Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial
Chronic rhinosinusitis with nasal polyps affects approximately 2–4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bila...
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| Veröffentlicht in: | The lancet respiratory medicine 2021-10, Vol.9 (10), p.1141-1153 |
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| creator | Han, Joseph K Fokkens, Wytske Desrosiers, Martin Wagenmann, Martin Lee, Stella E Smith, Steven G Mayer, Bhabita Sousa, Ana R Chan, Robert Hopkins, Claire Armstrong, Michael Bardin, Philip Barnes, Sara Bergna, Miguel Beule, Achim Blotter, James Bronescu, Valeriu Brown, Matthew Carrie, Sean Chaker, Adam Cho, Hyung-Ju Corriveau, Marie-Noëlle Courville, Timothy Cuevas, Mandy DeConde, Adam Del Carpio, Jaime De Salvo, María Dhong, Hun-Jong Durham, Stephen Edin, Anton Ehmer Jr, Dale Elías, Pedro Fatakia, Adil Franzese, Christine Gane, Simon García, Gabriel Groeger, Moritz Harvey, Richard Higgins, Thomas Hobson, Jonathan Jangard, Mattias Janjua, Arif Kara, Naveed Karpischenko, Sergey Kerwin, Edward Khanova, Fatimat Kilty, Shaun Kim, Chang-Hoon Kim, Seontae Klimek, Ludger LaForce, Craig Leong, Samuel Marple, Bradley Mårtensson, Anders Maspero, Jorge Massey, Neil Matz, Jonathan Mella, Corina Miller, Steven Mirzabekyan, Ekaterina Moss, Jonathan Mumneh, Nayla Ovchinnikov, Andrey Polyakov, Dmitriy Radeanu, Doinel Rhee, Chae-Seo Rojas, Ramón Rosenbloom, Jeffrey Ryazantsev, Sergei Sader, Chady Saez Scherbovsky, Pablo Scadding, Guy Schlosser, Rodney Shah-Patel, Heena Shealy, Ronald Siddiqi, Ayesha Silvers, Stacey Singh, Narinder Sommer, Doron Soong, Weily Sowerby, Leigh Spafford, Peter Stefan, Catalin Sterling, Richard Talreja, Neetu Tarasova, Galina Tarpay, Martha Tolcachier, Alberto Toll, Karin Toll van Schaik, Carolina Webb, Luke Wedner, H James Wehbe, Luis Whan Kim, Soo Wollenberg, Barbara Yakusevich, Vladimir Yañez, Anahí Yarin, Yury Yen, David Yeol Kim, Hyo |
| description | Chronic rhinosinusitis with nasal polyps affects approximately 2–4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.
SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Eligible patients were aged 18 years or older with recurrent, refractory, severe, bilateral nasal polyp symptoms (nasal obstruction symptom visual analogue scale [VAS] score of >5), were eligible for repeat nasal surgery (overall symptoms VAS score >7 and endoscopic nasal polyps score of ≥5, with a minimum score of 2 in each nasal cavity) despite standard of care treatment, and had to have at least one nasal surgery in the past 10 years. Patients were randomly assigned (1:1), using permuted block design, to receive either 100 mg mepolizumab subcutaneously or placebo once every 4 weeks, in addition to standard of care (mometasone furoate intranasal spray for at least 8 weeks before screening and during the study, saline nasal irrigations, systemic corticosteroids or antibiotics, or both), as required, for 52 weeks. Site staff, the central study team, and patients were masked to study treatment and absolute blood eosinophil counts. The coprimary endpoints were change from baseline in total endoscopic nasal polyp score at week 52 and in mean nasal obstruction VAS score during weeks 49–52, assessed in the intention-to-treat population (ITT). This study is registered with ClinicalTrials.gov, NCT03085797.
