Improving Biologic Treatment Experience in Severe Asthma
Research type
Research Study
Full title
Improving the treatment experience for patients receiving biologics in the severe asthma service through the use of patient-reported outcomes
IRAS ID
313271
Contact name
Yik Lam Pang
Contact email
Sponsor organisation
Nottingham University Hospitals Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary:
Severe asthma affects 1 in 10 people suffering from asthma. These patients have debilitating symptoms and frequent life-threatening asthma attacks. Oral steroids are effective at controlling these symptoms but incur undesirable side effects such as weight gain, thinning of bones, diabetes etc.Mepolizumab is a new type of treatment for patients with severe asthma to reduce the steroid requirement whilst maintaining good asthma control. Currently, patients need to have treatment for 1 year before it can be decided whether the treatment is continued or not. Unfortunately, Mepolizumab does not benefit everyone. Our current preliminary work shows that those with a bigger change in their Severe Asthma questionnaire (SAQ) between treatment initiation and 12 weeks are more likely to respond to treatment at 1 year.
We would like to gain more experience with this questionnaire and explore its potential in predicting long-term response to Mepolizumab. This may eradicate the need for 12 month treatment trials, allowing patients to try other treatments more quickly and reducing their exposure to a medication which will not benefit them but may cause side effects.
Lay summary of study results:
Severe asthma is a debilitating condition affecting one in ten patients with asthma. Novel monoclonal antibodies such as Mepolizumab (Nucala) have revolutionised treatment for severe asthma by targeting inflammation in the lung. However, approximately one-third of patients do not respond to treatment, which is assessed at 12 months after initiation of therapy. This is time and cost consuming as well as delaying patients to alternative treatments. We aimed to verify whether the Severe Asthma Questionnaire (SAQ) could be used as a potential adjunct in assessing treatment response at 3 or 6 months after initiation of treatment.We found that an improvement of the SAQ Domain score of 0.5 (minimally clinically important difference), was able to predict treatment response at 12 months. This supports finding from our previous work. An improvement of the SAQ score at 3 months was able to predict 12-month response to Mepolizumab, with a sensitivity of 83% and a specificity of 75% in this study.
Therefore, the SAQ questionnaire may be a useful adjunct in assessing patients initiating biologic therapy.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/PR/0902
Date of REC Opinion
8 Jul 2022
REC opinion
Favourable Opinion