Risankizumab (4) – Skyrizi®

Ulcerative colitis, pre-treated

Characteristics

Start date 01.09.2024 – Marketing authorisation: 24.07.2024
Resolution 20.02.2025
INN Risankizumab
Brand name Skyrizi®
Pharm. company AbbVie Deutschland GmbH & Co. KG
G-BA Procedure ID D-1090
ATC code L04AC18 Interleukin inhibitors (L04AC)
ICD-10 codes (AIS) K51.0Backwash ileitis, K51.2Ulcerative (chronic) proctitis, K51.3Ulcerative (chronic) rectosigmoiditis, K51.4Inflammatory polyps of colon, K51.5Left hemicolitis, K51.8Other ulcerative colitis, K51.9Ulcerative colitis, unspecified
Alpha-ID codes (AIS) I115712Chronic ulcerative pancolitis, I115938Left-sided colitis, I26042Ulcerative colitis, I5661Chronic ulcerative proctitis, I5664Chronic rectosigmoiditis ulcerosa, I74949Colitis polyposa
Therapeutic area Digestive system diseases Ulcerative colitis / Pouchitis
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Skyrizi is used to treat adult patients with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy or biologic therapy, have not tolerated it or no longer respond to it.
Subpopulation Indication Comparator
a) Adults with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy, no longer respond to it or show intolerance Adalimumab or golimumab or infliximab or ozanimod or ustekinumab or vedolizumab
b) Adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor), no longer respond to it or show intolerance Adalimumab or filgotinib or golimumab or infliximab or ozanimod or tofacitinib or ustekinumab or vedolizumab

Studies and Results

No. of studies
(best subpopulation) 		2 (INSPIRE, COMMAND) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + no ITC)
Reason for dividing into subpopulations (G-BA) Previous treatment

  • Clinical trials
    • In the dossier, the pharmaceutical manufacturer presents data from the randomised INSPIRE (induction study) and COMMAND (maintenance study) trials comparing risankizumab with placebo.

a) Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or are intolerant of it

  • For adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, they no longer respond to it, or are intolerant to it, the additional benefit is not proven.
  • For both patient group a) and patient group b), there are no direct comparative data available for risankizumab versus the appropriate comparator therapy.
  • Overall, therefore, both for patient group a) – adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it or are intolerant of it – and for patient group b) adults with moderate to severe active ulcerative colitis who have responded inadequately to, no longer respond to, or are intolerant of a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it, or are intolerant to it, additional benefit is not proven for risankizumab compared with the appropriate comparator therapy.

b) Adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant to it

  • For adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant to it, the additional benefit is not proven.
  • For both patient group a) and patient group b), there are no direct comparative data available for risankizumab versus the appropriate comparator therapy.
  • Overall, therefore, for both patient group a) – adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it or are intolerant of it – and for patient group b) adults with moderate to severe active ulcerative colitis who have responded inadequately to, no longer respond to, or are intolerant of a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), no longer respond to it or are intolerant of it, additional benefit is not proven for risankizumab compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.

Associated procedures



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