Positioning Biologics in Asthma: GINA Step 5 and Earlier Treatment

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

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.