From May 25, 2017, to Dec 12, 2018, 854 patients were screened for eligibility. 414 patients were randomly assigned with 407 included in the ITT population; 206 received mepolizumab and 201 received placebo. Total endoscopic nasal polyp score significantly improved at week 52 from baseline with mepolizumab versus placebo (adjusted difference in medians −0·73, 95% CI −1·11 to −0·34; p |
| doi_str_mv | 10.1016/S2213-2600(21)00097-7 |
| format | Article |
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Fokkens, Wytske ; Desrosiers, Martin ; Wagenmann, Martin ; Lee, Stella E ; Smith, Steven G ; Mayer, Bhabita ; Sousa, Ana R ; Chan, Robert ; Hopkins, Claire ; Armstrong, Michael ; Bardin, Philip ; Barnes, Sara ; Bergna, Miguel ; Beule, Achim ; Blotter, James ; Bronescu, Valeriu ; Brown, Matthew ; Carrie, Sean ; Chaker, Adam ; Cho, Hyung-Ju ; Corriveau, Marie-Noëlle ; Courville, Timothy ; Cuevas, Mandy ; DeConde, Adam ; Del Carpio, Jaime ; De Salvo, María ; Dhong, Hun-Jong ; Durham, Stephen ; Edin, Anton ; Ehmer Jr, Dale ; Elías, Pedro ; Fatakia, Adil ; Franzese, Christine ; Gane, Simon ; García, Gabriel ; Groeger, Moritz ; Harvey, Richard ; Higgins, Thomas ; Hobson, Jonathan ; Jangard, Mattias ; Janjua, Arif ; Kara, Naveed ; Karpischenko, Sergey ; Kerwin, Edward ; Khanova, Fatimat ; Kilty, Shaun ; Kim, Chang-Hoon ; Kim, Seontae ; Klimek, Ludger ; LaForce, Craig ; Leong, Samuel ; Marple, Bradley ; Mårtensson, Anders ; Maspero, Jorge ; Massey, Neil ; Matz, Jonathan ; Mella, Corina ; Miller, Steven ; Mirzabekyan, Ekaterina ; Moss, Jonathan ; Mumneh, Nayla ; Ovchinnikov, Andrey ; Polyakov, Dmitriy ; Radeanu, Doinel ; Rhee, Chae-Seo ; Rojas, Ramón ; Rosenbloom, Jeffrey ; Ryazantsev, Sergei ; Sader, Chady ; Saez Scherbovsky, Pablo ; Scadding, Guy ; Schlosser, Rodney ; Shah-Patel, Heena ; Shealy, Ronald ; Siddiqi, Ayesha ; Silvers, Stacey ; Singh, Narinder ; Sommer, Doron ; Soong, Weily ; Sowerby, Leigh ; Spafford, Peter ; Stefan, Catalin ; Sterling, Richard ; Talreja, Neetu ; Tarasova, Galina ; Tarpay, Martha ; Tolcachier, Alberto ; Toll, Karin Toll ; van Schaik, Carolina ; Webb, Luke ; Wedner, H James ; Wehbe, Luis ; Whan Kim, Soo ; Wollenberg, Barbara ; Yakusevich, Vladimir ; Yañez, Anahí ; Yarin, Yury ; Yen, David ; Yeol Kim, Hyo</creator><creatorcontrib>Han, Joseph K ; Fokkens, Wytske ; Desrosiers, Martin ; Wagenmann, Martin ; Lee, Stella E ; Smith, Steven G ; Mayer, Bhabita ; Sousa, Ana R ; Chan, Robert ; Hopkins, Claire ; Armstrong, Michael ; Bardin, Philip ; Barnes, Sara ; Bergna, Miguel ; Beule, Achim ; Blotter, James ; Bronescu, Valeriu ; Brown, Matthew ; Carrie, Sean ; Chaker, Adam ; Cho, Hyung-Ju ; Corriveau, Marie-Noëlle ; Courville, Timothy ; Cuevas, Mandy ; DeConde, Adam ; Del Carpio, Jaime ; De Salvo, María ; Dhong, Hun-Jong ; Durham, Stephen ; Edin, Anton ; Ehmer Jr, Dale ; Elías, Pedro ; Fatakia, Adil ; Franzese, Christine ; Gane, Simon ; García, Gabriel ; Groeger, Moritz ; Harvey, Richard ; Higgins, Thomas ; Hobson, Jonathan ; Jangard, Mattias ; Janjua, Arif ; Kara, Naveed ; Karpischenko, Sergey ; Kerwin, Edward ; Khanova, Fatimat ; Kilty, Shaun ; Kim, Chang-Hoon ; Kim, Seontae ; Klimek, Ludger ; LaForce, Craig ; Leong, Samuel ; Marple, Bradley ; Mårtensson, Anders ; Maspero, Jorge ; Massey, Neil ; Matz, Jonathan ; Mella, Corina ; Miller, Steven ; Mirzabekyan, Ekaterina ; Moss, Jonathan ; Mumneh, Nayla ; Ovchinnikov, Andrey ; Polyakov, Dmitriy ; Radeanu, Doinel ; Rhee, Chae-Seo ; Rojas, Ramón ; Rosenbloom, Jeffrey ; Ryazantsev, Sergei ; Sader, Chady ; Saez Scherbovsky, Pablo ; Scadding, Guy ; Schlosser, Rodney ; Shah-Patel, Heena ; Shealy, Ronald ; Siddiqi, Ayesha ; Silvers, Stacey ; Singh, Narinder ; Sommer, Doron ; Soong, Weily ; Sowerby, Leigh ; Spafford, Peter ; Stefan, Catalin ; Sterling, Richard ; Talreja, Neetu ; Tarasova, Galina ; Tarpay, Martha ; Tolcachier, Alberto ; Toll, Karin Toll ; van Schaik, Carolina ; Webb, Luke ; Wedner, H James ; Wehbe, Luis ; Whan Kim, Soo ; Wollenberg, Barbara ; Yakusevich, Vladimir ; Yañez, Anahí ; Yarin, Yury ; Yen, David ; Yeol Kim, Hyo ; SYNAPSE study investigators</creatorcontrib><description>Chronic rhinosinusitis with nasal polyps affects approximately 2–4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.
SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Eligible patients were aged 18 years or older with recurrent, refractory, severe, bilateral nasal polyp symptoms (nasal obstruction symptom visual analogue scale [VAS] score of >5), were eligible for repeat nasal surgery (overall symptoms VAS score >7 and endoscopic nasal polyps score of ≥5, with a minimum score of 2 in each nasal cavity) despite standard of care treatment, and had to have at least one nasal surgery in the past 10 years. Patients were randomly assigned (1:1), using permuted block design, to receive either 100 mg mepolizumab subcutaneously or placebo once every 4 weeks, in addition to standard of care (mometasone furoate intranasal spray for at least 8 weeks before screening and during the study, saline nasal irrigations, systemic corticosteroids or antibiotics, or both), as required, for 52 weeks. Site staff, the central study team, and patients were masked to study treatment and absolute blood eosinophil counts. The coprimary endpoints were change from baseline in total endoscopic nasal polyp score at week 52 and in mean nasal obstruction VAS score during weeks 49–52, assessed in the intention-to-treat population (ITT). This study is registered with ClinicalTrials.gov, NCT03085797.
From May 25, 2017, to Dec 12, 2018, 854 patients were screened for eligibility. 414 patients were randomly assigned with 407 included in the ITT population; 206 received mepolizumab and 201 received placebo. Total endoscopic nasal polyp score significantly improved at week 52 from baseline with mepolizumab versus placebo (adjusted difference in medians −0·73, 95% CI −1·11 to −0·34; p<0·0001) and nasal obstruction VAS score during weeks 49–52 also significantly improved (−3·14, −4·09 to −2·18; p<0·0001). Adverse events considered related to study treatment were reported in 30 (15%) of 206 patients receiving mepolizumab and 19 (9%) of 201 receiving placebo. On-treatment serious adverse events occurred in 12 (6%) patients receiving mepolizumab and 13 (6%) receiving placebo; none were considered related to treatment in those receiving mepolizumab. One death was reported in the placebo group (myocardial infarction; death occurred 99 days after the last dose) and was considered unrelated to the treatment.
