Pediatric patients treated with ixekizumab achieved significant and rapid improvement in their psoriasis, according to data presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience.
Findings from the ongoing IXORA-PEDS Phase 3 clinical trial demonstrated that the high affinity monoclonal antibody targeting interleukin-17A was associated with near complete and complete psoriasis clearance.
These data follow nearly 13 months since ixekizumab received approval from the U.S. Food and Drug Administration (FDA) for use in patients 6 years of age and older with moderate to severe plaque psoriasis.
Led by Lisa Swanson, MD, Rocky Mountain Hospital for Children, a research team evaluated time to response to PASI 90 and PASI 100 in the clinical trial population. All participants were ≥6 and <18 years of age and had disease ≥6 months prior to baseline.
Other inclusion criteria were PASI ≥12, Static Physician’s Global Assessment ≥3, and disease involvement of ≥10% body surface area.
Patients with pustular, erythrodermic and / or guttate forms of plaque psoriasis or drug-induced psoriasis were excluded from the study, as were those with clinical and / or laboratory data of untreated latent or active tuberculosis.
As such, a total of 171 patients were randomized 2: 1 at the start of the study to receive ixekizumab every 4 weeks or placebo for up to 12 weeks (double-blind induction period).
The patients received different weight doses of ixekizumab. Thus, those> 50 kg received 160 mg at week 0 followed by 80 mg, those ≥25 to ≤50 kg received 80 mg at week 0 followed by 40 mg, and those <25 kg received 40 mg followed by 20 mg.
Time to PASI 90 and PASI 100 for the total population and age / weight subgroups were evaluated and assessed using the Kaplan Meier method.
Swanson and colleges reported that the median time to PASI 90 for ixekizumab was 43.0 (95% CI, 42.0-57.0) days; the median time to PASI 100 was 85.0 (95% CI, 82.0-90.0) days. However, not enough patients receiving placebo reached neither endpoint for the researchers to calculate time to response for each result.
Patients <12 years receiving ixekizumab reported a median time to PASI 90 of 43.0 (95% CI, 40.0-57.0) days and PASI 100 of 90.0 days. Similarly, patients ≥ 12 years of age achieved PASI 90 with a median of 43.0 days (95% CI, 41.0-58.0) and PASI 100 at 85.0 days (95% CI, 57.0-88.0) .
The median time to first PASI 90 response for patients ≥25 to ≤50 kg was 43.0 (95% CI, 30.0-46.0) days; the median time to PASI 100 was 85.0 days. Patients> 50 kg reported a median time of 43.5 days (95% CI, 42.0-58.0) to PASI 90 and 85.0 days to PASI 100.
“Pediatric patients with moderate to severe psoriasis treated with ixekizumab rapidly achieved near-complete and complete clearance of psoriasis with a similar response time in all ixekizumab subgroups, regardless of age or weight,” the researchers emphasized.
The study, “Rapid Skin Improvement with ixekizumab Treatment for Pediatric Patients with Psoriasis: Results of IXORA-peds,” was presented at AAD VMX 2021.