Trial Outcomes & Findings for Severe Asthma, MepolizumaB and Affect: SAMBA Study (NCT NCT04680611)

Participants were recruited from severe asthma specialist centres in 5 locations in the United Kingdom.

This study had three phases. Participants in Phase 1 were 30 individuals who have already received mepolizumab treatment and were a different cohort from the participants in Phase 2. Participants in Phase 2 consisted of 45 individuals who were mepolizumab treatment naive at the time of enrolment and their romantic partners (n=45). Participants in Phase 3 were sub-set of participants from Phase 2.

Phase 2: age, gender, working status. marital status, same sex partner and length of relationship was available for 44 partners. Ethnicity, height and weight data was available for 42 partners. Phase 3 participants were a sub-set of Phase 2 participants, baseline measures have not been collected separately.

A 20-item self-report questionnaire identifying 20 discrete emotions with positive or negative valence. Emotions with positive valence are Interest, Amusement, Pride, Joy, Pleasure, Acceptance, Love, Admiration, relief, Compassion. Emotions with negative valence are: Sadness, Guilt, Regret, Shame, Disappointment, Hopelessness, Fear, Contempt, Hate and Anger. The intensity of each emotion can be marked on a 6-point Likert-type scale with circles indicating intensities. For the statistical analysis, these were computed between 0 ( smallest circles ) to 5 ( largest circles) . Lower scores indicate lower intensity of emotions, higher scores indicate higher intensity of emotions. Changes in the individual emotion scores were the outcomes of interest and are given below.

Clinical diagnostic self-report questionnaire to assess psychological distress. Consists of anxiety and depression sub-scales. It consists of seven questions for anxiety and seven questions for depression that are in mixed order in the questionnaire. Each question has four possible answers scored from 0-3. There are separate sub-scale scores for anxiety and depression each with cut-off scores 0-7: normal, 8-10: borderline abnormal and 11-21: abnormal. Lower scores mean better outcomes. The HADS is a self-report tool and takes 2-5minutes to complete.

6-item clinical questionnaire to establish self-assessed asthma control (questions 1-6) and lung function measured by healthcare professional (item 7). 6 of the questions are patients self-report about their asthma during the previous week regarding symptoms and bronchodilator use. Responses are given on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of all the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). In general, patients with a score below 1.0 have adequately controlled asthma and above 1.0 their asthma is not controlled. Patients with a score between 0.75 and 1.25 have borderline of adequate control. The smallest clinically important change is 0.5.

Clinical questionnaire to assess disease impact on quality of life. The questionnaire has two parts. Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over the preceding period (range 1 month to 1 year). Part 2 (Questions 9 to 16) is related to the patients' current state. The answers to the questions can be grouped in to 3 subscales. The Symptom score is reflective of physical wellbeing over the last year .The Activity score covers functioning related to patients' current daily physical activity. The Impacts score relates to the psychosocial functioning. Subscale total scores can be between 0 (no impairment ) to 100 ( maximum impairment). Scoring is weighted and higher scores indicate worse outcomes. Clinically, the total score is used as a meaningful outcome measure.

Severe Asthma Questionnaire (SAQ) assesses the impact of severe asthma and the effects of treatment on patient's self-reported health-related quality of life. The questionnaire produces two scores: a total domain score and a global quality of life score.1. The total domain score is the aggregation of 16 different Quality of Life (QoL) domains ( individual scores are between 1 and 7) where higher scores indicate higher adverse impact on the responder's life. The total score for this domain is obtained by the sum of scores divided by the number of questions answered and can be between 1 and 7. 2. SAQ-global score where participants scire their quality of life on a 100-point scale. Higher scores mean better quality of life. The scale takes between 3 to 6 minutes to complete, but completion time reduces on subsequent occasions.

Questionnaire assessing the beliefs individuals have about the cause, controllability and impact on them of the illness. Comprises 9 questions. 8 questions use a Likert scale response. Question 9 can be answered by free text about the perceived cause of illness. Total scores can be between 0 and 80 with higher scores indicating worse outcomes.