Psoriatic Arthritis Drug Approved Abroad

A new drug to treat psoriatic arthritis (PsA) has been approved in Europe and Japan, with regulatory approval pending worldwide. Researchers recently reviewed data from clinical studies to evaluate the effectiveness and efficacy of secukinumab. The review was conducted by Philip Mease, MD, of the Swedish Medical Center and the University of Washington and Professor Iain McInnes of the Institute of Infection, Immunity and Inflammation at the University of Glasgow, was published in the journal Rheumatology and Therapy on April 23, 2016.

Although treatment options for PsA patients expanded with the development of tumor necrosis factor (TNF) inhibitors, the authors say, “a number of unmet needs remain; for example, some patients have an inadequate response to, or intolerance of anti-TNF agents, long-term therapy with these agents is associated with decreasing drug survival rates, and the increased risk of infection may be of concern to some patients.” Thus, researchers are seeking alternative options, including those involving the inflammatory cytokine IL-17, which “has been shown to play an important role in the pathology of PsA” according to the authors.

The reviewers looked at two clinical trials: FUTURE 1 and FUTURE 2, both of which tested various doses of secukinumab against a placebo. Additionally, both studies are ongoing; FUTURE 2 is planned to extend an additional 4 years to test the long term efficacy and safety of the drug.

The reviewers report, “Across FUTURE 1 and FUTURE 2, secukinumab provided rapid and clinically meaningful improvements in multiple facets of PsA, including joint symptoms, skin symptoms, dactylitis, and enthesitis.” Additionally, both trials found secukinumab was safe. The researchers say that “more than 1200 patients were assessed for safety across the two FUTURE trials” and it was well-tolerated. Finally, the reviewers found “no radiographic disease progression was observed in more than 80% of the patients receiving secukinumab.”

The results of the clinical trials performed to date suggest “that secukinumab will be a valuable addition to the available treatment options for PsA and other chronic and disabling rheumatic diseases,” say the authors. This is the first anti-IL-17A therapy which has been shown to be effective in phase 3 clinical trials in PsA.