CIBINQO (abrocitinib) - Atopic dermatitis in adolescents 12 years

The Committee deems that the clinical benefit of CIBINQO 50 mg, 100 mg and 200 mg (abrocitinib) film-coated tablets is substantial in the MA indication in adolescents 12 years and older. 

Considering:

•  demonstration in phase 3 studies of good methodological quality having included patients with moderate to severe atopic dermatitis who are candidates for systemic therapy:
  • the superiority of abrocitinib 100 mg and 200 mg compared to placebo, with a statistically significant difference, as monotherapy, in adult or adolescent patients (16 to 20% of the study population):
  •  in terms of IGA 0 or 1 responses, EASI-75 response and reduction of pruritus (ranked secondary endpoints) after 12 weeks of treatment (JADE MONO 1 and 2 studies),
  • in terms of maintenance of the effect of treatment, with a higher probability of the absence of flares during the maintenance period (up to 40 weeks) in the abrocitinib groups than in the placebo group (JADE REGIMEN study),
  • the superiority of abrocitinib 100 mg and 200 mg compared to placebo, with a statistically significant difference, in combination with topical corticosteroids, in adolescent patients ≥ 12 years, on the EASI-75 or IGA 0 or 1 response and on the reduction of pruritus (only at week 2 for the 100 mg strength) after 12 weeks of treatment (JADE TEEN study),
•  exploratory results suggesting maintenance of clinical responses (IGA 0 or 1 and EASI-75) for up to 96 weeks of follow-up (JADE EXTEND study);
• the medium-term safety profile of abrocitinib, primarily marked by nausea, headaches, acne, herpes simplex and CPK elevations;

but: 

• the lack of evidence of an impact in terms of quality of life, even though moderate to severe atopic dermatitis has a significant psychological, emotional and social impact on patients’ lives,
• the risks of major cardiovascular events, malignancies, serious infections and all-cause mortality associated with the JAK inhibitor class of drugs making it necessary to limit exposure of patients to these medicinal products and restrict their use in some patients, although these risks are lower in the paediatric population;
• the absence of data enabling the role of abrocitinib to be assessed compared to the other first line systemic therapies (IL inhibitors and JAK inhibitors) with an MA in adolescents, in the absence of comparative data with these treatments, which can be justified by their concomitant development, 

the Committee deems that CIBINQO 50 mg, 100 mg and 200 mg (abrocitinib) film-coatedtablets provides no clinical added value (CAV V) in the care pathway for the treatment of moderate to severe atopic dermatitis in adolescents 12 years and older who are candidates for systemic therapy, which includes three interleukin inhibitors (dupilumab, tralokinumab and lebrikizumab) and one JAK inhibitor (upadacitinib)