Standard adult dosing of Stelara efficacious in adolescents with psoriasis

VANCOUVER, British Columbia — Standard adult dosing of Stelara produced greater efficacy in adolescents with moderate-to-severe plaque psoriasis when compared with half dosing and placebo treatment in a 1-year study, according to research presented at the World Congress of Dermatology.

Stelara (ustekinumab, Janssen) is currently indicated for adults 18 years or older with plaque psoriasis or psoriatic arthritis.

The double-blind, placebo-controlled, parallel multicenter trial included 110 patients (median age, 15.5 years) who were diagnosed at least 6 months prior to the first study session. The patients had a Psoriasis Area and Severity Index (PASI) score of at least 12, Physician Global Assessment (PGA) score of at least 3 and a body surface area involvement of at least 10%. The patients had inadequate control of psoriasis with topical therapy or were considered candidates for systemic or phototherapy.

Subcutaneous placebo, standard adult dose of ustekinumab or half the standard adult dose of ustekinumab were given at weeks 0 and 4 and based on patients’ body weight: ≤ 60kg, 0.375 mg/kg half-dose or 0.75 mg/kg standard dose; > 60 to ≤100 kg, 22.5 mg half-dose or 45 mg standard dose; >100 kg, 45 mg half-dose or 90 mg standard dose. All patients who received placebo crossed over to ustekinumab treatment at weeks 12 and 16. All patients continued receiving ustekinumab, once every 12 weeks, through week 40. Final efficacy evaluation was conducted at week 52 and safety evaluation at week 60. A PGA score of cleared (0) or minimal (1) at week 12 was used as primary endpoint.

Baseline measurements included median body weight of 61.6 kg, median PASI score of 18.8, median body surface area involvement of 23.3% and a PGA of ≥ 4 in 38.2% of patients. The discontinuation rate at week 12 was 0% and at week 40 the discontinuation rate was 8.2%. The most common reason for discontinuation was lack of efficacy in five patients.

At week 12, 67.6% of patients in the half-dose ustekinumab group and 69.4% in the standard-dose ustekinumab group achieved a PGA score of 0 or 1, compared with 5.4% of patients who received placebo.

At week 52, the standard dosing group maintained better efficacy. The number of patients with at least one adverse event was comparable between the treatment arms: 47.9% in the combined ustekinumab cohort vs. 56.8% for placebo-treated patients. In the ustekinumab patients, 1.4% of the combined groups experienced at least one serious adverse event through week 12. Adverse events occurred in 81.8% of the patients treated with ustekinumab through week 60, with only 5.5% reporting a serious adverse event. Malignancies, opportunistic infections and anaphylactic reactions did not occur. – by Bruce Thiel

Reference:

Landells I, et al. FC09-07. Results Through 1 year of the Phase 3 CADMUS Trial: Safety and Efficacy of Ustikinumab in Adolescent Patients With Moderate-to-Severe Plaque Psoriasis. Presented at: 23rd World Congress of Dermatology; June 8-13, 2015; Vancouver, British Columbia.