WASHINGTON, DC — Researchers evaluating the 3-year efficacy of secukinumab found that it safe and efficacious in the treatment of psoriatic arthritis (PsA) across multiple dosages, according to recent research recently presented at the American College of Rheumatology 2016 annual meeting.
Philip J Mease, MD, from the Swedish Medical Center and University of Washington, Seattle, WA, and colleagues randomized 606 patients with PsA to receive either secukinumab (308 patients) or placebo, where those assigned to secukinumab received an initial 10 mg/kg loading dose at baseline, 2 weeks and 4 weeks with additional subcutaneous injections at 75 mg or 150 mg every 4 weeks, according to the abstract.
The placebo group mirrored the dosing schedule of those assigned to receive secukinumab, but were then re-randomized into the secukinumab group at 16 weeks or 24 weeks based on clinical response, where they received 75 mg or 150 mg doses every 4 weeks.
Patients were then given the option to enter the extension phase of the study at 104 weeks and at 156 weeks. Researchers analyzed dactylitis, enthesitis, American College of Rheumatology (ACR) response criteria 20/50/70, Psoriasis Area and Severity Index (PASI) 75, Disease Activity Score 28 C-reactive Protein (DAS28 CRP), short form-36 Physical Component Summary (SF-36 PCS), and Health Assessment Questionnaire Disability Index (HAQ-DI).
Dr Mease and colleagues also analyzed the differential effects of secukinumab on patients who were either anti-tumor necrosis factor (TNF)-naïve or had a history of inadequate response (IR) to anti-TNF therapy.
Four hundred fifty seven patients entered into the extension study, of these, 435 patients underwent 156 weeks of therapy, with 151 patients in the 150 mg group and 142 patients in the 75 mg group. There were 142 patients in the placebo group who transferred to the secukinumab group.
At 156 weeks, there was a 76.8% ACR20 response rate, 54.9% ACR 50 response rate, and 32.9% ACR 70 response rate in the 150 mg secukinumab group. In the latter group, there was a 65.2% response rate to ACR 20, 39% response rate to ACR 50 and 26% response rate to ACR 90, according to the abstract.
Researchers noted a comparable response rate to ACR 20, ACR 50, ACR 90, and PASI 75 in their anti-TNF- naïve and anti-TNF-IR analysis. Among the mean exposure to secukinumab among all patients in the study (1025.1 ± 372.7 days), Dr Mease and colleagues found there were no adverse events outside of the types, incidences or severity previously reported for this therapy.
Secukinumab provided sustained improvements in signs and symptoms and multiple clinical domains of active PsA in pts who completed 3 years of therapy,” Dr Mease and colleagues wrote in their study abstract.
“Secukinumab was well tolerated with a safety profile consistent with that previously reported.”
Dr Mease received research grants from Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB; is a paid consultant for Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB; and is on the speaker’s bureau for Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB.
Dr Kavanaugh received consulting fees from Novartis Pharmaceutical Corporation.
Dr Reimold received research grants from Abbvie.
Dr Tahir is on the speaker’s bureau for Novartis, Eli Lilly, and Abbvie. Rech is on the speaker’s bureau for Abbvie, BMS, Celgene, Fresenius, medicap, MSD, Novartis, Pfizer, and Roche.
Dr Geusens received research grants for Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche, and is on the speaker’s bureau for Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche.
Drs Pascale and Delicha receive stock or stock options from and are paid employees of Novartis Pharmaceutical Corporation.
Drs Pricop and Mpofu receive stock or stock options from and are paid employees of Novartis.
Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis through 3 Years: Efficacy and safety results from a phase 3 trial. Presented at: ACR/ARHP Annual Meeting; November 11-16, 2016; Washington D.C. Abstract #961.