Background

Patients with severe eosinophilic asthma (SEA) may benefit significantly from biological treatment.The efficacy of such therapy is proven by randomized controlled trials (RCTs),which have stringent inclusion criteria. The aim of the study is to evaluate how RCTs data about biological therapy in severe asthma can be generalized comparing them with those obtained in real life (RL).

Methods

15 patients with SEA were enrolled; 3 were treated with Mepolizumab (MZ), 3 with Dupilumab (DP), 4 with Omalizumab (OMA), and 5 with Benralizumab (BZ). We compared the data obtained after one year of treatment with the corresponding RCTs. 

Results

At one year of treatment with OMA, FEV1 increased by 9% from baseline (vs 3.7% in RCTs); MZ and DP determined a FEV1 increase a of 0.23L (vs 0.11L in RCTs) and 0.93L (vs 0.18L in RCTs) respectively. BZ results were consistent with RCTs.

After 6 months, both BZ and MZ showed eosinophil blood count reduction (BZ:72% vs 100% in RCTs; MZ: 96% vs 55% in RCTs); with DP, on the other hand, results are comparable to RCTs.

In all patients asthma symptoms control markedly improved, together with a statistically significant reduction in ICS and OCS doses and exacerbations; unfortunately these data weren?t directly comparable to RCTs.

Conclusions

Patients enrolled in the RCTs don't reflect the heterogeneity of the SEA population, which typically suffers from other comorbidities. This makes clear the need to take strides toward "patient-tailored" medicine. Our RL experience is in line with the results of RCTs, showing that the latter are generalizable.