In active psoriatic arthritisStart With an Established Safety Profile

PHASE 3: Pooled safety data: PSUMMIT I and PSUMMIT II at Week 16 (placebo-controlled period)1-3

 

 

  • Through Week 16, no cases of tuberculosis (TB) or opportunistic infections were reported2
  • Through Week 24, injection-site reactions occurred in 14 (1.5%) patients taking placebo, 6 (1.5%) patients taking STELARA® 45 mg, and 8 (2.2%) patients taking STELARA® 90 mg2

*Squamous cell carcinoma in situ in an area of cleared psoriasis.2

The safety profile of STELARA® is consistent across all other approved indications

 

IN ACTIVE PSORIATIC ARTHRITIS Stay With STELARA®: Consistent Long-term Safety Profile

RATE OF SELECTED TREATMENT-EMERGENT AEs THROUGH WEEK 108 (PSUMMIT I OPEN-LABEL EXTENSION)*

*Includes patients who received STELARA® 45 mg and those who received STELARA® 90 mg.2

PSUMMIT I was considered an open-label trial after Week 24.2

 

 
SAFETY DATA THROUGH WEEK 108

Open-Label Extension (PSUMMIT I)2,4

*PSUMMIT I was considered an open-label trial after Week 24.2

Combined 45-mg group: includes those randomized to 45 mg and those switched from 45 mg to 90 mg.2

One of these was from the placebo crossover to 45-mg group.2

§Includes all patients randomized to the placebo group, including those who early escaped at Week 16 to receive ustekinumab 45 mg.

 

References: 1. McInnes IB, Kavanaugh A, Gottlieb AB, et al; for the PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780-789. 2. Data on file. Janssen Biotech, Inc. 3. Ritchlin C, Rahman P, Kavanaugh A, et al. Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990-999. 4. Kavanaugh A, Puig L, Gottlieb AB, et al; on behalf of the PSUMMIT 1 Study Group. Maintenance of clinical efficacy and radiographic benefit through two years of ustekinumab therapy in patients with active psoriatic arthritis: results from a randomized, placebo-controlled phase III trial. Arthritis Care Res (Hoboken). 2015;67(12):1739-1749.