I believe that these new biologics will have an extremely important role in the management of chronic sinusitis with and without NP, but this is a process and we must temper our exuberance. —Timothy L. Smith, MD, MPH
Explore This IssueJune 2019
Another study endpoint was the sense of smell, which patients rated as more important than congestion. “In our study,” said Dr. Han, “patients whose sense of smell had disappeared were actually able to regain it, [which is] remarkable and vital to the quality of their lives.”
He thinks biologics will be effective for the management of nasal polyps but added that it’s unclear where within the range of available treatments they will fall.
Bias and Clinical Relevance
Timothy L. Smith, MD, MPH, vice chair of otolaryngology–head and neck surgery and professor of otolaryngology–head and neck surgery in the division of rhinology and sinus/skull base surgery at Oregon Health and Science University in Portland, said he has reservations about biologics.
First, he said, there is the risk of bias assessment. One systematic review looking at the potential for bias in biologics research found “encouraging” results, he said, but added that there there were indeed biases present and a high risk of bias for attrition and reporting, in particular (Rhinology. 2018;56:11–21).
“I sometimes question the clinical relevance of the outcomes in these studies,” Dr. Smith said. He referenced a 2017 randomized, double-blind, placebo-controlled trial that assessed the need for surgery; 105 patients received mepolizumab (n = 54) or placebo (n = 51) (J Allergy Clin Immunol. 2017;140:1024–1031). At the outset, 100% of patients needed surgery; by week 25 the mepolizumab group dropped to 70% and the control dropped to 90%. “That is not statistically significant until you do a post hoc analysis,” he added. “I think it is telling that after six months of expensive therapy, a full 70% [of participants] still needed sinus surgery.”
Regarding the visual analog scale (VAS) scores for NPs, the investigators did find a statistically significant improvement in nasal polyposis severity, but, asked Dr. Smith, “how important to the patient is being at 6.5 versus 5 after six months of expensive, systemic therapy?”
He added that one global issue is that nearly all studies involve some sort of relationship with a pharmaceutical company, with recent larger studies demonstrating multiple potential conflicts of interest.
“Looking back, it seems that we have been down this road before,” said Dr. Smith. “A study published in 2001 looking at montelukast resulted in tremendous hype about using it for NP (J Allergy Clin Immunol. 2001;108:466–467). But reflect on how it figures in our current practice … in my practice it is virtually irrelevant. I believe that these new biologics will have an extremely important role in the management of chronic sinusitis with and without NP, but this is a process and we must temper our exuberance.”