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New 108 week data found that treatment with the biologic resulted in significant skin clearance in pediatric patients with psoriasis.
A new investigation into the efficacy of ixekizumab found that pediatric patients who received the biologic showed improvements in patient-reported outcomes and objective measures of complete skin clearance of psoriasis.
Psoriasis affects approximately 1% of children and adults, typically manifesting in patients around 7-10 years of age.
Several biologics have been approved by the Food and Drug Administration (FDA) for the management of psoriasis, with ixekizumab in particular being approved as a first-line option for children between 6-18 years with moderate to severe disease.
In the present trial, investigators led by Amy S. Paller, MD, Chair of the Department of Dermatology at Northwestern Feinberg School of Medicine, evaluated the long-term efficacy and safety of ixekizumab in pediatric patients for up to 108 weeks.
From March 28, 2017 to March 23, 2021, investigators conducted the IXORA-PEDS trial, which enrolled patients from a total of 68 participating sites.
Throughout a 12-week, double-blind treatment period, patients were randomized 2:1 to receive either a subcutaneous, weight-based dose of ixekizumab every 4 weeks or placebo.
Following this period, all patients entered a 48-week maintenance period where they received open-label ixekizumab every 4 weeks. From there, patients entered another extension period that lasted through 108.
A post-extension substudy would be conducted to evaluate the randomized withdrawal of ixekizumab after week 60.
Study participants had moderate to severe psoriasis that was defined as PASI-12 or higher sPGA score of 3 or higher, and psoriasis-affected body surface area of 10% or greater at screening and baseline. Additionally, patients were candidates for phototherapy or systemic therapy.
A data analysis was conducted from May to October 2021 following the intention-to-treat principle.
A total of 171 patients were included in the trial, 115 of whom received ixekizumab every 4 weeks while 56 received placebo. The mean age among all patients was 13.5 years.
Furthermore, the study consisted of 99 female and 72 male children, with a majority (83.8%) identifying as White and 4 patients choosing not to report their race.
Among the 166 patients who entered the maintenance and extension periods, 139 (83.7%) completed week 108 and 27 (16.3%) discontinued their participation.
Investigators observed that primary and gated secondary endpoints were sustained through week 108, with patients achieving PASI 75 (91.7%), PASI 90 (79.0%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). A total of 55 patients (78.5%) reported an Itch Numeric Rating Scale improvement of 4 points or higher
Meanwhile, 68.1% of patients who received ixekizumab reported clearance of nail psoriasis at week 108, while clearance of palmoplantar psoriasis was reported in 90% , clearance of scalp psoriasis was reported in 76.2%, and clearance of genital psoriasis was reported in 87.5%.
No new safety findings were seen during weeks 48 to108 as well as no new cases of inflammatory bowel disease or candida infection.
Overall, significant improvements in patient-reported outcomes and objective measures of complete skin clearance were observed in the 108-week trial.
“Additional studies are warranted to address lingering questions, such as the effect of ixekizumab on additional patient-reported outcomes and the effectiveness and safety of ixekizumab for children with psoriasis in the real world,” the team wrote.
The study, "Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis The IXORA-PEDS Randomized Clinical Trial," was published online JAMA Dermatology.