from the outside. Our goal and our target are to prevent further damage to limit disability. If we know there’s significant radiological damage, for example, that leads to disability with that patient, and many of our patients within 10 years of their diagnosis of rheumatoid arthritis are disabled. Our goal is to keep them working, keep them enjoying their lives with their families, being able to meet their potential as a human being. I think if they understand some of that and we can show them that objective data, they are more responsive when we want to make changes.

Transcript edited for clarity