COSENTYX (secukinumab) - Hidradenitis suppurativa - (HS, Verneuil disease)

Considering all these elements, the Committee deems that the clinical benefit of COSENTYX (secukinumab) 150 and 300 mg solution for injection in pre-filled syringe and pen is low in the MA indication.

Considering:

• demonstration in two phase 3 studies with the same protocol having included adult patients with moderate to severe hidradenitis suppurativa, most of whom were treated with antibiotic therapy (approximately 83%) before inclusion:
  • of the superiority of secukinumab (300 mg every two weeks) compared to placebo in the SUNSHINE and SUNRISE studies, with a modest effect size on all the endpoints, including the proportion of responders on the HiSCR50 score (primary endpoint; differences approximately of 11%, p = 0.007 and p = 0.0149), decrease in the number of inflammatory lesions and improvement in the NRS30 skin pain score (grouped analysis of both studies),
  • of the superiority of secukinumab (300 mg every 4 weeks) compared to placebo only in the SUNRISE study, with a modest effect size, on the percentage of responders on the HiSCR50 score (difference of 15%, p = 0.0022), decrease in the number of inflammatory lesions and decrease in the number of flares;
• exploratory medium-term results, at week 52, suggesting maintenance of the clinical responses observed at week 16 for the two dosage regimens;
• the safety profile of secukinumab in the short term (16 weeks) and medium term (52 weeks) similar to that established in the other MA indications, and similar between the two dosage regimens;
• the absence of a demonstrated benefit in terms of quality of life, which is nonetheless particularly impaired in moderate to severe forms of this disease, with the exception of the NRS30 pain score for the Q2W dosage regimen only;
• the lack of evidence of an impact on recourse to elective surgery (cancellation or reduction of its extent);
• the absence of comparison with adalimumab (HUMIRA), another treatment with a MA in hidradenitis suppurativa with an identical indication wording as that of COSENTYX (secukinumab),

the Committee deems that COSENTYX (secukinumab) 150 mg and 300 mg solution for injection in pre-filled syringe and pen provides no clinical added value (CAV V) in the care pathway for the treatment of active moderate to severe hidradenitis suppurativa in adults.