Secukinumab has shown sustained improvement in active psoriatic arthritis (PsA) signs and symptoms over four years. Reported during the 2018 ACR/ARHP Annual Meeting in October, these results are from the FUTURE 2 study, a long-term, four-year safety and efficacy study with dose escalation in patients with active PsA.1 Secukinumab is a fully human, monoclonal IgG1 antibody that selectively neutralizes IL-17A.
In the study, patients (N=397) were randomized to receive 300 mg secukinumab, 150 mg secukinumab, 75 mg secukinumab or placebo weekly. At Week 8, patients received the treatment or placebo every four weeks. At Week 128, if a patient still had active signs of disease, based on physician judgment, the dose was escalated: from 150 mg to 300 mg secukinumab, or from 75 mg to 150 mg or 300 mg secukinumab. Week 208 assessments included ACR20, ACR50, ACR70, PASI 75, PASI 90, HAQ-DI, SF-36 PCS and dactylitis and enthesitis resolution.
Of all the randomized patients, approximately one-third had inadequate response to prior anti-tumor necrosis factor (TNF) alpha use. Analyses were conducted on prior anti-TNF users, as well as on patients who used or did not use concomitant methotrexate. For secukinumab-treated patients who were anti-TNF alpha therapy naive, 71–77% achieved ACR20. For patients who were anti-TNF alpha therapy inadequate responders, 60–71% achieved ACR20. Patients who used concomitant methotrexate had ACR20 responses of 68–79%. And patients who did not use concomitant methotrexate had ACR20 responses of 59–75%.
Patients tolerated the treatment well. The study concluded that secukinumab led to sustained improvement in the signs and symptoms of PsA over four years. Secukinumab treatment effectiveness was sustained or further improved after dose escalation.
The incidence, type and severity of adverse events were consistent with previous reports. Treatment-emergent anti-drug antibody was reported in three patients, with no neutralizing antibody or efficacy loss. Only one death, due to sepsis, was reported during the study in a patient who received 150 mg secukinumab.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- McInnes IB, Kivitz AJ, Nash P, et al. Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis: Long-term (four year) data from a phase 3 study [abstract]. Arthritis Rheumatol. 2018;70(suppl 10).