DUPIXENT (dupilumab) - Prurigo nodularis (PN)

The clinical added value provided by DUPIXENT 300 mg (dupilumab), solution for injection in pre-filled syringe or pre-filled pen, is significant in the MA indication.

In view of:

• the unmet medical need,
• the demonstration in two phase III, randomised, double blind studies, of the superiority of dupilumab compared to placebo, with a significant and clinically relevant effect on:
  • the percentage of patients who experienced a reduction in the maximum pruritus score, WI-NRS ≥ 4 between inclusion and week 12 (LIBERTY-PN-PRIME2 study) or week 24

(LIBERTY-PN-PRIME and LIBERTY-PN-PRIME2 studies),

• the variation in the DLQI quality of life score,
• the variation in the Skin Pain-NRS pain score and
• the variation in the HADS score assessing anxiety and depression (only in LIBERTY-PN-PRIME),

• but of the absence of demonstration of the superiority of dupilumab compared to placebo with regard to sleep quality, while this is strongly impacted by the symptoms of prurigo nodularis,
• a tolerance comparable to that observed in the other indications of dupilumab, marked mainly by the occurrence of rhinopharyngitis, upper airway infections, ocular disorders (conjunctivitis, keratitis, keratoconjunctivitis) and injection site reactions,

the Committee considers that DUPIXENT (dupilumab), solution for injection in pre-filled syringe or pre-filled pen, provides moderate clinical added value (CAV III) in the management of moderate-to-severe prurigo nodularis in adults which requires systemic treatment.