Mepolizumab treatment improved nasal polyp size and nasal obstruction compared with placebo, with no new safety indications, in patients with recurrent, refractory severe chronic rhinosinusitis with nasal polyps. These findings suggest that mepolizumab provides an effective add-on treatment option to standard of care in this population.
GlaxoSmithKline.</description><identifier>ISSN: 2213-2600</identifier><identifier>ISSN: 2213-2619</identifier><identifier>EISSN: 2213-2619</identifier><identifier>DOI: 10.1016/S2213-2600(21)00097-7</identifier><identifier>PMID: 33872587</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Medicin och hälsovetenskap</subject><ispartof>The lancet respiratory medicine, 2021-10, Vol.9 (10), p.1141-1153</ispartof><rights>2021 Elsevier Ltd</rights><rights>Copyright © 2021 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c591t-c00b59f893c459268865d0e7cf91acc7fd4188df354ba569704846c1aa631a4d3</citedby><cites>FETCH-LOGICAL-c591t-c00b59f893c459268865d0e7cf91acc7fd4188df354ba569704846c1aa631a4d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33872587$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://urn.kb.se/resolve?urn=urn:nbn:se:shh:diva-4281$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:148673263$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:233872587$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Han, Joseph K</creatorcontrib><creatorcontrib>Fokkens, Wytske</creatorcontrib><creatorcontrib>Desrosiers, Martin</creatorcontrib><creatorcontrib>Wagenmann, Martin</creatorcontrib><creatorcontrib>Lee, Stella E</creatorcontrib><creatorcontrib>Smith, Steven G</creatorcontrib><creatorcontrib>Mayer, Bhabita</creatorcontrib><creatorcontrib>Sousa, Ana R</creatorcontrib><creatorcontrib>Chan, Robert</creatorcontrib><creatorcontrib>Hopkins, Claire</creatorcontrib><creatorcontrib>Armstrong, Michael</creatorcontrib><creatorcontrib>Bardin, Philip</creatorcontrib><creatorcontrib>Barnes, Sara</creatorcontrib><creatorcontrib>Bergna, Miguel</creatorcontrib><creatorcontrib>Beule, Achim</creatorcontrib><creatorcontrib>Blotter, James</creatorcontrib><creatorcontrib>Bronescu, Valeriu</creatorcontrib><creatorcontrib>Brown, Matthew</creatorcontrib><creatorcontrib>Carrie, Sean</creatorcontrib><creatorcontrib>Chaker, Adam</creatorcontrib><creatorcontrib>Cho, Hyung-Ju</creatorcontrib><creatorcontrib>Corriveau, Marie-Noëlle</creatorcontrib><creatorcontrib>Courville, Timothy</creatorcontrib><creatorcontrib>Cuevas, Mandy</creatorcontrib><creatorcontrib>DeConde, Adam</creatorcontrib><creatorcontrib>Del Carpio, Jaime</creatorcontrib><creatorcontrib>De Salvo, María</creatorcontrib><creatorcontrib>Dhong, Hun-Jong</creatorcontrib><creatorcontrib>Durham, Stephen</creatorcontrib><creatorcontrib>Edin, Anton</creatorcontrib><creatorcontrib>Ehmer