Patients with active psoriatic arthritis treated with secukinumab for 2 years in the FUTURE-1 trial experienced sustained decreases in disease activity and symptoms, leading to improvements in physical function and quality of life.
New data from a randomized phase 3 trial indicate that patients with psoriatic arthritis tend to sustain improvements resulting from the use of secukinumab for at least 2 years. Most patients experience very little radiographic progression over that period and tolerate the treatment well.
The FUTURE-1 study gave 606 psoriatic arthritis patients intravenous secukinumab (10 mg per kg of body weight) at baseline, Week 2 and Week 4. Investigators then randomized patients to 150 mg of subcutaneous secukinumab, 75 mg subcutaneous secukinumab or placebo. Depending on response, placebo patients were randomized to one of the two secukinumab doses after either Week 16 or Week 24. Treatment continued until Week 104 for the 476 patients (78.5%) who chose to finish the trial.
At the end of that period, 66.8% of patients taking the 150 mg dose and 58.6% of patients taking the 75 mg dose maintained 20% reductions in disease activity as defined by criteria from the American College of Rheumatology (ie, an ACR20 response). Also, 74.6% of secukinumab 150 mg patients and 63.0% of secukinumab 75 mg patients maintained 75% reductions in their psoriatic arthritis severity index scores (ie, PASI 75 responses).
When investigators looked for radiographic disease progression, they found no signs of it in 84.3% of secukinumab 150 mg patients and 83.8% of secukinumab 75 mg patients.
“Secukinumab showed sustained efficacy across multiple domains of psoriatic arthritis through Week 104, including signs and symptoms, disease activity, quality of life, physical function, skin symptoms, dactylitis and enthesitis,” the study authors wrote in Arthritis Care & Research. “No new or unexpected safety signals were reported during two years of treatment. Immunogenicity to secukinumab was low.”
Secukinumab is an interleukin-17A inhibitor that sells under the tradename Cosentyx. The US Food and Drug Administration (FDA) approved it for the treatment of psoriatic arthritis (along with ankylosing spondylitis) in January. The FDA also approved it, a year earlier, for the treatment of moderate-to-severe plaque psoriasis.
The psoriatic arthritis indication rests in part upon the 24-week results from the FUTURE-1 study, which appeared last year in The New England Journal of Medicine. The primary endpoint of that trial was an ACR20 response at week 24. Exactly half of the secukinumab 150 mg patients and 50.5% of the secukinumab 75 mg patients achieved ACR20 responses by 24 weeks, compared to only 17.3% of placebo patients (p<0.001 for superiority of both secukinumab doses over placebo).
The FDA approval also hinged upon the very similar one-year results of another phase 3 study, which appeared in The Lancet a few months earlier. A total of 100 patients received 300 mg injections, while 100 received 150 mg injections, 99 received 75 mg injections and 98 received placebo injections. By the one-year point, 64% of the patients who received either the 300 mg dose or the 150 mg dose met ACR 20 response criteria. Also, 44% of the 300 mg patients and 39% of the 150 mg patients met the more demanding criteria of ACR50.
Results from several of those trials indicate that secukinumab works better in patients who have never been exposed to the current standard of care, drugs that inhibit the tumor necrosis factor that plays a role in inflammatory response.