Skyrizi has now received approval from the UK regulator, the MHRA, for use in the treatment of patients with active psoriatic arthritis
Skyrizi (risankizumab) has been approved by the UK regulator, the MHRA, for the use in adults with active psoriatic arthritis. This follows the EMA approval earlier this month.
The Summary of Product Characteristics (SPC) of the drug has been updated to reflect this change, stating that it is indicated either ‘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 anti-rheumatic drugs (DMARDs).’
Skyrizi is a monoclonal antibody and blocks the action of interleukin 23, (IL-23), which is believed to play an important role in psoriatic arthritis. The approved dose for risankizumab is 150mg, administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter.
The approval was based on data from two clinical studies, KEEPsAKE-1 and KEEPsAKE-2 and although both of the trials included patients with moderate to severe PsA, the populations were slightly different. For example, KEEPsAKE-1 included patients who had with an inadequate respond to one or more DMARDs whereas KEEPsAKE-2 recruited those with an inadequate response to other biologicals. However, both studies had the same primary endpoint of an ACR20 response at week 24. In addition, secondary outcomes included improvements in several clinical manifestations of psoriatic arthritis such as physical functioning (as assessed by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) and both the primary and secondary endpoints were assessed after 24 weeks of therapy.
In KEEPsAKE-1 57.3% of patients receiving risankizumab achieved the primary endpoint at week 24 compared to 33.5% in the placebo group (p < 0.001). Similarly, in KEEPsAKE 2, 51.3% achieved the primary endpoint compared with 26.5% in the placebo arm (P< 0.001).
There were also significantly greater improvements in the secondary outcomes for risankizumab-treated patients. For example, in KEEPsAKE-1, there was a -0.31 change in HAQ-DI compared to -0.11 (placebo) and in KEEPsAKE 2, a change of -0.22, compared to -0.05 in the placebo group (for both differences, p <0.001).