TY - JOUR
T1 - Comparative effectiveness of omalizumab, mepolizumab, and dupilumab in asthma
T2 - A target trial emulation
AU - Akenroye, Ayobami T.
AU - Segal, Jodi B.
AU - Zhou, Guohai
AU - Foer, Dinah
AU - Li, Lily
AU - Alexander, G. Caleb
AU - Keet, Corinne A.
AU - Jackson, John W.
N1 - Funding Information:
Supported by the National Institutes of Health (NIH)/ National Institute on Minority Health and Health Disparities (NIMHD) program K99/R00 MOSAIC (grant K99MD015767 [to A.T.A.]), a Brigham and Women’s Hospital Minority Faculty Career Development Award (to A.T.A.), NIH/ National Heart, Lung, and Blood Institute (NHLBI) (grant K23HL161332 [to D.F.]), the NIH/ National Institute of Allergy and Infectious Diseases (NIAID) (grant K23AI163371 [to L.L.]), the NIH/NHLBI (grant K01HL145320 [to J.W.J.]), the NIH/National Institute on Aging (NIA) ( K24AG049036 [to J.B.S.]).
Funding Information:
Disclosure of potential conflict of interest: G. C. Alexander is past chair; in addition, he is a current member of the US Food and Drug Administration’s Peripheral and Central Nervous System Advisory Committee and a cofounding principal and equity holder in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation, and a past member of OptumRx’s National Pharmacy and Therapeutics Committee. J. B. Segal has received unrelated grant funding from Bristol-Myers Squibb and has conducted unrelated consultancy for Sanofi and Provention Bio. The rest of the authors declare that they have no relevant conflicts of interest.
Funding Information:
Supported by the National Institutes of Health (NIH)/National Institute on Minority Health and Health Disparities (NIMHD) program K99/R00 MOSAIC (grant K99MD015767 [to A.T.A.]), a Brigham and Women's Hospital Minority Faculty Career Development Award (to A.T.A.), NIH/National Heart, Lung, and Blood Institute (NHLBI) (grant K23HL161332 [to D.F.]), the NIH/National Institute of Allergy and Infectious Diseases (NIAID) (grant K23AI163371 [to L.L.]), the NIH/NHLBI (grant K01HL145320 [to J.W.J.]), the NIH/National Institute on Aging (NIA) (K24AG049036 [to J.B.S.]).Disclosure of potential conflict of interest: G. C. Alexander is past chair; in addition, he is a current member of the US Food and Drug Administration's Peripheral and Central Nervous System Advisory Committee and a cofounding principal and equity holder in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation, and a past member of OptumRx's National Pharmacy and Therapeutics Committee. J. B. Segal has received unrelated grant funding from Bristol-Myers Squibb and has conducted unrelated consultancy for Sanofi and Provention Bio. The rest of the authors declare that they have no relevant conflicts of interest.
Publisher Copyright:
© 2023 The Authors
PY - 2023/5
Y1 - 2023/5
N2 - Background: Multiple mAbs are currently approved for the treatment of asthma. However, there is limited evidence on their comparative effectiveness. Objective: Our aim was to compare the effectiveness of omalizumab, mepolizumab, and dupilumab in individuals with moderate-to-severe asthma. Methods: We emulated a hypothetical randomized trial using electronic health records from a large US-based academic health care system. Participants aged 18 years or older with baseline IgE levels between 30 and 700 IU/mL and peripheral eosinophil counts of at least 150 cells/μL were eligible for study inclusion. The study period extended from March 2016 to August 2021. Outcomes included the incidence of asthma-related exacerbations and change in baseline FEV1 value over 12 months of follow-up. Results: In all, 68 individuals receiving dupilumab, 68 receiving omalizumab, and 65 receiving mepolizumab met the inclusion criteria. Over 12 months of follow-up, 31 exacerbations occurred over 68 person years (0.46 exacerbations per person year) in the dupilumab group, 63 over 68 person years (0.93 per person year) in the omalizumab group, and 86 over 65 person years (1.32 per person year) in the mepolizumab group (adjusted incidence rate ratios: dupilumab vs mepolizumab, 0.28 [95% CI = 0.09-0.84]; dupilumab vs omalizumab, 0.36 [95% CI = 0.12-1.09]; and omalizumab vs mepolizumab, 0.78 [95% CI = 0.32-1.91]). The differences in the change in FEV1 comparing patients who received the different biologics were as follows: 0.11 L (95% CI = –0.003 to 0.222 L) for dupilumab versus mepolizumab, 0.082 L (95% CI –0.040 to 0.204 L) for dupilumab versus omalizumab, and 0.026 L (95% CI –0.083 to 0.140 L) for omalizumab versus mepolizumab. Conclusions: Among patients with asthma and eosinophil counts of at least 150 cells/μL and IgE levels of 30 to 700 kU/L, dupilumab was associated with greater improvements in exacerbation and FEV1 value than omalizumab and mepolizumab.
AB - Background: Multiple mAbs are currently approved for the treatment of asthma. However, there is limited evidence on their comparative effectiveness. Objective: Our aim was to compare the effectiveness of omalizumab, mepolizumab, and dupilumab in individuals with moderate-to-severe asthma. Methods: We emulated a hypothetical randomized trial using electronic health records from a large US-based academic health care system. Participants aged 18 years or older with baseline IgE levels between 30 and 700 IU/mL and peripheral eosinophil counts of at least 150 cells/μL were eligible for study inclusion. The study period extended from March 2016 to August 2021. Outcomes included the incidence of asthma-related exacerbations and change in baseline FEV1 value over 12 months of follow-up. Results: In all, 68 individuals receiving dupilumab, 68 receiving omalizumab, and 65 receiving mepolizumab met the inclusion criteria. Over 12 months of follow-up, 31 exacerbations occurred over 68 person years (0.46 exacerbations per person year) in the dupilumab group, 63 over 68 person years (0.93 per person year) in the omalizumab group, and 86 over 65 person years (1.32 per person year) in the mepolizumab group (adjusted incidence rate ratios: dupilumab vs mepolizumab, 0.28 [95% CI = 0.09-0.84]; dupilumab vs omalizumab, 0.36 [95% CI = 0.12-1.09]; and omalizumab vs mepolizumab, 0.78 [95% CI = 0.32-1.91]). The differences in the change in FEV1 comparing patients who received the different biologics were as follows: 0.11 L (95% CI = –0.003 to 0.222 L) for dupilumab versus mepolizumab, 0.082 L (95% CI –0.040 to 0.204 L) for dupilumab versus omalizumab, and 0.026 L (95% CI –0.083 to 0.140 L) for omalizumab versus mepolizumab. Conclusions: Among patients with asthma and eosinophil counts of at least 150 cells/μL and IgE levels of 30 to 700 kU/L, dupilumab was associated with greater improvements in exacerbation and FEV1 value than omalizumab and mepolizumab.
KW - Asthma
KW - allergic
KW - comparative effectiveness
KW - dupilumab
KW - eosinophilic
KW - mAbs
KW - mepolizumab
KW - omalizumab
KW - target trial emulation
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U2 - 10.1016/j.jaci.2023.01.020
DO - 10.1016/j.jaci.2023.01.020
M3 - Article
C2 - 36740144
AN - SCOPUS:85148897764
SN - 0091-6749
VL - 151
SP - 1269
EP - 1276
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 5
ER -