Anifrolumab (1) – Saphnelo®

• Clinical trials
  • The TULIP-1, TULIP-2 and MUSE trials are registration-supporting, double-blind, randomised trials with a 52-week treatment duration, comparing anifrolumab as an add-on therapy to standard therapy with placebo plus standard therapy in adults with chronic, moderate to severe autoantibody-positive SLE according to ACR criteria who were on stable prior therapy.
  • The BLISS-52 and BLISS-76 trials are registration-supporting, double-blind, randomised trials with treatment durations of 52 weeks and 76 weeks respectively, designed to compare belimumab as an add-on therapy to standard therapy in adults with SLE according to ACR criteria.

Adults with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE) who are already receiving standard therapy

• For adults with moderate to severe, active, autoantibody-positive systemic lupus erythematosus (SLE) who are already receiving standard therapy, the additional benefit is not proven.
• There are no direct comparative studies of anifrolumab versus belimumab as an appropriate comparator therapy.
• The pharmaceutical manufacturer therefore presents three adjusted indirect comparisons using the bridge comparator placebo plus standard therapy.
• However, the three adjusted indirect comparisons submitted are not suitable for drawing conclusions about the additional benefit of anifrolumab compared with belimumab.
• In the first adjusted indirect comparison, the comparator group was not restricted to the authorised therapeutic indication for belimumab; the standard therapy used contains active ingredients not authorised in Germany for the treatment of SLE, and the study pool is incomplete.
• In the second and third adjusted indirect comparisons, the patient populations under consideration are not sufficiently similar in terms of study characteristics and, in particular, patient characteristics.
• Consequently, no data relevant to the benefit assessment of anifrolumab are available, meaning that additional benefit is not proven.
• Overall assessment
  • In the overall assessment, the three adjusted indirect comparisons presented are deemed unsuitable for evaluating the additional benefit of anifrolumab compared with the appropriate comparator therapy.
  • The first adjusted indirect comparison is deemed unsuitable, in particular due to the lack of restriction to the authorised therapeutic indication for belimumab on the comparator side, the use of active ingredients (INN) not authorised in Germany for the treatment of SLE as part of standard therapy, and the incomplete study pool, and is therefore not suitable for drawing conclusions regarding the additional benefit of anifrolumab.
  • The patient populations considered in the second and third adjusted indirect comparisons are not sufficiently similar in terms of study characteristics and, in particular, patient characteristics to allow conclusions to be drawn regarding the additional benefit of anifrolumab on the basis of these comparisons.

Courtesy translation only, please refer to the German original.