AN ESTABLISHED SAFETY PROFILE

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5 years of clinical safety data

Studies reflect exposure in 3117 patients with plaque psoriasis1

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8998 patient-years of exposure

Median follow-up of 3.2 years1

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Psoriasis Longitudinal Assessment and Registry (PSOLAR)

An observational study of approximately 12,000 patients with plaque psoriasis2

Cumulative rates of serious infections consistent over 5 years1,2*

 

 

In the placebo-controlled period of clinical studies of patients with psoriasis (average follow-up of 12.6 weeks for placebo-treated patients and 13.4 weeks for STELARA®-treated patients)2:

  • 27% of STELARA®-treated patients reported infections (1.39 per patient-year of follow-up) compared with 24% of placebo-treated patients (1.21 per patient-year of follow-up)
  • Serious infections occurred in 0.3% of STELARA®-treated patients (0.01 per patient-year of follow-up) and in 0.4% of placebo-treated patients (0.02 per patient-year of follow-up)

In the controlled and noncontrolled portions of psoriasis clinical trials (median follow-up of 3.2 years, representing 8998 patient-years of exposure)2:

  • 72.3% of STELARA®-treated patients reported infections (0.87 per patient-year of follow-up)§
  • Serious infections were reported in 2.8% of patients (0.01 per patient-year of follow-up)

Cumulative overall safety was evaluated during the placebo-controlled period (12 or 20 weeks) and up to 5 years of treatment.3

*Safety results reported using cumulative rates through the controlled period (12 or 20 weeks of exposure); 2007 analysis (up to 18 months of exposure); 2009 analysis (up to 3 years of exposure); 2010 analysis (up to 4 years of exposure); and 2011 analysis (up to 5 years of exposure).1-3

Average follow-up of 12.6 weeks for placebo-treated patients and 13.4 weeks for STELARA®-treated patients.2

Median follow-up of 3.2 years, representing 8998 patient-years of exposure.2

§Based on any adverse event, regardless of body system, which in the opinion of the investigator would be considered an infection.

 

Cumulative rate of malignancies over 5 years2*

Rate per 100 Patient-Years

Rate of malignancies (excluding NMSC) with STELARA® are similar in type and number to the general US population2,3

Number of Patients with Events

In the controlled and noncontrolled portions of psoriasis clinical trials (median follow-up of 3.2 years, representing 8998 patient-years of exposure)2:

  • 1.7% of STELARA®-treated patients reported malignancies excluding nonmelanoma skin cancers (NMSC) (0.60 per hundred patient-years of follow-up)
  • NMSC was reported in 1.5% of STELARA®-treated patients (0.52 per hundred patient-years of follow-up)
  • The most frequently observed malignancies other than NMSC during the clinical trials were prostate, melanoma, colorectal, and breast

Malignancies other than NMSC in STELARA®-treated patients during the controlled and noncontrolled portions of studies were similar in type and number to what would be expected in the general US population according to the Surveillance, Epidemiology, and End Results (SEER) database (adjusted for age, gender, and race).2,3

Cumulative overall safety was evaluated during the placebo-controlled period (12 or 20 weeks) and up to 5 years of treatment.3

*Median follow-up of 3.2 years, representing 8998 patient-years of exposure.

Excluding NMSC.

SEER database (2009), adjusted for age, gender, and race, compared with STELARA® through the 2011 analysis.3

§Since cervical cancer in situ is not captured in SEER, a single case in 90 mg is not included in this analysis.3

References: 1. Data on file. Janssen Biotech, Inc. 2. STELARA® (ustekinumab) [package insert]. Horsham, PA: Janssen Biotech, Inc. 3. Papp KA, Griffiths CEM, Gordon K, et al; on behalf of the PHOENIX 1, PHOENIX 2, and ACCEPT Investigators. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013;168(4):844-854.