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Ustekinumab can safely treat moderate to severe psoriasis in pediatric patients ≥6 years of age to <12 years of age, suggesting the potential expansion of the drug’s indication to children with this disease. This is according to study findings published in the British Journal of Dermatology.
In this phase 3, open-label, multicenter study, a total of 44 pediatric patients (median age, 9.5 years [interquartile range, 7.5-10.0) with moderate to severe plaque psoriasis were treated with ≥1 dose of ustekinumab. Dosing of ustekinumab was based on weight: children who weighed <60 kg received 0.75mg/kg, those who weighed ≥60 to ≤100 kg received 45mg, and those who weighed >100 kg received 90 mg. Ustekinumab was administered subcutaneously at weeks 0 and 4, and afterwardsevery 12 weeks through week 40.
Week 12 endpoints included the percentages of patients who achieved a Physician’s Global Assessment score of cleared/minimal (PGA 0/1) and a ≥75%/90% improvement in the Psoriasis Area and Severity Index (PASI 75/90). In addition, the change in the Children’s Dermatology Life Quality Index (CDLQI) was assessed at 12 weeks. At week 52, levels of serum ustekinumab concentrations, anti-drug antibodies (ADA), and cytokines were measured. Safety was assessed at week 56.
The study included 3 patients who discontinued ustekinumab through week 40. Discontinuations were due to lack of efficacy and protocol violations. Approximately 77.3% (95% CI, 62.2-88.5) of patients achieved PGA 0/1 at week 12. In addition, 84.1% of patients achieved PASI 75 (95% CI, 69.9-93.4), and 63.6% (95% CI, 47.8-77.6) achieved PASI 90 response. The mean ± standard deviation change in the CDLQI was -6.4 ± 6.10.
At weeks 28 to 52, the median trough serum concentrations of ustekinumab reached steady state (0.34 μg/mL to 0.38 μg/mL, respectively). There was no evidence of attenuation or accumulation in serum concentrations of ustekinumab over time. The incidence of ADA through week 52 was 9.5%. At weeks 12 and 52, the mean serum concentrations of IL-17A/F and IL-22 reduced significantly. Approximately 77.3% of patients experienced ≥1 adverse event, whereas 6.8% experienced a serious adverse event.
Limitations of the study included the small number of enrolled participants as well as the lack of a placebo arm.
The study authors concluded that these data “demonstrate a favorable benefit-risk profile of ustekinumab for the treatment of younger pediatric patients with moderate-to-severe psoriasis.”
Disclosure: This clinical trial was supported by Janssen Research & Development. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Reference
Philipp S, Menter A, Nikkels AF, et al. Ustekinumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients (≥6 to <12 years of age): efficacy, safety, pharmacokinetic, and biomarker results from the open-label CADMUS Jr study [published online March 16, 2020]. Br J Dermatol. doi: 10.1111/bjd.19018
