Eosinophilic asthma

The benefits of Nucala in severe eosinophilic asthma that is not well controlled by previous treatment have been shown in three main studies, in which it was compared with a placebo (dummy) injection. The first study involved 616 adults and adolescents given Nucala every 4 weeks for a year, in addition to their regular asthma medicines. The second study involved 576 adults and adolescents given Nucala every 4 weeks for 28 weeks. The main measure of effectiveness in these studies was the number of severe attacks (exacerbations) of asthma that occurred during treatment, which was reduced by about half in patients given Nucala.

The third study involved 135 mostly adult patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids, and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo. Over half (37 of 69) of the patients given Nucala were able to reduce their daily corticosteroid dose by more than 50% to a dose of 5 mg or less, and 10 of them were able to stop corticosteroids altogether, compared with about a third of those given placebo (22 of 66, of whom 5 were able to stop corticosteroids).

An additional study was carried out in children aged 6 to 11 years which showed that a dose of 40 mg Nucala given under the skin produced comparable levels of active substance in the body to those seen with standard doses in adults. The reduction in eosinophil levels in the blood achieved in children was also comparable to that seen with standard doses in adults.

Severe chronic rhinosinusitis with nasal polyps

Nucala was studied in 407 patients with severe chronic rhinosinusitis with nasal polyps. The main measure of effectiveness was based on the size of the polyps measured by the nasal polyp score (score ranges from 0 to 8 (scored 0, no polyp to 4, large polyps)), as well as nasal obstruction measured by the symptom scoring system VAS (which ranges from 0 (no obstruction) to 10 (complete obstruction)). In patients treated with Nucala the nasal polyp score improved by 1.0 point after 52 weeks of treatment compared with 0 in those who received placebo. Nasal obstruction improved by 4.4 points with Nucala compared with 0.82 with placebo.

Eosinophilic granulomatosis with polyangiitis (EGPA)

Nucala was studied in 136 patients who received standard of care in addition to either Nucala or placebo. After 36 and 48 weeks of treatment 32% (22 out of 68) of patients treated with Nucala achieved remission (no signs and symptoms of vasculitis) compared with 3% (2 out of 68) of patients who received placebo.

Hypereosinophilic syndrome (HES)

A study in 108 patients showed that treatment with Nucala led to fewer flare-ups of the condition.  During treatment with either placebo or Nucala for 32 weeks, 15 out of 54 (28%) patients on Nucala had a flare-up, compared with 30 out of 54 (56%) patients on placebo.