Secukinumab demonstrates long-term benefit in active psoriatic arthritis
The benefits of the fully human monoclonal antibody secukinumab at doses of either 150 or 300 mg weekly in patients with active psoriatic arthritis are sustained even after 4 years, according to updated results of the FUTURE 2* study presented at the Inflammatory Skin Disease Summit (ISDS 2018).
In this multicentre, double-blind study, a total of 397 patients with active psoriatic arthritis were randomized to receive secukinumab at doses of either 300 (n=100), 150 (n=100), or 75 mg (n=99), or placebo (n=98) weekly followed by every 4 weeks. Dose escalation was allowed beginning at week 128 if there was inadequate disease control; 46 percent of patients escalated treatment from 150 to 300 mg, while 57 percent of patients escalated treatment from 75 mg to 150 or 300 mg. Sixty-five percent of patients were anti-tumour necrosis factor-naïve at baseline, while 47 percent were on concomitant treatment with methotrexate.
Sixty-nine, 70, and 63 percent of patients who initially received secukinumab 300, 150, and 75 mg completed 208 weeks of treatment.
At week 208, a greater proportion of patients who received secukinumab 150 mg achieved ACR 20** (75.0 percent), followed by those who received secukinumab 300 mg (71.2 percent) and 75 mg (69.4 percent). [ISDS 2018, abstract LB 7]
Achievement of PASI 75*** at week 208 was also highest among patients who received secukinumab 150 mg (81.4 percent), followed by secukinumab 300 and 75 mg (80.6 and 66.7 percent, respectively).
Complete resolution of enthesitis occurred most frequently among patients on secukinumab 150 mg (71.7 percent), followed by secukinumab 300 and 75 mg (70.7 and 64.4 percent, respectively), while complete resolution of dactylitis was highest among those who received secukinumab 75 mg (92.3 percent) followed by 150 mg (88.0 percent) and 300 mg (85.3 percent).
These findings follow up on the previously published 2-year results of the FUTURE 2 trial which saw 69.4, 64.4, and 50.3 percent of patients on secukinumab 300, 150, and 75 mg, respectively, achieve ACR 20 and 79.5, 73.3, and 58.4 percent, respectively, achieve PASI 75. [Rheumatology (Oxford) 2017;56:1993-2003]
“In patients who had dose escalation, the proportion of patients with non or low level ACR responses improved [at 4 years], with corresponding increases in the proportion of patients achieving moderate or high ACR responses,” said the researchers.
At 2 years, the exposure-adjusted incidence rates of adverse events (AE) were 163.3, 181.2, and 159.2 per 100 patient-years for patients who received ≥1 dose of secukinumab 300, 150, and 75 mg, respectively, with infections and infestations the most frequently occurring AE (overall rate of 65.0 per 100 patient-years), specifically upper respiratory tract infection (13.6 per 100 patient-years) and nasopharyngitis (12.6 per 100 patient-years).
“The type, incidence, and severity of AEs with secukinumab [in the 4-year follow up] were consistent with previous reports,” said the researchers.
“Secukinumab 300 and 150 mg provided sustained improvement in the signs and symptoms of active psoriatic arthritis over 4 years. Secukinumab was well-tolerated, with no new or unexpected safety signals,” they said.