Dr Nicola Hanania: Patient, Clinician Collaboration Is Key to Choosing Optimal Biologic Therapy

Nicola Hanania, MD, MS, pulmonary critical care physician and director of the Airways Clinical Research Center at Baylor College of Medicine in Houston, Texas, presented a session at this year’s CHEST meeting, “Beyond the Guidelines: Choosing a Biological Agent in Children and Adults with Severe Th2 Asthma.” Here, he details what the presentation covers.

Transcript

How will “Beyond the Guidelines” address choosing biologic agents?

Over the years now, over the last few years, we’ve had an increasing number of biologics that are available for treating T2-high asthma. Of course, this is a major type of severe asthma. Approximately 60% of severe asthmatics have T2-high asthma.

The biologics we have really cover different aspects or targets. One targeting IgE [immunoglobulin E], which is omalizumab, has been there for a long time. The second group are targeting interleukin-5, or IL-5, which are marketed or approved for eosinophilic asthma. And the third one, the most recent is dupilumab, which started as an IL-4 receptor, and it is approved for eosinophilic asthma as well as for oral steroid–dependent asthma.

So for a clinician, like myself, when we are faced with patients with T2 asthma, we ask ourselves, which one do we choose? Because guidelines have certain strategies and recommendations based on clinical trials, which are very important. For example, an allergic asthma patient, early onset, may best respond to an anti-IgE if the IgE is within the range and allergen sensitization or skin testing is positive. But anti-IL-5 and anti-IL-4s also work in allergic asthma as well.

In patients with nonallergic eosinophilic asthma with very high blood eosinophils, anti-IL-5 agents would work best on these, especially if they have late-onset asthma with nasal polyps. These are some data from clinical trials. And then obviously with dupilumab, it's approved for atopic dermatitis and rhinosinusitis, so patients with eosinophilic asthma who have these qualities may best fit. So that’s in general what the guidelines say.

But beyond the guidelines, there are certain things that help us as clinicians to choose one biologic versus the other. Obviously, there’s quite a bit of overlap. And there are no good head-to-head studies to show one is better than the other, so we look at different things. We look at obviously the phenotype of the patient, the presence or absence of certain comorbidities, as I mentioned. We look at biomarkers. We look at feasibility of injections. A couple of these agents are approved to be given at home, at least 3 of them. Others are given in the clinic. We look at frequency of those. Some of them are every 2 weeks; others are every month. One of them is every 2 months. And we look at the patient’s preference. So that’s why shared decision-making is very important when it comes to biologics.

Not only that, the patient has to know this is not just a one-time deal; it’s a long-term process. So compliance is very important, especially with these drugs, which are not cheap. But also we like to know his or her opinion on what best works for him or her, especially when there’s quite a bit of overlap.

So this session will discuss these aspects. What do we learn from clinical trials? What do we learn from guidelines that are there based on these clinical trials? But also in real life, what should somebody look at to judge which biologic would work best for the patient?

Obviously, one other thing that I would like to touch base on that presentation, is that once you start a biologic, you have to give it time to work. And in general we like to see at least a 4-month time period before we decide the patient is not responding and we need to switch to a different biologic. That’s an important aspect to keep that in mind, not only by clinicians but also by the patients, because some patients are very impatient. They want to see a big dramatic response right away. Some of them do, but some of them may not have the best response in a week or month after starting injections.