Ixekizumab Effective Long-term for Treatment of Psoriasis in Pediatric Patients

Ixekizumab showed results including long-term improvement in patient-reported outcomes and objective measures of complete skin clearance among pediatric patients with psoriasis, according to study findings 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.

Moreover, disease manifestations in certain locations, such as the face, scalp, palms and soles, nails, and genital region, could have a disproportionately greater effect on a patient’s quality of life, “because of its high visibility or challenge in treating given the involvement of more sensitive areas that may be more recalcitrant to topical agents,” noted researchers.

Among the several biologic agents approved for first-line treatment of moderate to severe psoriasis in children aged 6 to 18 years, ixekizumab has been shown to be superior to placebo after 12 weeks of treatment in the phase 3 multicenter randomized IXORA-PEDS clinical trial (NCT03073200), with responses sustained through week 48.

The extension period of the IXORA-PEDS trial lasting through week 108 was evaluated by researchers to determine long-term efficacy and safety of ixekizumab for pediatric patients with moderate to severe psoriasis, defined as Psoriasis Area and Severity Index (PASI) of 12 or higher, static Physician’s Global Assessment (sPGA) score of 3 or higher, and psoriasis-affected body surface area of 10% or greater at screening and baseline.

“A total of 171 patients (mean [SD] age, 13.5 [3.04] years; 99 female children [57.9%]) were randomized to 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 evaluated:

• 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 score of 0; and improvement of 4 points or higher from baseline in the Itch Numeric Rating Scale (NRS).
• Secondary outcomes included improvement from baseline in a range of challenging body areas.
• Safety outcomes included assessments of adverse events (AEs), including treatment-emergent AEs, serious AEs, and AEs of special interest.

Findings showed that primary and gated secondary end points that were achieved by week 12 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%). Moreover, 55 patients (78.5%) reported an Itch NRS improvement of 4 points or higher.

Regarding treatment efficacy on more sensitive affected areas, clearance of nail psoriasis was reported in 68.1%, clearance of palmoplantar psoriasis was reported in 90.0%, clearance of scalp psoriasis was reported in 76.2%, and clearance of genital psoriasis was reported in 87.5% of patients who received ixekizumab through 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.

“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,” concluded researchers.

Reference

Paller AS, Seyger MMB, Magariños GA, et al. 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. JAMA Dermatol. Published online April 13, 2022. doi:10.1001/jamadermatol.2022.0655