Biologics for chronic rhinosinusitis
Background This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis. Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pa...
Gespeichert in:
| Veröffentlicht in: | Cochrane database of systematic reviews 2020-02, Vol.2020 (2), p.CD013513 |
|---|---|
| Hauptverfasser: | , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | |
|---|---|
| container_issue | 2 |
| container_start_page | CD013513 |
| container_title | Cochrane database of systematic reviews |
| container_volume | 2020 |
| creator | Chong, Lee‐Yee Piromchai, Patorn Sharp, Steve Snidvongs, Kornkiat Philpott, Carl Hopkins, Claire Burton, Martin J Burton, Martin J |
| description | Background
This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis.
Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.
'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in related inflammatory conditions (e.g. asthma and atopic dermatitis).
Objectives
To assess the effects of biologics for the treatment of chronic rhinosinusitis.
Search methods
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2019, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 September 2019.
Selection criteria
Randomised controlled trials (RCTs) with at least three months follow‐up comparing biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.
Data collection and analysis
We used standard Cochrane methodological procedures. Our primary outcomes were disease‐specific health‐related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome.
Main results
We included eight RCTs. Of 986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All the studies were sponsored or supported by industry.
Anti‐IL‐4Rα mAb (dupilumab) versusplacebo/no treatment (all receiving intranasal steroids)
Three studies (784 participants) evaluated dupilumab.
Disease‐specific HRQL was measured with the SNOT‐22 (score 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, the SNOT‐22 score was 19.61 points lower (better) in participants receiving dupilumab (mean difference (MD) ‐19.61, 95% confidence interval (CI) ‐22.54 to ‐16.69; 3 studies; 784 participants; high certainty).
Symptom severity measur |
| doi_str_mv | 10.1002/14651858.CD013513.pub2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7043934</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2366635902</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4732-edd7b8c9f12d8efef1db50803098fbc2785e683d85c3e002c8334f2edc7c8a4b3</originalsourceid><addsrcrecordid>eNqFkEtPAyEUhYnR2Fr9C00XLtxMBe7AMBsTW59JEze6JjMMtJjpUKGj6b-XSR9RN64gnHPP4X4IDQkeE4zpNUk5I4KJ8fQOE2AExqu2pEeo3wlJpxz_uPfQWQjvGAPPaXaKekAJpoTQPrqcWFe7uVVhZJwfqYV3jVUjv7CNC7Zpg13bcI5OTFEHfbE7B-jt4f51-pTMXh6fp7ezRKUZ0ERXVVYKlRtCK6GNNqQqGRYYcC5MqWgmmOYCKsEU6LiEEgCpobpSmRJFWsIA3Wxz4y7L-KybtS9qufJ2WfiNdIWVv5XGLuTcfcoMp5BDGgOudgHefbQ6rOXSBqXrumi0a4OkwDkHlmMarXxrVd6F4LU51BAsO8Ryj1juEXfl3eDw5ycPY3um0TDZGr5srTdSuQg19v-T-6flGwtHjKQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2366635902</pqid></control><display><type>article</type><title>Biologics for chronic rhinosinusitis</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Cochrane Library</source><source>Alma/SFX Local Collection</source><creator>Chong, Lee‐Yee ; Piromchai, Patorn ; Sharp, Steve ; Snidvongs, Kornkiat ; Philpott, Carl ; Hopkins, Claire ; Burton, Martin J ; Burton, Martin J</creator><creatorcontrib>Chong, Lee‐Yee ; Piromchai, Patorn ; Sharp, Steve ; Snidvongs, Kornkiat ; Philpott, Carl ; Hopkins, Claire ; Burton, Martin J ; Burton, Martin J</creatorcontrib><description>Background
This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis.
Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.
'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in related inflammatory conditions (e.g. asthma and atopic dermatitis).
Objectives
To assess the effects of biologics for the treatment of chronic rhinosinusitis.
Search methods
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2019, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 September 2019.
Selection criteria
Randomised controlled trials (RCTs) with at least three months follow‐up comparing biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.
