Long Term Biologic Efficacy

Published on: 

Kristi V. Mizelle, MD, MPH, FACR comments on long term efficacy data on the use of biologics in lupus, with a focus on preventing organ damage.

Anne E. Winkler, MD, PhD, MACP: Regarding fatigue, which is key because it’s very hard for us to measure this very subjective complaint. And one of the things about the IV biologics or sub-Q biologics we now have available, is that for most of our patients who end up getting on those, their fatigue seems to get quite a bit better. At least that’s been my experience. Sometimes we don’t always see that with our immunosuppressants. That the fatigue which we may not realize is as significant a problem as the patients realizes in terms of functioning on a daily basis, particularly because we’re talking about a lot of young women who may be working full-time and raising a family. That takes a lot of energy, I can tell you.

Kristi V. Mizelle, MD, MPH, FACR: Even without Lupus.

Anne E. Winkler, MD, PhD, MACP: Without Lupus. That’s right. Exactly right. Since we mentioned belimumab, there’s been some long-term data in terms of how patients do when they’ve been on belimumab for a long period of time, at least in terms of SCI or SLE damage index. Do you want to talk about that in terms of what you feel about that data?

Kristi V. Mizelle, MD, MPH, FACR: This is, again, a shift within the rheumatology community in regard to outcomes we’re discussing. I feel like this shift happened with a remission probably a couple of years ago when there was a lot of information coming out in trials about remission. Which prior to that we talked about it, but it wasn’t feasible, etc. And we’re at the place now with SLE. Now the interesting thing is that yes, we’re starting to talk about remission. That discussion is a little farther off when it comes to Lupus, honestly. But the conversation that’s more in front of us now is how do we prevent damage long term. And there’s a couple of things that are very important in preventing that. One is early and quick diagnosis. Nothing beats that. The earlier and the quicker you diagnose, the better chance you have to get patients on therapy to prevent damage. Another thing that speaks to the SDI, and it being elevated in patients who have delayed diagnosis, is also we have to make sure that when we do make that diagnosis that we are assertive with treatment. We don’t want to play around with drugs that are mild if patients truly have moderate level disease or severe disease. We don’t want to do that. We want to quickly get patients on the standard therapy, which is at least an anti-malarial, and I’d go very quickly with an immunosuppressant if patients are coming in with at least moderate level disease. We don’t play around because the longer that we wait to escalate medications to an appropriate level based on disease activity, the more time there is for damage to occur. And in one of Dr Urowitz’s [Murray B Urowitz], papers looking at the Toronto Lupus cohort, that when you look at standard therapy and then you compare that, you’re doing matching with other patients that are on a biologic plus standard of care, the damage was greater in those who were on just standard of care in those first 5–10-year time frame. It’s important to understand that standard of care is probably not enough, and that we need to be thinking more and more about how do we prevent damage long term, And that’s where these biologics are coming in similar to how they came in with rheumatoid arthritis, in that patients were also on low dose steroids for a number of years plus immunosuppressants without necessarily complete disease control, and that biologics actually helped bridge some of that gap so that prednisone was not needed so often, or corticosteroids were not needed so often, and you could get patients under good control with a fairly decent adverse effect profile. And now I feel like we’re in that same similar scenario with Lupus and damage and getting patients under good control quickly, so that we can prevent that. And that the biologics that we have now available are going to be helpful in getting us to that place that we’ve already gotten to with rheumatoid arthritis.

Transcript Edited for Clarity