Jacqueline Ross, MD, a physician at Allergy Partners of New Jersey.

Jacqueline Ross, MD

This episode, "Tapering Inhalers and Initiating Biologics Earlier in Severe Asthma," features the panel closing on two unresolved practical questions.

Tapering Inhalers and Initiating Biologics Earlier in Severe Asthma

Dr. Chupp asks Dr. Hanania whether he tapers inhalers in patients on biologics, noting the SHAMAL results were dramatic but ran under a year, that most remission data are observational, and that controlled studies suggest perhaps 20% reduce inhaled steroids versus controls. Dr. Hanania says patients announcing they stopped their inhalers freaks him out, partly because insurers want documented inhaler compliance. He reduces the dose but does not stop inhaled steroids completely, noting SHAMAL met its primary endpoint but raised lung function concerns in those who came off entirely, over a period he considered too short. He will not extrapolate across agents with different mechanisms, and awaits ongoing studies. Oral steroids, by contrast, should already be gone. He does not space biologics, though patients ration doses on their own for co-pay reasons, and he awaits the studies Dr. Wechsler and another colleague are pursuing.

Dr. Chupp closes on initiation. Trials enrolled patients on high-dose ICS-LABA who were exacerbating, so the agents are seen as exacerbation-reducers. He asks whether the panel waits for exacerbations, and whether approval becomes difficult otherwise. Dr. Wechsler primarily treats exacerbation-prone patients but will use a biologic for significant symptoms, decrement in lung function, or oral steroid dependence, and finds a symptomatic patient on triple therapy who cannot live fully is usually approvable despite pushback.

Dr. Ross agrees, describing patients who are clinical but do not fit the insurer's box: up all night scratching with atopic dermatitis, or symptomatic with subclinical polyps. Her prescription is documentation. Gather every biomarker and objective measure, including post-bronchodilator FEV1 showing reversibility on appropriate therapy, submit it, and keep appealing. Dr. Chupp thanks the panel and the audience.

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Patients taper their own inhalers, and payers approve on exacerbations alone. The panel closes on where the evidence runs out and where documentation and advocacy take over.

In "Selecting a Biologic in Severe Asthma: Biomarkers, Comorbidities, and Payers," our experts turn to the decision every clinician faces once the diagnosis is settled.

Selecting a Biologic in Severe Asthma: Biomarkers, Comorbidities, and Payers

Dr. Chupp asks Dr. Hanania whether anti-TSLP availability has shifted him toward using an anti-alarmin first, given trial data showing efficacy across the spectrum without requiring a biomarker, and whether he considers combination therapy or overlapping agents when switching. Dr. Hanania says the choice remains multifactorial. For an oral steroid-dependent patient with no high eosinophils and no elevated FeNO, anti-IL-4 receptor therapy would be his choice, though emerging anti-TSLP data in that group are being presented.

Otherwise, he reads the biomarker profile and the comorbidities. Atopic dermatitis with severe asthma leaves only one approved option. Polyposis leaves several. For severe asthma with low biomarkers, anti-TSLP is the only agent that targets non-type 2 disease. For very high eosinophils above 1,500 with polyposis he may choose an anti-IL-5, though anti-TSLP might also work. Patient preference and payer coverage matter just as much: some patients refuse injections every two weeks but accept monthly, every two months, or the twice-yearly agent, which is approved only in eosinophilic asthma.

On assessment, he tells patients to be patient with him. This is not one injection and a verdict; he waits three to four months, unless side effects intervene. Exacerbations are hard to judge over three months, so he assesses how the patient feels. If nothing changes and exacerbations continue, he returns to biomarkers and phenotyping to choose the next agent.

Asked about two biologics at once, he says he does not, though colleagues have obtained reimbursement for it. He expects bispecific and tri-specific agents to change that soon. He asks Dr. Wechsler the question patients ask him constantly: once remission is reached, is this treatment for life?

Dr. Wechsler lays out the options a patient in remission faces. The default is continuing both the biologic and background therapy. Most patients feel so well they see no reason to change. But some want to reduce cost or exposure.

The second option is cutting back the background inhaled steroids. He cites the SHAMAL study with anti-IL-5 receptor therapy in well-controlled patients, notes ongoing anti-TSLP tapering studies, and adds that real-world data show many patients taper background therapy and do well.

The third is stopping the biologic and continuing background inhalers. Real-world data argue against it: exacerbations increase rapidly in about 50% of patients. The fourth, which his group is studying, is continuing both while extending the dosing interval, from every two weeks to four, or four to six or eight. Because these are largely long-acting drugs, control may hold, and the cost to society would fall. Data in chronic sinusitis with nasal polyps suggest it can be done safely; the equivalent asthma study is still needed.

