Abbvie seeks to add new indication, psoriatic arthritis to Skyrizi

With first-line treatments proving unsuccessful against psoriatic arthritis, Skyrizi intends to be an addition treatment option.

Abbvie has recently received a recommendation from the Committee for Medical Products for Human Use (CHMP), for the approval of Skyrizi in psoriatic arthritis (PsA). The immunologic drug was previously approved for use in psoriasis. However, Skyrizi has now been recommended to treat adults that have not been successful with at least one treatment option for PsA. The conventional first-line treatments are anti-rheumatic drugs like methotrexate. These drugs are generally effective; though, it was found that 71% of people with PsA have not responded positively to their first line treatment. Earlier this year Abbvie revealed that in the Keepsake-1 and Keepsake-2 clinical trials, Skyrizi had a higher efficacy than the placebo. The drug also achieved its secondary endpoints of skin clearance, reduced disease activity as well as physical function.

As measured by the Psoriasis Area Severity Index (PASI900), Skyrizi demonstrated to have a skin clearance improvement of no less than 90% after 6 months in comparison to the placebo. In addition, patients receiving the drug experienced an improvement in joint pain more often than the patients on the placebo injections. A 20% decrease in combination symptoms was reported in 57% and 51% of patients on the Keepsake-1 and Keepsake-2 trails, respectively. Taking into account the positive strides the drug has made with both clinical trials and the recommendation from CHMP, Skyrizi could be approved and released to the European Union market in months. Gary Nachman, market analyst at the Bank of Montreal indicted that the current approval could broaden Abbvie’s market, with a projected $350 million sales in 2025.