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  • 1. Han, Joseph K
    et al.
    Bachert, Claus
    Fokkens, Wytske
    Desrosiers, Martin
    Wagenmann, Martin
    Lee, Stella E
    Smith, Steven G
    Martin, Neil
    Mayer, Bhabita
    Yancey, Steven W
    Sousa, Ana R
    Chan, Robert
    Hopkins, Claire
    Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): A randomised, double-blind, placebo-controlled, phase 3 trial2021In: The Lancet Respiratory Medicine, ISSN 2213-2600, E-ISSN 2213-2619, Vol. 9, no 10, p. 1141-1153, article id S2213-2600(21)00097-7Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: 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.

    METHODS: 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.

    FINDINGS: 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.

    INTERPRETATION: 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.

    FUNDING: GlaxoSmithKline.

  • 2.
    Jangard, Mattias
    et al.
    Sophiahemmet University.
    Svedberg, Marie
    Sophiahemmet University.
    Gladh, Hanna
    Araya Holmqvist, Susana
    Ryott, Michael
    Sophiahemmet University.
    Kumlin, Maria
    Sophiahemmet University.
    Nasal irrigation with hot saline provides better postoperative outcome after fess compared to the traditional use of nasal packing2018Conference paper (Other academic)
  • 3. Knutsson, Johan
    et al.
    Priwin, Claudia
    Sophiahemmet University.
    Hessén-Söderman, Anne-Charlotte
    Rosenblad, Andreas
    von Unge, Magnus
    A randomized study of four different types of tympanostomy ventilation tubes: Full-term follow-up2018In: International Journal of Pediatric Otorhinolaryngology, ISSN 0165-5876, E-ISSN 1872-8464, Vol. 107, p. 140-144, article id S0165-5876(18)30078-8Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To evaluate the impact of tympanostomy ventilation tube material (silicone vs fluoroplastic) and shape (short vs long) regarding time to extrusion, occurrence of otorrhea, occlusion, tube removal and occurrence of persistent perforation.

    METHODS AND MATERIAL: Four different types of ventilation tubes were used; Long Armstrong tubes, Donaldson tubes, Shepard tubes and straight tubes, representing four specific combinations of VT material (silicone or fluoroplastic) and shape (short, double flanged or long, single flanged). Four hundred children scheduled for bilateral tube insertion were included in a randomized trial. The patients received one type of tube in the right ear and another type in the left ear. The incidence of tube extrusion and complications were monitored postoperatively every third month by an otolaryngologist.

    RESULTS: Twenty-two children were excluded during surgery. Out of the studied 378 children the mean age was 35.3 months. 63.8% were boys. Short tubes extruded earlier than long tubes; hazard ratio (HR) 4.84 (95% CI 3.50-6.69, p < 0.001). Long Armstrong tubes were least prone to extrude. Silicone tubes resulted in significantly longer time to first infection in a VT ear, HR 1.68 (95% CI 1.03-2.76, p = 0.039). Donaldson tubes rendered the longest mean time to first infection (p = 0.025). Infections did not affect tube extrusion rates significantly (p = 0.879). No significant differences were found regarding tube occlusion, tube extraction or persistent perforation.

    CONCLUSIONS: Long tubes are less prone to extrude early. Long Armstrong tubes have the least propensity to extrude early. Silicone tubes render significantly longer time to first infection. Donaldson tubes result in least infections. Infection does not affect extrusion rates significantly.

    LEVEL OF EVIDENCE: 1b.

  • 4.
    Nordström, Axel
    et al.
    Sophiahemmet University.
    Jangard, Mattias
    Svedberg, Marie
    Sophiahemmet University.
    Kullenberg, Helena
    Sophiahemmet University.
    Ryott, Michael
    Kumlin, Maria
    Sophiahemmet University.
    Hot saline irrigation in comparison to nasal packing after sinus surgery2021Conference paper (Other academic)
  • 5.
    Nordström, Axel
    et al.
    Sophiahemmet University.
    Jangard, Mattias
    Svedberg, Marie
    Sophiahemmet University.
    Kullenberg, Helena
    Sophiahemmet University.
    Ryott, Michael
    Kumlin, Maria
    Sophiahemmet University.
    Hot saline irrigation in comparison to nasal packing after sinus surgery2021In: Laryngoscope Investigative Otolaryngology (LIO), E-ISSN 2378-8038, Vol. 6, no 6, p. 1267-1274Article in journal (Refereed)
    Abstract [en]

    Objectives: Previous studies have shown that hot saline solution (HSS) nasal irrigation is effective against nasal bleeding and is used to treat nasal hemorrhage. In a pilot study, we evaluated hot saline nasal irrigation in comparison to a routinely used nasal packing in terms of self-reported complications and mucosal healing after functional endoscopic sinus surgery.

