Ixekizumab shows strong efficacy, safety through 108 weeks in pediatric psoriasis

Pediatric patients with moderate to severe psoriasis experienced encouraging efficacy and safety outcomes through 108 weeks of treatment with ixekizumab, according to a study.

“About 1% of children and adolescents worldwide are affected by plaque psoriasis,” Amy S. Paller, MD, of the departments of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago, and colleagues wrote.

In the multicenter, randomized clinical trial, Paller and colleagues assessed the long-term efficacy and safety of ixekizumab (Taltz, Lilly) in a cohort of pediatric patients aged 6 years to younger than 18 years with moderate to severe psoriasis. They defined eligibility criteria as having a PASI score of 12 or higher, static Physician Global Assessment (sPGA) score of 3 or higher and impacted body surface area of 10% or greater at screening and baseline. Eligibility criteria also included possible treatment with phototherapy or systemic therapy and poor disease control with topical interventions.

Treatment protocols called for participants to receive either weight-based ixekizumab or placebo every 4 weeks for 12 weeks, followed by a 48-week open label ixekizumab maintenance period. After this, patients entered an extension period through 108 weeks.

Of the 171 total patients (mean age, 13.5 years; 57.9% girls), 115 received ixekizumab and 56 received placebo in the initial treatment period. Among 166 patients who entered the second part of the trial, 139 ultimately completed 108 weeks.

Results at the final follow-up showed that 91.7% of patients reached PASI 75, while 79% reached PASI 90 and 55.1% reached PASI 100.

In addition, 78.3% of the cohort achieved sPGA 0 or 1 and 52.4% reported sPGA 0.

Regarding Itch Numeric Rating Scale outcomes, 78.5% of patients improved by 4 or more points after 108 weeks.

Ixekizumab was also associated with a nail psoriasis clearance rate of 68.1% at 108 weeks. The drug additionally yielded a 90% rate of clearance of palmoplantar psoriasis, while 76.2% reported clearance of scalp psoriasis and 87.5% reported clearance of genital psoriasis.

Safety data showed no new findings between 48 weeks and 108 weeks. Specifically, no new cases of inflammatory bowel disease or candida infections were reported.

“Results of this study showed improvements across patient-reported outcomes and objective measures of complete skin clearance of psoriasis among pediatric patients who received ixekizumab, and these response rates were sustained through week 108 of the trial,” the researchers concluded. “Safety of ixekizumab was consistent with previously reported findings in this population and the known safety profile of this treatment.”