Pragmatic and Observational Research (Mar 2025)

Real-World Biologic Use Patterns in Severe Asthma, 2015–2021: The CLEAR Study

  • Tran TN,
  • Chen S,
  • Emmanuel B,
  • Altraja A,
  • Bourdin A,
  • Sheu CC,
  • Tsai MJ,
  • Hoyte FC,
  • Quinton A,
  • Cook B,
  • Bulathsinhala L,
  • Henley W,
  • Goh CYY,
  • Liu Y,
  • Ariti C,
  • Carter V,
  • Price DB

Journal volume & issue
Vol. Volume 16
pp. 51 – 66

Abstract

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Trung N Tran,1 Stephanie Chen,1 Benjamin Emmanuel,1 Alan Altraja,2,3 Arnaud Bourdin,4,5 Chau-Chyun Sheu,6,7 Ming-Ju Tsai,6,7 Flavia CL Hoyte,8 Anna Quinton,9 Bill Cook,1 Lakmini Bulathsinhala,10 William Henley,10,11 Celine Yun Yi Goh,10,12 Yang Liu,10 Cono Ariti,10,12 Victoria Carter,10,12 David B Price10,12,13 On behalf of the CLEAR Study Working Group1Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA; 2Department of Pulmonary Medicine, University of Tartu, Tartu, Estonia; 3Lung Clinic, Tartu University Hospital, Tartu, Estonia; 4Phymedexp, CNRS, INSERM, University of Montpellier, Montpellier, France; 5Department of Pulmonology and Addiction, University Hospital of Montpellier, Montpellier, France; 6Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; 7Department of Internal Medicine, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; 8Division of Allergy and Immunology, National Jewish Health, Denver, CO, USA; 9BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK; 10Observational and Pragmatic Research Institute, Singapore; 11Department of Health and Community Sciences, University of Exeter Medical School, Exeter, UK; 12Optimum Patient Care Global, Cambridge, UK; 13Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence: David B Price, Observational and Pragmatic Research Institute, 22 Sin Ming Lane, #06 Midview City, Singapore, 573969, Tel +6531051489, Email [email protected]: Biologics targeting immunoglobulin E, interleukin (IL)-4/IL-13 or IL-5 signaling are effective at treating severe asthma; however, individual patients’ responses may be suboptimal, leading to therapy switching or stopping. The CLEAR study aimed to assess real-world biologic use patterns and associated clinical outcomes in patients receiving care for severe asthma.Methods: CLEAR was a multicenter, observational study that included adults (≥ 18 years old) from 23 countries enrolled in the International Severe Asthma Registry between December 2015 and August 2021. Patients who initiated biologic therapy were categorized as continuing the initial biologic for 6 months, switching to another biologic within 6 months or stopping biologic treatment within 6 months. Outcomes were assessed using the closest available data to 12 months after biologic initiation, using propensity score-weighted multivariable regression models.Results: Among 1,859 patients who initiated biologic therapy, 1,116 (60.0%) continued, 474 (25.5%) switched and 269 (14.5%) stopped treatment. Patients who switched or stopped therapy had a higher annualized asthma exacerbation rate post-initiation than those who continued (adjusted incidence rate ratio [aIRR] [95% confidence interval]: switched, 1.83 [1.51, 2.22]; stopped, 1.53 [1.19, 1.95]) and were more likely to have uncontrolled asthma at last assessment (adjusted odds ratio: switched, 5.40 [3.12, 9.33]; stopped, 4.02 [2.32, 6.98]). Compared with those who continued therapy, patients who switched had a higher long-term daily oral corticosteroid dose (adjusted β: 3.77 [1.71, 4.37] mg) and higher rates of hospitalizations (aIRR: 2.58 [1.52, 4.37]) and emergency room visits (aIRR: 2.12 [1.39, 3.24]).Conclusion: Switching or stopping biologic therapy was associated with worse clinical outcomes than continuing the initial therapy.Keywords: biologics, effectiveness, ISAR, real-world, severe asthma

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