Two-Year Results Affirm Efficacy of Secukinumab in Psoriatic Arthritis

Results from the FUTURE 5 study show that more than 80% of patients had no radiographic progression of psoriatic arthritis, regardless of dose cohort or whether a loading dose was used.

New end-of-study results show that secukinumab (Cosentyx) provides long-term improvement and limits radiographic progression in patients with psoriatic arthritis (PsA).

The results, published in RMD Open, showed patients who completed the 2-year regimen saw the benefits of the therapy whether or not they received a loading dose.

Secukinumab is a human monoclonal antibody that directly inhibits interleukin 17-A. Earlier studies have suggested that it can rapidly stop PsA progression with sustained benefits and limited safety concerns. The newly published data cover the end of the FUTURE 5 study, which analyzed the results in patients following 2 years of therapy.

A total of 996 patients were randomized into the study, and 783 completed the full 2 years of treatment. Those patients were divided into 4 groups on a 2:2:2:3 basis. The first 3 groups received subcutaneous secukinumab with a 300 mg load, 150 mg load, and 150 mg with no load. The final group received placebo. Treatments or placebo were given at baseline and each of the first 4 weeks, then every 4 weeks after that.

Patients who were started at 150 mg could be escalated to 300 mg starting at week 52 if a physician observed signs of active disease, but patients were not allowed to deescalate their dose. About 4 in 10 patients in both 150-mg groups had their doses escalated, according to investigators.

Patients were assessed both in terms of clinical end points and in terms of radiographic damage, which was measured by mean change in van der Heijde-modified total Sharp score (vdH-mTSS).

After 2 years, the authors found that patients who completed the treatment had improvements in clinical end points and low rates of vdH-mTSS change. The lowest rate of change was in the 300-mg group, which had a mean (SD) change of 0.10 (1.74). Patients in the 150-mg load group had a mean (SD) change of 0.52 (2.66); patients in the 150-mg no-load group had a mean (SD) change of 0.41 (2.20). Most patients had no radiographic progression, defined as a vdH-mTSS change of 0.5 or less. Rates of no progression were 89.5% in the 300-mg group, 82.3% in the 150-mg load group, and 81.1% in the 150-mg no-load group.

The authors noted that the data clearly showed that increasing the dosage had a significant benefit, according to American College of Rheumatology (ACR) 20/50/70 criteria, even for patients who were anti–tumor necrosis factor (anti-TNF) naive or who had inadequate responses (IR) to the therapy.

“After secukinumab dose escalation from 150 mg to 300 mg, the proportion of ACR20 and ACR50 responders increased,” the authors wrote. “Notably, the percentage of patients with ACR response ≥50 (ACR50 and ACR70 responders) increased after dose escalation in both anti-TNF-naive and anti-TNF-IR subgroups.”

Safety reports from this study were consistent with earlier reports—rates of discontinuation due to adverse events were 4.4% in the 300-mg group and 4.6% in the 150-mg groups. The most frequently reported adverse events were nasopharyngitis and upper respiratory tract infection.

“Secukinumab was well tolerated with no new or unexpected safety signals reported,” the investigators concluded. “Overall, the findings from this study strengthen the existing evidence on the efficacy of long-term secukinumab treatment in patients with PsA.”

Reference

Mease PJ, Landewé R, Rahman P, et al. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study. RMD Open. 2021;7(2):e001600. doi:10.1136/rmdopen-2021-001600