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Table 2 Consensus statements for use of biologics in upper airway disease

From: Canadian multidisciplinary expert consensus on the use of biologics in upper airways: a Delphi study

 

Statement

Recommendation

Patient Population

1

Patients with chronic symptoms of upper airway disease which include facial pressure/pain, nasal obstruction/congestion, nasal discharge or a loss of smell should be evaluated for upper airway disease

Recommendation

2

Patients treated appropriately for asthma with persistent chronic upper airway symptoms should be referred for further evaluation of upper airway disease

Recommendation

3

All CRSwNP patients with lower respiratory symptoms who have not previously been evaluated for asthma should be evaluated for possible asthma and referred to a clinician who can provide a systematic evaluation

Recommendation

4

Clinician(s) evaluating for upper airway disease should evaluate the nose with nasal endoscopy or in communities where no nasal endoscopy is available, anterior rhinoscopy is acceptable when the diagnosis of nasal polyps is apparent. If nasal endoscopy is unremarkable or unavailable, a CT scan could be ordered to rule out sinus disease without polyps

Recommendation

5

CT reports indicating polyps are not sufficient to make the diagnosis of CRSwNP and starting on biologics

Recommendation

6

All endotypes of CRSwNP confirmed by endoscopy or anterior rhinoscopy are considered eligible for a trial of biologic therapy

Recommendation

7

Biologics should be principally considered for those who have undergone adequate sinus surgery within the past 5 years and are refractory to oral and nasal steroids. Patients unsuitable for surgery who have failed medical therapy may also be considered candidates for biologic therapy based on shared patient decision making

Recommendation

8

The adequacy of previous surgery matters in determining if subsequent surgical management is required versus initiation of biologic therapy. This could be evaluated with a CT scan and/or endoscopy to determine if each of the diseased sinus cavities can receive appropriate topical drug delivery

Recommendation

9

Patients with refractory CRSwNP after surgery should be counselled regarding their options which include revision sinus surgery or biologics. Referral to a specialist that can counsel and/or perform extended surgical procedures should be sought if available

Recommendation

10

Patients with CRSwNP do not need co-existing Type 2 inflammatory condition such as asthma to be considered for biologic therapy

Recommendation

11

For most patients, CRSwNP symptoms need to be severe based on the clinician’s choice of a validated patient reported outcome measure (PROM) for chronic sinus disease to warrant the use of biologics. There are a subgroup of patients that may score lower than severe disease on a PROM due to acclimatization to their symptoms (i.e. allergic fungal rhinosinusitis and chronic prednisone users) and these cases should be considered for biologics based on shared decision making

Recommendation

12

In patients with CRSwNP and coexisting asthma, who qualify for a biologic therapy based on upper airway indications, a consultation with a specialist experienced in managing asthma is recommended before choosing the most appropriate biologic

Recommendation

13

There is insufficient evidence to make a recommendation for providing biologics to patients with CRSsNP

Recommendation

14

Where possible, patients with Aspirin Exacerbated Respiratory Disease (AERD) should be preferentially managed by a multidisciplinary team

Recommendation

Biological Markers

15

At the time of writing, there are no biological markers required to start CRSwNP patients on biologics nor any markers to indicate best biologic to use

Option

Biological Response

16

Nasal response to biologics should be assessed by 16 weeks after initiating biologic therapy with subjective and objective measures. If these improvements are not met at 16 weeks, the biologic should be re-evaluated

Recommendation

17

Patients should be evaluated every 6 months in the first two years of biologic initiation and yearly thereafter

Recommendation

19

When treating co-existing CRSwNP and asthma, an attempt should be made to obtain optimal results with a single biologic in both diseases

Recommendation

19

Pre-biologic criteria may be used to qualify a patient for a second or subsequent biologic therapies in case of sub-optimal response to the first biologic

Recommendation

20

CRSwNP who have exhausted biologics and not achieved simultaneous adequate response in both the upper and lower airways could be evaluated for possible revision sinus surgery

Recommendation

Safety Profile

21

The risk of side effects is low in the short-term use of biologics in CRSwNP

Recommendation

Cost of Biologics

22

Cost and access to biologics should be considered in the decision making of the use of biologics

Recommendation