Abrocitinib (1) – Cibinqo®

• Clinical trials
  • For the benefit assessment, the pharmaceutical manufacturer has submitted the randomised controlled trial JADE DARE, in which abrocitinib is compared with dupilumab.

Adults with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy

• For the treatment of moderate to severe atopic dermatitis in adult patients who are eligible for continuous systemic therapy, there is a hint of a considerable additional benefit of abrocitinib compared with the appropriate comparator therapy, dupilumab.
• Overall, there is a hint of a considerable additional benefit of abrocitinib compared with dupilumab in adults with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy.
• Overall, there is a hint regarding the reliability of the results of the JADE DARE study.
• mortality
  • For the endpoint of all-cause mortality, there were 2 deaths in the abrocitinib arm and none in the dupilumab arm.
• morbidity
  • In this assessment, morbidity is evaluated on the basis of disease severity and remission (assessed using EASI and SCORAD), pruritus (assessed using the Peak Pruritus NRS), pain (assessed using the Skin Pain NRS), sleep disturbances (assessed using the MOS Sleep Scale), patient-reported symptoms (assessed using POEM) and health status (assessed using the EQ-5D VAS).
  • Eczema Area and Severity Index (EASI 100 remission, EASI 75 and EASI 90 response)
  • A statistically significant difference in favour of abrocitinib was observed for remission (EASI 100).
  • The response thresholds EASI 90 and EASI 75 show no statistically significant differences between the treatment groups.
  • Scoring Atopic Dermatitis (SCORAD)
  • A statistically significant difference in favour of abrocitinib was observed for remission (SCORAD 100) and the SCORAD 90 response.
  • The SCORAD 75 response threshold showed no statistically significant difference between the treatment groups.
  • Itching (Peak Pruritus NRS)
  • No statistically significant difference was observed between abrocitinib and dupilumab, either for the assessment of improvement by ≥ 4 points or for the assessment of peak pruritus NRS 0–1.
  • Sleep disturbances (MOS Sleep Scale)
  • No statistically significant differences were observed between the treatment groups.
  • Pain (Skin Pain NRS)
  • No statistically significant differences were observed between the treatment groups.
  • Patient-reported symptoms (POEM)
  • A statistically significant advantage in favour of abrocitinib over dupilumab is observed in both the POEM 0 and POEM 0–2 measures.
  • For the endpoint ‘patient-reported symptoms’ (POEM 0), there is an effect modification by the characteristic of age.
  • Health status (EQ-5D VAS)
  • For the health status endpoint (EQ-5D-VAS), there is no statistically significant difference between the treatment groups in the mean change at week 26 compared with baseline.
• quality of life
  • Dermatology Life Quality Index (DLQI) response
  • For the proportion of patients with a DLQI of 0 or 1, there was no statistically significant difference between the treatment groups at week 26.
• Side effects
  • Overall rate of serious adverse events (SUEs), discontinuations due to adverse events, infections, serious infections and eye diseases (SOC, adverse events)
  • For the endpoints SUEs, discontinuation due to AEs, infections, serious infections and eye diseases (SOC, AEs), there was no statistically significant difference between the treatment groups in any case.
  • Conjunctivitis (PT, AEs)
  • For the endpoint of conjunctivitis (PT, AEs), a statistically significant advantage was observed in favour of abrocitinib compared with dupilumab.
  • Neurological disorders (SOC, UEs), nausea (PT, UEs) and acne (PT, UEs)
  • For the endpoints nervous system disorders (SOC, UEs), nausea (PT, UEs) and acne (PT, UEs), a statistically significant disadvantage was observed in each case compared with dupilumab for abrocitinib.
• Overall assessment
  • In the morbidity endpoint category, a statistically significant difference in favour of abrocitinib compared with dupilumab was observed for the endpoints of remission (EASI 100, SCORAD 100), a 90% improvement in SCORAD (SCORAD 90), and patient-reported symptoms (POEM 0; POEM 0–2), a statistically significant difference was observed in favour of abrocitinib compared with dupilumab.
  • For the other morbidity endpoints – pruritus, skin pain and health status – there was no statistically significant or clinically relevant difference between the two treatment groups.
  • In the health-related quality of life endpoint category, there was no statistically significant difference between the treatment groups for the DLQI 0–1 endpoint.
  • In the side effect endpoint category, no statistically significant difference was observed between the treatment groups for the endpoints SUEs, discontinuation due to adverse events, infections, serious infections and eye diseases (SOC, adverse events).
  • In detail, with regard to specific adverse events, abrocitinib showed both advantages (conjunctivitis) and disadvantages (nervous system disorders, nausea and acne) compared with dupilumab.
  • Overall, the positive effects of abrocitinib on disease severity (EASI 100, SCORAD 100, SCORAD 90) and patient-reported symptoms (POEM 0, POEM 0–2) compared with dupilumab are classified as a significant improvement in treatment-related benefit that has not been achieved to date.
  • Consequently, in adults with moderate to severe atopic dermatitis who are eligible for continuous systemic therapy, a considerable additional benefit of abrocitinib over dupilumab can be inferred.

Courtesy translation only, please refer to the German original.