Secukinumab 300 mg and 150 mg given subcutaneously achieved significant and sustained reductions in the burden of psoriasis on skin and nails in patients with active psoriatic arthritis (PsA) in the phase 3 FUTURE 2 trial. Improvements were also seen on the skin-specific Dermatology Life Quality Index (DLQI).
About 30% of patients with psoriasis will eventually develop PsA, typically within 5 to 10 years after the onset of skin disease. Secukinumab, a monoclonal antibody targeted to interleukin (IL)-17A, has shown rapid and sustained efficacy in patients with both psoriasis and PsA, said lead author Alice B. Gottlieb, MD, Tufts Medical Center, Boston, MA.
“Secukinumab met primary end points demonstrating statistically significant improvements versus placebo in the signs and symptoms of active PsA in FUTURE 2. This is promising information for rheumatologists, who will continue to track the progress of secukinumab, as not all patients respond to existing medications, and approximately 45% of PsA patients are dissatisfied with their treatments,” Gottlieb wrote in an email to Value-Based Care in Rheumatology.
FUTURE 2 is a multicenter, randomized, double-blind, parallel-group placebo-controlled trial that included 397 individuals with active PsA. Patients were randomized 1:1:1:1 to receive subcutaneous secukinumab 300 mg, 150 mg, or 75 mg, or placebo at baseline. They were treated weekly for the first 4 weeks and then every 4 weeks through 52 weeks.
The primary end point was the proportion of patients who achieved American College of Rheumatology 20% improvement criteria (ACR20) at week 24. A key secondary end point was the proportion who achieved 75% and 90% improvement on the Psoriasis Area and Severity Index (PASI) at week 24 among those patients with psoriasis that affected at least 3% of their body surface area (BSA) at baseline. Of the 397 patients enrolled, 192 (48.4%) met the criteria of at least 3% BSA at baseline (psoriasis subset) and 279 (70.3%) had nail involvement (nail subset).
Baseline demographics and characteristics were similar in all 4 arms of the study. More than 60% of patients were anti–tumor necrosis factor naive. Mean PASI score was 11.9, 16.2, 12.1, and 11.6, for secukinumab 300 mg, 150 mg, 75 mg, and placebo, respectively. Psoriasis was present in greater than 3% of BSA in 41%, 58%, 50.5%, and 43.9%, respectively. Nail psoriasis was present in 63%, 75%, 76.8%, and 66.3%, respectively.
The 300-mg and 150-mg doses of secukinumab achieved significantly higher ACR20 responses compared with placebo at week 24. The 75-mg dose achieved a higher response than placebo. The percentages of patients with ACR20 at week 24 were 54% (secukinumab 300 mg, P <.0001), 51% (150 mg, P <.0001), and 29.3% (75 mg, P <.05) versus placebo (15.3%).
The pattern of response was similar among patients with psoriasis who achieved PASI 75 and PASI 90 at week 24: for the PASI 75 response, 63.4%, 48.3%, 28%, for the 300-mg, 150-mg, and 75-mg doses of secukinumab, respectively, versus 16.3% for placebo; for the PASI 90 response, 48.8%, 32.8%, 12%, with the 3 doses of secukinumab, respectively, versus 9.3% for placebo.
The DQLI responses showed that the change from baseline reflected an improvement for all 3 doses of secukinumab compared with placebo at all time points.
No new safety concerns were reported with secukinumab treatment.
Gottlieb A, McInnes IB, Mease P, et al. Secukinumab significantly reduces psoriasis burden in patients with psoriatic arthritis: results from the phase 3 FUTURE 2 study. Presented at: 16th Annual European Congress of Rheumatology; June 10-13, 2015; Rome, Italy. Abstract THU0418.