Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information on dosage and administration for STELARA.
• In a pooled analysis of 2 phase 3 pivotal trials in adult patients, the ≥75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75) response rates at week 28 were similar between the STELARA 90-mg and 45-mg groups (80.8% [350/433] and 76.9% [347/451]; P=0.1823) for the subpopulation weighing ≤100 kg, respectively.¹

CLINICAL DATA

Phase 3 Pooled Analysis

Lebwohl et al (2010)¹ evaluated pooled data from the PHOENIX (A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis Followed by Long-term Extension) 1 (n=766) and PHOENIX 2 (n=1230) studies to examine the impact of weight on STELARA efficacy, safety, and pharmacokinetics.

Study Design/Methods

• At week 28, the efficacy and ustekinumab serum concentrations were evaluated in groups of adult patients defined by 10 kg increments of body weight.

Results

Patient Characteristics

• At baseline, the mean weights of patients in PHOENIX 1 and PHOENIX 2 were 93.9 kg and 91.0 kg, respectively.
• Among patients enrolled in PHOENIX 1 and PHOENIX 2, 50.4% and 48.3% were obese (body mass index [BMI] ≥30), and 34.2% and 31.7% were overweight but not obese (BMI ≥25 to <30), respectively.

Efficacy

• At week 28, the PASI 75 response rates were approximately 20% higher in the STELARA 90-mg group than in the 45-mg group for the subpopulation of patients weighing >100 kg (74.2% [155/209] and 54.6% [107/196], respectively; P<0.0001).
• In addition, the PASI 75 response rates at week 28 were similar between the STELARA 90-mg and 45-mg groups (80.8% [350/433] and 76.9% [347/451]; P=0.1823) for the subpopulation weighing ≤100 kg, respectively.
• There was an impact of weight on response when measured by at least 90% improvement from baseline in Psoriasis Area and Severity Index score (PASI 90) response from baseline or a Physician's Global Assessment (PGA) of cleared or minimal (score of 0 or 1, respectively).
  • At week 28, better responses across studies with the 90-mg group were observed than with the 45-mg group in the subpopulation of patients weighing >100 kg, however, responses were similar between the 45-mg and 90-mg groups in the subpopulation of patients weighing ≤100 kg.
• Ustekinumab serum concentrations were affected by weight, with lower serum concentrations observed in heavier patients at both doses.
• The median ustekinumab serum concentrations in patients weighing >100 kg in the 90-mg group were similar over time to those in patients weighing ≤100 kg in the 45-mg group.

Safety

• Weight had no effect on the safety of STELARA. Regardless of baseline weight, approximately half of the patients experienced ≥1 adverse event (AE) in each treatment group.
• During the placebo-controlled period (weeks 0-12), the rates and types of serious AEs, infections, and AEs leading to discontinuation were similar in the subpopulation of patients weighing <100 kg and ≥100 kg.
• The overall incidences of antibodies to ustekinumab were reported to be higher in patients weighing ≥100 kg with the 45-mg group compared to the 90-mg group (18.4% vs 2.2% in PHOENIX 1) and (13.6% vs 6.7% in PHOENIX 2).

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 22 March 2024.