The standard of care does not control chronic rhinosinusitis with nasal polyps for a third of patients, but approved biologics may improve quality of life (QoL).
Biologics are entering the fray to treat chronic rhinosinusitis with nasal polyps (CRSwNP) and may benefit patients who have not benefited from corticosteroids and endoscopic sinus surgery.
A review of literature and clinical data highlighted that standard of care (SoC) is not leading to satisfactory improvements in clinical outcomes or quality of life (QoL), but that biologics offer new promise and may be the best option for some patients, according to a paper published in The Journal of Allergy and Clinical Immunology: In Practice.
CRSwNP can have a “profound impact” on patients’ QoL, according to the researchers. In addition to the symptoms of CRSwNP, such as nasal congestion and facial pressure/pain, patients experience secondary consequences, like sleep impairment and depression. In approximately one-third of patients, their CRSwNP is not well controlled on SoC, which includes intranasal and systemic corticosteroids as well as endoscopic sinus surgery (ESS).
“Biologics offer a new therapeutic option for patients and significant QoL impairment is a key criterion for the indication of biologic treatment in CRSwNP,” the authors explained.
The authors conducted a clinical review to evaluate QoL data from clinical trials and real-world studies published between 2010 and 2021. There were 43 studies included. While they did show significant improvements in QoL, such as short-term efficacy with intranasal corticosteroids and oral corticosteroids, there were potential side effects associated with intermittent long-term use of systemic corticosteroids.
The longer the duration or the higher the dosing, the greater the risk of side effects, such as osteoporosis, cardiovascular conditions or gastrointestinal and metabolic disturbances. “There is also evidence that efficacy of oral corticosteroids is limited to the short term, with differences between placebo and treatment groups becoming insignificant over time,” the authors noted.
For patients undergoing ESS, there is post-surgical improvement in QoL; however, it varies, and revision surgery is common, estimated at being between 15% and 20% of patients 5 to 10 years after surgery.
While the use of biologics is not yet well established in treatment guidelines for CRSwNP, asthma guidelines recommend their use in comorbid CRSwNP. The European Position Paper on Rhinosinusitis and Nasal Polyps and the European Forum for Research and Education in Allergy and Airway Diseases both recommend biologics to treat CRSwNP. They both identified 5 criteria to identify eligible patients for biologics. Of the criteria, patients must fulfill 3 after having prior sinus surgery. The 5 criteria are:
“Additional research is needed to define which patients with CRSwNP will benefit most from biologics, though they are likely to have severe or refractory/recurrent NP not adequately controlled by SoC, profoundly impacted QoL, NP and uncontrolled asthma, or be poor surgical candidates,” the authors wrote.
There are 3 biologics—Dupixent (dupilumab), Xolair (omalizumab), and Nucala (mepolizumab)—approved in the United States to treat adults with inadequately controlled CRSwNP.
Trials of Dupixent showed significant improvements in Sino-Nasal Outcome Test (SNOT-22) and University of Pennsylvania Smell Identification Test (UPSIT). In one trial, a large majority (93.3%) of patients experienced improved QoL vs 26.7% in the placebo group. Another found symptoms worsened after Dupixent was discontinued after 24 weeks.
Xolair is approved as an add-on maintenance therapy for adults who have inadequate response to intranasal corticosteroids. Trials have shown Xolair has a positive impact on QoL in patients with comorbid asthma and/or aspirin-exacerbated respiratory disease. There was improvement in SNOT-22 and UPSIT scores vs placebo. Again, after discontinuation, symptoms worsened.
Nucala has been shown to improve SNOT-22 and nasal obstruction. Similar to the other 2 biologics, it improves patient QoL.
There have not been any head-to-head studies, but a meta-analysis of 8 randomized clinical trials identified Dupixent as having the best efficacy in terms of SNOT-22, UPSIT score, and nasal congestion score, followed by omalizumab, and mepolizumab, which had the greatest risk of adverse events.
Trials for 3 other biologics—benralizumab, tezepelumab, and etokimab—are ongoing.
“Improved better understanding of the QoL impact of CRSwNP will help physicians provide optimal treatment for their patients and will aid decision-making on treatment choice and suitability for the use of biologics,” the authors concluded.