In active psoriatic arthritisSafety Data From Clinical Trials
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 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 overall safety profile of STELARA® was consistent with that seen in plaque psoriasis and Crohn’s disease studies.4
See the safety data of STELARA® evaluated in plaque psoriasis clinical studies.
Integrated Safety Summary Through 1 Year of Treatment (PsA) 2,5†
- The percentage of patients in the PsA phase 2 study who received MTX was 20.5%. No concomitant DMARDs with the exception of MTX (approximately 50% of patients in each study) were permitted in the 2 PsA phase 3 studies
†PsA studies included the Phase 2 (through Week 36), PSUMMIT 1 (through Week 52), and PSUMMIT 2 (through Week 60) trials with 222, 615, and 312 patients exposed to STELARA®, respectively.
‡Includes data up to the time of early escape or crossover.
§Includes data from the first ustekinumab dose onward for subjects from placebo crossover, early escape, STELARA® 45 mg, and STELARA® 90 mg groups.
║Confidence intervals based on an exact method assuming that the observed number of events follows a Poisson distribution.
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. STELARA [package insert]. Horsham, PA: Janssen Biotech, Inc; 2016. 5. Gensler LS, Hsia EC, Gasink C, et al. An integrated safety data analysis across all phase II and phase III clinical programs for ustekinumab in psoriatic arthritis, Crohn’s disease, and psoriasis. Presented at: 2016 American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting; November 11-16, 2016; Washington, DC. Abstract 1726.