Secukinumab 300 mg viable first-line biologic in patients with psoriatic arthritis
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Secukinumab 300 mg is a safe and effective first-line biologic for patients with psoriatic arthritis, according to data from a biologic-naïve population based in the United States.
“Secukinumab (SEC), a human monoclonal antibody that selectively targets interleukin 17A, has proven to be efficacious and safe for the treatment of PsA,” Tien Nguyen, MD, of First OC Dermatology, in Irvine, California, and co-authors wrote in The Journal of Rheumatology. “Responses to therapy include resolution of enthesitis and dactylitis; improvement in skin and nail PsO and in axial manifestations of PsA; and prevention of radiographic progression in these patients, and response rates were sustained through 5 years. Overall, SEC was well tolerated and demonstrated a favorable safety profile.
“However, U.S. patients were a minority of those enrolled in these studies,” they added. “Additionally, U.S. patients in these studies had a baseline clinical profile indicating harder-to-treat disease than the total study population, including higher BMI, higher tender and swollen joint counts, increased prevalence of enthesitis and dactylitis, and more tumor necrosis factor inhibitor (TNFi) experience.”
To investigate the impact of secukinumab (Cosentyx, Novartis) in U.S. patients with PsA and psoriatic skin lesions who were biologic-naïve, Nguyen and colleagues conducted the CHOICE study, a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 4 trial. Participants were recruited between July 2016 and October 2017. Eligible patients demonstrated moderate-to-severe PsA as measured by the Classification Criteria for Psoriatic Arthritis and had symptoms for 6 or more months, three or more tender joints, three or more swollen joints, skin lesions with a psoriasis area and severity index of one or more.
Patients were randomized 2:2:1 with a total of 103 receiving secukinumab 300 mg, 103 treated with secukinumab 150 mg and 52 receiving placebo every 4 weeks from week 4 to 16. Patients received loading doses weekly from weeks 1 through 4. At week 16, patients randomized to placebo began receiving secukinumab 300 mg through 52 weeks. Additionally, patients receiving secukinumab 150 mg who achieved less than 20% improvement from baseline in tender and swollen joints at weeks 16, 28 or 40 were switched to secukinumab 300 mg.
The primary outcome was to demonstrate the proportion of patients among the secukinumab 300 mg and placebo groups achieving 20% improvement in the American College of Rheumatology score (ACR20) at week 16. Secondary objectives compared those receiving secukinumab 150 mg and placebo based on proportion of patients achieving ACR20 at week 16. Comparisons investigating all three cohorts achieving ACR50, ACR70 and resolution of dactylitis were also investigated.
At week 16, ACR20 response rates were higher among patients receiving secukinumab 300 mg than those receiving placebo — 51.5% vs. 23.1% (OR= 3.51; 95% CI, 1.65-7.45). More ACR50 and ACR70 responses were seen in patients treated with secukinumab 300 mg, and patients who began with secukinumab 150 mg who had therapy increased also demonstrated improved results, according to the researchers. There was no reported inflammatory bowel disease and no new safety signals identified. Common adverse events included respiratory tract infections and diarrhea.
“The drug is so effective now as monotherapy so patients will not have to be on a combo of TNF and methotrexate anymore, and starting out at 300 mg instead of 150 mg is better for our patients.” Nguyen told Healio.
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