CIBINQO (abrocitinib) - Atopic dermatitis (AD)

The Committee deems that the clinical benefit of CIBINQO 50 mg, 100 mg and 200 mg (abrocitinib), film-coated tablet remains substantial only for the treatment of moderate to severe atopic dermatitis in adults requiring systemic treatment, in cases of failure to respond, intolerance or contraindication to ciclosporin.

Within the reimbursement scope selected by the Committee:

In view of:

• the evidence in phase III studies of good methodological quality including moderate to severe atopic dermatitis patients requiring systemic treatment:
  • the superiority of abrocitinib 100 mg and 200 mg versus placebo, with a substantial effect size, in terms of IGA 0 or 1, EASI-75 responses, and pruritus after 12 weeks of treatment (ranked outcome measures), as monotherapy (JADE MONO-1 and 2 studies) or in association with a topical basic treatment (JADE COMPARE study) in adult or adolescent patients;
  • the superiority of abrocitinib 200 mg in relation to dupilumab, in terms of EASI-90 response at week 4 (28.5% versus 14.6%, p < 0.0001) which was also maintained at week 16 (54.3% versus 41.9%, p < 0.0008) and the PP-NRS4 response percentage at week 2 (48.2% versus 25.5%, p < 0.0001) in the JADE DARE study (ranked outcome measures);
  • the probability of a lack of flare-up during the maintenance period in patients responding to the induction treatment, which was lower in the placebo group (19.1%) compared to the abrocitinib 200 mg group (81.1%, p < 0.0001) and to the abrocitinib 100 mg group (57.4%, p < 0.0001) in the JADE REGIMEN study;
• a safety profile in the studies among patients aged approximately 35 years on average primarily marked by acne, nausea, headaches, vomiting, creatine phosphokinase (CPK) elevation, upper abdominal pain, herpes simplex and vertigo;

but also considering:

• the lack of evidence of a benefit on patients’ quality of life in a condition that particularly affects patients’ quality of life with substantial psychosocial repercussions;
• the uncertainties around continued efficacy beyond 26 weeks of treatment for the outcome measures assessing seriousness of the condition and pruritus intensity, and beyond 52 weeks for the probability of a lack of flare-up during the maintenance phase in patients responding to the induction treatment;
• the lack of comparison to ciclosporin, the conventional first-line systemic treatment in atopic dermatitis;
• the risks of major cardiovascular events, malignant tumours, serious infections and all-cause mortality linked with JAK inhibitor class medicinal products requiring restrictions of their use in some patients and persisting uncertainties relating to the populations not studied in the ORAL Surveillance safety study, in particular patients aged under 65 years (average age of approximately 35 years in studies on atopic dermatitis);

the Committee deems that CIBINQO 50 mg, 100 mg and 200 mg (abrocitinib), film-coated tablet, provides minor clinical added value (CAV IV) in relation to DUPIXENT (dupilumab) in adults with atopic dermatitis requiring systemic treatment in cases of failure to respond, intolerance or contraindication to ciclosporin.