Patient-reported outcomes provide crucial insight into the lived experience of severe asthma, capturing impacts beyond traditional clinical measures. Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) is a pan-European clinical research consortium focused on advancing patient-centred research and improving outcomes for people living with severe asthma. In this Q&A, Dr Joseph Lanario (University of Plymouth, Plymouth, UK) discusses the burden of severe asthma and two of his current projects with SHARP, highlighting their clinical relevance and implications for patients.

The abstracts “Variability in time to response in severe asthma biologics: a SHARP survey” and “Disease Severity, Not Specific Comorbidities Predicts Fatigue in Severe Asthma (SHARP)” were presented at ERS 2025, 27 September–1 October, Amsterdam, The Netherlands.

touchRESPIRATORY coverage from ERS 2025:

I’m Dr Joseph Lanario. I’m a research fellow in respiratory health at the University of Plymouth, where my asthma work is currently based. I am also a research fellow with Birmingham University’s Biomedical Research Centre working on patient-reported outcomes.

Q. What is the burden of severe asthma on patient quality-of-life?

The burden is considerable, and it is not always appreciated in the literature how all-encompassing the burden to quality-of-life is. We are talking family impact, impact on social and working lives. We know that people with severe asthma often end up being medically retired because of how severe it is. This is a result of it being unmanaged for a very long period and people becoming deconditioned or being unable to work to the level they want to work. There is also a huge psychological burden, especially the impact on family life and self-esteem, for example, people not being able to interact or play with their children.

Q. Could you describe SHARP and its visions and aims for patients living with severe asthma?

SHARP are an incredibly exciting organisation, and they are a European Respiratory Society Clinical Research Consortium (CRC). The vision for SHARP originally was a severe asthma registry across Europe, and many countries are involved in SHARP now. The uniqueness of SHARP is that they are very patient-centred, they have a patient co-chair that sits with the two clinical chairs who guides the direction of SHARP. They are also heavily involved with the European Lung Foundation’s Patient Advisory Group (PAG) who effectively act as SHARP’s PAG.

As I mentioned, SHARP are principally a registry, but the work that I do with them does not collect or use data directly from their registry. I interact with their network of people to deliver research on a larger scale than I otherwise would be able to, because the structures of communication are already there and the meetings are already happening. I have been very lucky to interact with the Patient Advisory Group, get their take on the research we should be carrying out, share my ideas with them, and effectively co-produce a lot of the work and research questions.

Q. Could you tell us more about your current SHARP projects?

ERS take applications for ideas to initiate a project or establish a working group. If approved, the ERS provides the funding, enabling you to deliver the project and secure further support to grow your CRC. I have two main projects with SHARP, the biggest of which is a study across seven countries assessing the burden of severe asthma from a patient perspective. This is using the severe asthma questionnaire, which is a severe asthma specific health-related, quality-of-life measure, as well as other questionnaires such as the asthma control questionnaire (ACQ), the ICECAP-A well-being measure, the EQ5D health-related quality of life measure, and the Work Productivity and Impairment (WPAI) questionnaire.

The idea of this study is to collect questionnaire data at baseline and then monthly for 11 subsequent months and assess from a patient perspective how asthma changes over that time and impacts the questionnaires. This also gives us an opportunity to demonstrate why these questionnaires are effective measures across various countries. We have recruited over 500 people for that project now.

I co-chaired a working group meeting at the ERS and we are expecting that about 8-10 publications will come from this work. We have collected many questionnaires and have data on different areas, for example, air quality and exacerbation history over 12 months. There really is an opportunity to look at many different aspects and collaborate across projects.

The second project is a cross-sectional survey conducted across 16 or 17 countries looking at patient perceptions of their response to biologic treatments for severe asthma. The rationale was from qualitative work that we published during COVID, where we interviewed people deemed to be super responders – so people experiencing significant improvements from their biologic and would now probably be deemed in remission. We found a huge variation in their experience of these drugs, particularly in reference to time to achieve initial response and time to achieve peak benefit on a biologic. Of course, biologics do have different mechanisms of action, but that raises other questions.

We had a wealth of information from the qualitative data. The need going forward was to get a broader description of what was going on and that is where this quantitative survey piece comes in. There is now data from around 600 people who are involved from 16/17 countries, and it will be a hypothesis generating piece of work that will lead on to future research questions.

