Considering the Role of Corticosteroids for COPD

Peter L. Salgo, MD: I want to circle back, just a little, and talk about inhaled corticosteroids (ICS). They’re out there in the community. Everybody knows about them. They’re prescribed a lot. Is there a role, in COPD management, for inhaled corticosteroids? Or, is it just for asthma? What are the guidelines saying? For example, what is data from FLAME saying about inhaled corticosteroids?

James F. Donohue, MD: Well, the role of triple therapies is being diminished by 2 pivotal studies. FLAME was a head-to-head comparison, first non-inferior, and then superior, on the prioritization of Seretide, which is the British Advair, and Ultibro, indacaterol plus glycopyrronium. The LABA and LAMA combination was more effective at reducing all exacerbations, including moderate and severe, than the ICS LABA. So, that was sort of against the grain. We did know that LAMAs were pretty effective. Tiotropium has an indication against exacerbations. But this study really kind of put it as superior, and that would enable you to reduce the risk of pneumonia, perhaps, by reducing the steroid.

The second study looked at a great many group of severe patients and others on triple therapy, LABA/LAMA/ICS. In this study, there was a withdrawal of the ICS. They wanted to know, “How did you do?” Well, it turns out that they did pretty well. There was no escalation in exacerbations by taking away the steroids. But there was some loss of lung function. However, subgroup studies were done. This is where those that had 3% and 4% peripheral eosinophilia, or a total count of around 300 cells per cubic mm, had trouble. So, that brought us back into, then, that eosinophil question that Frank has just raised.

Peter L. Salgo, MD: I want to come back to eosinophils, but when you are talking about non-inferiority studies and then superiority studies, this doesn’t really make inhaled corticosteroids look very good. In fact, there’s some morbidity to corticosteroids. What do you do when a patient comes to you, who is already on triple therapy? Do you take them off the steroid?

James F. Donohue, MD: You know, I don’t do too much. One of the principles of being a doctor, for many years, is that when the patient comes in, you sort of leave them alone if they’re doing good. That’s a pretty good policy to follow.

Peter L. Salgo, MD: What’s this WISDOM trial?

James F. Donohue, MD: The WISDOM trial was a study where people who were on triple therapy, LABA/LAMA/ICS, were weaned off the ICS. It was an excellent study. It had a big number of patients with an adequate time coming off the treatment for 52 weeks. What it showed was that there was no increase in exacerbations in people in whom the steroid was discontinued versus those who stayed on triple therapy. But when they did a subgroup analysis, it turned out that the patients that had 3% and 4% peripheral eosinophilia, or a total of 300 cells per cubic mm, had more exacerbations. So, clearly, withdrawing from triple therapy down to dual therapy could be tried and probably should be tried, but not everyone is going to flourish. And, maybe based on some of the points that Frank made about that allergic eosinophilia group, one would be cautious.

Peter L. Salgo, MD: I have been avoiding this eosinophilic issue until right now. What is going on? Why do these patients, in a subgroup, have eosinophilia? What does that tell you?

Fernando J. Martinez, MD: We have to understand that the role of ICS is evolving. There’s a large study, that just read out, that showed that ICS did pretty well. There’s another large study, that’s ongoing, that’s testing 2 different doses of combination inhaled steroids. I think part of what we’ve realized is that steroids have been overused. I think all of us accept that as correct. And so, all of us are now in a quandary trying to figure out, if they’re overused, when are we going to use them? And, when are we not going to use them? There are some components that are very practical. If I come to see you, Dr. Sciurba, and I’m your COPD patient and I had pneumonia on my inhaled steroid 3 months ago, and I’m doing pretty well now, would you consider ICS withdrawal in that setting?

Frank C. Sciurba, MD, FCCP: I would.

Fernando J. Martinez, MD: Because that’s clearly a risk factor that’s associated with inhaled corticosteroids. If I had significant osteoporosis, would you have concerns regarding keeping the patient on inhaled corticosteroids, long-term?

Frank C. Sciurba, MD, FCCP: I’d have to have a good reason to continue them.

Fernando J. Martinez, MD: Dr. Sciurba is synthesizing information regarding risk-benefit, realizing that there is some risk involved. And so, I think all of us realize that we start personalizing those combinations and therapeutic approaches, and we are making decisions based on some of the risk components.

Transcript edited for clarity.