دورية أكاديمية
Effect of 2 Years of Treatment With Sublingual Grass Pollen Immunotherapy on Nasal Response to Allergen Challenge at 3 Years Among Patients With Moderate to Severe Seasonal Allergic Rhinitis: The GRASS Randomized Clinical Trial.
| العنوان: | Effect of 2 Years of Treatment With Sublingual Grass Pollen Immunotherapy on Nasal Response to Allergen Challenge at 3 Years Among Patients With Moderate to Severe Seasonal Allergic Rhinitis: The GRASS Randomized Clinical Trial. |
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| المؤلفون: | Scadding GW; Imperial College, London, and Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom., Calderon MA; Imperial College, London, and Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom., Shamji MH; Imperial College, London, and Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom., Eifan AO; Imperial College, London, and Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom., Penagos M; Imperial College, London, and Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom., Dumitru F; Imperial College, London, and Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom., Sever ML; Rho Federal Systems Division, Chapel Hill, North Carolina., Bahnson HT; Rho Federal Systems Division, Chapel Hill, North Carolina3currently with the Immune Tolerance Network, Benaroya Research Institute, Seattle, Washington., Lawson K; Rho Federal Systems Division, Chapel Hill, North Carolina., Harris KM; Immune Tolerance Network, Bethesda, Maryland., Plough AG; Immune Tolerance Network, San Francisco, California., Panza JL; National Institute of Allergy and Infectious Diseases, Rockville, Maryland., Qin T; Immune Tolerance Network, Bethesda, Maryland., Lim N; Immune Tolerance Network, Bethesda, Maryland., Tchao NK; Immune Tolerance Network, San Francisco, California7currently with the Department of Early Development Hematology/Oncology, Amgen, San Francisco, California., Togias A; National Institute of Allergy and Infectious Diseases, Rockville, Maryland., Durham SR; Imperial College, London, and Royal Brompton and Harefield Hospitals NHS Foundation Trust, London, United Kingdom. |
| مؤلفون مشاركون: | Immune Tolerance Network GRASS Study Team |
| المصدر: | JAMA [JAMA] 2017 Feb 14; Vol. 317 (6), pp. 615-625. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Allergens/*therapeutic use , Phleum/*immunology , Pollen/*immunology , Rhinitis, Allergic, Seasonal/*therapy , Sublingual Immunotherapy/*methods, Adult ; Double-Blind Method ; Female ; Humans ; Intention to Treat Analysis ; Male ; Phleum/adverse effects ; Pollen/adverse effects ; Rhinitis, Allergic, Seasonal/ethnology ; Sublingual Immunotherapy/adverse effects ; Time Factors ; Treatment Outcome |
| مستخلص: | Importance: Sublingual immunotherapy and subcutaneous immunotherapy are effective in seasonal allergic rhinitis. Three years of continuous treatment with subcutaneous immunotherapy and sublingual immunotherapy has been shown to improve symptoms for at least 2 years following discontinuation of treatment. Objective: To assess whether 2 years of treatment with grass pollen sublingual immunotherapy, compared with placebo, provides improved nasal response to allergen challenge at 3-year follow-up. Design, Setting, and Participants: A randomized double-blind, placebo-controlled, 3-parallel-group study performed in a single academic center, Imperial College London, of adult patients with moderate to severe seasonal allergic rhinitis (interfering with usual daily activities or sleep). First enrollment was March 2011, last follow-up was February 2015. Interventions: Thirty-six participants received 2 years of sublingual immunotherapy (daily tablets containing 15 µg of major allergen Phleum p 5 and monthly placebo injections), 36 received subcutaneous immunotherapy (monthly injections containing 20 µg of Phleum p 5 and daily placebo tablets) and 34 received matched double-placebo. Nasal allergen challenge was performed before treatment, at 1 and 2 years of treatment, and at 3 years (1 year after treatment discontinuation). Main Outcomes and Measures: Total nasal symptom scores (TNSS; range; 0 [best] to 12 [worst]) were recorded between 0 and 10 hours after challenge. The minimum clinically important difference for change in TNSS within an individual is 1.08. The primary outcome was TNSS comparing sublingual immunotherapy vs placebo at year 3. Subcutaneous immunotherapy was included as a positive control. The study was not powered to compare sublingual immunotherapy with subcutaneous immunotherapy. Results: Among 106 randomized participants (mean age, 33.5 years; 34 women [32.1%]), 92 completed the study at 3 years. In the intent-to-treat population, mean TNSS score for the sublingual immunotherapy group was 6.36 (95% CI, 5.76 to 6.96) at pretreatment and 4.73 (95% CI, 3.97 to 5.48) at 3 years, and for the placebo group, the score was 6.06 (95% CI, 5.23 to 6.88) at pretreatment and 4.81 (95% CI, 3.97 to 5.65) at 3 years. The between-group difference (adjusted for baseline) was -0.18 (95% CI, -1.25 to 0.90; [P = .75]). Conclusions and Relevance: Among patients with moderate to severe seasonal allergic rhinitis, 2 years of sublingual grass pollen immunotherapy was not significantly different from placebo in improving the nasal response to allergen challenge at 3-year follow-up. Trial Registration: clinicaltrials.gov Identifier: NCT01335139; EudraCT Number: 2010-023536-16. |
| التعليقات: | Comment in: JAMA. 2017 Feb 14;317(6):591-593. (PMID: 28196239) |
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| معلومات مُعتمدة: | G1000758 United Kingdom MRC_ Medical Research Council; HHSN272201200002C United States AI NIAID NIH HHS; UM2 AI117870 United States AI NIAID NIH HHS; HHSN272201200004C United States AI NIAID NIH HHS; G0601303 United Kingdom MRC_ Medical Research Council; N01AI15416 United States AI NIAID NIH HHS; HHSN272200800029C United States AI NIAID NIH HHS; UM1 AI109565 United States AI NIAID NIH HHS |
| سلسلة جزيئية: | EudraCT 2010-023536-16 ClinicalTrials.gov NCT01335139 |
| المشرفين على المادة: | 0 (Allergens) |
| تواريخ الأحداث: | Date Created: 20170215 Date Completed: 20170317 Latest Revision: 20220321 |
| رمز التحديث: | 20221213 |
| مُعرف محوري في PubMed: | PMC5479315 |
| DOI: | 10.1001/jama.2016.21040 |
| PMID: | 28196255 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2016.21040 |