January 07, 2021 // -- AbbVie recently announced positive topline results for two Phase 3 studies (KEEPsAKE-1 and KEEPsAKE-2) evaluating the treatment of active psoriasis arthritis (PsA) adult patients with the new anti-inflammatory drug IL-23 inhibitor Skyrizi (risankizumab).
of these studies, the group included adult patients with active PSA who had inadequate or insatiable responses to modified rheumatoid drugs (DMARD) for biological and/or non-biological diseases.
results showed that a significantly higher proportion of patients in the Skyrizi (150 mg) treatment group reached the primary endpoint of ACR20 response in week 24: in two studies, 57 percent of patients in the 24th week of treatment and 51 percent of patients in the placebo group achieved ACR20 response, compared with 34 percent in the placebo group (p<001).
secondary endpoint results showed significant improvements in physical function (measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and minimum disease activity (MDA) compared to the placebo group at the 24th week of treatment.
in the KEEPsAKE-1 study, the Skyrizi group and the placebo group scored 0.23 and 0.32 (PsA mTSS) in week 24 of the secondary endpoint, respectively. michael Severino, M.D., vice-chairman and president of AbbVie
PsA (Photo: rheumatologyadvisor.com), said: "We are encouraged by these positive results that show Skyrizi's potential for treating psoriasis arthritis.
results underscore our commitment to research that provides important treatment options for people with psoriasis.
study, Skyrizi's safety within 24 weeks of treatment was essentially consistent with previous psoriasis studies.
in KEEPsAKE-1 and KEEPsAKE-2, 2.5% of patients in the Skyrizi group and 4.0% had severe adverse events, respectively, and 3.7% and 5.5% in the placebo group.
rates were similar among the treatment groups, with the KeEPsAKE-1 and KEEPsAKE-2 studies reporting severe infection rates of 1.0% and 0.9% in the Skyrizi group and 1.2% and 2.3% in the placebo group, respectively.
in the KEEPsAKE-1 and KEEPsAKE-2 studies, the rates of adverse events that led to drug suspension were 0.8 percent and 0.9 percent, respectively, in the Skyrizi group and 0.8 percent and 2.3 percent in the placebo group.
in the KEEPsAKE-1 study, there was one death in the Skyrizi group that was not related to the drug in the study;
results of the KEEPsAKE study will be presented at an upcoming medical conference and will be published in a peer-reviewed medical journal.
Skyrizi's active drug ingredient is risankizumab, a monoclonal antibody drug that selectively blocks the immune inflammatory medium leukocyte interleukin-23 (IL-23), a cytokine that is thought to play a key role in many chronic immune diseases by specifically targeting IL-23p19 sub-base.
was originally developed by German drug company Blinger Ingham (BI), which acquired the global commercialization rights to Risankizumab in February 2016 with an advance payment of $600 million.
in 2019, Skyrizi was approved in the United States and the European Union for the treatment of adult patients with moderate to severe plaque psoriasis.
currently, Skyrizi's treatment of Crohn's disease and psoriasis arthritis is clinical in Phase III.
addition, AbbVie is evaluating Skyrizi's treatment of other inflammatory and immunological diseases such as ulcerative colitis.
Skyrizi is entering a very crowded market that will compete with a number of drugs, including Novarce Cosentyx and Ilaris, Lilly's Taltz, Valeant's Siliq, Johnson and Johnson's Tremfya, Sun Pharmaceuticals' Ilumya and others.
these drugs, Tremfya and Ilumya are also selectively targeted at IL-23 biotherapy.
, despite all these rivals, the industry remains bullish on Skyrizi's business prospects.
pharmaceutical market research agency, had predicted annual sales of $2.2 billion by 2024.
() Origin: Risankizumab (SKYRIZI?) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients