FDA Approves Guselkumab for Active Psoriatic Arthritis

The US Food and Drug Administration (FDA) has given the green light to guselkumab (TREMFYA) to treat adult patients with active psoriatic arthritis.

The treatment, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, represents the first FDA approved medication for active psoriatic arthritis that selectively inhibits interleukin-23 (IL-23), a naturally occurring cytokine involved in normal inflammatory and immune responses associated with the symptoms of the disease.

The approval is based on a pair of phase 3 clinical trials and calls for the drug to be administered in 100 mg subcutaneous injections every 8 weeks, after 2 starter doses at weeks 0 and 4.

In the DISCOVER-1 and DISCOVER-2 trials, investigators evaluated the efficacy and safety of the drug administered by subcutaneous injections in comparison to placebo.

The investigators found a significant percentage of patients treated with the study drug reached the primary endpoint of ACR20 at week 24, with 52 and 64% of patients achieving an ACR20 response compared to 22 and 33% in patients treated with placebo.

Patients treated with guselkumab also sustained improved symptoms, including skin manifestations of psoriasis, physical functioning measured by the Health Assessment Questionnaire Disease Index, and SF-36 Physical Component Summary score, and soft tissue, as well as improvement in fatigue measured by the Functional Assessment of Chronic Illness Therapy.

Guselkumab can be taken alone or in combination with conventional Disease Modifying Anti-Rheumatic Drugs such as methotrexate.

Currently there are approximately 1.5 millions suffering from psoriatic arthritis, with studies showing up to 30% of the 8 million in the US living with psoriasis expected to develop psoriatic arthritis.

"Psoriatic arthritis is a complex multi-faceted disease and, for many patients, additional biologic options are very much needed," Philip J. Mease, MD, DISCOVER-2 Lead Study Investigator, Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine, said in a statement. "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..”