Biologics for Treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Anju Peters, MD: Let’s move on to the biologics, which have, in my mind, have been one of the biggest changes recently for CRS with nasal polyps. Let's talk about the different biologics that are approved for patients with nasal polyps. If you guys wouldn't mind go a little bit about the efficacy and safety data of these medications. In which patients you would use biologics, and some of the challenges, and we'll split this up a little bit. The challenging part we'll let Naveen answer in the end. Dareen, why don't we have you talk a little bit about mepolizumab and then omalizumab.

Dareen Siri, MD, FAAAAI, FACAAI: Perfect. We have this wonderful generation of biologics. Very precise medications that target the specific inflammatory cytokines that we are concerned about. Certainly, starting off with the initial, the top of the slide, with mepolizumab. From the CYNAPS studies we know, at least with these outcomes, many of these studies enrolled very similar patients to start off. Their patients are typically with severe symptoms, obviously polyps that are at least moderate to severe in nature, and then they typically also were on maintenance medications, usually mometasone nasal spray. There weren't monotherapy patients they had additional therapies that they could use. And certainly, in most of them the patients, just like an EDS-FLU trial, they were considered potentially surgical candidates as well. In mepolizumab those patients, have had an intervention in the past, but their results showed, as you know mepolizumab being aisle 5 antagonist, a point improvement in nasal polyps and you can see the data there. There was a significance between placebo and mepolizumab, and you can see there those asthma subgroups and AERD subgroups, which are significant. What’s nice to think about some of the medications being that, because we think of these patients with eosinophil inflammation, type 2 inflammation. Then certainly some of these medications may target some of those other common diseases. And I'm sure Drew has some comments in some of those AERD patients. The next one being omalizumab, and certainly with their clinical trials, a very similar reduction. Maybe in about the same range I would say in their polyp one and polyp 2 studies, also studied at 24 weeks and again, also looking at the reduction of nasal polyps. I'll let Drew talk about dupilumab.

Andrew White, MD: Thanks Dareen. Dupilumab is another biologic that has indication for asthma, polyps, and a few other indications. It binds to the aisle 4 receptor alpha sub-unit. It effects signaling through aisle 4 and aisle 13, which are both real important cytokines in type 2 diseases. There were the 2 registry studies for dupilumab for polyps, one was a 24-week study and the other was a 52-week study. Very similar in the study design. It was dupilumab versus placebo. And this is an injection that is given every 2 weeks. The outcomes were congestion and polyp score as the primary outcome. And both studies met those primary end points. You can see listed there's this reduction in the polyp score, and these are listed here, but this isn't meant to be comparing one study to the other because they are done differently and with different patient populations, but the end result is that this treatment definitely showed a lot of effectiveness, also improvement in quality of life with the stock 22 score and improvement in sense of smell, which is another really bothersome symptom for these patients.

Anju Peters, MD: Thank you Drew.

Transcript edited for clarity