    Methods: Patients undergoing surgery for bilateral chronic rhinosinusitis received polyvinyl acetate (PVA) nasal packing in the left nostril, and the right nostril was rinsed with 47°C sterile saline immediately after surgery. Patients' experiences of pain, bleeding, and other types of uncomfortable experiences were measured using a visual analog scale for each nostril before, during, and immediately after nasal packing removal. Two weeks post-surgery, the assessments were repeated including an endoscopic evaluation of the mucosa by the surgeon.

    Results: Twenty-seven patients completed the study. Prior to removal of the packing, the patients experienced significantly more pain and other uncomfortable experiences in the nostril treated with nasal packing, as compared to the nostril solely rinsed with hot saline. After removal, patients reported significantly more uncomfortable experiences from the packing treated nostril. Two weeks post-surgery, no difference in mucosal healing was observed between the two nostrils.

    Conclusions: The results from this study indicate that irrigation with HSS could be an alternative postoperative treatment to conventional PVA nasal packing. Hot saline irrigation may contribute to patients experiencing improved control of postoperative bleeding, pain, and less suffering of other causes as well as health-economic benefits, without affecting the mucosal healing up to 2 weeks post-surgery.

    Level of Evidence: 1b.

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  • 6.
    Nordström, Axel
    et al.
    Sophiahemmet University.
    Jangard, Mattias
    Svedberg, Marie
    Sophiahemmet University.
    Ryott, Michael
    Kumlin, Maria
    Sophiahemmet University.
    Altered eicosanoid profile in association with nasal polyp severity in patients with chronic rhinosinusitis2022Conference paper (Other academic)
  • 7.
    Nordström, Axel
    et al.
    Sophiahemmet University.
    Jangard, Mattias
    Svedberg, Marie
    Sophiahemmet University.
    Ryott, Michael
    Kumlin, Maria
    Sophiahemmet University.
    Distinct eicosanoid patterns in severe recalcitrant nasal polyposis2023In: International Forum of Allergy & Rhinology, ISSN 2042-6984, Vol. 13, no 11, p. 2043-2054Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Although altered eicosanoid levels are related to disease severity in chronic rhinosinusitis with nasal polyps (CRSwNP), identifying patients prone to recurrent NPs is still difficult. We investigated levels of nasally secreted eicosanoids before and after NP surgery in patients with or without NP recurrence and explored potential endotypes based on pre-surgical eicosanoid levels.

    METHODS: Levels of leukotriene (LT) E4 , LTB4 , prostaglandin (PG) D2 , PGE2 and 15(S) hydroxyeicosatetraenoic acid (15(S)-HETE) were measured in nasal secretions with specific immunoassays at pre-surgery (n = 38) and six- and 12-months post-surgery (n = 35) where NP recurrence was identified endoscopically. Pre- and post-surgical levels were compared between patients with and without NP recurrence. Eicosanoid patterns among patients were explored with cluster analysis and evaluated with clinical parameters.

    RESULTS: Patients with recurrent NPs had pronounced pre-surgical levels of nasal 15(S)-HETE, PGD2 and LTE4 . From pre-surgery to 12-months after, NP recurrence was associated with significant decrease of 15(S)-HETE and PGD2 relative to non-recurrence whereas levels of LTE4 decreased at six-months but increased again at 12-months. Clustering revealed three potential endotypes. Cluster 1 and 3 featured high and low eicosanoid levels, respectively. Cluster 2 had higher levels of LTE4 and PGD2 , lower levels of PGE2 and LTB4 , and more cases of recurrent NPs and previous NP surgeries.

    CONCLUSION: Elevated nasal LTE4 , 12-month post-surgery, in NP recurrent subjects suggests that postoperative LTE4 measurements may indicate rapid NP regrowth. A distinct nasal eicosanoid profile may be used for the identification of the most severe recalcitrant patients in need of targeted immunomodulatory therapies. This article is protected by copyright. All rights reserved.

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  • 8.
    Nordström, Axel
    et al.
    Sophiahemmet University.
    Jangard, Mattias
    Svedberg, Marie
    Sophiahemmet University.
    Ryott, Michael
    Kumlin, Maria
    Sophiahemmet University.
    Exploring nasally secreted eicosanoids as prognostic markers for nasal polyp recurrence in chronic rhinosinusitis2022Conference paper (Other academic)
  • 9.
    Nordström, Axel
    et al.
    Sophiahemmet University.
    Jangard, Mattias
    Svedberg, Marie
    Sophiahemmet University.
    Ryott, Michael
    Kumlin, Maria
    Sophiahemmet University.
    Levels of eicosanoids in nasal secretions and urine associated with nasal polyp severity in chronic rhinosinusitis2022Conference paper (Other academic)
  • 10.
    Nordström, Axel
    et al.
    Sophiahemmet University.
    Jangard, Mattias
    Svedberg, Marie
    Sophiahemmet University.
    Ryott, Michael
    Kumlin, Maria
    Sophiahemmet University.
    Levels of eicosanoids in nasal secretions associated with nasal polyp severity in chronic rhinosinusitis2022In: Prostaglandins, Leukotrienes and Essential Fatty Acids, ISSN 0952-3278, E-ISSN 1532-2823, Vol. 184, article id 102474Article in journal (Refereed)
    Abstract [en]

