PsA Progression Slowed, Symptoms Improved with Biologic
Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, effectively improved symptoms of patients with psoriatic arthritis (PsA), according to the findings of a recent study.
The findings were presented at the American College of Rheumatology annual meeting in San Diego, California.
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For their study, the researchers recruited 996 adult patients with active PsA. Participants were randomly assigned to receive 300 mg of subcutaneous secukinumab with loading dosage (LD), 150 mg of secukinumab with LD, 150 mg of secukinumab without LD, or placebo. All participants were administered secukinumab or placebo at baseline and weeks 1 through 4, followed by administration every 4 weeks. At week 16, participants not responding to the placebo were switched to secukinumab, and the remaining participants receiving the placebo were switched at week 24.
The primary endpoint was changes in the American College of Rheumatology criteria (ACR20) score at week 16. The key secondary endpoint was radiographic structural progression, measured by modified total van der Heijde Sharp scores (mTSS).
Overall, patients who received secukinumab showed significantly improved ACR20 scores at week 16 and significantly inhibited radiographic progression at week 24 compared with placebo. A greater proportion of patients receiving secukinumab had no radiographic progression compared with placebo: 88% among those who received 300 mg, 79% among those who received 150 mg, 83% among those who received 150 mg without LD, and 73% among those who received placebo.
All other hierarchical endpoints significantly favored secukinumab compared with placebo at week 16, expect for enthesitis and dactylitis resolution among those who received 150 mg secukinumab without LD.
Additionally, the efficacy of secukinumab was greater among patients who were anti-tumor necrosis factor treatment naïve. Patients who received 300 mg and 150 mg of secukinumab with LD experienced earlier responses to treatment compared with those who received 150 mg without LD.
At week 16, the adverse event rate was 51.6% among patients who received 300 mg, 52.7% among those who received 150 mg, 52.7% among those who received 150 mg without LD, and 58.7% among those who received placebo. No deaths were reported. Non-fatal serious adverse event rates were 2.3% for 300 mg, 3.2% for 150 mg, 1.4% for 150 mg without LD, and 3% for placebo.
“Subcutaneous secukinumab 300 mg with LD and 150 mg with and without LD, inhibited radiographic structural progression and provided rapid and clinically significant improvements in the signs, symptoms and physical function of pts with PsA,” the researchers concluded. “The safety profile was consistent with that previously reported with no new safety signals identified.”
—Melissa Weiss
Reference:
Mease PJ, van der Heijde D, Landewé RBM, et al. Subcutaneous secukinumab inhibits radiographic progression in psoriatic arthritis: primary results from a large randomized, controlled, double-blind phase 3 study. Presented at: American College of Rheumatology Annual Meeting; November 3-8, 2017; San Diego, CA; Abstract 17L.