Subcutaneous Cosentyx effective against PsA at week 24
Subcutaneous secukinumab in doses of 300 mg and 150 mg significantly improved symptoms of psoriatic arthritis, and slowed the disease’s radiographic progression at 24 weeks, according to findings published in Annals of the Rheumatic Diseases.
“There is now an extensive body of evidence involving more than 2,700 patients demonstrating the efficacy of secukinumab in PsA,” Philip Mease, MD, of the University of Washington and Swedish Medical Center, Seattle, and colleagues wrote. “Data from the phase 3 studies, FUTURE 1 and FUTURE 2, have shown that secukinumab provides rapid and significant improvements in the signs and symptoms of PsA that are sustained for up to 3 years of therapy.”
To determine the impact of subcutaneous secukinumab (Cosentyx, Novartis) in doses of 300 mg and 150 mg on the symptoms and radiographic progression of PsA, as well as whether there is a short-term benefit of the loading dose, the researchers commenced the FUTURE 5 trial, a randomized, double-blind phase 3 study of 996 adults with active PsA. The researchers randomly assigned the participants to one of four groups — 222 received 300 mg of subcutaneous secukinumab with the loading dose, 220 received 150 mg with the loading dose, 222 were treated with 150 mg without the loading dose and 332 received placebo.
The treatments were administered at baseline, week 1, week 2, week 3 and every 4 weeks following week 4. The primary endpoint was the proportion of patients who demonstrated an ACR20 response at week 16. Radiographic progression was measured using the van der Heijde-modified total Sharp score. The FUTURE 5 trial is currently ongoing, and is designed to produce data for up to 2 years.
According to Mease and colleagues, 62.2% of patients demonstrated an ACR20 response at week 16 in the 300-mg group with the loading dose, while 55.5% achieved the response in the 150-mg group with the loading dose. In the 150-mg group without the loading dose, 59.5% achieved the response, whereas in the placebo group, 27.4% demonstrated ACR20. In addition, radiographic progression of the disease was significantly slowed at week 24 in all groups treated with secukinumab, compared with those who received placebo.
Adverse event rates at this time were 63.1% in the 300-mg group with the loading dose, 62.7% in those treated with 150 mg with the loading dose, 61.1% among those who received 150 mg without a loading dose and 62% in the placebo group.
“FUTURE 5 is the largest randomized phase 3 trial to date of a biologic in PsA,” Mease and colleagues wrote. “In this study, [subcutaneous] administration of secukinumab 300 mg and 150 mg provided rapid and significant improvement vs. placebo in most clinical domains of PsA and inhibited radiographic progression at week 24. FUTURE 5 confirms and extends the results of previous data demonstrating the efficacy of [subcutaneous] administration of secukinumab in achieving comprehensive treatment goals in PsA.” – by Jason Laday
Disclosure: Mease reports grant funding from AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB; consulting fees from AbbVie, Amgen, BMS, Celgene, Covagen, Crescendo, Janssen, LEO, Lilly, Merck, Novartis, Pfizer, SUN and UCB; and speaking fees from AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Pfizer and UCB. Please see the full study for all other authors’ disclosures.