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Treatment with the ...
Treatment with the SQ tree sublingual immunotherapy tablet is safe and well tolerated in real-life
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- Pfaar, Oliver (författare)
- Philipps Univ Marburg, Univ Hosp Marburg, Dept Otorhinolaryngol Head & Neck Surg, Sect Rhinol & Allergy, Marburg, Germany.
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- Wolf, Hendrik (författare)
- ALK Abello Arzneimittel GmbH, Med Dept Clin Dev, Hamburg, Germany.
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- Reiber, Rainer (författare)
- Univ Utrecht, Univ Med Ctr Utrecht, Dept Dermatol Allergol, Utrecht, Netherlands.
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- Knulst, Andre (författare)
- Univ Utrecht, Univ Med Ctr Utrecht, Dept Dermatol Allergol, Utrecht, Netherlands.
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- Sidenius, Kirsten (författare)
- Allergiklin & Bagsvaerd, Bagsvaerd, Denmark.;Aleris Hosp Kobenhavn, Soborg, Denmark.
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- Makela, Mika J. (författare)
- Helsinki Univ Hosp, Skin & Allergy Hosp, HUS, Helsinki, Finland.
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- Steinsvag, Sverre (författare)
- Sorlandet Sykehus, Kristiansand, Norway.
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- Janson, Christer (författare)
- Uppsala universitet,Lung- allergi- och sömnforskning
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- van der Zwan, Leonard (författare)
- ALK Abello Benelux, Almere, Netherlands.
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- Uss, Elena (författare)
- ALK Abello Benelux, Almere, Netherlands.
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- Arvidsson, Peter (författare)
- ALK Nord AS, Danmark Filial, Kungsbacka, Sweden.
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- Borchert, Kathrin (författare)
- Xcenda GmbH, Hannover, Germany.
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- Himmelhaus, Helena (författare)
- Xcenda GmbH, Hannover, Germany.
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- Wuestenberg, Eike (författare)
- ALK Abello Arzneimittel GmbH, Med Dept Clin Dev, Hamburg, Germany.;Tech Univ Dresden, Dept Otorhinolaryngol Head & Neck Surg, Fac Med, Dresden, Germany.;Tech Univ Dresden, Univ Hosp Carl Gustav Carus, Dresden, Germany.
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Philipps Univ Marburg, Univ Hosp Marburg, Dept Otorhinolaryngol Head & Neck Surg, Sect Rhinol & Allergy, Marburg, Germany ALK Abello Arzneimittel GmbH, Med Dept Clin Dev, Hamburg, Germany. (creator_code:org_t)
- John Wiley & Sons, 2024
- 2024
- Engelska.
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Ingår i: Clinical and Translational Allergy. - : John Wiley & Sons. - 2045-7022. ; 14:7
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- BackgroundThe SQ tree sublingual immunotherapy (SLIT)-tablet is authorised for treatment of allergic rhinoconjunctivitis with or without asthma in trees of the birch homologous group in 21 European countries. The primary objective of this study was to explore the safety in real-life.MethodsIn a prospective, non-interventional post-authorisation safety study (EUPAS31470), adverse events (AEs) and adverse drug reactions (ADRs) at first administration and follow-up visits, symptoms, medication use, and pollen food syndrome were recorded by physicians in 6 European countries during the first 4-6 months of treatment.ResultsADRs with the SQ tree SLIT-tablet were reported in 57.7% of 1069 total patients (median age 36.0 years, 53.7% female) during the entire observation period (severity, mild-to-moderate: 70.1%, severe: 4.7%, serious: 0.7%) and in 45.9% after first administration. ADRs were not increased with pollen exposure at first administration. With coadministration of the SQ tree and grass SLIT-tablet AEs were reported in 73.8% of patients and in 52.8% with the SQ tree SLIT-tablet alone. Nasal and eye symptoms improved in 86.9% and 80.9% of patients and use of symptomatic medication in 76.0%. PFS with symptoms was reported in 43.0% of patients at baseline and in 4.3% at the individual last visit.ConclusionsThe results of this non-interventional safety study with the SQ tree SLIT-tablet confirm the safety profile from placebo-controlled clinical trials and support effectiveness in real-life according to the published efficacy data. Safety was not impaired by pollen exposure at first administration or co-administration with other SLIT-tablets.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
Nyckelord
- allergen immunotherapy
- post-authorisation safety study
- real-life
- SQ tree-SLIT-tablet
- tolerability
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Pfaar, Oliver
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Wolf, Hendrik
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Reiber, Rainer
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Knulst, Andre
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Sidenius, Kirste ...
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Makela, Mika J.
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Steinsvag, Sverr ...
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Janson, Christer
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van der Zwan, Le ...
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Uss, Elena
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Arvidsson, Peter
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Borchert, Kathri ...
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Himmelhaus, Hele ...
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Wuestenberg, Eik ...
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Uppsala universitet