An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

• Dupilumab (Drug), also known as SAR231893, REGN668: Solution for injection, Subcutaneous injection
• placebo (Drug): Solution for injection, Subcutaneous injection
• ICS/LABA therapy (Drug): Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
• Salbutamol/albuterol (Drug): Oral inhalation as needed
• Levosalbutamol/levalbuterol (Drug): Oral inhalation as needed

Primary outcomes

• Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population [Baseline, Week 12]: FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
• Absolute Change From Baseline in FEV1 at Week 12: ITT Population [Baseline, Week 12]: FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

Secondary outcomes

• Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population [Baseline, Week 12]: FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
• Percent Change From Baseline in FEV1 at Week 12: ITT Population [Baseline, Week 12]: FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
• Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population [Baseline to Week 24]: A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
• Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population [Baseline to Week 24]: A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
• Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population [Baseline up to Week 24]: The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.
• Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population [Baseline up to Week 24]: The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.
• Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population [Baseline to Week 24]: LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in inhaled corticosteroid (ICS) >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
• Annualized Event Rate of LOAC During The Treatment Period: ITT Population [Baseline to Week 24]: LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
• Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population [Baseline up to Week 24]: The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.
• Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population [Baseline up to Week 24]: The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.
• Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population [Baseline, Week 12]: Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
• Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population [Baseline, Week 12]: Morning asthma symptom score was determined using AM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
• Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population [Baseline, Week 12]: Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
• Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population [Baseline, Week 12]: Evening asthma symptom score was determined using PM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
• Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population [Baseline, Week 12]: The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
• Change From Baseline in ACQ-5 Score at Week 12: ITT Population [Baseline, Week 12]: The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
• Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population [Baseline, Week 12]: The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
• Change From Baseline in AQLQ Global Score at Week 12: ITT Population [Baseline, Week 12]: The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
• Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population [Baseline, Week 12]: Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.
• Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population [Baseline, Week 12]: Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.

Sex: All, ages: 18 Years to any

Inclusion criteria:

Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

* Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist
* Forced expiratory volume (FEV1) 40 to 80% of predicted normal
* Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5
* Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
* Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma

Exclusion criteria:

* Participants <18 years
* Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired pulmonary function tests
* Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma
* Current smoker or cessation of smoking within 6 months prior to Visit 1
* Previous smoker with a smoking history >10 pack-years

