Asthma
Conditions
Brief summary
This is a retrospective clinical study on adult patients (18 years or more) with biological therapy for severe asthma at the Helsinki University Central Hospital (HUCH). This is a real-life study with a broader patient population than in a randomized controlled trial. Omalizumab has been used for treatment of asthma in HUCH since January 2009, anti-IL5 therapies starting with mepolizumab since April 2016.
Detailed description
The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.
Interventions
DRUGIL5 Antagonist or anti-IL5R-antibody or Omalizumab
mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
Sponsors
Ida Montini Foundation
Helsinki University Central Hospital
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* asthma that remains uncontrolled despite moderate to high dose inhaled corticosteroid and additional therapy with at least one other controller medication and need for continuous per oral corticosteroids (OCS) or contraindications (or clinically significant side effects of OCS) against OCS and/or frequent courses (two or more per year) of OCS
Exclusion criteria
* patients without asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Exacerbations of the Participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Corticosteroid Dose in Milligrams | 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 |
| Change in the Number of Courses of Antimicrobics | The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals | Change in the number of courses of antimicrobics |
| Change in the Number of Emergency Room Visits of the Participants | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Polypectomy, FESS and Ethmoidectomy | The baseline (before biologicals) and the latest 12 months after initiation of biologicals | Change in number of Polypectomy, FESS and ethmoidectomy |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 42 |
| 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 | 22 |
| Total | 64 |
Baseline characteristics
| Characteristic | Anti-IL5/IL5R-therapy Group | Anti-IgE-therapy Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 1 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 21 Participants | 55 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 9.75 | 48 years STANDARD_DEVIATION 10.67 | 52 years STANDARD_DEVIATION 11.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 22 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Finland | 42 Participants | 22 Participants | 64 Participants |
| Sex: Female, Male Female | 23 Participants | 15 Participants | 38 Participants |
| Sex: Female, Male Male | 19 Participants | 7 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 22 |
| other Total, other adverse events | 7 / 42 | 4 / 22 |
| serious Total, serious adverse events | 1 / 42 | 0 / 22 |
Outcome results
Primary
Change in Number of Exacerbations of the Participants
Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.
Time frame: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-IL5/IL5R-therapy Group | Change in Number of Exacerbations of the Participants | 2.77 Change in number of courses of oral c | Standard Deviation 7.91 |
| Anti-IgE-therapy Group | Change in Number of Exacerbations of the Participants | 1.32 Change in number of courses of oral c | Standard Deviation 2.01 |
Secondary
Change in Oral Corticosteroid Dose in Milligrams
Change in oral corticosteroid dose in milligrams
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-IL5/IL5R-therapy Group | Change in Oral Corticosteroid Dose in Milligrams | 3.0 Milligrams | Standard Deviation 7.91 |
| Anti-IgE-therapy Group | Change in Oral Corticosteroid Dose in Milligrams | 2.29 Milligrams | Standard Deviation 5.8 |
Secondary
Change in the Number of Courses of Antimicrobics
Change in the number of courses of antimicrobics
Time frame: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-IL5/IL5R-therapy Group | Change in the Number of Courses of Antimicrobics | 0.69 Change in antimicrobial courses/year | Standard Deviation 2.08 |
| Anti-IgE-therapy Group | Change in the Number of Courses of Antimicrobics | 0.23 Change in antimicrobial courses/year | Standard Deviation 1.47 |
Secondary
Change in the Number of Emergency Room Visits of the Participants
Change in the number of emergency room visits of the participants
Time frame: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-IL5/IL5R-therapy Group | Change in the Number of Emergency Room Visits of the Participants | 0.29 Change in number of emergency visits | Standard Deviation 1.3 |
| Anti-IgE-therapy Group | Change in the Number of Emergency Room Visits of the Participants | 0.18 Change in number of emergency visits | Standard Deviation 1.19 |
Other Pre-specified
Change in Number of Polypectomy, FESS and Ethmoidectomy
Change in number of Polypectomy, FESS and ethmoidectomy
Time frame: The baseline (before biologicals) and the latest 12 months after initiation of biologicals
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-IL5/IL5R-therapy Group | Change in Number of Polypectomy, FESS and Ethmoidectomy | Polypectomy | 1.24 Procedures | Standard Deviation 3.03 |
| Anti-IL5/IL5R-therapy Group | Change in Number of Polypectomy, FESS and Ethmoidectomy | FESS | 0.95 Procedures | Standard Deviation 0.89 |
| Anti-IL5/IL5R-therapy Group | Change in Number of Polypectomy, FESS and Ethmoidectomy | Ethmoidectomy | 0.71 Procedures | Standard Deviation 0.94 |
| Anti-IgE-therapy Group | Change in Number of Polypectomy, FESS and Ethmoidectomy | Polypectomy | 1.41 Procedures | Standard Deviation 4.69 |
| Anti-IgE-therapy Group | Change in Number of Polypectomy, FESS and Ethmoidectomy | FESS | 0.82 Procedures | Standard Deviation 1.25 |
| Anti-IgE-therapy Group | Change in Number of Polypectomy, FESS and Ethmoidectomy | Ethmoidectomy | 0.12 Procedures | Standard Deviation 0.68 |