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Patients who received ixekizumab achieved PASI 90 at a median of 43.0 days and PASI 100 at 85.0 days.
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 showed that the high-affinity monoclonal antibody targeting interleukin-17A was associated with nearly complete and complete psoriasis clearance.
This data follows nearly 13 months since ixekizumab received clearance by the US Food and Drug Aministration (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, an investigative team evaluated time to response to PASI 90 and PASI 100 in the clinical trial population. All participants were ≥6 and <18 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 evidence of untreated latent or active tuberculosis
As such, at study outset, a total of 171 patients were randomized 2:1 to receive either ixekizumab every 4 weeks or placebo for up to 12 weeks (double-blind induction period).
Patients were administered different dosings of ixekizumab by weight. 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 overall 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; median time to PASI 100 was 85.0 (95% CI, 82.0-90.0) days. However, not enough patients on placebo achieved either endpoints for the investigators to calculate time to response for each outcome.
Patients <12 years of age who received 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 achieved PASI 90 at 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).
Median time to first PASI 90 response for patients ≥25 to ≤50 kg was 43.0 (95% CI, 30.0-46.0) days; 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.
“Ixekizumab-treated pediatric patients with moderate-to-severe psoriasis rapidly achieved nearly complete and complete psoriasis clearance with a similar time to response in all ixekizumab subgroups regardless of age or weight,” the investigators stressed.
The study, “Rapid skin improvement with ixekizumab treatment for pediatric patients with psoriasis: Results from IXORA-peds,” was presented at AAD VMX 2021.