AbbVie announces that the European Commission has approved Skyrizi * (risankizumab, 150 mg, given by subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (Mtx), for the treatment of arthritis active psoriatic disease in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (Dmards). This is the second indication, the company informs, for risankizumab and the granting of the marketing authorization will be valid in all member states of the European Union, including Iceland, Liechtenstein, Norway and Northern Ireland.
“We are very pleased that the European Commission has recognized the potential of risankizumab in controlling the skin and joint manifestations of psoriatic arthritis – says Ketty Peris, president of the Italian Society of Medical, Surgical, Aesthetic Dermatology and Sexually Transmitted Diseases (Sidemast) – Patients can benefit from this new treatment which, by improving symptoms, allows them to resume normal daily activities with a positive impact on the quality of life “. “The much deeper understanding of the immunopathological mechanisms underlying psoriatic arthritis has allowed the development of specific drugs that have proved to be very effective, such as risankizumab – highlights Roberto Gerli, president of Sir, Italian Society of Rheumatology – Now rheumatologists have a important new therapeutic option to help patients find important relief from the debilitating symptoms of this disease “.
“Psoriatic arthritis can be very disabling due to the joint pain it generates and certainly impacts on everyday life – underlines Valeria Corazza, president of Apiafco, Italian Psoriatic Association Friends of the Corazza Foundation – We welcome the European approval of risankizumab and we hope that this new and promising therapeutic option will soon be made available throughout Italy. An extra chance to significantly improve the quality of life of those suffering from this disease “.
In psoriatic arthritis, rheumatologist and dermatologist play a key role in the patient’s diagnostic path and in the subsequent choice of treatment. “The European approval of risankizumab can help rheumatologists and dermatologists to better treat a disease that severely affects people of productive age and that too often is discovered and treated late – underlines Silvia Tonolo, president of Anmar, National Association of Rheumatic Patients – Patients need to know that psoriatic arthritis can now be effectively treated and that a much better life is possible for them. ”
The European approval is based on data from two Phase 3 clinical trials, Keepsake-1 and Keepsake-2. In these studies, risankizumab met the primary endpoint of Acr20 response at week 24 versus placebo, and achieved secondary endpoints, including but not limited to improvements in the severity of clinical manifestations of psoriatic arthritis such as physical function at week 24.
“Psoriatic disease is a chronic inflammatory pathology, in which signs and symptoms affecting the skin are often associated with those typical of arthritis, including pain, stiffness and fatigue – highlights Francesco Cusano, president of Adoi, president of the Association of dermatologists venereologists Italian hospitals – There is an evident unmet clinical need for patients with this disease and the results of this clinical trial program confirm that risankizumab is effective in improving standards of care, providing patients and their doctors with a new treatment option ” .
Risankizumab is the result of a collaboration between Boehringer Ingelheim and AbbVie, which will handle development and commercialization globally.