In "Tapering Inhalers and Initiating Biologics Earlier in Severe Asthma," the panel will close on tapering and the fight to start earlier.

With an anti-alarmin option that does not require a biomarker, selection could have become simpler. Dr. Hanania explains why it stays multifactorial, and why he waits before judging response.

This episode, "Remission in Severe Asthma: Aligning Physician Goals with Patient Goals," features the panel setting the practical issues aside to ask what success looks like.

Remission in Severe Asthma: Aligning Physician Goals with Patient Goals

Dr. Chupp reframes the discussion around the patient. The goal is no longer stopping exacerbations; it is remission. He imagines patients on an injection monthly or every six months with only a rescue inhaler, rather than stacking inhaled therapies plus a biologic just to avoid prednisone twice a year. The obstacle is insurance and the absence of randomized data, though observational and retrospective data support it.

Dr. Ross describes triage: allergists control the most life-threatening problem first, and severe asthma still carries mortality risk. Once that fire is out, the prevention work begins with allergen immunotherapy and household control measures. She then makes a pointed argument about case-finding. GINA reserves biologics for severe asthmatics, but she believes severe patients are being missed and put in the wrong bucket. They go to urgent care and cannot get in with a physician. History-taking is long, but it identifies the patient with an FEV1 of 85 who visited urgent care four times last year and is oral steroid-dependent. That patient is high risk and is not being reported.

She also cites data that controlling atopic dermatitis calms the type 2 cascade and improves both asthma and allergic rhinitis, supporting treatment of the whole systemic condition.

Asked about switching, Dr. Ross says remission is the goal for everybody, but it requires shared decision-making. Physicians set goals like no exacerbations and staying out of hospital. Patients want to play with their kids, sleep well, or visit an amusement park without shortness of breath. When a clinician calls a patient controlled and the patient disagrees, she switches the biologic. Emerging agents targeting TSLP and IL-13, or IL-4, IL-5, and IL-13, plus ultra-long-acting options, make her optimistic.

Up next, in "Selecting a Biologic in Severe Asthma: Biomarkers, Comorbidities, and Payers," Dr. Hanania explains how he chooses among them.

Clinicians define control as no exacerbations and no hospital stays. Dr. Ross argues patients define it differently, and that the gap between the two should drive treatment decisions.

"Positioning Biologics in Asthma: GINA Step 5 and Earlier Treatment" takes up where these agents sit today, and where the panel thinks they belong.

Positioning Biologics in Asthma: GINA Step 5 and Earlier Treatment

Dr. Chupp asks Dr. Hanania whether biologics remain reserved for the most severe patients or are moving earlier. Dr. Hanania starts from evidence and guidelines. The evidence sits at GINA Step 5, because that is the population enrolled in the trials he has run for years: patients with exacerbations and high biomarker profiles, studied by indication across allergic, eosinophilic, steroid-dependent, and severe asthma.

Before any biologic, he insists on documentation. Many patients are referred as severe asthma but have uncontrolled disease, or no asthma at all, sending him back to square one. Severe means high-dose ICS plus LABA plus another bronchodilator with continued symptoms, after comorbidities and triggers have been addressed. Exacerbations on top of that, or oral steroid dependence, is where biologics make a real difference. He notes four of the seven agents Dr. Wechsler described are approved for polyposis.

The agents are boxed into the 5% to 10% with severe asthma, he says, yet the concept of earlier use is very justified. Some data suggest at-risk patients with high biomarker profiles might benefit, but those studies are not published, guidelines will not embrace Step 3 or 4 use, and reimbursement follows guidelines. Clinical remission is real, reached by about 30%, but in severe patients. Whether early treatment prevents progression is unanswered.

Dr. Wechsler calls early treatment akin to preventing a fire rather than putting one out once the damage is done. His caveats are practical. Will payers fund expensive biologics earlier? Will patients accept them to prevent something that may never happen? If they would, he argues, vaccination rates would already be higher, since vaccines effectively prevent frequent exacerbations.

In "Remission in Severe Asthma: Aligning Physician Goals with Patient Goals," the panel will ask what clinicians are actually treating toward.

Evidence places biologics at GINA Step 5, and that is where reimbursement holds them. Dr. Hanania and Dr. Wechsler examine the case for moving earlier, and what it would require.

Jacqueline Ross, MD

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