    Severe nasal polyposis and mucosal inflammation, in patients with chronic rhinosinusitis (CRS) may include a dysregulated eicosanoid profile, but a clinical role for eicosanoids in CRS with nasal polyps (NP; CRSwNP) remains to be elucidated. This study focused on assessing levels and clinical implications of inflammatory mediators in nasal secretions and urine from patients with different NP severity or Aspirin Exacerbated Respiratory Disease (AERD). Levels of leukotrienes E4 and B4, prostaglandins D2 and E2 as well as 15(S)-hydroxyeicosatetraenoic acid were measured with enzyme immunoassays and cytokines with magnetic bead immunoassays. Patients with CRSwNP were subdivided based on NP score; CRSwNP-low (NP score ≤ 4, n = 11) or CRSwNP-high (NP score ≥ 5, n = 32) and compared to CRS without polyps (CRSsNP, n = 12), CRSwNP-AERD (n = 11) and individuals without CRS (n = 25). Smell test score, fractional exhaled nitric oxide (FeNO), blood eosinophils and Sinonasal outcome test-22 were assessed as clinical markers. Leukotriene E4, prostaglandin D2 and 15(S)-hydroxyeicosatetraenoic acid in nasal secretions correlated with NP score. Nasal leukotriene E4 also correlated with FeNO and smell test score, with highest levels found in CRSwNP-AERD. Levels of prostaglandin D2 in nasal secretion as well as urinary levels of the prostaglandin D2 metabolite 11β-prostaglandin F differed between CRSNP-high and CRSwNP-low. Urinary 11β-prostaglandin F was associated with asthma comorbidity whereas a similar association with prostaglandin D2 in nasal secretions was not observed. In conclusion, subdividing patients based on NP severity in combination with analysis of eicosanoids in non-invasively collected nasal secretions, may have clinical implications when assessing CRS disease severity.

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  • 11. Wu, Shengru
    et al.
    Hammarstedt-Nordenvall, Lalle
    Jangard, Mattias
    Sophiahemmet University.
    Cheng, Liqin
    Radu, Sebastian Alexandru
    Angelidou, Pia
    Zha, Yinghua
    Hamsten, Marica
    Engstrand, Lars
    Du, Juan
    Ternhag, Anders
    Tonsillar microbiota: A cross-sectional study of patients with chronic tonsillitis or tonsillar hypertrophy2021In: mSystems, E-ISSN 2379-5077, Vol. 6, no 2, article id e01302-20Article in journal (Refereed)
    Abstract [en]

    Chronic tonsillitis (CT) and tonsillar hypertrophy (TH) are common tonsillar diseases that are related to infection and inflammation. Little is known about tonsillar microbiota and its role in CT and TH. This study aims to identify palatine tonsillar microbiota both on the surface and in the core tissues of CT and TH patients. In total, 22 palatine tonsils were removed and collected from CT and TH patients who underwent surgery. The surface and core microbiota in the tonsils of CT and TH patients were compared using 16S rRNA gene sequencing of V3-V4 regions. Differential tonsillar microbiotas were found in the CT versus TH patients and surface versus core tissues. Further, a higher relative abundance of bacterial genera, including Haemophilus, Streptococcus, Neisseria, Capnocytophaga, Kingella, Moraxella, and Lachnospiraceae [G-2] in patients with TH and Dialister, Parvimonas, Bacteroidales [G-2], Aggregatibacter, and Atopobium in patients with CT, was observed. Of these, the differential genera of Dialister, Parvimonas, and Neisseria served as key factors in the tonsillar microbiota network. Notably, four representable tonsillar microbial types were identified, with one, consisting of a higher abundance of Haemophilus and Neisseria, exclusively detected in the TH patients. This study analyzed the different tonsillar microbiota from the surface and core tissues of CT and TH patients. Several bacteria and various microbial types related to CT and TH were identified, along with potential bacterial networks and related immune pathways.

    IMPORTANCE: The human microbiota has been shown to be functionally connected to infectious and inflammation-related diseases. So far, only limited studies had been performed on tonsillar microbiota, although tonsils play an essential role in the human immune defense system and encountered numerous microorganisms. Our work presented different tonsillar microbiota from surface and core tissues of chronic tonsillitis (CT) and tonsillar hypertrophy (TH) patients. Notably, one tonsillar microbiota type, which contains a higher abundance of Haemophilus and Neisseria, was only detected in the TH patients. Furthermore, certain bacteria, such as Haemophilus, Neisseria, Dialister, and Parvimonas, may serve as microbial biomarkers to discriminate CT patients from TH patients. These data provide important microbiota data in the tonsillar research area and are highly useful for researchers both in the oral microbiome field and clinical field.

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