Ixekizumab Linked to Low Risk of Major Cardiovascular Events in Psoriatic Patients

Mark Lebwohl, MD

Psoriatic disease therapy ixekizumab (Taltz) was associated with a low and consistent rates of major adverse cardiovascular events (MACE) among patients being treated for psoriasis and arthritis, according to new data.¹

In findings presented at the Maui Derm 2023 NP + PA Summer Conference in Colorado Springs this week, US investigators supported by Eli Lilly reported that the interleukin 17A (IL-17A) biologic was associated with low incidence rates (IRs) for MACE including myocardial infarction among patients receiving care for their psoriasis, psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA).

The data provide a level of reassurance for clinicians using the pathway-targeting biologic to treat chronic psoriatic disease over longer periods of time.

The investigators, led by Mark Lebwohl, MD, dean of clinical therapeutics at the Icahn School of Medicine at Mount Sinai, sought to report long-term, end-of-study-program safety outcomes as they relate to MACE in patients receiving ≥1 dose of ixekizumab over 5 years of psoriasis treatment or 3 years of PsA or axSpA treatment. The team used data from 25 randomized clinical trials that included long-term safety data with ixekizumab.

Their data pool consisted of 17 psoriasis trials, 4 PsA trials and 4 axSpA trials. Incident MACE rates were analyzedby years of therapy administered through March 2022; exposure-adjusted IRs per 100 patient-years were calculated.

Lebwohl and colleagues reported IRs of 0.5 MACE per 100 patient-years with ixekizumab for those treating psoriasis or PsA. Among patients with axSpA, IR of MACE was 0.3 per 100 patient-years.

Among the 103 patients with psoriasis to report MACE, 20 (19.4%) were fatal, 57 (55.3%) resulted in recovery, and 17 (16.5%) resulted in recovery with sequelae. Among the 12 patients with PsA to report MACE, 2 (16.7%) were fatal, 9 (75.0%) resulted in recovery, and 1 (8.3%) resulted in recovery with sequelae. All 6 patients with axSpA to report MACE recovered.

The most common form of MACE across the 3 cohorts was non-fatal myocardial infarction; each patient population reported an IR of 0.3 per 100 patient-years. The next most common MACE types were nonfatal stroke (psoriasis IR, 0.1; PsA IR, 0.2) and vascular death (psoriasis IR, 0.1; PsA IR, 0.1).

In a recent study from an international team of investigators, ixekizumab was associated with a consistent retention rate among patients with PsA through 2 years of treatment. The investigators, led by Ruben Queiro, MD, PhD, additionally observed that cardiometabolic risk factors including obesity were not negatively associated with patient survival rate while receiving ixekizumab.

In an interview with HCPLive at the time of the study’s publication, Queiro praised the biologic’s favorable safety data in “real clinical practice conditions,” such as his team’s research pool including patients with active disease and a history of failing ≥2 biological and target-specific therapies.²

“In this difficult-to-approach patient population, ixekizumab retention rates at the first and second year have been optimal, and the safety profile acceptable, with no alarm signals other than what is already known with the drug,” Queiro said. “In particular, we have seen that the factors that usually penalize the persistence of other biologics (particularly female gender, previous use of other biologics, and cardiometabolic comorbidities such as obesity and others) did not affect the persistence rates of ixekizumab.”

Indeed, Lebwohl and colleagues concluded in their analysis that MACE incidence was low and stable over the examined periods of psoriatic disease treatment with ixekizumab.

References

1. ^{Lebwohl M, Deodhar A, Schwartzman S, Salvarani C. Long-Term Safety of Ixekizumab Treatment in Adult Patients with Psoriasis, Psoriatic Arthritis, or Axial Spondylarthritis: A Post-hoc Analysis of End-Of-Study Program Data Relating to Major Adverse Cardiovascular Events. Abstract presented at: Maui Derm 2023 NP + PA Summer Conference, Colorado Springs, CO, June 22 – 25, 2023.}
2. ^{Robinson K. Q&A: Retention, Safety of Ixekizumab in Patients with Psoriatic Arthritis. HCPLive. Published February 15, 2023. https://www.hcplive.com/view/q-a-retention-safety-of-ixekizumab-in-patients-with-psoriatic-arthritis}