Jannsen’s Tremfya becomes first FDA-approved IL-23 inhibitor for active psoriatic arthritis
pharmafile | July 15, 2020 | News story | Research and Development, Sales and Marketing | FDA, Jannsen, Tremfya, active psoriatic arthritis
Janssen has reported that its therapy Tremfya (guselkumab) has become the first selective interleukin (IL)-23 inhibitor approved by the FDA for the treatment of active psoriatic arthritis.
Data from two Phase 3 trials submitted in support of the regulatory decision confirmed that 52% and 64% of patients receiving Tremfya across both trials had achieved an ACR20 response, representing an improvement of 20% in symptoms as measured by the American College of Rheumatology (ACR) scale – the primary endpoint of both studies. This was compared to 22% and 33% in those receiving placebo.
It was also reported that the therapy improved patient symptoms when measured against the Health Assessment Questionnaire Disease Index and SF-36 Physical Component Summary score, including soft tissue pain and inflammation of the extremities.
“Psoriatic arthritis is a complex multi-faceted disease and, for many patients, additional biologic options are very much needed,” commented Dr Philip J Measei, Lead Study Investigator on one of the studies as well as Director of Rheumatology Research at the Swedish Medical Center/Providence St Joseph Health and Clinical Professor at the University of Washington School of Medicine. “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.”
Matt Fellows
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