Ixekizumab is effective in the long term for the treatment of psoriasis in pediatric patients
Pediatric patients with psoriasis showed significant improvements in self-reported outcomes and objective measures of complete skin clearance when treated with ixekizumab compared to placebo, with no new safety results reported. identified.
Ixekizumab has shown results, including long-term improvement in patient-reported outcomes and objective measures of complete skin clearance in pediatric patients with psoriasis, according to study results published in JAMA Dermatology.
Affecting approximately 1% of children and adolescents, psoriasis has a significant impact on the quality of life of pediatric patients and their parents.
In addition, disease manifestations in certain locations, such as the face, scalp, palms and soles, nails, and genital area, may have a disproportionately greater effect on a person’s quality of life. patient, “due to its high visibility or difficulty in treating it given the involvement of more sensitive areas that may be more recalcitrant to topical agents,” the researchers noted.
Of the many biologic agents approved for the first-line treatment of moderate to severe psoriasis in children aged 6 to 18 years, ixekizumab was shown to be superior to placebo after 12 weeks of treatment in the multicenter randomized clinical trial of phase 3 IXORA-PEDS (NCT03073200), with sustained responses through week 48.
The IXORA-PEDS trial extension period that lasts through week 108 was evaluated by investigators to determine the long-term efficacy and safety of ixekizumab for pediatric patients with moderate psoriasis to severe, defined as a Psoriasis Area and Severity Index (PASI) of 12 or greater. , a static Physician’s Global Assessment (sPGA) score of 3 or greater, and a body surface area affected by psoriasis of 10% or greater at screening and baseline.
“A total of 171 patients (average [SD] age, 13.5 [3.04] years; 99 girls [57.9%]) were randomized to receive either ixekizumab (n=115) or placebo (n=56). Of 166 patients who entered the maintenance period, 139 (83.7%) completed week 108 of the trial,” the study authors wrote. “Data analysis, which followed the intention-to-treat principle, was conducted from May to October 2021.”
Several primary/secondary efficacy and safety outcomes at week 108 were assessed:
- Primary outcomes assessed included percentage of patients achieving 75% (PASI 75), 90% (PASI 90), or 100% (PASI 100) improvement from baseline; an sPGA score of 0 or 1 or a score of 0; and improvement of 4 or more points from baseline on the Numerical Itching Rating Scale (NRS).
- Secondary outcomes included improvement from baseline in a range of challenging body areas.
- Safety results included assessments of adverse events (AEs), including treatment-emergent AEs, serious AEs, and AEs of special interest.
Results showed that primary and secondary controlled endpoints achieved at week 12 were maintained 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%). In addition, 55 patients (78.5%) reported an improvement in the itch NRS of 4 or more points.
Regarding treatment efficacy on more sensitive affected areas, disappearance of nail psoriasis was reported in 68.1%, disappearance of palmoplantar psoriasis was reported in 90.0%, disappearance of psoriasis of the scalp was reported in 76.2% and resolution of genital psoriasis was reported in 87.5% of patients who received ixekizumab for 108 weeks.
No new safety findings during weeks 48 to 108 of the trial were identified, including no new cases of inflammatory bowel disease or Candida infection.
“Further studies are warranted to answer lingering questions, such as the effect of ixekizumab on other patient-reported outcomes and the efficacy and safety of ixekizumab for children with psoriasis in the real world,” the researchers concluded.
Paller AS, Seyger MMB, Magariños GA, et al. Long-term efficacy and safety up to 108 weeks of ixekizumab in pediatric patients with moderate to severe plaque psoriasis: the IXORA-PEDS randomized clinical trial. JAMA Dermatol. Published online April 13, 2022. doi:10.1001/jamadermatol.2022.0655