STELARA® is indicated for the treatment of patients 12 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Significant Skin Clearance at Week 12
After 2 Starter Doses

*P<0.001 vs placebo.

STELARA® approved dose for adolescent patients is 0.75 mg/kg for patients weighing less than 60 kg; 45 mg for patients weighing 60 kg to 100 kg; and 90 mg for patients weighing greater than 100 kg administered subcutaneously at Weeks 0 and 4 and every 12 weeks thereafter.

Prespecified, exploratory endpoints: During the blinded placebo-crossover and active-treatment period (Weeks 12 to 52), patients continued to receive STELARA® every 12 weeks through Week 40 with efficacy assessments continuing through Week 52. No formal statistical comparisons were performed at Week 52.

IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Safety profile in adolescent patients consistent with adult studies1

ADVERSE EVENTS (AEs)

   

  • The safety of STELARA® was assessed in a study of 110 patients from 12 to 17 years of age with moderate to severe plaque psoriasis. The safety profile in these patients through Week 60 was similar to the safety profile from studies in adults with plaque psoriasis2
  • Through Week 12, the most common AEs were nasopharyngitis (STELARA®, 2.8% [1/36]; placebo, 27.0% [10/37]) and headache (STELARA®, 8.3% [3/36]; placebo, 5.4% [2/37]). Through Week 60, the most common AEs across all treatment arms were nasopharyngitis (34.5%, 38/110), upper respiratory tract infection (12.7%, 14/110), and pharyngitis (8.2%, 9/110)1,3

IN ADOLESCENT PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Only 4 doses per year

After 2 starter doses

FIRST 52 WEEKS OF THERAPY:

STELARA® DOSING FOR ADOLESCENTS BASED ON BODY WEIGHT, GIVEN AT WEEKS 0 AND 4, THEN EVERY 12 WEEKS THEREAFTER

See Table 2 of the full Prescribing Information.

References: 1. Landells I, Marano C, Hsu M-C, et al. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015;73(4):594-603. 2. STELARA® (ustekinumab) [package insert]. Horsham, PA: Janssen Biotech, Inc. 3. Data on file. Janssen Biotech, Inc. 4. Enbrel® (etanercept) [package insert]. Thousand Oaks, CA: Immunex Corporation.