Expert Opinion on Biological Treatment of Chronic Rhinosinusitis with Nasal Polyps in the Gulf Region

Figures & data

Table 1 Definition of Chronic Rhinosinusitis in Adults

Chronic rhinosinusitis

● Inflammation of the nose and paranasal sinuses characterized by the presence of two or more symptoms for ≥12 weeks.^Citation7^–^Citation9  ● one of which should be either nasal congestion or nasal discharge  ● ± facial pain/pressure  ● ± reduction in or loss of smell

Figure 1 Flow chart representation of consensus development.

Table 2 University of Pennsylvania Smell Identification Test (UPSIT) Scores and Outcomes

UPSIT Score	Outcome
6–18	Anosmia (complete loss of smell)
19–25	Severe microsmia
26–30 in women and 26–29 in men	Moderate microsmia
31–34 in women and 30–33 in men	Mild microsmia
>34 in women and 33 in men	Normosmia (normal smell appreciation)

Note: Definition: microsmia, diminished sense of smell.

Abbreviation: UPSIT, University of Pennsylvania Smell Identification Test.

Table 3 Clinical Guidelines for the Diagnosis of CRSwNP

Canadian Guidelines^Citation30

Based on  ● Symptoms  ● Nasal endoscopy: Presence of bilateral polyps in middle meatus  ● CT scan: Bilateral mucosal disease

EPOS Guidelines^Citation7

A step-wise approach is designed for the diagnosis of CRSwNP:  ● Based on symptoms assessed, saline spray/rinses INCS (if OTC) are administered as part of self-care and primary care.  ● Nasal endoscopy is done if there are no signs of improvement. If diffuse bilateral primary CRS* is diagnosed, AMT is prescribed that include nasal steroid (drops/spray/rinses) and saline rinses.  ● CT scan, SPT, lab tests such as blood eosinophils, IgE, and tissue eosinophils should be done if there is no improvement with AMT. The Lund–Mackay score is used for the quantification of radiologic disease severity as indicated by sinus CT scans.  ● If the primary complaint is often smell loss, or blockage/congestion, N-ERD and/or asthma and atopy are observed, then nasal endoscopy is performed to confirm polyposis.

● Evaluation tests:

1.Allergy is evaluated by SPT and lab tests such as blood eosinophils, IgE, and tissue eosinophils.  2.Anosmia is evaluated by UPSIT and Sniffin’ Sticks test. Smell test is not recommended at initial presentation to ENT/secondary care with highly suggestive symptoms of CRS and normal mucosa on endoscopy. However, there is an ambiguity in performing a smell test in CRS after failure of appropriate medical or surgical treatment in ENT/secondary care with continued symptoms and abnormal mucosa on endoscopy.  3.Nasal patency may be objectively evaluated with peak nasal inspiratory flow (PNIF), (active anterior) rhinomanometry (AAR), and acoustic rhinometry (AR)  4.Lund–Kennedy endoscopy scoring is performed to evaluate poly size.  5.The tests used for quantifying the severity of symptoms, thereby health-related quality of life, include VAS and SNOT-22 ● For confirming diagnosis, histopathology is important to assist in the endotyping of inflammatory diseases.

Abbreviations: AMT, appropriate medical therapy; SPT, skin prick test; UPSIT, University of Pennsylvania Smell Identification Test; VAS, visual analog scale; SNOT-22, Sino-nasal outcome test-22; ENT, ear, nose and throat; N-ERD, NSAID-exacerbated respiratory disease; CT, computed tomography; CRSwNP, chronic rhinosinusitis with nasal polyps; INCS, intranasal corticosteroids; OTC, over-the-counter; IgE, immunoglobulin E.

Table 4 Clinical Guidelines for the Management of CRSwNP

Canadian Guidelines^Citation30

The following treatment approaches are recommended: ● INCS ● Short course of oral steroids ● Antibiotic if suspicion of infection (purulence or pain): Broad-spectrum antibiotics such as fluoroquinolones or amoxicillin–clavulanic acid combinations ● Consider LTRA in appropriate patients ● Other specialty referral based on the condition of the patient ● Allergy testing if suspected allergen present in environment  ● Reassessment is done after 2 to 4 months    o If the symptoms persist or recur, then refer to surgeon.    o Continue INCS and consider saline irrigation, if persistent improvement is noted.

EPOS Guidelines^Citation7

● AMT (± OCS) or FESS is the recommended choice of treatment for CRSwNP. Consider additional therapy that include: biologicals, OCS taper, and revision surgery; if significant improvement in symptoms is not observed after 6 to 12 weeks of treatment.

Abbreviations: INCS, intranasal corticosteroids; VAS, visual analog scale; LTRA, leukotriene receptor antagonists; AMT, appropriate medical therapy; FESS, functional endoscopic sinus surgery; OCS, oral corticosteroids; ENT, ear, nose and throat.

Table 5 Studies on Dupilumab and Omalizumab in CRSwNP

Biologics	Mechanism	Study	Study Design	Result	Conclusion
Dupilumab	Anti-IL-4α	LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52 (N=724)	International, double-blind, placebo-controlled phase 3 studies that assessed the efficacy of dupilumab 300 mg subcutaneous injection every 2 weeks or 4 weeks for 24 or 52 weeks. Subjects also received background therapy of mometasone furoate nasal spray.	Significant improvement in co-primary end points of least mean difference compared to placebo LIBERTY-24 Nasal polyp Score: −2.06 (95% CI: −2.43 to −1.69); Nasal congestion score: −0.89 (95% CI: −1.07 to −0.71) LIBERTY-52 Nasal polyp Score: −1.80 (95% CI: −2.10 to −1.51); Nasal congestion score: −0.87 (95% CI: −1.03 to −0.71)	Dupilumab improved symptoms, including sense of smell and disease-specific quality of life. Use of systemic corticosteroids or nasal polyp surgery was decreased in the dupilumab group by 76% during the treatment period.
Omalizumab	Anti-IgE	POLYP I (n = 138) and POLYP II (n = 127)	Phase 3 studies in which patients were randomized to subcutaneous omalizumab versus placebo for 24 weeks	Significant mean improvement in co-primary end points compared to placebo POLYP I Nasal polyp Score: −1.14 (95% CI: −1.59 to −0.69); Nasal congestion score: −0.55 (95% CI: −0.84 to −0.25) POLYP II Nasal polyp Score: −0.59 (95% CI: −1.05 to −0.12); Nasal congestion score: −0.50 (95% CI: −0.80 to −0.19)	Omalizumab significantly improved the total nasal symptom score (includes nasal congestion, sense of smell, runny nose, and postnasal drip), and individual symptoms such as sense of smell, and disease-specific quality of life compared to placebo.

Abbreviations: CRSwNP, chronic rhinosinusitis with nasal polyps; IL, interleukin.

Figure 2 Algorithm for the biological treatment in CRSwNP patients.

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