Data collection and analysis
We used standard Cochrane methodological procedures. Our primary outcomes were disease‐specific health‐related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome.
Main results
We included eight RCTs. Of 986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All the studies were sponsored or supported by industry.
Anti‐IL‐4Rα mAb (dupilumab) versusplacebo/no treatment (all receiving intranasal steroids)
Three studies (784 participants) evaluated dupilumab.
Disease‐specific HRQL was measured with the SNOT‐22 (score 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, the SNOT‐22 score was 19.61 points lower (better) in participants receiving dupilumab (mean difference (MD) ‐19.61, 95% confidence interval (CI) ‐22.54 to ‐16.69; 3 studies; 784 participants; high certainty).
Symptom severity measured on a 0‐ to 10‐point visual analogue scale (VAS) was 3.00 lower in those receiving dupilumab (95% CI ‐3.47 to ‐2.53; 3 studies; 784 participants; moderate certainty).
The risk of serious adverse events may be lower in the dupilumab group (risk ratio (RR) 0.45, 95% CI 0.28 to 0.75; 3 studies; 782 participants; low certainty).
The number of participants requiring nasal polyp surgery (actual or planned) during the treatment period is probably lower in those receiving dupilumab (RR 0.17, 95% CI 0.05 to 0.52; 2 studies; 725 participants; moderate certainty).
Change in the extent of disease using the Lund Mackay computerised tomography (CT) score (0 to 24, higher = worse) was ‐7.00 (95% CI ‐9.61 to ‐4.39; 3 studies; 784 participants; high certainty), a large effect favouring the dupilumab group.
The EQ‐5D visual analogue scale (0 to 100, higher = better; MCID 8 points) was used to measure change in generic quality of life. The mean difference favouring dupilumab was 8.59 (95% CI 5.31 to 11.86; 2 studies; 706 participants; moderate certainty).
There may be little or no difference in the risk of nasopharyngitis (RR 0.95, 95% CI 0.72 to 1.25; 3 studies; 783 participants; low certainty).
Anti‐IL‐5 mAb (mepolizumab) versusplacebo/no treatment (all receiving intranasal steroids)
Two studies (137 participants) evaluated mepolizumab.
Disease‐specific HRQL measured with the SNOT‐22 at 25 weeks was 13.26 points lower (better) in participants receiving mepolizumab (95% CI ‐22.08 to ‐4.44; 1 study; 105 participants; low certainty; MCID 8.9).
It is very uncertain whether there is a difference in s ymptom severity: on a 0‐ to 10‐point VAS symptom severity was ‐2.03 lower in those receiving mepolizumab (95% CI ‐3.65 to ‐0.41; 1 study; 72 participants; very low certainty).
It is very uncertain if there is difference in the risk of serious adverse events (RR 1.57, 95% CI 0.07 to 35.46; 2 studies; 135 participants, very low certainty).
It is very uncertain whether or not the overall risk that patients still need surgery at trial end is lower in the mepolizumab group (RR 0.78, 95% CI 0.64 to 0.94; 2 studies; 135 participants; very low certainty).
It is very uncertain whether mepolizumab reduces the extent of disease as measured by endoscopic nasal polyps score (scale range 0 to 8). The mean difference was 1.23 points lower in the mepolizumab group (MD ‐1.23, 95% ‐1.79 to ‐0.68; 2 studies; 137 participants; very low certainty).
The difference in generic quality of life (EQ‐5D) was 5.68 (95% CI ‐1.18 to 12.54; 1 study; 105 participants; low certainty), favouring the mepolizumab group. This difference is smaller than the MCID of 8 points.
There may be little or no difference in the risk of nasopharyngitis (RR 0.73, 95% 0.36 to 1.47; 2 studies; 135 participants; low certainty).
Anti‐IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids)
Three very small studies (65 participants) evaluated omalizumab. We are very uncertain about the effect of omalizumab on disease‐specific HRQL, severe adverse events, extent of disease (CT scan scores), generic HRQL and adverse effects.