Jr, Dale</creatorcontrib><creatorcontrib>Elías, Pedro</creatorcontrib><creatorcontrib>Fatakia, Adil</creatorcontrib><creatorcontrib>Franzese, Christine</creatorcontrib><creatorcontrib>Gane, Simon</creatorcontrib><creatorcontrib>García, Gabriel</creatorcontrib><creatorcontrib>Groeger, Moritz</creatorcontrib><creatorcontrib>Harvey, Richard</creatorcontrib><creatorcontrib>Higgins, Thomas</creatorcontrib><creatorcontrib>Hobson, Jonathan</creatorcontrib><creatorcontrib>Jangard, Mattias</creatorcontrib><creatorcontrib>Janjua, Arif</creatorcontrib><creatorcontrib>Kara, Naveed</creatorcontrib><creatorcontrib>Karpischenko, Sergey</creatorcontrib><creatorcontrib>Kerwin, Edward</creatorcontrib><creatorcontrib>Khanova, Fatimat</creatorcontrib><creatorcontrib>Kilty, Shaun</creatorcontrib><creatorcontrib>Kim, Chang-Hoon</creatorcontrib><creatorcontrib>Kim, Seontae</creatorcontrib><creatorcontrib>Klimek, Ludger</creatorcontrib><creatorcontrib>LaForce, Craig</creatorcontrib><creatorcontrib>Leong, Samuel</creatorcontrib><creatorcontrib>Marple, Bradley</creatorcontrib><creatorcontrib>Mårtensson, Anders</creatorcontrib><creatorcontrib>Maspero, Jorge</creatorcontrib><creatorcontrib>Massey, Neil</creatorcontrib><creatorcontrib>Matz, Jonathan</creatorcontrib><creatorcontrib>Mella, Corina</creatorcontrib><creatorcontrib>Miller, Steven</creatorcontrib><creatorcontrib>Mirzabekyan, Ekaterina</creatorcontrib><creatorcontrib>Moss, Jonathan</creatorcontrib><creatorcontrib>Mumneh, Nayla</creatorcontrib><creatorcontrib>Ovchinnikov, Andrey</creatorcontrib><creatorcontrib>Polyakov, Dmitriy</creatorcontrib><creatorcontrib>Radeanu, Doinel</creatorcontrib><creatorcontrib>Rhee, Chae-Seo</creatorcontrib><creatorcontrib>Rojas, Ramón</creatorcontrib><creatorcontrib>Rosenbloom, Jeffrey</creatorcontrib><creatorcontrib>Ryazantsev, Sergei</creatorcontrib><creatorcontrib>Sader, Chady</creatorcontrib><creatorcontrib>Saez Scherbovsky, Pablo</creatorcontrib><creatorcontrib>Scadding, Guy</creatorcontrib><creatorcontrib>Schlosser, Rodney</creatorcontrib><creatorcontrib>Shah-Patel, Heena</creatorcontrib><creatorcontrib>Shealy, Ronald</creatorcontrib><creatorcontrib>Siddiqi, Ayesha</creatorcontrib><creatorcontrib>Silvers, Stacey</creatorcontrib><creatorcontrib>Singh, Narinder</creatorcontrib><creatorcontrib>Sommer, Doron</creatorcontrib><creatorcontrib>Soong, Weily</creatorcontrib><creatorcontrib>Sowerby, Leigh</creatorcontrib><creatorcontrib>Spafford, Peter</creatorcontrib><creatorcontrib>Stefan, Catalin</creatorcontrib><creatorcontrib>Sterling, Richard</creatorcontrib><creatorcontrib>Talreja, Neetu</creatorcontrib><creatorcontrib>Tarasova, Galina</creatorcontrib><creatorcontrib>Tarpay, Martha</creatorcontrib><creatorcontrib>Tolcachier, Alberto</creatorcontrib><creatorcontrib>Toll, Karin Toll</creatorcontrib><creatorcontrib>van Schaik, Carolina</creatorcontrib><creatorcontrib>Webb, Luke</creatorcontrib><creatorcontrib>Wedner, H James</creatorcontrib><creatorcontrib>Wehbe, Luis</creatorcontrib><creatorcontrib>Whan Kim, Soo</creatorcontrib><creatorcontrib>Wollenberg, Barbara</creatorcontrib><creatorcontrib>Yakusevich, Vladimir</creatorcontrib><creatorcontrib>Yañez, Anahí</creatorcontrib><creatorcontrib>Yarin, Yury</creatorcontrib><creatorcontrib>Yen, David</creatorcontrib><creatorcontrib>Yeol Kim, Hyo</creatorcontrib><creatorcontrib>SYNAPSE study investigators</creatorcontrib><title>Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial</title><title>The lancet respiratory medicine</title><addtitle>Lancet Respir Med</addtitle><description>Chronic rhinosinusitis with nasal polyps affects approximately 2–4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.
SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Eligible patients were aged 18 years or older with recurrent, refractory, severe, bilateral nasal polyp symptoms (nasal obstruction symptom visual analogue scale [VAS] score of >5), were eligible for repeat nasal surgery (overall symptoms VAS score >7 and endoscopic nasal polyps score of ≥5, with a minimum score of 2 in each nasal cavity) despite standard of care treatment, and had to have at least one nasal surgery in the past 10 years. Patients were randomly assigned (1:1), using permuted block design, to receive either 100 mg mepolizumab subcutaneously or placebo once every 4 weeks, in addition to standard of care (mometasone furoate intranasal spray for at least 8 weeks before screening and during the study, saline nasal irrigations, systemic corticosteroids or antibiotics, or both), as required, for 52 weeks. Site staff, the central study team, and patients were masked to study treatment and absolute blood eosinophil counts. The coprimary endpoints were change from baseline in total endoscopic nasal polyp score at week 52 and in mean nasal obstruction VAS score during weeks 49–52, assessed in the intention-to-treat population (ITT). This study is registered with ClinicalTrials.gov, NCT03085797.
From May 25, 2017, to Dec 12, 2018, 854 patients were screened for eligibility. 414 patients were randomly assigned with 407 included in the ITT population; 206 received mepolizumab and 201 received placebo. Total endoscopic nasal polyp score significantly improved at week 52 from baseline with mepolizumab versus placebo (adjusted difference in medians −0·73, 95% CI −1·11 to −0·34; p<0·0001) and nasal obstruction VAS score during weeks 49–52 also significantly improved (−3·14, −4·09 to −2·18; p<0·0001). Adverse events considered related to study treatment were reported in 30 (15%) of 206 patients receiving mepolizumab and 19 (9%) of 201 receiving placebo. On-treatment serious adverse events occurred in 12 (6%) patients receiving mepolizumab and 13 (6%) receiving placebo; none were considered related to treatment in those receiving mepolizumab. One death was reported in the placebo group (myocardial infarction; death occurred 99 days after the last dose) and was considered unrelated to the treatment.
Mepolizumab treatment improved nasal polyp size and nasal obstruction compared with placebo, with no new safety indications, in patients with recurrent, refractory severe chronic rhinosinusitis with nasal polyps. These findings suggest that mepolizumab provides an effective add-on treatment option to standard of care in this population.
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Scherbovsky, Pablo ; Scadding, Guy ; Schlosser, Rodney ; Shah-Patel, Heena ; Shealy, Ronald ; Siddiqi, Ayesha ; Silvers, Stacey ; Singh, Narinder ; Sommer, Doron ; Soong, Weily ; Sowerby, Leigh ; Spafford, Peter ; Stefan, Catalin ; Sterling, Richard ; Talreja, Neetu ; Tarasova, Galina ; Tarpay, Martha ; Tolcachier, Alberto ; Toll, Karin Toll ; van Schaik, Carolina ; Webb, Luke ; Wedner, H James ; Wehbe, Luis ; Whan Kim, Soo ; Wollenberg, Barbara ; Yakusevich, Vladimir ; Yañez, Anahí ; Yarin, Yury ; Yen, David ; Yeol Kim, Hyo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c591t-c00b59f893c459268865d0e7cf91acc7fd4188df354ba569704846c1aa631a4d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Medicin och hälsovetenskap</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Han, Joseph K</creatorcontrib><creatorcontrib>Fokkens, 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Richard</creatorcontrib><creatorcontrib>Talreja, Neetu</creatorcontrib><creatorcontrib>Tarasova, Galina</creatorcontrib><creatorcontrib>Tarpay, Martha</creatorcontrib><creatorcontrib>Tolcachier, Alberto</creatorcontrib><creatorcontrib>Toll, Karin