Evaluation treatment with biologicals in severe asthma

A lot of patients with severe asthma are treated in severe asthma centres with biologicals and it is expected that the amount of these patients will increase. These patients are systematically evaluated at the onset of the treatment and at 2 and 4 months after starting. After 4 months most of the patients can be evaluated as a responder or non-responder and responders continue their treatment with a systematical follow-up. However, (non) responding is partly based on subjective judgement of the patient and clinician, and on the improvement of miscellaneous parameters. Yet, which patient characteristics are predictors of response and which parameters are the most useful for response evaluation is still unravelled. Likewise, there is a lack of knowledge about the variation in time to response between the patients. Finally, the registration studies of the biologicals showed a good effect after 6 months of treatment, but there are little data on longterm effects. So the optimal use of biologicals is still questioned. In this study we hope to unravel these questions and give answers for optimal treatment with biological in the daily practice.

In patients with severe asthma identification of patient characteristics, biomarkers and parameters can be helpful for response evaluation in treatment with biologicals.

The study consist of a baseline visite, visit at 2 and 4 months, and follow-up during continuing biological treatment.

At baseline, 2, 4 months and continuing fase parameters as part of the clinical proces are registered: demographics and patient characteristics, prednisolone and inhaled corticosteroids doses, adverse events, questionnaires (ACQ, AQLQ, HCU, BORG-ENT symptoms), lungfunction (spirometry, FeNO), blood sampling (cel differentation, IgE, RAST).

Prospective evaluation of patients with severe asthma treated with biologicals.