Mepolizumab (4) – Nucala®

• Clinical trials
  • The pharmaceutical manufacturer has submitted the MIRRA study for the benefit assessment pursuant to Section 35a of the German Social Code, Book V (SGB V). This is a randomised, controlled, double-blind trial comparing mepolizumab with placebo, each administered in addition to an oral glucocorticoid (OCS) and, where appropriate, an immunosuppressant, in adults diagnosed with EGPA at least six months previously.

Patients aged 6 years and over with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA)

• For patients aged 6 years and over with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA), the additional benefit is not proven.
• Taking the available information as a whole, there is such a high degree of uncertainty as to whether, for at least some of the included patients, the initiation or adjustment of immunosuppressive therapy would have been indicated that the appropriate comparator therapy is considered, on the whole, not to have been adequately implemented.
• Consequently, the study cannot be taken into account, and there are therefore no suitable data available to assess the additional benefit of mepolizumab compared with the appropriate comparator therapy.
• morbidity
  • The endpoints recorded included, amongst others, the duration of remission and the proportion of patients in remission. In the MIRRA study, remission was defined as BVAS = 0 and an OCS dose ≤ 4 mg/day.
  • The study description did not explain why, for the remaining patients, it would not have been appropriate to adjust or initiate treatment with the other immunosuppressants beyond the adjustment of the OCS dose.
• Overall assessment
  • Taking the available information as a whole, there is such a high degree of uncertainty as to whether, at least for some of the included patients, the initiation or adjustment of immunosuppressive therapy would have been indicated that the appropriate comparator therapy is considered, on the whole, not to have been adequately implemented.

Courtesy translation only, please refer to the German original.