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Participant flow

Outcome results

• Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population (Primary), Mean, liter: Placebo q2w 1.86 +/- 0.68; Dupilumab 300 mg q2w 1.77 +/- 0.5; Dupilumab 200 mg q2w 1.8 +/- 0.52; Dupilumab 300 mg q4w 1.87 +/- 0.6; Dupilumab 200 mg q4w 1.8 +/- 0.49 (p 0.0063)
• Absolute Change From Baseline in FEV1 at Week 12: ITT Population (Primary), Mean, liter: Placebo q2w 1.82 +/- 0.55; Dupilumab 300 mg q2w 1.85 +/- 0.53; Dupilumab 200 mg q2w 1.79 +/- 0.52; Dupilumab 300 mg q4w 1.86 +/- 0.57; Dupilumab 200 mg q4w 1.88 +/- 0.54 (p 0.0002)
• Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population (Secondary), Mean, percent change: Placebo q2w 10.07 +/- 19.65; Dupilumab 300 mg q2w 25.29 +/- 36.15; Dupilumab 200 mg q2w 27.42 +/- 25.68; Dupilumab 300 mg q4w 20.68 +/- 24.86; Dupilumab 200 mg q4w 18.07 +/- 29.18
• Percent Change From Baseline in FEV1 at Week 12: ITT Population (Secondary), Mean, percent change: Placebo q2w 7.04 +/- 19.26; Dupilumab 300 mg q2w 16.64 +/- 27.78; Dupilumab 200 mg q2w 19.15 +/- 23.53; Dupilumab 300 mg q4w 13.55 +/- 23.01; Dupilumab 200 mg q4w 13.04 +/- 24.21
• Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population (Secondary), Number, exacerbation per participant-year: Placebo q2w 1.044 (0.572 to 1.904); Dupilumab 300 mg q2w 0.201 (0.078 to 0.517); Dupilumab 200 mg q2w 0.30 (0.133 to 0.678); Dupilumab 300 mg q4w 0.678 (0.356 to 1.29); Dupilumab 200 mg q4w 0.358 (0.158 to 0.809)
• Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population (Secondary), Number, exacerbation per participant-year: Placebo q2w 0.897 (0.619 to 1.30); Dupilumab 300 mg q2w 0.265 (0.157 to 0.445); Dupilumab 200 mg q2w 0.269 (0.157 to 0.461); Dupilumab 300 mg q4w 0.599 (0.369 to 0.907); Dupilumab 200 mg q4w 0.415 (0.26 to 0.664)
• Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population (Secondary), Number, probability of Severe Exacerbation: Placebo q2w 0.21 (0.122 to 0.314); Dupilumab 300 mg q2w 0.082 (0.03 to 0.167); Dupilumab 200 mg q2w 0.082 (0.03 to 0.167); Dupilumab 300 mg q4w 0.094 (0.038 to 0.181); Dupilumab 200 mg q4w 0.052 (0.014 to 0.13)
• Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population (Secondary), Number, probability of Severe Exacerbation: Placebo q2w 0.207 (0.147 to 0.274); Dupilumab 300 mg q2w 0.092 (0.053 to 0.145); Dupilumab 200 mg q2w 0.07 (0.036 to 0.119); Dupilumab 300 mg q4w 0.112 (0.068 to 0.168); Dupilumab 200 mg q4w 0.075 (0.04 to 0.125)
• Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population (Secondary), Number, LOAC per participant-year: Placebo q2w 1.312 (0.804 to 2.142); Dupilumab 300 mg q2w 0.322 (0.153 to 0.677); Dupilumab 200 mg q2w 0.446 (0.231 to 0.864); Dupilumab 300 mg q4w 0.788 (0.458 to 1.355); Dupilumab 200 mg q4w 0.424 (0.212 to 0.851)
• Annualized Event Rate of LOAC During The Treatment Period: ITT Population (Secondary), Number, LOAC per participant-year: Placebo q2w 1.107 (0.801 to 1.53); Dupilumab 300 mg q2w 0.326 (0.206 to 0.515); Dupilumab 200 mg q2w 0.347 (0.217 to 0.555); Dupilumab 300 mg q4w 0.73 (0.508 to 1.048); Dupilumab 200 mg q4w 0.563 (0.378 to 0.839)
• Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population (Secondary), Number, probability of LOAC: Placebo q2w 0.30 (0.195 to 0.411); Dupilumab 300 mg q2w 0.115 (0.05 to 0.208); Dupilumab 200 mg q2w 0.113 (0.05 to 0.206); Dupilumab 300 mg q4w 0.126 (0.059 to 0.22); Dupilumab 200 mg q4w 0.052 (0.014 to 0.13)
• Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population (Secondary), Number, probability of LOAC: Placebo q2w 0.258 (0.192 to 0.329); Dupilumab 300 mg q2w 0.112 (0.068 to 0.168); Dupilumab 200 mg q2w 0.09 (0.051 to 0.144); Dupilumab 300 mg q4w 0.145 (0.095 to 0.206); Dupilumab 200 mg q4w 0.096 (0.055 to 0.15)
• Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 1.15 +/- 0.82; Dupilumab 300 mg q2w 1.45 +/- 0.81; Dupilumab 200 mg q2w 1.22 +/- 0.81; Dupilumab 300 mg q4w 1.31 +/- 0.72; Dupilumab 200 mg q4w 1.18 +/- 0.82
• Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 1.17 +/- 0.79; Dupilumab 300 mg q2w 1.25 +/- 0.78; Dupilumab 200 mg q2w 1.24 +/- 0.81; Dupilumab 300 mg q4w 1.33 +/- 0.78; Dupilumab 200 mg q4w 1.29 +/- 0.82
• Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 1.33 +/- 0.83; Dupilumab 300 mg q2w 1.72 +/- 0.89; Dupilumab 200 mg q2w 1.46 +/- 0.73; Dupilumab 300 mg q4w 1.52 +/- 0.72; Dupilumab 200 mg q4w 1.39 +/- 0.87
• Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 1.32 +/- 0.81; Dupilumab 300 mg q2w 1.47 +/- 0.85; Dupilumab 200 mg q2w 1.42 +/- 0.79; Dupilumab 300 mg q4w 1.50 +/- 0.74; Dupilumab 200 mg q4w 1.47 +/- 0.84
• Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 2.55 +/- 0.84; Dupilumab 300 mg q2w 2.98 +/- 0.90; Dupilumab 200 mg q2w 2.65 +/- 0.74; Dupilumab 300 mg q4w 2.69 +/- 0.81; Dupilumab 200 mg q4w 2.76 +/- 0.91
• Change From Baseline in ACQ-5 Score at Week 12: ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 2.69 +/- 0.80; Dupilumab 300 mg q2w 2.80 +/- 0.83; Dupilumab 200 mg q2w 2.73 +/- 0.82; Dupilumab 300 mg q4w 2.70 +/- 0.79; Dupilumab 200 mg q4w 2.78 +/- 0.84
• Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 4.16 +/- 1.27; Dupilumab 300 mg q2w 3.82 +/- 1.13; Dupilumab 200 mg q2w 4.02 +/- 1.15; Dupilumab 300 mg q4w 3.99 +/- 1.06; Dupilumab 200 mg q4w 3.89 +/- 1.88
• Change From Baseline in AQLQ Global Score at Week 12: ITT Population (Secondary), Mean, scores on a scale: Placebo q2w 4.12 +/- 1.10; Dupilumab 300 mg q2w 3.91 +/- 1.13; Dupilumab 200 mg q2w 4.03 +/- 1.15; Dupilumab 300 mg q4w 4.02 +/- 1.01; Dupilumab 200 mg q4w 4.00 +/- 1.09
• 3 more outcome measures not shown.

Adverse events

Time frame: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 40) regardless of seriousness or relationship to investigational product.

Serious adverse events by term

Other adverse events by term

101 more sites not listed.

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• Results publication: Pavord ID, Bourdin A, Papi A, Domingo C, Corren J, Altincatal A, Radwan A, Pandit-Abid N, Jacob-Nara JA, Deniz Y, Rowe PJ, Laws E, Lederer DJ, Hardin M. Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose. Allergy. 2023 Nov;78(11):2921-2932. doi: 10.1111/all.15792. Epub 2023 Jul 11. PMID 37431558
• Results publication: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28. PMID 35636689
• Results publication: Bourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21. PMID 33010038
• Results publication: Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24. PMID 31351189
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• Results publication: Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbe A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21. PMID 30138668
• Results publication: Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31. PMID 29355679

• Clinical Sciences & Operations, Study director, Sanofi