Last month, the US Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) for ixekizumab (Taltz) 80 mg/mL injection for patients aged 6-17 years old with moderate to severe plaque psoriasis.
The indication for pediatric patients who are already candidates for systemic or phototherapy makes the fourth for the Eli Lilly and Company monoclonal antibody—it was previously approved for the care of plaque psoriasis, psoriatic arthritis, and active ankylosing spondylitis in adults.
But this newest indication fits into a trend of treatment benefit with ixekizumab, an interleukin 17A (IL-17A)-targeting injectable biologic with an anti-inflammatory clinical portfolio. It has shown significant benefit in treating patients’ long-term, chronic symptoms.
In a 52-week head-to-head clinical trial
between the biologic and competitor adalimumab (Humira) for patients with psoriatic arthritis presented last year, ixekizumab was associated with significantly greater rates of patients achieving American College of Rheumatology 50% improvement (ACR50) response and Psoriasis Area and Severity Index 100% clearance (PASI 100).
Another trial presented earlier in the year
showed the biologic helped patients with non-radiographic axial spondyloarthritis achieve statistically significant Ankylosing Spondylitis Disease Activity (ASDAS) improvements at 52 weeks versus placebo.
And now, ixekizumab’s first pediatric indication is supported by phase 3 data showing 89% of children with plaque psoriasis achieved PASI 75 by week 12 of treatment.
The trial data also showed the biologic achieved its major secondary endpoints versus placebo, including proportion of patients achieving PASI 90, static Physician’s Global Assessment (sPGA) 0, and PASI 100 (P
Ixekizumab also showed benefit in itch reduction for pediatric patients with plaque psoriasis, as well as early benefit in the observed metrics for skin clearance. These quality-of-life associated symptoms are significant, especially in a pediatric patient population with fewer therapy options than their adult counterparts, and a hindered lifestyle due to their condition.
Stacie Bell, chief scientific and medical officer of the National Psoriasis Foundation, emphasized the particular challenge of treating moderate to severe plaque psoriasis.
"Having more FDA approved pediatric psoriasis treatment options available is a positive step forward in helping relieve the burden of psoriasis for pediatric patients, their families and the health care providers that treat these young patients,” Bell said in a statement.
Indeed, one of the reasons clinicians and caregivers were even initially drawn to dermatology care is to address the needs of chronically-inflicted young patients. The introduction of interleukin-targeting biologics including ixekizumab to the pipeline has bettered the cause.
PASI 90 has become the adopted gold standard for new agent outcomes in clinical trials, Melissa Davis, PA-C, of the Associates in Dermatology practice in Louisville, told HCPLive®.
A supplemental benefit of near-clear skin treatment has been the end of burdensome symptoms.
“They're no longer itchy and no longer suffering the psychosocial impacts that go on along with that, too,” Davis said. “So it's sort of like the holistic improvement of the patient, in my opinion.”