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Session 2: What experts say about biologics for severe asthma

MDlinx Oct 09, 2024

Biologics in Asthma session 2, a follow-up to Monday’s crowd-favourite, Biologics in Asthma session 1, expanded on the undoubtedly hot topic, looking at biologics in special circumstances, as well as background therapies and duration of use.

Here are some of the key takeaways from the discussion:

 

Biologics may help patients come off background therapies

 

Dr Khurana asked everyone in the room if they prescribed biologics to patients, leading to a resounding Yes!

She then asked the room if they had trouble getting biologics renewed because insurance requires patients (who may not want to or need to) to continue filling their maintenance inhalers.

To explore that conundrum, Dr. Khurana referenced a randomized phase 4 2024 Lancet study (spanning 22 study sites in four countries) which focused on dose reductions for Benralizumab.

“92% of patients reduced high-dose ICS and more than 60% could get to anti-inflammatory reliever therapy as needed. And the majority remained exacerbation-free,” Dr. Khurana said.

 

 

The findings could eventually lead to a meaningful win for clinicians and their patients, as long-term corticosteroid use is risky: “This is great data and guides us in trying to see if we can start heading down on the expense and burden of background therapy,” Dr. Khurana noted. 

 

 

Patients may not have to be on biologics forever

 

Dr. Khurana discussed the OPTIMAL study, which also looked at dose titrations in biologics.

Voices from the floor

But just how long should a patient remain on a biologic, especially as data has found “a gradual but variable loss of control after treatment cessation”? This study aimed to find a dose-titration algorithm in patients who did achieve remission in anti-IL-5 biologic. The findings? “Most patients could increase time duration between biologics, and one in five could come off biologics altogether,” Dr. Khurana said.

“I think this is going to result in a paradigm shift—and provide guidance on how to manage these patients.” rather than patients having to be stuck with a needle for life.

 

Difference between efficacy and effectiveness data

 

Effectiveness data is meaningful. According to the National Library of Medicine, “Efficacy trials (explanatory trials) determine whether an intervention produces the expected result under ideal circumstances. Effectiveness trials (pragmatic trials) measure the degree of beneficial effect under “real world” clinical settings.”

Voices from the floor

This difference is meaningful, says Linda Rogers, MD, FCCP.  “We need to [also] look at how the drug behaves in the real world…as opposed to in trials,” Dr Rogers says, pointing to the fact that most patients wouldn’t even be eligible to take part in studies owing to stringent efficacy requirements.

She then cited a 2023 study which found that one in five patients achieved four-domain remission within one year of biologic initiation. “Patients with less severe impairment and shorter asthma duration at initiation had a greater chance of achieving remission after biologic treatment, indicating that biologic treatment should not be delayed if remission is the goal,” the study found. 

This real-world study—reflecting how biologics perform clinically—revealed a lot, Dr. Rogers said. “It tells us we may be starting [biologics] too late. Some patients may be in bad shape. And so it’s a nice example of how the real world teaches us.”

Biologic use in pregnancy, obesity, and dual therapy Allergist Syed Shahzad Mustafa, MD discussed the use of biologics in “special circumstances.” The key takeaways:

  • Biologics are generally safe for pregnant women: There isn’t lots and lots of data, he says, but biologics are considered okay for pregnant and breastfeeding patients. “Asthma is a risk factor for poor outcomes in pregnancy and we don’t want to disrupt progesterone homeostasis (which corticosteroids do),” he says. The point? “We have safe medicines, like biologics, for pregnant patients.” He also says women of childbearing age (not just pregnant patients) should be considered for biologics. “A lot of asthmatic patients are younger and of childbearing age, so it’s a conversation we should be having sooner versus later when they’re already pregnant,” Dr. Mustafa said. He says that “shared decision making” between clinician and patient is key here.

  • Biologics may work in obese patients: “We’ve been taught that adipose tissue is steroid resistant. Not so much so. It increases steroid clearance. The bang you get for your buck is lower in people with higher BMI,” and there are mixed reviews on how certain biologics (like Omalizumab) perform in obese patients, but that doesn’t mean it won’t work for those patients. Dupilumab, for example, seems to be effective for patients with obesity. “The general takeaway is that these biologics are likely to maintain efficacy in individuals with high BMI.”

  • Dual biologic use seems to be well-tolerated: Dr. Mustafa said that dual biologic use, especially biologics with different targets seem to be ok, although more data is needed. “This comes up for patients with need for TNF inhibitors,” he says. “It’s well tolerated. It’s reassuring, but there’s a lot more to learn.”

Lastly, Dr. Mustafa reminded the room that cutting back on steroid use is important: “I’m as guilty of prescribing steroids as anyone,” Dr. Mustafa says—but MDs, he says, need to reflect on the concept of “steroid stewardship,” as steroids impact bone health.  “It’s really easy to get  to over 1000 milligrams of prednisone,” he says, but it’s important to reduce use. Calling on biologics earlier is a good idea, he reminds the room.

 

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