New Sunovion data at ATS 2019 shows expected trends of comorbidity effect on patients, and surprising results of care between men and women.
Thomas H. Goodin, PhD
It has been a full year since glycopyrrolate inhalation solution (Lonhala Magnair) became the first US Food and Drug Administration (FDA)-approved nebulized long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD).
Now, Sunovion Pharmaceuticals is delving into deeper analyses to understand the specific COPD patient population, and how their 25 mcg twice-daily LAMA could fit as a potentially personalized therapy. At the American Thoracic Society (ATS) 2019 International Meeting in Dallas, TX, the company is presenting a series of data highlighting their findings.
In the first part of an interview series with MD Magazine®, Thomas H. Goodin, PhD, senior director of Clinical Development at Sunovion, described what the company’s new research shows in relation to COPD comorbidities and gender disparities.
MD Mag: Regarding comorbidities in COPD, could you highlight where assessments were made, and what are their clinical significances?
Goodin: GOLDEN 3 and GOLDEN 4 were a couple of the key pivotal trials supporting registration of Lonhala Magnair. We did a post hoc analysis. These patients with COPD are highly complex—it’s very rare to find a patient in the doctor’s office with only COPD. They tend to present with other comorbidities. And when we looked at our pivotal patient population, we did a median analysis and found the breakpoint at 3.
When you cut down that discriminating line, you find things the comorbidities common in COPD—hypertension, high cholesterol, osteoarthritis, reflux disease, depression, obesity, anxiety—are in themselves difficult to manage. And now you have an overlay of these on top of COPD.
But the percentage differences are quite striking: hypertension is in 30% versus 75% in patients with <3 comorbidities than patients with ≥3 comorbidities. Osteoarthritis was 14% versus 38%, high cholesterol was 19% versus 71%. With these statistics, it gives you a good feel that not only are the comorbidities present, they likely contribute to the interpretation of the disease and what the doctor sees in terms of lung function. In the 2 groups, function was generally similar, meaning you would see a drug performing as expected per the label. But it’s when you get to the symptom scores, there’s a difference.
You see in the patients with lower comorbidities do generally better on symptom scores. Our drug is a bronchodilator, so it opens up the airway and helps you breathe better. What happens when you have comorbidities, they themselves engender some feeling to the patient about how they feel. So when they’re asked these questions, they respond not only because of what’s happening to their respiratory condition, but because some of the comorbidities may be influencing their decisions.
Are we seeing a significant disparity in COPD state and care across genders?
The answer is that we’re continuing to build on data that’s been generated. Virtually every bronchodilator that goes to the FDA for the treatment of COPD has a component of regulatory submission that involves gender analysis. People are taking their data on various products and looking at gender rates.
It’s somewhat important, because there’s a rise of COPD in women that’s occurring in the last several years. And women tend to report their symptoms differently than men. They tend to be more overt in their reporting. There’s also some anatomic differences in women, in terms of lung size and airway size. That’s just a body size attribute across males and females.
One of the interesting findings here in our poster was yes, the drug provided effective bronchodilation—the airways were opened, pulmonary function improved—but we found a surprise in the symptom response. The females ended up doing a little bit better, which goes against the literature that they tend to be more overt in reporting their symptoms.
Now, some of this data is due to functioning variability at baseline. This is post hoc analyses. But in terms of being able to have the exact numbers to balance the head-to-head statistics in a post hoc analysis, you’re somewhat dependent on what the overall pivotal trial showed. So there is some variability presented on the poster.
We got a little bit surprised by our own reporting, but the big takeaway here is the similarities in lung function improvement and no safety differentials between males and females. What this data does is build on other data coming out from other groups. Gender is something that, when a doctor has someone come in, there’s something about being male or female that might be important to know in selecting the best medicine.