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“The data continue to validate our hypothesis that izokibep offers differentiated efficacy with high potency and small size and reinforces izokibep’s potential to manage the hard-to-treat manifestations of PsA."
Izokibep, a unique interleukin-17 (IL-17) inhibitor, demonstrated notable dose-dependent improvements in sleep, pain, and function in patients with active psoriatic arthritis (PsA), according to data presented at the American College of Rheumatology Convergence 2022. The study “Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes – 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis” revealed clinically meaningful improvements across patient-reported outcomes in those receiving izokibep, including the 36-Item Short Form Health Survey (SF-36) and Psoriatic Arthritis Impact of Disease (PsAID) subdomains.
“Psoriatic arthritis is a disease of multiple clinical manifestations including enthesitis, joint pain, skin lesions and dactylitis. Improvement broadly across all of the aspects of disease drives reduction in overall disease activity, and, as expected, also improves overall quality of life – helping patients feel better and function better,” Shao-Lee Lin, MD, PhD, Co-founder and CEO of ACELYRIN, stated.
The prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding trial analyzed subcutaneous izokibep 80 mg or 40 mg once every 2 weeks (Q2W) compared with placebo through week 16. Eligible patients had ≥ 3 swollen and ≥ 3 tender joints, met the classification criteria for psoriatic arthritis (CASPAR) standards, and had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), or tumor necrosis factor (TNF) inhibitors.
Other endpoints included the SF-36, PsAID-9, Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire-Disability Index (HAQ-DI), Treatment Satisfaction Questionnaire for Medication (TSQM-9), as well as pain, itch, and patient-reported global disease activity. Post-hoc analyses determined minimal clinically important differences (MCIDs) regarding DLQI, HAQ-DI, and PsAID-9.
A total of 135 patients were enrolled in the study between June 2020 and July 2021, with a mean age of 48.5 years, a mean PsA disease duration of 7.1 years, and a mean psoriasis (PsO) duration of 18 years. At baseline, patients had a mean HAQ-DI of 1.3, PsAID of 5.9, a numerical rating scale (NRS) itch of 4.5, swollen joint count (SJC) of 9.9, and a tender joint count (TJC) of 16.7. The visual analogue scale (VAS) global disease activity was 60.2 and the VAS pain was 62.8.
Patient-reported outcomes (PROs) reported clinically meaningful and significant improvements in PsAID, TSQM, global disease activity, and pain. SF-36 subdomains improved in those receiving 80 mg, except for Role-Emotional and Social Functioning. The most notable effects were on Bodily Pain, Vitality, Physical Functioning, and Role-Physical (p < 0.001). All PsAID subdomains improved in the 80 mg cohort, with an emphasis on sleep, pain, and function.
A DLQI ≤ 5 was attained by 81% in the 40 mg group, 80% in the 80 mg group, and 63% in the placebo cohort. Regarding the HAQ-DI, 54% of patients in the 80 mg cohort were able to reach MCID (>0.35) compared with 43% in the 40 mg group and 26% receiving placebo.
“The data continue to validate our hypothesis that izokibep offers differentiated efficacy with high potency and small size and reinforces izokibep’s potential to manage the hard-to-treat manifestations of PsA,” Lin concluded. “The consistency of the clinical outcome and health-related quality of life measures only strengthens our enthusiasm for the ongoing phase 2b/3 study in psoriatic arthritis, the planned phase 3 program in axial spondyloarthritis, and the potential for izokibep in multiple other indications for the benefit of patients globally.”
Taylor P, Behrens F, Mease P, Wetzel D, Peloso P, Brun N, Wiens B, Brandt-Juergens J, Drescher E, Dokoupilova E, Rowińska-Osuch A, Abdel- Kader Martin N, de Vlam K. Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes – 16-Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2022; 74