Inebilizumab (3) – Uplizna®

• Clinical trials
  • The double-blind, multicentre, randomised MINT trial compared the efficacy and safety of inebilizumab with placebo.

a) Adults with acetylcholine receptor antibody-positive generalised myasthenia gravis who are eligible for add-on therapy to standard treatment

• The double-blind, multicentre, randomised MINT trial compared the efficacy and safety of inebilizumab with placebo. The trial therefore does not allow for a comparison with the specific appropriate comparator therapy.
• Consequently, the additional benefit of inebilizumab over the appropriate comparator therapy is not proven for this patient group.

b) Adults with muscle-specific tyrosine kinase antibody-positive generalised myasthenia gravis who are eligible for adjunctive therapy to standard treatment

• For adults with generalised myasthenia gravis who are MuSK-antibody-positive and who are eligible for add-on treatment to standard therapy, no data are available for comparison with the appropriate comparator therapy.
• In the double-blind, multicentre, randomised MINT study, the efficacy and safety of inebilizumab were compared with placebo. The study therefore does not allow for a comparison with the specific appropriate comparator therapy.
• Consequently, the additional benefit of inebilizumab over the appropriate comparator therapy is not proven for this patient group.

Courtesy translation only, please refer to the German original.