Secukinumab improves active psoriatic arthritis
By Lorraine L. Janeczko
NEW YORK (Reuters Health) - In patients with active psoriatic arthritis (PsA), secukinumab improves symptoms and inhibits radiographic disease progression, researchers report.
"Whilst the interleukin-17A inhibitor secukinumab has previously been shown to provide significant efficacy in psoriatic arthritis, the results of the FUTURE 5 study are important because they are the first data to show that the approved doses of secukinumab (i.e., 300 mg and 150 mg) inhibit structural damage in patients with psoriatic arthritis with or without a subcutaneous loading dosage," said lead author Dr. Philip Mease of Swedish Medical Center in Seattle.
"The results also show that the loading dosage provides a more rapid and robust clinical benefit compared with no loading. Also, the safety experience was commensurate with the safety data from previous PsA trials with secukinumab," Dr. Mease told Reuters Health by email.
In the phase 3 double-blind FUTURE 5 study, the research team randomized 996 adults with active PsA into four groups: secukinumab 300 mg with loading dose (LD), secukinumab 150 mg with LD, secukinumab 150 mg without LD, or placebo. The patients used pre-filled syringes to self-administer the treatment subcutaneously.
At baseline, at weeks 1, 2 and 3, then every four weeks thereafter, all groups received secukinumab or placebo. At 16 weeks, the researchers determined the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.
As reported in Annals of the Rheumatic Diseases, online March 22, at week 16, significantly more patients taking secukinumab 300 mg with LD (62.6%), 150 mg with LD (55.5%), or 150 mg without LD (59.5%), achieved an ACR20 response compared with those on placebo (27.4%, P<0.0001 for all).
At week 24, progression of joint damage seen by x-ray was significantly inhibited in all secukinumab groups compared with placebo.
The adverse-event rates in all the groups were similar, between 61.1% and 63.1%. No deaths occurred and no new safety signals were reported.
"FUTURE 5 is the largest randomized controlled study of a biologic therapy ever conducted in psoriatic arthritis,” Dr. Mease said.”The results give physicians further evidence that the approved doses of secukinumab provide significant efficacy across critical clinical domains of this disease including arthritis, enthesitis, dactylitis, skin disease, pain, functioning, quality of life, and inhibition of structural damage.”
Dr. Saira Bilal, a rheumatologist at the George Washington University School of Medicine and Health Sciences, who was not involved in the study, told Reuters Health by email, "This is an important study for physicians treating patients with psoriatic arthritis because the investigators included patients with moderate to severe disease activity, the majority of whom were anti-TNF naive."
Dr. Celso Velazquez, division director of immunology and rheumatology at MU Health Care at the University of Missouri in Columbia, said, "Psoriasis is a common skin condition and up to one in four patients with psoriasis may develop psoriatic arthritis. Secukinumab is approved in the United States to treat psoriasis and this study demonstrates that it slows down joint damage as seen on x-rays."
"These findings are welcome but not surprising," Dr. Velazquez told Reuters Health by email, "because they expand previous studies that showed similar findings over a shorter period of time."
"For most patients, psoriatic arthritis is a lifelong illness and some medications lose efficacy over time," he noted, "so it is good to know when a medication's benefits extend to a longer time frame."
Dr. Velazquez, who also was not involved in the study, would like to see further related research with longer follow-up periods.
Novartis Pharmaceuticals Corporation supported the study and had financial to all of the authors.
Drs. Bilal and Velazquez said they had no conflicts of interest relating to the study.
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