MAINTENANCE STUDY
AT 54 WEEKS
PRIMARY ENDPOINT
50% of patients (n=75/151) taking SIMPONI® 100 mg demonstrated sustained clinical response vs 31% of patients (n=48/154) receiving placebo (P<0.001)1,3*†
Half of Patients Receiving SIMPONI® Demonstrate Fast, Sustained Clinical Response1-3
INDUCTION STUDY
AT 6 WEEKS
PRIMARY ENDPOINT
51% of patients (n=129/253) taking SIMPONI® 200 mg/100 mg achieved clinical response vs 30% of patients (n=76/251) receiving placebo (P<0.0001)1,2*
Primary endpoint (induction)
Primary endpoint (Maintenance)
STUDY DESIGN
INDUCTION
Maintenance
The primary endpoint was the percentage of patients in clinical response at Week 6, defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, accompanied by a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 (no blood seen) or 1 (streaks of blood with stool less than half the time).
Primary endpoint (Maintenance)
The primary endpoint was the percentage of patients maintaining clinical response through Week 54.
STUDY DESIGN
The safety and efficacy of SIMPONI® were evaluated in 2 multicenter, randomized, double-blind, placebo-controlled clinical trials in patients ≥18 years of age (Trials UC-1 and UC-2).
INDUCTION
Trial UC-1 was a randomized, dose-finding, double-blind, placebo-controlled, multicenter trial conducted in patients with moderately to severely active UC who had an inadequate response or were intolerant to conventional therapy and was divided into 2 parts. In Part 1 (dose finding), patients were randomized to one of 4 treatment groups: 400 mg SIMPONI® administered subcutaneously (SC) at Week 0 and 200 mg at Week 2 (400/200 mg), 200-mg SIMPONI® SC at Week 0 and 100 mg at Week 2 (200/100 mg), 100-mg SIMPONI® SC at Week 0 and 50 mg at Week 2 (100/50 mg), or placebo SC at Weeks 0 and 2. In Part 2 (dose confirming), efficacy was evaluated in 761 patients who were randomized to receive either 400 mg SIMPONI® SC at Week 0 and 200 mg at Week 2, 200-mg SIMPONI® SC at Week 0 and 100 mg at Week 2, or placebo SC at Weeks 0 and 2.
Maintenance
Trial UC-2 was a randomized-withdrawal maintenance trial that evaluated 456 patients who achieved clinical response with SIMPONI® induction and tolerated SIMPONI® treatment. Patients were randomized to receive SIMPONI® 50 mg, SIMPONI® 100 mg or placebo administered subcutaneously every 4 weeks.
Both induction and maintenance studies permitted concomitant treatment with stable doses of oral 5-aminosalicylates (5-ASA), corticosteroids, and/or immunomodulators. However, corticosteroids were to be tapered at the start of the maintenance study in patients in clinical response at Week 6.
*Patients who had a prohibited change in concomitant UC medication, an ostomy or colectomy, discontinued trial agent due to lack of therapeutic effect, or a dose adjustment (in maintenance study) were considered not to be in clinical response, or in clinical remission, or have an improvement in endoscopic appearance of the mucosa from the time of the event onward.1
†Among Week 6 responders.1
For adults with moderately to severely active UC
SIMPONI® requires nearly half the injections compared with Humira® (per first year of treatment)1,4*†
*The recommended SIMPONI® induction dosage regimen is a 200-mg subcutaneous injection at Week 0, followed by 100 mg at Week 2, and then maintenance therapy with 100 mg every 4 weeks.The total number of injections (including both induction and maintenance) during the first year of treatment is 15 injections.1
†Humira® is indicated for the treatment of adults with moderately to severely active UC. Induction regimen for adults with UC is 160 mg on Day 1 (given in one day or split over two consecutive days), followed by 80 mg at Day 15, and then 40 mg at Day 29 and every other week thereafter. The total number of injections (including both induction and maintenance) during the first year of treatment is 28 injections.4
A single 100-mg injection administered subcutaneously every 4 weeks after 3 initial induction injections at Week 0 and Week 21
Explore how the SIMPONI® dosing compares with its competitor.
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The American Gastroenterological Association (AGA) Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis (UC), published in 2024, includes golimumab as a treatment option for adults with moderately to severely active UC. For additional details, click on the link below:
Learn More
Reference: Singh S, Loftus EV Jr, Limketkai BN, et al. AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2024;167(7):1307-1343. doi:10.1053/
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for adult patients with moderately to severely active ulcerative colitis
Once a decision has been made to prescribe SIMPONI®
J&J withMe Is Your Single Source For Access, Affordability, and Treatment Support for Your Patients
J&J withMe helps verify insurance coverage for your patients, provides reimbursement information, helps find cost support options for eligible patients, and provides ongoing support to help patients start and stay on SIMPONI®. Learn more
Affordability Support for Patients Using Commercial or Private Insurance
The J&J withMe Savings Program can help eligible patients save on their out-of-pocket medicine costs for SIMPONI®.
The patient support and resources provided by J&J withMe are not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, provide case management services, or serve as a reason to prescribe SIMPONI®.