BIMZELX (bimekizumab) - Hidradenitis suppurativa

The Committee deems that the clinical benefit of BIMZELX 160 mg (bimekizumab) solution for injection in pre-filled syringe or pre-filled pen is low in the MA indication.

Considering:

• demonstration in two phase 3 clinical studies (BE HEARD I and II) with the same protocol having included adult patients with active moderate to severe hidradenitis suppurativa, most of whom were treated with antibiotic therapy (approximately 80%) before inclusion:
  • of the superiority of bimekizumab (320 mg every 2 weeks) compared to placebo in both studies, with a modest effect size, on HiSCR50 response (primary endpoint; differences in the region of 19%, p = 0.006) and HiSCR75 response (differences of 15% to 20% depending on the studies, p < 0.03) and on the skin pain score (HSSDD),
  • of the superiority of bimekizumab (320 mg every 4 weeks) compared to placebo only in the BE HEARD II study, with a modest effect size, on HiSCR50 response (difference of 21.6%, p = 0.004) and HiSCR75 response (difference of 18.1%, p = 0.007);
• exploratory medium-term results, at week 48, suggesting maintenance of the clinical responses observed at week 16 for the two dosage regimens;
• the safety profile of bimekizumab in the short term (16 weeks) and medium term (48 weeks) similar to that established in the other MA indications;
• the lack of evidence of a clinically relevant benefit in terms of quality of life, which is nonetheless particularly impaired in moderate to severe forms of this disease;
• the lack of evidence of an impact on recourse to elective surgery (cancellation, delay or reduction of its extent);
• the absence of direct comparison in a phase 3 study with adalimumab (HUMIRA), another treatment with an MA in hidradenitis suppurativa with an identical indication wording to that of BIMZELX (bimekizumab),
• the absence of direct comparison with secukinumab (COSENTYX) in a phase 3 study given their concomitant development;

the Committee deems that BIMZELX 160 mg (bimekizumab) solution for injection in pre-filled syringe or pre-filled pen provides no clinical added value (CAV V) in the current treatment of active moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS therapy, which includes HUMIRA (adalimumab) and COSENTYX (secukinumab).