Mepolizumab (6) – Nucala®

• Clinical trials
  • The three studies are double-blind, randomised controlled trials comparing mepolizumab as an add-on maintenance therapy with placebo in adult patients with COPD whose condition was inadequately controlled despite combination therapy comprising an ICS, a LABA and a LAMA.

Adults with COPD characterised by an elevated eosinophil count in the blood and whose condition is inadequately controlled despite combination therapy comprising an ICS, a LABA and a LAMA

• For adults with COPD characterised by an elevated eosinophil count in the blood and whose condition is inadequately controlled despite combination therapy comprising an ICS, a LABA and a LAMA, the additional benefit compared with the appropriate comparator therapy is not proven.
• For adult patients with COPD characterised by an elevated eosinophil count in the blood and which is inadequately controlled despite combination therapy comprising an ICS, a LABA and a LAMA, there are no direct comparative studies of mepolizumab against the appropriate comparator therapy.
• Treatment with placebo as an additional maintenance therapy in the respective comparison arm of the three RCTs does not correspond to the appropriate comparator therapy.
• Overall, there are no data suitable for a benefit assessment that would allow a comparison of mepolizumab with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.