Dupilumab found to be effective in patients with moderate to severe asthma
In an important breakthrough, researchers have found IL-4 antagonist dupilumab to be effective in preventing asthma exacerbations in patients suffering from moderate to severe asthma. The research was led by Sally Wenzel from the University of Pittsburgh and has been reported online in the New England Journal of Medicine.
For their research, Wenzel and colleagues chose patients with moderate to severe asthma with eosinophil count ≥300 cells/mL and a sputum eosinophil count of ≥3%. All the participants were suffering from asthma for at least one year and had a forced expiratory volume at 1 second (FEV1) ≥50% of predicted. The patients were administered either dupilumab (300 mg) or a placebo simultaneously once a week for 12 weeks or until an exacerbation of asthma occurred. Patients also received fluticasone and salmeterol twice a day for 4 weeks. In patients who were already on steroids, the dose of steroid was tapered and finally discontinued from 6th to 9th week.
It was seen that 87% of the patients who received dupilumab completed the therapy compared to 67% of those who received the placebo. This shows that dupilumab has a better efficacy. Of the 26 exacerbations seen during the therapy, 23 were in the placebo group compared to only 3 in the dupilumab group. Patients on dupilumab therapy showed fewer nocturnal awakenings, better morning and evening peak expiratory flow, better morning and evening asthma score and less requirement of short acting beta agonists. The asthma exacerbations decreased by a whopping 87% in patients who received dupilumab. The biomarkers associated with Th-2 driven inflammation were also found to be reduced with dupilumab. However, side-effects like injection-site reactions, naso-pharyngitis and headache were seen more frequently. The researchers reached the conclusion that lung functions showed a marked improvement and there was a considerable decrease in the Th-2 associated markers of inflammation with dupilumab therapy.
However, the researchers have cautioned that in their study, the long acting beta agonists and inhaled steroids were withdrawn beforehand. This is something not seen in actual clinical practice. Therefore, further trials are necessary before using dupilumab in the patients.