Authors' conclusions
In adults with severe chronic rhinosinusitis and nasal polyps, using regular topical nasal steroids, dupilumab improves disease‐specific HRQL compared to placebo, and reduces the extent of the disease as measured on a CT scan. It probably also improves symptoms and generic HRQL and there is no evidence of an increased risk of serious adverse events. It may reduce the need for further surgery. There may be little or no difference in the risk of nasopharyngitis.
In similar patients, mepolizumab may improve both disease‐specific and generic HRQL. It is uncertain whether it reduces the need for surgery or improves nasal polyp scores. There may be little or no difference in the risk of nasopharyngitis. It is uncertain if there is a difference in symptom severity and the risk of serious adverse events.
We are uncertain about the effects of omalizumab.</description><identifier>ISSN: 1465-1858</identifier><identifier>ISSN: 1469-493X</identifier><identifier>EISSN: 1465-1858</identifier><identifier>EISSN: 1469-493X</identifier><identifier>DOI: 10.1002/14651858.CD013513.pub2</identifier><identifier>PMID: 32102112</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Biological Products ; Biological Products - therapeutic use ; Chronic Disease ; Chronic rhinosinusitis (CRS) ; CRS (with or without nasal polyps) ; Ear, nose & throat ; Humans ; Medicine General & Introductory Medical Sciences ; Nasal Obstruction ; Nasal Obstruction - drug therapy ; Nasal Polyps ; Nasal Polyps - drug therapy ; Non‐malignant disease ; Nose & sinus ; Nose and sinuses ; Quality of Life ; Randomized Controlled Trials as Topic ; Rhinitis ; Rhinitis - drug therapy ; Sinusitis ; Sinusitis - drug therapy ; Treatment Outcome</subject><ispartof>Cochrane database of systematic reviews, 2020-02, Vol.2020 (2), p.CD013513</ispartof><rights>Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4732-edd7b8c9f12d8efef1db50803098fbc2785e683d85c3e002c8334f2edc7c8a4b3</citedby><cites>FETCH-LOGICAL-c4732-edd7b8c9f12d8efef1db50803098fbc2785e683d85c3e002c8334f2edc7c8a4b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,778,782,883,27907,27908</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32102112$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chong, Lee‐Yee</creatorcontrib><creatorcontrib>Piromchai, Patorn</creatorcontrib><creatorcontrib>Sharp, Steve</creatorcontrib><creatorcontrib>Snidvongs, Kornkiat</creatorcontrib><creatorcontrib>Philpott, Carl</creatorcontrib><creatorcontrib>Hopkins, Claire</creatorcontrib><creatorcontrib>Burton, Martin J</creatorcontrib><creatorcontrib>Burton, Martin J</creatorcontrib><title>Biologics for chronic rhinosinusitis</title><title>Cochrane database of systematic reviews</title><addtitle>Cochrane Database Syst Rev</addtitle><description>Background
This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis.
Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.
'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in related inflammatory conditions (e.g. asthma and atopic dermatitis).
Objectives
To assess the effects of biologics for the treatment of chronic rhinosinusitis.
Search methods
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2019, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 September 2019.
Selection criteria
Randomised controlled trials (RCTs) with at least three months follow‐up comparing biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.
Data collection and analysis
We used standard Cochrane methodological procedures. Our primary outcomes were disease‐specific health‐related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome.
Main results
We included eight RCTs. Of 986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All the studies were sponsored or supported by industry.
Anti‐IL‐4Rα mAb (dupilumab) versusplacebo/no treatment (all receiving intranasal steroids)
Three studies (784 participants) evaluated dupilumab.
Disease‐specific HRQL was measured with the SNOT‐22 (score 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, the SNOT‐22 score was 19.61 points lower (better) in participants receiving dupilumab (mean difference (MD) ‐19.61, 95% confidence interval (CI) ‐22.54 to ‐16.69; 3 studies; 784 participants; high certainty).
