eek 44. In the placebo arm, 27/61 (44%) patients were in clinical remission at Week 0 while 16/61 (26%) of these patients were in remission at Week 44.
At Week 0 of Study CD-3, 46/72 (64%) STELARA® treated patients who had previously failed immunomodulator therapy or corticosteroids (but not TNF blockers) were in clinical remission and 45/72 (63%) of these patients were in clinical remission at Week 44. In the placebo arm, 50/70 (71%) of these patients were in clinical remission at Week 0 while 31/70 (44%) were in remission at Week 44. In the subset of these patients who were also naïve to TNF blockers, 34/52 (65%) of STELARA® treated patients were in clinical remission at Week 44 as compared to 25/51 (49%) in the placebo arm.
Patients who were not in clinical response 8 weeks after STELARA® induction were not included in the primary efficacy analyses for Study CD-3; however, these patients were eligible to receive a 90 mg subcutaneous injection of STELARA® upon entry into Study CD-3. Of these patients, 102/219 (47%) achieved clinical response eight weeks later and were followed for the duration of the study.
15 REFERENCES
1
Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 6.6.2 Regs Research Data, Nov 2009 Sub (1973–2007) - Linked To County Attributes - Total U.S., 1969–2007 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2010, based on the November 2009 submission.
16 HOW SUPPLIED/STORAGE AND HANDLING
STELARA® (ustekinumab) Injection is a sterile, preservative-free, colorless to slightly yellow solution. STELARA® is available in single-dose prefilled syringes containing 45 mg or 90 mg or single-dose vials containing 45 mg of ustekinumab for subcutaneous use. Each prefilled syringe is equipped with a 27 gauge fixed ½ inch needle, a needle safety guard, and a needle cover that contains dry natural rubber.
STELARA® is also available in single-dose vials containing 130 mg ustekinumab for intravenous use.
Subcutaneous Use NDC
45 mg/0.5 mL single-dose prefilled syringe 57894-060-03
90 mg/mL single-dose prefilled syringe 57894-061-03
45 mg/0.5 mL single-dose vial 57894-060-02
Intravenous Infusion NDC
130 mg/26 mL (5 mg/mL) single-dose vial 57894-054-27
Storage and Stability
STELARA® vials and prefilled syringes must be refrigerated at 2°C to 8°C (36°F to 46°F). Store STELARA® vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)
Infections
Inform patients that STELARA® may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see WARNINGS AND PRECAUTIONS (5.1)].
Malignancies
Inform patients of the risk of developing malignancies while receiving STELARA® [see WARNINGS AND PRECAUTIONS (5.4)].
Hypersensitivity Reactions
Advise patients to seek immediate medical attention if they experience any signs or symptoms of serious hypersensitivity reactions and discontinue STELARA® [see WARNINGS AND PREC |
