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Stelara effective in adolescents with psoriasis

Weight-based standard dosing of Stelara was effective in adolescents with moderate-to-severe psoriasis with no unexpected adverse events, according to recently published study results.

Stelara (ustekinumab, Janssen) is currently approved as treatment for adults aged 18 years and older with plaque psoriasis, as well as adults with psoriatic arthritis either alone or with methotrexate.

Researchers studied 110 patients aged 12 to 17 years (mean age, 15.2 years) with moderate-to-severe plaque psoriasis. The patients were randomly assigned to weight-based ustekinumab standard dosing (0.75 mg/kg [≤60 kg], 45 mg [>60 to ≤100 kg] and 90 mg [>100 kg]), half-standard dosing (0.375 mg/kg [≤60 kg], 22.5 mg [>60 to ≤100 kg] and 45 mg [>100 kg]) at weeks 0 and 4 and every 12 weeks, or placebo at weeks 0 and 4 with crossover to ustekinumab standard-or half-dose at week 12.

Proportion of patients achieving a Physician’s Global Assessment (PGA) of cleared/minimal (PGA 0/1), a Psoriasis Area and Severity Index of improvements of at least 75% (PASI 75) and at least 90% (PASI 90) were endpoints.

PGA 0/1 was achieved by 67.6% and 69.4% in the half-dose and standard-dose cohorts, respectively, at week 12 compared with 5.4% in the placebo-treated cohort (P < .001). PASI 75 was achieved by 78.4% and 80.6% in the half-dose and standard-dose cohorts, respectively, compared with 10.8% in the placebo-treated cohort. PASI 90 was achieved by 54.1% and 61.1% in the half-dose and standard-dose cohorts, respectively, compared with 5.4% in the placebo-treated cohort at week 12 (P<.001).

At least one adverse event was reported by 56.8% of patients receiving placebo, 51.4% of the half-dose cohort and 44.4% of the standard-dose cohort through week 12, with most adverse events being mild or moderate. There were 81.8% of patients reporting adverse events through week 60. No malignancies, active tuberculosis cases, opportunistic infections, anaphylactic reactions or serum sickness-like reactions were reported.

“A weight-based dosing strategy achieving exposure similar to that observed with the current adult dosage resulted in robust improvements in disease activity and [health-related quality of life] with no unexpected [adverse events] noted,” the researchers concluded. – By Bruce Thiel

Disclosure: Landells reports serving as a consultant, receiving research grants and honoraria from Janssen. Please see the full study for list of other researchers’ relevant financial disclosures.