Symptom severity measured on a 0‐ to 10‐point visual analogue scale (VAS) was 3.00 lower in those receiving dupilumab (95% CI ‐3.47 to ‐2.53; 3 studies; 784 participants; moderate certainty).
The risk of serious adverse events may be lower in the dupilumab group (risk ratio (RR) 0.45, 95% CI 0.28 to 0.75; 3 studies; 782 participants; low certainty).
The number of participants requiring nasal polyp surgery (actual or planned) during the treatment period is probably lower in those receiving dupilumab (RR 0.17, 95% CI 0.05 to 0.52; 2 studies; 725 participants; moderate certainty).
Change in the extent of disease using the Lund Mackay computerised tomography (CT) score (0 to 24, higher = worse) was ‐7.00 (95% CI ‐9.61 to ‐4.39; 3 studies; 784 participants; high certainty), a large effect favouring the dupilumab group.
The EQ‐5D visual analogue scale (0 to 100, higher = better; MCID 8 points) was used to measure change in generic quality of life. The mean difference favouring dupilumab was 8.59 (95% CI 5.31 to 11.86; 2 studies; 706 participants; moderate certainty).
There may be little or no difference in the risk of nasopharyngitis (RR 0.95, 95% CI 0.72 to 1.25; 3 studies; 783 participants; low certainty).
Anti‐IL‐5 mAb (mepolizumab) versusplacebo/no treatment (all receiving intranasal steroids)
Two studies (137 participants) evaluated mepolizumab.
Disease‐specific HRQL measured with the SNOT‐22 at 25 weeks was 13.26 points lower (better) in participants receiving mepolizumab (95% CI ‐22.08 to ‐4.44; 1 study; 105 participants; low certainty; MCID 8.9).
It is very uncertain whether there is a difference in s ymptom severity: on a 0‐ to 10‐point VAS symptom severity was ‐2.03 lower in those receiving mepolizumab (95% CI ‐3.65 to ‐0.41; 1 study; 72 participants; very low certainty).
It is very uncertain if there is difference in the risk of serious adverse events (RR 1.57, 95% CI 0.07 to 35.46; 2 studies; 135 participants, very low certainty).
It is very uncertain whether or not the overall risk that patients still need surgery at trial end is lower in the mepolizumab group (RR 0.78, 95% CI 0.64 to 0.94; 2 studies; 135 participants; very low certainty).
It is very uncertain whether mepolizumab reduces the extent of disease as measured by endoscopic nasal polyps score (scale range 0 to 8). The mean difference was 1.23 points lower in the mepolizumab group (MD ‐1.23, 95% ‐1.79 to ‐0.68; 2 studies; 137 participants; very low certainty).
The difference in generic quality of life (EQ‐5D) was 5.68 (95% CI ‐1.18 to 12.54; 1 study; 105 participants; low certainty), favouring the mepolizumab group. This difference is smaller than the MCID of 8 points.
There may be little or no difference in the risk of nasopharyngitis (RR 0.73, 95% 0.36 to 1.47; 2 studies; 135 participants; low certainty).
Anti‐IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids)
Three very small studies (65 participants) evaluated omalizumab. We are very uncertain about the effect of omalizumab on disease‐specific HRQL, severe adverse events, extent of disease (CT scan scores), generic HRQL and adverse effects.
Authors' conclusions
In adults with severe chronic rhinosinusitis and nasal polyps, using regular topical nasal steroids, dupilumab improves disease‐specific HRQL compared to placebo, and reduces the extent of the disease as measured on a CT scan. It probably also improves symptoms and generic HRQL and there is no evidence of an increased risk of serious adverse events. It may reduce the need for further surgery. There may be little or no difference in the risk of nasopharyngitis.
In similar patients, mepolizumab may improve both disease‐specific and generic HRQL. It is uncertain whether it reduces the need for surgery or improves nasal polyp scores. There may be little or no difference in the risk of nasopharyngitis. It is uncertain if there is a difference in symptom severity and the risk of serious adverse events.
