Risankizumab (2) – Skyrizi®

Psoriatic arthritis (PA), monotherapy or combination with methotrexate

Characteristics

Start date 01.12.2021 – Marketing authorisation: 15.11.2021
Resolution 19.05.2022
INN Risankizumab
Brand name Skyrizi®
Pharm. company AbbVie Deutschland GmbH & Co. KG
G-BA Procedure ID D-744
ATC code L04AC18 Interleukin inhibitors (L04AC)
ICD-10 codes (AIS) L40.5Arthropathic psoriasis
DDD 1.67 mg P
Therapeutic area Skin diseases Psoriatic Arthritis (PA)
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Subpopulation Indication Comparator
a) Adults with active psoriatic arthritis who have had an inadequate response or intolerance to previous disease-modifying antirheumatic (DMARD) therapy have not tolerated it. A TNF-alpha antagonist (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) or an interleukin inhibitor (ixekizumab or secukinumab or ustekinumab), possibly in combination with methotrexate
b) Adults with active psoriatic arthritis who have had an inadequate response to, or have not tolerated previous therapy with disease-modifying biological antirheumatic drugs (bDMARDs). Switching to another biological disease-modifying antirheumatic drug (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab or ixekizumab or secukinumab or ustekinumab), possibly in combination with methotrexate.

Studies and Results

No. of studies
(best subpopulation) 		2 (UltIMMa-1, UltIMMa-2)
Study design
(best subpopulation) 		H2H vs. ACT (off-label)
Meta analysis
(best subpopulation) 		no
Reason for dividing into subpopulations (G-BA) Previous treatment

  • Clinical trials
    • The UltIMMa-1 and UltIMMa-2 studies were randomised, double-blind, twin studies with identical study protocols.
    • In both trials, risankizumab was investigated in comparison with placebo and ustekinumab in adults with plaque psoriasis.

a) Adults with active psoriatic arthritis who have responded inadequately to, or are unable to tolerate, previous disease-modifying antirheumatic drug (DMARD) therapy.

  • For adults with active psoriatic arthritis who have responded inadequately to, or are unable to tolerate, prior disease-modifying antirheumatic drug (DMARD) therapy, additional benefit is not proven with risankizumab compared with the appropriate comparator therapy.
  • Due to the lack of information on patients’ prior treatment, no conclusions can be drawn from the data provided regarding the additional benefit of risankizumab compared with ustekinumab in adults with active psoriatic arthritis who have had an inadequate response to, or are intolerant of, prior disease-modifying antirheumatic (DMARD) therapy or have not tolerated it.
  • Overall assessment
    • Due to a lack of information on prior treatment, no conclusions can be drawn regarding the additional benefit of risankizumab. The additional benefit is therefore not proven.

b) Adults with active psoriatic arthritis who have responded inadequately to, or are intolerant of, prior therapy with disease-modifying biological anti-rheumatic drugs (bDMARDs).

  • For adults with active psoriatic arthritis who have responded inadequately to, or are intolerant of, prior treatment with disease-modifying biological antirheumatic drugs (bDMARDs) or have been unable to tolerate such treatment, the additional benefit of risankizumab over the appropriate comparator therapy is not proven.
  • Due to the lack of information on patients’ prior treatment, no conclusions can be drawn from the data provided regarding the additional benefit of risankizumab compared with ustekinumab in adults with active psoriaticwho have responded inadequately to, or are intolerant of, prior treatment with disease-modifying biological antirheumatic drugs (bDMARDs).
  • Overall assessment
    • Due to a lack of information on prior treatment, no conclusions can be drawn regarding the additional benefit of risankizumab. An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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