Toll</creatorcontrib><creatorcontrib>van Schaik, Carolina</creatorcontrib><creatorcontrib>Webb, Luke</creatorcontrib><creatorcontrib>Wedner, H James</creatorcontrib><creatorcontrib>Wehbe, Luis</creatorcontrib><creatorcontrib>Whan Kim, Soo</creatorcontrib><creatorcontrib>Wollenberg, Barbara</creatorcontrib><creatorcontrib>Yakusevich, Vladimir</creatorcontrib><creatorcontrib>Yañez, Anahí</creatorcontrib><creatorcontrib>Yarin, Yury</creatorcontrib><creatorcontrib>Yen, David</creatorcontrib><creatorcontrib>Yeol Kim, Hyo</creatorcontrib><creatorcontrib>SYNAPSE study investigators</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Sophiahemmet Högskola</collection><jtitle>The lancet respiratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Han, Joseph K</au><au>Fokkens, Wytske</au><au>Desrosiers, Martin</au><au>Wagenmann, Martin</au><au>Lee, Stella E</au><au>Smith, Steven G</au><au>Mayer, Bhabita</au><au>Sousa, Ana R</au><au>Chan, Robert</au><au>Hopkins, Claire</au><au>Armstrong, Michael</au><au>Bardin, Philip</au><au>Barnes, Sara</au><au>Bergna, Miguel</au><au>Beule, Achim</au><au>Blotter, James</au><au>Bronescu, Valeriu</au><au>Brown, Matthew</au><au>Carrie, Sean</au><au>Chaker, Adam</au><au>Cho, Hyung-Ju</au><au>Corriveau, Marie-Noëlle</au><au>Courville, Timothy</au><au>Cuevas, Mandy</au><au>DeConde, Adam</au><au>Del Carpio, Jaime</au><au>De Salvo, María</au><au>Dhong, Hun-Jong</au><au>Durham, Stephen</au><au>Edin, Anton</au><au>Ehmer Jr, Dale</au><au>Elías, Pedro</au><au>Fatakia, Adil</au><au>Franzese, Christine</au><au>Gane, Simon</au><au>García, Gabriel</au><au>Groeger, Moritz</au><au>Harvey, Richard</au><au>Higgins, Thomas</au><au>Hobson, Jonathan</au><au>Jangard, Mattias</au><au>Janjua, Arif</au><au>Kara, Naveed</au><au>Karpischenko, Sergey</au><au>Kerwin, Edward</au><au>Khanova, Fatimat</au><au>Kilty, Shaun</au><au>Kim, Chang-Hoon</au><au>Kim, Seontae</au><au>Klimek, Ludger</au><au>LaForce, Craig</au><au>Leong, Samuel</au><au>Marple, Bradley</au><au>Mårtensson, Anders</au><au>Maspero, Jorge</au><au>Massey, Neil</au><au>Matz, Jonathan</au><au>Mella, Corina</au><au>Miller, Steven</au><au>Mirzabekyan, Ekaterina</au><au>Moss, Jonathan</au><au>Mumneh, Nayla</au><au>Ovchinnikov, Andrey</au><au>Polyakov, Dmitriy</au><au>Radeanu, Doinel</au><au>Rhee, Chae-Seo</au><au>Rojas, Ramón</au><au>Rosenbloom, Jeffrey</au><au>Ryazantsev, Sergei</au><au>Sader, Chady</au><au>Saez Scherbovsky, Pablo</au><au>Scadding, Guy</au><au>Schlosser, Rodney</au><au>Shah-Patel, Heena</au><au>Shealy, Ronald</au><au>Siddiqi, Ayesha</au><au>Silvers, Stacey</au><au>Singh, Narinder</au><au>Sommer, Doron</au><au>Soong, Weily</au><au>Sowerby, Leigh</au><au>Spafford, Peter</au><au>Stefan, Catalin</au><au>Sterling, Richard</au><au>Talreja, Neetu</au><au>Tarasova, Galina</au><au>Tarpay, Martha</au><au>Tolcachier, Alberto</au><au>Toll, Karin Toll</au><au>van Schaik, Carolina</au><au>Webb, Luke</au><au>Wedner, H James</au><au>Wehbe, Luis</au><au>Whan Kim, Soo</au><au>Wollenberg, Barbara</au><au>Yakusevich, Vladimir</au><au>Yañez, Anahí</au><au>Yarin, Yury</au><au>Yen, David</au><au>Yeol Kim, Hyo</au><aucorp>SYNAPSE study investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial</atitle><jtitle>The lancet respiratory medicine</jtitle><addtitle>Lancet Respir Med</addtitle><date>2021-10-01</date><risdate>2021</risdate><volume>9</volume><issue>10</issue><spage>1141</spage><epage>1153</epage><pages>1141-1153</pages><issn>2213-2600</issn><issn>2213-2619</issn><eissn>2213-2619</eissn><abstract>Chronic rhinosinusitis with nasal polyps affects approximately 2–4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.
SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Eligible patients were aged 18 years or older with recurrent, refractory, severe, bilateral nasal polyp symptoms (nasal obstruction symptom visual analogue scale [VAS] score of >5), were eligible for repeat nasal surgery (overall symptoms VAS score >7 and endoscopic nasal polyps score of ≥5, with a minimum score of 2 in each nasal cavity) despite standard of care treatment, and had to have at least one nasal surgery in the past 10 years. Patients were randomly assigned (1:1), using permuted block design, to receive either 100 mg mepolizumab subcutaneously or placebo once every 4 weeks, in addition to standard of care (mometasone furoate intranasal spray for at least 8 weeks before screening and during the study, saline nasal irrigations, systemic corticosteroids or antibiotics, or both), as required, for 52 weeks. Site staff, the central study team, and patients were masked to study treatment and absolute blood eosinophil counts. The coprimary endpoints were change from baseline in total endoscopic nasal polyp score at week 52 and in mean nasal obstruction VAS score during weeks 49–52, assessed in the intention-to-treat population (ITT). This study is registered with ClinicalTrials.gov, NCT03085797.
From May 25, 2017, to Dec 12, 2018, 854 patients were screened for eligibility. 414 patients were randomly assigned with 407 included in the ITT population; 206 received mepolizumab and 201 received placebo. Total endoscopic nasal polyp score significantly improved at week 52 from baseline with mepolizumab versus placebo (adjusted difference in medians −0·73, 95% CI −1·11 to −0·34; p<0·0001) and nasal obstruction VAS score during weeks 49–52 also significantly improved (−3·14, −4·09 to −2·18; p<0·0001). Adverse events considered related to study treatment were reported in 30 (15%) of 206 patients receiving mepolizumab and 19 (9%) of 201 receiving placebo. On-treatment serious adverse events occurred in 12 (6%) patients receiving mepolizumab and 13 (6%) receiving placebo; none were considered related to treatment in those receiving mepolizumab. One death was reported in the placebo group (myocardial infarction; death occurred 99 days after the last dose) and was considered unrelated to the treatment.
Mepolizumab treatment improved nasal polyp size and nasal obstruction compared with placebo, with no new safety indications, in patients with recurrent, refractory severe chronic rhinosinusitis with nasal polyps. These findings suggest that mepolizumab provides an effective add-on treatment option to standard of care in this population.
GlaxoSmithKline.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>33872587</pmid><doi>10.1016/S2213-2600(21)00097-7</doi><tpages>13</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2213-2600 |
| ispartof | The lancet respiratory medicine, 2021-10, Vol.9 (10), p.1141-1153 |
| issn | 2213-2600 2213-2619 2213-2619 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_462685 |
| source | Alma/SFX Local Collection |
| subjects | Medicin och hälsovetenskap |
| title | Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial |
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