We are uncertain about the effects of omalizumab.</description><subject>Biological Products</subject><subject>Biological Products - therapeutic use</subject><subject>Chronic Disease</subject><subject>Chronic rhinosinusitis (CRS)</subject><subject>CRS (with or without nasal polyps)</subject><subject>Ear, nose & throat</subject><subject>Humans</subject><subject>Medicine General & Introductory Medical Sciences</subject><subject>Nasal Obstruction</subject><subject>Nasal Obstruction - drug therapy</subject><subject>Nasal Polyps</subject><subject>Nasal Polyps - drug therapy</subject><subject>Non‐malignant disease</subject><subject>Nose & sinus</subject><subject>Nose and sinuses</subject><subject>Quality of Life</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Rhinitis</subject><subject>Rhinitis - drug therapy</subject><subject>Sinusitis</subject><subject>Sinusitis - drug therapy</subject><subject>Treatment Outcome</subject><issn>1465-1858</issn><issn>1469-493X</issn><issn>1465-1858</issn><issn>1469-493X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>RWY</sourceid><sourceid>EIF</sourceid><recordid>eNqFkEtPAyEUhYnR2Fr9C00XLtxMBe7AMBsTW59JEze6JjMMtJjpUKGj6b-XSR9RN64gnHPP4X4IDQkeE4zpNUk5I4KJ8fQOE2AExqu2pEeo3wlJpxz_uPfQWQjvGAPPaXaKekAJpoTQPrqcWFe7uVVhZJwfqYV3jVUjv7CNC7Zpg13bcI5OTFEHfbE7B-jt4f51-pTMXh6fp7ezRKUZ0ERXVVYKlRtCK6GNNqQqGRYYcC5MqWgmmOYCKsEU6LiEEgCpobpSmRJFWsIA3Wxz4y7L-KybtS9qufJ2WfiNdIWVv5XGLuTcfcoMp5BDGgOudgHefbQ6rOXSBqXrumi0a4OkwDkHlmMarXxrVd6F4LU51BAsO8Ryj1juEXfl3eDw5ycPY3um0TDZGr5srTdSuQg19v-T-6flGwtHjKQ</recordid><startdate>20200227</startdate><enddate>20200227</enddate><creator>Chong, Lee‐Yee</creator><creator>Piromchai, Patorn</creator><creator>Sharp, Steve</creator><creator>Snidvongs, Kornkiat</creator><creator>Philpott, Carl</creator><creator>Hopkins, Claire</creator><creator>Burton, Martin J</creator><creator>Burton, Martin J</creator><general>John Wiley & Sons, Ltd</general><scope>7PX</scope><scope>RWY</scope><scope>ZYTZH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200227</creationdate><title>Biologics for chronic rhinosinusitis</title><author>Chong, Lee‐Yee ; Piromchai, Patorn ; Sharp, Steve ; Snidvongs, Kornkiat ; Philpott, Carl ; Hopkins, Claire ; Burton, Martin J ; Burton, Martin J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4732-edd7b8c9f12d8efef1db50803098fbc2785e683d85c3e002c8334f2edc7c8a4b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Biological Products</topic><topic>Biological Products - therapeutic use</topic><topic>Chronic Disease</topic><topic>Chronic rhinosinusitis (CRS)</topic><topic>CRS (with or without nasal polyps)</topic><topic>Ear, nose & throat</topic><topic>Humans</topic><topic>Medicine General & Introductory Medical Sciences</topic><topic>Nasal Obstruction</topic><topic>Nasal Obstruction - drug therapy</topic><topic>Nasal Polyps</topic><topic>Nasal Polyps - drug therapy</topic><topic>Non‐malignant disease</topic><topic>Nose & sinus</topic><topic>Nose and sinuses</topic><topic>Quality of Life</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Rhinitis</topic><topic>Rhinitis - drug therapy</topic><topic>Sinusitis</topic><topic>Sinusitis - drug therapy</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chong, Lee‐Yee</creatorcontrib><creatorcontrib>Piromchai, Patorn</creatorcontrib><creatorcontrib>Sharp, Steve</creatorcontrib><creatorcontrib>Snidvongs, Kornkiat</creatorcontrib><creatorcontrib>Philpott, Carl</creatorcontrib><creatorcontrib>Hopkins, Claire</creatorcontrib><creatorcontrib>Burton, Martin J</creatorcontrib><creatorcontrib>Burton, Martin J</creatorcontrib><collection>Wiley-Blackwell Cochrane Library</collection><collection>Cochrane Library</collection><collection>Cochrane Library (Open Aceess)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cochrane