pharmafileJanuary 25, 2018
Eli Lilly has revealed that its IgG4 monoclonal antibody Taltz (ixekizumab) has been awarded marketing approval from the European Commission for the treatment of active psoriatic arthritis (PsA) in patients for which disease-modifying anti-rheumatic drug (DMARD) therapies are not an option or have proved ineffective, when used alone or in combination with methotrexate.
The approval was based on data from two Phase 3 studies comprising 780 adult patients which analysed the proportion of biologic-naïve and tumour necrosis factor inhibitor (TNFi)-experienced patients that achieved a 20% reduction in disease activity according to the American College of Rheumatology scale at 24 weeks, as well the number who achieved a 75% reduction in the Psoriasis Severity Index (PASI). The trials found that Taltz "achieved significant improvement in joint symptoms and skin symptoms" when compared to placebo.
"Psoriatic arthritis is a common inflammatory arthritis that causes serious joint pain and swelling. This makes even simple daily activities hard to do. New effective treatments which make lives better are very welcome" said Professor Bruce Kirkham, Consultant Rheumatologist, Guy’s and St Thomas’ NHS Foundation Trust, London.
Arash Tahbaz, Senior Medical Director at Eli Lilly UK and Northern Europe, added: "PsA affects up to 30% of people who are already living with psoriasis. Symptoms often begin around a decade after the onset of psoriasis, and can severely impact people’s lives and ability to work. We are proud to be able to offer a new treatment option that addresses both the joint and skin symptoms of PsA."
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