Experience of Biologic Treatments for Severe Asthma: a Survey

A multi-centre cross-sectional survey to retrospectively assess patients' perceptions of their responses to biologic treatments for their severe asthma.

Methods A total of 400 patients will be recruited from the severe asthma centres responsible for their clinical care.

Leads from each participating site will identify patient's eligible to take part in the study. Each lead for a site will be provided with unique 'Collector IDs' (that are linked with a unique survey web URL). After receiving verbal consent from each patient, the researcher at the site will allocate the patient a 'Collector ID' and unique web URL to a survey hosted on SurveyMonkey.

On visiting the survey URL, patients will be provided with study information, provide informed consent and complete the survey information.

Participants will complete the survey without any assistance from physicians or the study staff. All survey questions and responses will be provided in the participants' native languages. All processes will be monitored by a study coordinator to assess recruitment and the completion of the survey.

Variables

Variables from the patient survey will include:

• Experience of starting a biologic treatment

o What changed, when did the change take place and to what degree was the change experienced.

• Side effects experienced after taking a biologic treatment. Demographics
• Gender
• Age Medication use
• Use of OCS
• Use of biologic treatment Data analysis

• To describe the time course and nature of response in people with severe asthma who continue to be prescribed biologics for between 6 - 18 months.
• Demographics data and other survey responses will be reported as descriptive statistics including mean (SD).
• We will report a frequency distribution of responses for each survey item to describe the samples experience of biologic drugs for their severe asthma.
• To assess for the presence of recall differences between those who have been on a biologic for <12 months vs those on a biologic for ≥12 months data from these participants will be stratified and compared.

• To identify subgroups of response pattern to biologic treatments for severe asthma.

Analysis will be exploratory and descriptive, with relationships between survey responses identified through correlations. These correlations will provide insight into which experiences of biologic treatment (response) are related. For example, the literature anticipates that a fast response will be associated with a "better" response to biologic treatments. We will define "better" from a patient perspective, by investigating the relationship between Question 8 (Satisfaction with treatment), and time to first noticed treatment response (Question 6).

• To describe the characteristics of the different subgroups of response pattern.

• Participants demographic data will be reported as a function of the different response patterns we identify in analysis 2.

• To identify a set of hypotheses driven characteristics which may predict response to biologics in future longitudinal studies for people with severe asthma, including the extra-pulmonary symptoms and side effects of treatment.
• Fatigue and other side effects from biologics may be predictors of fast response or high satisfaction with treatment.
• Correlations between the different response patterns identified in analysis 2, and questions concerning side effects and extra-pulmonary questions will be calculated. These include questions: 17, 18 and 19.
• We will also calculate correlations between the response patterns we identify in analysis 2, and the biologic the patient was prescribed.

Inclusion criteria

Receiving a biologic treatment for at least 6 months.

• But has not been on the treatment for longer than 18 months. Note: In clinical practice, a 12-month trial of biologic treatments is needed before a decision to stop/switch treatment is made. Therefore, our inclusion criteria will capture people who are non-responders to biologic treatments.

Exclusion criteria

• Patients will be excluded if they are unwilling/unable to provide consent to use their data.
• Patients who have switched biologics will also be excluded.
• In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.