database of systematic reviews</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chong, Lee‐Yee</au><au>Piromchai, Patorn</au><au>Sharp, Steve</au><au>Snidvongs, Kornkiat</au><au>Philpott, Carl</au><au>Hopkins, Claire</au><au>Burton, Martin J</au><au>Burton, Martin J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Biologics for chronic rhinosinusitis</atitle><jtitle>Cochrane database of systematic reviews</jtitle><addtitle>Cochrane Database Syst Rev</addtitle><date>2020-02-27</date><risdate>2020</risdate><volume>2020</volume><issue>2</issue><spage>CD013513</spage><pages>CD013513-</pages><issn>1465-1858</issn><issn>1469-493X</issn><eissn>1465-1858</eissn><eissn>1469-493X</eissn><abstract>Background
This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis.
Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.
'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in related inflammatory conditions (e.g. asthma and atopic dermatitis).
Objectives
To assess the effects of biologics for the treatment of chronic rhinosinusitis.
Search methods
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2019, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 16 September 2019.
Selection criteria
Randomised controlled trials (RCTs) with at least three months follow‐up comparing biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.
Data collection and analysis
We used standard Cochrane methodological procedures. Our primary outcomes were disease‐specific health‐related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome.
Main results
We included eight RCTs. Of 986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All the studies were sponsored or supported by industry.
Anti‐IL‐4Rα mAb (dupilumab) versusplacebo/no treatment (all receiving intranasal steroids)
Three studies (784 participants) evaluated dupilumab.
Disease‐specific HRQL was measured with the SNOT‐22 (score 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, the SNOT‐22 score was 19.61 points lower (better) in participants receiving dupilumab (mean difference (MD) ‐19.61, 95% confidence interval (CI) ‐22.54 to ‐16.69; 3 studies; 784 participants; high certainty).
Symptom severity measured on a 0‐ to 10‐point visual analogue scale (VAS) was 3.00 lower in those receiving dupilumab (95% CI ‐3.47 to ‐2.53; 3 studies; 784 participants; moderate certainty).
The risk of serious adverse events may be lower in the dupilumab group (risk ratio (RR) 0.45, 95% CI 0.28 to 0.75; 3 studies; 782 participants; low certainty).
The number of participants requiring nasal polyp surgery (actual or planned) during the treatment period is probably lower in those receiving dupilumab (RR 0.17, 95% CI 0.05 to 0.52; 2 studies; 725 participants; moderate certainty).
Change in the extent of disease using the Lund Mackay computerised tomography (CT) score (0 to 24, higher = worse) was ‐7.00 (95% CI ‐9.61 to ‐4.39; 3 studies; 784 participants; high certainty), a large effect favouring the dupilumab group.
The EQ‐5D visual analogue scale (0 to 100, higher = better; MCID 8 points) was used to measure change in generic quality of life. The mean difference favouring dupilumab was 8.59 (95% CI 5.31 to 11.86; 2 studies; 706 participants; moderate certainty).
There may be little or no difference in the risk of nasopharyngitis (RR 0.95, 95% CI 0.72 to 1.25; 3 studies; 783 participants; low certainty).
Anti‐IL‐5 mAb (mepolizumab) versusplacebo/no treatment (all receiving intranasal steroids)
Two studies (137 participants) evaluated mepolizumab.
Disease‐specific HRQL measured with the SNOT‐22 at 25 weeks was 13.26 points lower (better) in participants receiving mepolizumab (95% CI ‐22.08 to ‐4.44; 1 study; 105 participants; low certainty; MCID 8.9).