Q. What insight did the SHARP survey give into time to response with severe asthma biologics?

The survey confirmed the variability that we had already seen in the qualitative work, and which is also seen in clinical practice. In the survey 18% of our sample noticed a response by the end of month 1, 20% between months 1 and 2, 21% between months 2 and 3, and then at the later stages – 13% between months 3 and 4. So there is a huge variation and when you look at the figure, it almost looks like a normal distribution curve, which is very interesting.

The variation in patient experience can be concerning from a patient perspective. They might sit next to someone in the waiting room who has had a response within the first month and they are comparing whether they have felt any benefit yet. This research provides an opportunity to convey to patients that everyone responds in a slightly different timeframe.

We also surveyed what people noticed first and a lot of the time it was symptom related. They noticed it was easier to breathe, with approximately 75% needing their reliever inhaler less, fewer asthma attacks, and wheezing less. There is always this response where people notice changes in their symptoms before applying the change to how it impacts their quality-of-life, and you do see this with questionnaires too. For example, we will see an asthma control questionnaire improve fast and then the patient perspective measures will catch up later, as the patient realises and applies these benefits.

What was interesting was that 26% of those surveyed reported that someone else noticed a difference in them first. We need to drill down a little bit how that presented itself, perhaps it was walking upstairs faster, walking around a shopping centre faster or just simply having more energy. Another point that really does need to be conveyed from this piece of work is that 41% of the sample reported the medicine as “life changing”, and we know from previous qualitative work that this is how patients describe drugs when they truly benefit from them. Then 33% reported that they were a good deal better, so the vast majority had great improvement.

We observed variability in time to achieve peak benefit in participants, with around 26% of people taking longer than 3 months, 22% achieving peak benefit within 2 months and 24% within 3 months. The variation in time to achieve peak benefit shows how every patient responds differently. I think there is a real need to work out why this is and I think comparing a response between the biologics is really where we are going to get some interesting information.

Q. What conclusions have SHARP drawn on the contributing factors to fatigue in severe asthma?

This work on fatigue is effectively a sub study that has come from the larger 12-month project I referred to earlier. We focussed on the baseline data from that project, and we were encouraged to look at fatigue by the Patient Advisory Group who themselves have expressed that fatigue is an underappreciated burden in severe asthma. Fatigue is quite a difficult thing to treat and the key point from this abstract was that fatigue was a very difficult problem for 24% of the sample.

My initial hypothesis was that fatigue may be associated with certain comorbidities, and I analysed the data to try and determine that. On the face of it, it appeared that fatigue was driven more broadly by disease severity, which also makes logical sense. When I presented this abstract, I was very cautious with how I conveyed this information. I reiterate that here because it is difficult to separate disease severity from the presence of comorbidities. There are many confounding factors, for example, patient with more severe asthma will be on more medications, which themselves may be associated with additional comorbidities.

The takeaway message here is that one-quarter of patients reported that fatigue made their lives very difficult, and this does need to be appreciated. There are alternative explanations of what is driving this fatigue, it could be a side effect of lung inflammation or a side effect of treatment. It requires further investigation. Inflammation can make people tired, so it would make sense if there was a severity effect, but comorbidities can also internally lead to more inflammation.

Q. What will be the impact of these findings for clinical practice?

In the first instance, regarding the variation in time to respond to biologic treatments, I want to co-produce information on this with patients for patients. This would include the variation in time to respond, the variation in time to achieve peak benefit, and how this is different across patients. I think this may address some of the anxieties and the expectations of what the drug is going to achieve. I think that would be a very useful resource to produce. I anticipate that being at least trialled in severe asthma clinics to see what patients think of those resources.

Going forward, it will lead to future research looking at how we can influence time to respond and time to achieve peak benefits. We will be looking at the role side effects play in those experiences to see whether side effects of the drug can predict response. We had published a hypothetical piece a few years ago, anticipating that fatigue early on after having a first or second dose would be a predictor of response. We can also compare response profile by biologic; there are very few studies comparing one biologic to another in severe asthma and even fewer comparing it from the patient perspective. So that is exactly what we’ll be able to produce at the end of this work. I think that will inform clinical practice and manage patient and clinician expectations.

The fatigue abstract is certainly a bit more preliminary and there is more work to do before it can be applied in a clinical setting. Primarily though, I see it as an awareness raising piece of work. There are more publications coming up in fatigue, including work produced by the Leiden University Medical Centre group using the Netherlands Rhapsody registry. We want to understand why some patients experience worse fatigue than others and if there is a possible intervention, like pulmonary rehabilitation in COPD. Is there some kind of lifestyle or psychoeducational intervention that we can develop for severe asthma that will help to moderate fatigue? That will be the next step, but that is a few years away.