Start Strong.† Stay The Course.ǂ  

 

At week 6 after IV induction, 55.5% of STELARA patients in UNITI-2 demonstrated a CDAI score reduction of ≥100 points (or total score <150) vs 28.7% of placebo patients (n=209 for each, p<0.001).#1

 

52 weeks after induction, 53.1% of 128 STELARA patients were in clinical remission (CDAI score <150 points) with 8-weekly maintenance doses vs 35.9% of 131 placebo (induction dose only) patients (p=0.005).1

 

§In psoriasis, based on an observational study in which 4,364 patients receiving STELARA were followed for a median of 3.3 years.2

#In UNITI-2, 68.6% of STELARA patients (n=209) were TNF inhibitor-naïve. The remaining population was previously exposed to, but did not fail, treatment with TNF inhibitors. All patients in the study had failed conventional treatment (eg azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).1

 

 

Stelara Starts Strong With A Single IV Induction Dose1,4  

Stelara - Graph

 

Study design: 
Multicentre double-blind, placebo-controlled induction trials in which all patients received a single intravenous dose of STELARA (either 130 mg or approximately 6 mg/kg) or placebo. The UNITI-1 trial included patients who were primary or secondary non-responders to TNF antagonists or had unacceptable side effects (n=741). The UNITI-2 trial included patients in whom conventional therapy failed or unacceptable side effects occurred (n=628). 68.6% of UNITI-2 STELARA patients (n=209) were TNF inhibitor-naïve. The primary endpoint was a clinical response at week 6 (a decrease from baseline in CDAI score of ≥100 points or a CDAI score <150).1†Reduction in CDAI score from baseline of ≥100 points or CDAI <150 points

 

Staying The Course With Stelara: A Majority Of Im-Uniti Patients Were In Clinical Remission At 52 Weeks1

Stelara Chart Dose

Study design: 
397 patients who had a response to STELARA 6 mg/kg IV at week 8 of the UNITI induction trials were randomly assigned to receive subcutaneous maintenance injections of STELARA 90 mg – either every 8 weeks (n=132) or every 12 weeks (n=132) – or placebo (n=133). The primary endpoint for the maintenance trial was remission at week 44 (CDAI score <150). Stable doses of immunosuppressants, mesalamine, antibiotics, or oral glucocorticoids (≤40 mg/day prednisone or ≤9 mg/day budesonide) or a combination of both were permitted from baseline through to week 44 of maintenance therapy.1

 

#In UNITI-2, 68.6% of STELARA patients (n=209) were TNF inhibitor-naïve. The remaining population was previously exposed to, but did not fail, treatment with TNF inhibitors. All patients in the study had failed conventional treatment (eg azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).1

 

 

 

Long-Term Safety Profile: Stelara Maintenance Therapy Is Generally Well-Tolerated Through To Week 441

 

Study design:
397 patients who had a response to STELARA 6 mg/kg IV at week 8 of the UNITI induction trials were randomly assigned to receive subcutaneous maintenance injections of STELARA 90 mg – either every 8 weeks (n=132) or every 12 weeks (n=132) – or placebo (n=133). The primary endpoint for the maintenance trial was remission at week 44 (CDAI score <150). Stable doses of immunosuppressants, mesalamine, antibiotics, or oral glucocorticoids (≤40 mg/day prednisone or ≤9 mg/day budesonide) or a combination of both were permitted from baseline through to week 44 of maintenance therapy.1 

 

 

AE, adverse event; CDAI, Crohn’s Disease Activity Index; IL, interleukin; IV, intravenous; q8w, every 8 weeks; subQ, subcutaneous; TNF, tumour necrosis factor. #In UNITI-2, 68.6% of STELARA patients (n=209) were TNF inhibitor-naïve. The remaining population was previously exposed to, but did not fail, treatment with TNF inhibitors. All patients in the study had failed conventional treatment (eg azathioprine, 6-mercaptopurine, methotrexate, or corticosteroids).1

References: 1. Feagan B et al. N Engl J Med 2016; 375: 1946–1960. 2. Papp K et al. J Drugs Dermatol 2015; 14: 706–714. 3. STELARA approved Product Information (27 February 2017). 4. Feagan B et al. N Engl J Med 2016; 375: 1946–1960 (Suppl appendix). 5. Leonardi C et al. Lancet 2008; 371: 1665–1674. 6. Papp K et al. Lancet 2008; 371: 1675–1684. 7.Kavanaugh A et al. Arth Care & Res 2015; 67: 1739 –1749. 8. Ritchlin C et al. Ann Rheum Dis 2014; 73: 990–999.  

 

 

 PBS Information: This product is not listed on the PBS for Crohn’s disease. 
Before prescribing, please review full Product Information.
Further information is available from Janssen-Cilag