It is very uncertain whether there is a difference in s ymptom severity: on a 0‐ to 10‐point VAS symptom severity was ‐2.03 lower in those receiving mepolizumab (95% CI ‐3.65 to ‐0.41; 1 study; 72 participants; very low certainty).
It is very uncertain if there is difference in the risk of serious adverse events (RR 1.57, 95% CI 0.07 to 35.46; 2 studies; 135 participants, very low certainty).
It is very uncertain whether or not the overall risk that patients still need surgery at trial end is lower in the mepolizumab group (RR 0.78, 95% CI 0.64 to 0.94; 2 studies; 135 participants; very low certainty).
It is very uncertain whether mepolizumab reduces the extent of disease as measured by endoscopic nasal polyps score (scale range 0 to 8). The mean difference was 1.23 points lower in the mepolizumab group (MD ‐1.23, 95% ‐1.79 to ‐0.68; 2 studies; 137 participants; very low certainty).
The difference in generic quality of life (EQ‐5D) was 5.68 (95% CI ‐1.18 to 12.54; 1 study; 105 participants; low certainty), favouring the mepolizumab group. This difference is smaller than the MCID of 8 points.
There may be little or no difference in the risk of nasopharyngitis (RR 0.73, 95% 0.36 to 1.47; 2 studies; 135 participants; low certainty).
Anti‐IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids)
Three very small studies (65 participants) evaluated omalizumab. We are very uncertain about the effect of omalizumab on disease‐specific HRQL, severe adverse events, extent of disease (CT scan scores), generic HRQL and adverse effects.
Authors' conclusions
In adults with severe chronic rhinosinusitis and nasal polyps, using regular topical nasal steroids, dupilumab improves disease‐specific HRQL compared to placebo, and reduces the extent of the disease as measured on a CT scan. It probably also improves symptoms and generic HRQL and there is no evidence of an increased risk of serious adverse events. It may reduce the need for further surgery. There may be little or no difference in the risk of nasopharyngitis.
In similar patients, mepolizumab may improve both disease‐specific and generic HRQL. It is uncertain whether it reduces the need for surgery or improves nasal polyp scores. There may be little or no difference in the risk of nasopharyngitis. It is uncertain if there is a difference in symptom severity and the risk of serious adverse events.
We are uncertain about the effects of omalizumab.</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>32102112</pmid><doi>10.1002/14651858.CD013513.pub2</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1465-1858 |
| ispartof | Cochrane database of systematic reviews, 2020-02, Vol.2020 (2), p.CD013513 |
| issn | 1465-1858 1469-493X 1465-1858 1469-493X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7043934 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Cochrane Library; Alma/SFX Local Collection |
| subjects | Biological Products Biological Products - therapeutic use Chronic Disease Chronic rhinosinusitis (CRS) CRS (with or without nasal polyps) Ear, nose & throat Humans Medicine General & Introductory Medical Sciences Nasal Obstruction Nasal Obstruction - drug therapy Nasal Polyps Nasal Polyps - drug therapy Non‐malignant disease Nose & sinus Nose and sinuses Quality of Life Randomized Controlled Trials as Topic Rhinitis Rhinitis - drug therapy Sinusitis Sinusitis - drug therapy Treatment Outcome |
| title | Biologics for chronic rhinosinusitis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-17T01%3A28%3A21IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Biologics%20for%20chronic%20rhinosinusitis&rft.jtitle=Cochrane%20database%20of%20systematic%20reviews&rft.au=Chong,%20Lee%E2%80%90Yee&rft.date=2020-02-27&rft.volume=2020&rft.issue=2&rft.spage=CD013513&rft.pages=CD013513-&rft.issn=1465-1858&rft.eissn=1465-1858&rft_id=info:doi/10.1002/14651858.CD013513.pub2&rft_dat=%3Cproquest_pubme%3E2366635902%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2366635902&rft_id=info:pmid/32102112&rfr_iscdi=true |