Trial Outcomes & Findings for Comparison of Biologicals in Treatment of Severe Asthma (NCT NCT04158050)

NCT ID: NCT04158050

Last Updated: 2023-12-04

Results Overview

Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.

• Recruitment status: COMPLETED
• Target enrollment: 64 participants
• Primary outcome timeframe: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)
• Results posted on: 2023-12-04

Participant Flow

Participant milestones

Measure	Anti-IL5/IL5R-therapy Group Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Overall Study STARTED	42	22
Overall Study COMPLETED	33	17
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Biologicals in Treatment of Severe Asthma

Baseline characteristics by cohort

Measure	Anti-IL5/IL5R-therapy Group n=42 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	21 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 9.75 • n=5 Participants	48 years STANDARD_DEVIATION 10.67 • n=7 Participants	52 years STANDARD_DEVIATION 11.54 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	15 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	7 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	22 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Finland	42 Participants n=5 Participants	22 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)

Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.

Outcome measures

Measure	Anti-IL5/IL5R-therapy Group n=42 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Change in Number of Exacerbations of the Participants	2.77 Change in number of courses of oral c Standard Deviation 7.91	1.32 Change in number of courses of oral c Standard Deviation 2.01

SECONDARY outcome

Timeframe: The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy"

Change in oral corticosteroid dose in milligrams

Outcome measures

Measure	Anti-IL5/IL5R-therapy Group n=42 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Change in Oral Corticosteroid Dose in Milligrams	3.0 Milligrams Standard Deviation 7.91	2.29 Milligrams Standard Deviation 5.80

SECONDARY outcome

Timeframe: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals

Change in the number of courses of antimicrobics

Outcome measures

Measure	Anti-IL5/IL5R-therapy Group n=42 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Change in the Number of Courses of Antimicrobics	0.69 Change in antimicrobial courses/year Standard Deviation 2.08	0.23 Change in antimicrobial courses/year Standard Deviation 1.47

SECONDARY outcome

Timeframe: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals

Change in the number of emergency room visits of the participants

Outcome measures

Measure	Anti-IL5/IL5R-therapy Group n=42 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Change in the Number of Emergency Room Visits of the Participants	0.29 Change in number of emergency visits Standard Deviation 1.30	0.18 Change in number of emergency visits Standard Deviation 1.19

OTHER_PRE_SPECIFIED outcome

Timeframe: The baseline (before biologicals) and the latest 12 months after initiation of biologicals

Change in number of Polypectomy, FESS and ethmoidectomy

Outcome measures

Measure	Anti-IL5/IL5R-therapy Group n=42 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 Participants Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Change in Number of Polypectomy, FESS and Ethmoidectomy Polypectomy	1.24 Procedures Standard Deviation 3.03	1.41 Procedures Standard Deviation 4.69
Change in Number of Polypectomy, FESS and Ethmoidectomy FESS	0.95 Procedures Standard Deviation 0.89	0.82 Procedures Standard Deviation 1.25
Change in Number of Polypectomy, FESS and Ethmoidectomy Ethmoidectomy	0.71 Procedures Standard Deviation 0.94	0.12 Procedures Standard Deviation 0.68

Adverse Events

Anti-IL5/IL5R-therapy Group

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Anti-IgE-therapy Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anti-IL5/IL5R-therapy Group n=42 participants at risk Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 participants at risk Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Cardiac disorders Pneumopleuritis and pericarditis	2.4% 1/42 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	0.00% 0/22 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.

Other adverse events

Measure	Anti-IL5/IL5R-therapy Group n=42 participants at risk Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Anti-IgE-therapy Group n=22 participants at risk Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Nervous system disorders Headache	4.8% 2/42 • Number of events 2 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	4.5% 1/22 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.
Nervous system disorders Fatique	2.4% 1/42 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	4.5% 1/22 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.
Immune system disorders Fever	2.4% 1/42 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	0.00% 0/22 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/42 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	4.5% 1/22 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.
Gastrointestinal disorders Rise in transaminases	2.4% 1/42 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	0.00% 0/22 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.
Musculoskeletal and connective tissue disorders Limb or joint pain or oedema	2.4% 1/42 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	4.5% 1/22 • Number of events 2 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.
Skin and subcutaneous tissue disorders Lip swelling	2.4% 1/42 • Number of events 1 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.	0.00% 0/22 • Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3). Adverse events information was collected in the medical records.

Additional Information

Dr Paula Kauppi

Helsinki University Hospital

Phone: +358504286802

Email: paula.kauppi@hus.fi

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place