Janssen Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for Tremfya (guselkumab) for the treatment of active psoriatic arthritis (PsA) in adults.
Tremfya is a fully human monoclonal antibody that binds selectively to the p19 subunit of interleukin (IL)-23 and prevents its interaction with the IL-23 receptor, as per Janssen.
The drug was previously approved in the US, Europe, and other countries for the treatment of moderate to severe plaque psoriasis in adults.
Its approval for active psoriatic arthritis has been granted by the FDA based on two phase 3 clinical trials – DISCOVER-1 and DISCOVER-2, which demonstrated its safety and efficacy in comparison to placebo.
Active psoriatic arthritis is a chronic progressive disease in which the symptoms include painful joints and inflammation of the skin.
A total of 1,120 adult patients with active psoriatic arthritis, who had an insufficient response to standard therapies, were enroled in the two phase 3 trials.
Results from the late-stage trials in patients with the disease showed that a substantial percentage of patients treated with Tremfya achieved their primary endpoint of ACR20a at 24 weeks. Janssen said that 52% and 64% of patients achieved an ACR20 response compared to 22% and 33% in patients in the placebo arm in the DISCOVER-1 and DISCOVER-2 trials, respectively.
DISCOVER-2 lead study investigator Philip Measei said: “The two Phase 3 pivotal trials evaluating the safety and efficacy of Tremfya, an IL-23 inhibitor, for the treatment of adults with active psoriatic arthritis provided insight into how it can improve joint symptoms.”
According to Janssen, Tremfya should be given to the patients as a 100mg subcutaneous injection every eight weeks, after administering two starter doses at weeks 0 and 4. The drug can be either used alone or in combination with a conventional disease-modifying anti-rheumatic drug (DMARD) such as methotrexate.
Janssen research and development immunology therapeutic area head David Lee said: “At Janssen, we strive to reimagine what is possible in how immune-mediated diseases like active psoriatic arthritis are understood and treated.
“Tremfya is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue as measured by FACIT-F included in the U.S. Prescribing Information.”