Izokibep demonstrates ‘marked improvements’ in psoriatic arthritis at 46 weeks
Click Here to Manage Email Alerts
Key takeaways:
- Izokibep achieved long-term effectiveness in adults with active psoriatic arthritis.
- Patients using either the 40 mg or 80 mg doses both showed improvement.
The interleukin-17 inhibitor izokibep has demonstrated positive safety and efficacy data at 46 weeks among patients with psoriatic arthritis, according to a press release from its manufacturer.
“Patients want both rapid and meaningful improvement of their symptoms, as well as lasting — and ideally improving resolution of disease over time,” Philip J. Mease, MD, of the Swedish Medical Center, in Seattle, and trial investigator, said in the release from Acelyrin. “Building on the 16-week data for izokibep reported at EULAR and [American College of Rheumatology Convergence] last year, the 46-week data now show not only continued but marked improvements over time in key areas of psoriatic arthritis, including joint pain, skin psoriasis and enthesitis.”
Positive week 16 results for the drug were previously reported at ACR Convergence 2022, with patients receiving izokibep 80 mg exhibiting “significant and clinically meaningful” improvements. In that study, a total of 135 patients with active PsA from 28 sites were randomized to receive either izokibep 40 mg or 80 mg, or placebo.
The current study — a randomized, double-blind, placebo-controlled, phase 2 trial —investigated izokibep (Acelyrin, Inc.) 80 mg, izokibep 40 mg and placebo administered every 2 weeks through 46 weeks in adult patients with PsA. The trial’s primary endpoints were ACR response, Psoriasis Area and Severity Index (PASI) score and the Leeds Enthesitis Index (LEI). After 16 weeks, patients who had received placebo up until that point were transitioned to 80 mg izokibep through 46 weeks.
At 46 weeks, among patients who received izokibep 80 mg, 79% achieved ACR50, 50% achieved ACR70 and 71% achieved PASI100, according to the release. Additionally, 89% of patients in this cohort achieved enthesitis resolution. Among the 40 mg cohort, 50% of patients achieved ACR50, 33% achieved ACR70 and 50% achieved PASI50. Among these patients, 83% achieved enthesitis resolution. Finally, among patients who received placebo before transitioning to izokibep at week 16, 73% achieved ACR50, 64% achieved ACR70 and 67% achieved PASI100, while 80% achieved enthesitis resolution.
“We hypothesized that the high potency and small molecular size of izokibep has the potential to impact clinical response,” Shao-Lee Lin, MD, PhD, founder and CEO of Acelyrin, said in the release. “It has been heartwarming to see the encouraging results in both the hidradenitis suppurativa data recently presented at AAD as well as independently within the PsA dataset, not only at 16 weeks, but now with increased rates of response in PsA with continued long-term dosing out to 46 weeks.”
Read more about
Click Here to Manage Email Alerts