For some decades already, some allergy patients can start a treatment option called allergen immunotherapy (AIT). Immunotherapy involves exposing patients to larger and larger amounts of allergen in an attempt to change the immune system's response. The efficacy of AIT has been proven in allergic rhinitis and allergic asthma, but according to the European Academy of Allergy and Clinical Immunology (EAACI), less than 1 patient out of 10 has tried the treatment. New findings obtained from Real World Evidence data could change this trend. According to
We talked to Professor Ulrich Wahn, one of the researchers behind the biggest AIT treatment study to date that shows AIT works for allergic rhinitis and allergic asthma, and also reduces the risk of developing asthma. We discussed with him the opportunities that Real World Evidence data brings to patients.
You recently participated in a large study using Real World Evidence data from patients under AIT. What is Real World Evidence and why is it important for allergy?
Every new drug in the market needs to have been approved by the European Medicines Agency. This means that pharmaceutical companies need to provide scientific evidence coming from clinical trials to proof the efficacy, side effects and effectiveness of a drug in people affected by certain symptoms. However, AIT approval relies much more in exclusion than exclusion criteria, meaning that volunteers selected for a clinical trial need to fulfil many disease and demographic requirements. Real World Evidence is data generated outside clinical trials, which do not exclude patients but on the contrary includes data from many kinds of people.
What kind of information did you use to study the treatment of patients suffering from grass pollen allergic rhinitis?
We wanted to picture the effects of immunotherapy in the whole country. In Germany, all doctors are in a huge data bank, so we decided to use Real World Evidence data in a novel way: we analysed the AIT prescriptions that had been documented by health insurances and data banks. This is a huge data power, with 15 million grass pollen allergic patients, 5 to 10% receiving prescriptions for sublingual immunotherapy, so we searched for immunotherapy within the German national prescription files, gathering anonymised data on treatment and demographics like sex, gender, age. I was used to do clinical trials but this way of analysing data files is a novel approach, it was an adventure for us.
What are the new findings this exercise brings?
This kind of analysis has been never done before with comparable numbers, and it cannot be done everywhere, as we need countries large enough, with a powerful file of data and a strong interest in AIT. The study in Germany is a premiere because there is a large amount of data which is digitalised, and with considerable quality. The findings are impressive:
- It shows that AIT reduces the need for allergy medication. Most allergic rhinitis patients where using anti-allergy drugs prior to AIT (antihistamine, corticosteroids), but after using AIT the need for drugs was reduced over time.
- Remarkably, patients used less drugs even after dropping the AIT treatment. AIT is recommended for a period of three years but we know some patients to do finish it, so our data comes from patients that have received AIT for at least two years.
- Finally, AIT reduced the risk of asthma development among allergic but non asthmatic patients, while slowing down asthma progression among asthmatics.
How do you think physicians can use the results of your study? continue
I think these findings are as exciting for the doctors as for the patients. Patients want to know what a medication will bring to them, not to someone who has been highly selected for a clinical trial. So when doing the analysis we brought to the table our patients’ critical questions: does AIT reduce drug-use, does it reduce long-term drug usage, does it really provide disease modification, and does it prevent asthma in children? I think physicians can easily take this findings to communicate with their patients because they answers their questions with data taken from the real world.
How do you think this type of information can impact the work done by patient organisations?
Real World Evidence data never had a good image in the past because it was considered as “soft evidence”, and “marketing-driven data”. But studies like this one show the real value of these trails. I also think patient organisations will express interest in Real World Evidence data because patients feel that it is their real world.
My personal hypothesis is that the data from study is not only valid for Germany but can be transferable from country to country. Other countries could start analysing the use of AIT too, but we need larger groups of prescribing doctors and to be precise looking at their relevant allergens. Our findings were only presented 2017, but I am sure it will have an impact for insurance companies and health authorities, and not only in Germany! I am sure other countries will follow. The claim for disease modification is of interest for the payers in the future.
Professor Ulrich Wahn is a German PhD Paediatric allergologist with over 40 years’ experience. He has served as President of the European Academy of Allergy and Clinical Immunology (EAACI) from 2003-2005.