Delgocitinib (1) – Anzupgo®

• Clinical trials
  • To demonstrate the additional benefit of delgocitinib, the pharmaceutical manufacturer has submitted the DELTA FORCE study, which is a completed, partially blinded, multicentre RCT comparing delgocitinib with alitretinoin.

a) Adults with severe chronic hand eczema for whom alitretinoin as monotherapy represents the appropriate treatment option on an individual patient basis

• The fact that it cannot be conclusively assessed whether alitretinoin monotherapy was the appropriate treatment for each individual patient included in the trial, together with the fact that, due to the partially blinded trial design, a high potential for bias must generally be assumed, further contribute to uncertainties in the interpretation of the results.
• mortality
  • No deaths occurred in the DELTA study.
• Morbidity – Symptoms (HECSI-90)
  • The HECSI is a valid tool for the treating doctor to assess the severity of hand eczema.
  • For the endpoint ‘symptoms’, as assessed using the HECSI-90, there was no statistically significant difference between the treatment groups at week 24.
• Morbidity – Symptoms (HESD)
  • The HESD is a questionnaire developed and validated by the pharmaceutical manufacturer to assess the symptoms of chronic hand eczema.
  • For the endpoint ‘symptoms’, assessed using the HESD, there was no statistically significant difference between the treatment groups at week 24.
• Morbidity – Health status (EQ-5D-VAS)
  • For the EQ-5D-VAS endpoint, there was no statistically significant difference between the treatment groups at week 24.
• Quality of life – HEIS
  • The HEIS is a questionnaire developed and validated by the pharmaceutical manufacturer to measure health-related quality of life in patients with chronic hand eczema.
  • For health-related quality of life, as assessed by the HEIS, there was no statistically significant difference between the treatment groups at week 24 compared with baseline.
• Side effects – SUEs
  • For the SUEs endpoint, there was no statistically significant difference between the treatment groups.
• Side effects – discontinuation due to AEs
  • For the endpoint ‘discontinuation due to adverse events’, a statistically significant advantage was observed between the treatment groups in favour of delgocitinib.
• Side effects – gastrointestinal disorders (SOC, AE) and headaches (PT, AE)
  • For the endpoints gastrointestinal disorders (SOC, AE) and headaches (PT, AE), a statistically significant advantage was observed between the treatment groups in each case, in favour of delgocitinib.
• Overall assessment
  • For adults with severe chronic hand eczema for whom alitretinoin as monotherapy represents the appropriate treatment option on an individual patient basis, results are available from the partially blinded, multicentre RCT study DELTA FORCE comparing delgocitinib with alitretinoin.
  • With regard to patient-relevant endpoints in the categories of mortality, morbidity and health-related quality of life, there were neither advantages nor disadvantages for delgocitinib compared with alitretinoin.
  • In the side effect category, there was no statistically significant difference between the treatment arms in the overall rate of serious side effects (SAEs). However, for the endpoint ‘discontinuation due to adverse events’, there was a statistically significant advantage for delgocitinib over alitretinoin. Furthermore, delgocitinib showed statistically significant advantages in the endpoints ‘gastrointestinal disorders’ and ‘headaches’.
  • Taking into account that there is no statistically significant difference between the treatment arms in the overall rate of SUEs, and that no differences relevant to the benefit assessment were observed between the treatment groups in the endpoints of morbidity and quality of life, the positive effect observed for the endpoint ‘discontinuation due to AEs’ is not sufficient in this case to justify the conclusion that delgocitinib offers additional benefit over alitretinoin as monotherapy.
  • Consequently, regardless of whether the appropriate comparator therapy was adequately implemented in the DELTA FORCE study, no additional benefit for delgocitinib can be inferred on the basis of the results presented.

b) Adults with moderate to severe chronic hand eczema for whom alitretinoin monotherapy is not the appropriate treatment option for the individual patient

• For adults with severe chronic hand eczema for whom alitretinoin as monotherapy is not the appropriate treatment option for the individual patient, the additional benefit is not proven.
• The pharmaceutical manufacturer has not provided any data for this patient population. The DELTA FORCE study did not collect any directly comparable data for adults with moderate to severe chronic hand eczema for whom alitretinoin monotherapy is not the appropriate treatment option on an individual basis.
• The pharmaceutical manufacturer’s attempt to extrapolate the results of the DELTA FORCE study to patients with moderate chronic hand eczema is not appropriate, as alitretinoin does not have marketing authorisation for this patient population.

Courtesy translation only, please refer to the German original.