For adults with moderate to severe ulcerative colitis
aZEPOSIA has been studied across multiple indications in 4 clinical trials, including TRUE NORTH (Ph 3); TOUCHSTONE (Ph 2); and SUNBEAM (Ph 3) and RADIANCE (Ph 3). 496 patients receiving the 0.92-mg dose of ZEPOSIA during induction in TRUE NORTH or TOUCHSTONE and 882 patients receiving the 0.92-mg dose of ZEPOSIA in SUNBEAM or RADIANCE were assessed in the safety analysis.1
*MS: Includes Phase 1, Phase 2, SUNBEAM, RADIANCE, and DAYBREAK (data cutoff: February 2, 2021). UC: Includes TOUCHSTONE, TRUE NORTH, TRUE NORTH OLE (data cutoff: September 30, 2020). Post-marketing Setting: data cutoff November 19, 2021. Exposure for patients with MS in clinical trials is 2631 patients and 11,938 patient-years. Exposure for patients with UC in clinical trials is 1158 patients and 2108 patient-years. Exposure for patients in the post-marketing setting across indications is 9738 patients and 6455 patient-years2-4
UC Study 3 (8-week induction): TOUCHSTONE is a Phase 2, multi-center, randomized, double-blind, placebo controlled parallel-group study to evaluate the clinical efficacy and safety of induction therapy with RPC1063 in 199 patients with moderately to severely active ulcerative colitis. Participants who completed the induction period and were responders at Week 8, continued to receive the same dose of ozanimod during the maintenance period up to Week 32.
For full study design of UC Study 1 and Study 2, click here.
gIncludes the following terms: gamma-glutamyl transferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, hyperbilirubinemia, blood bilirubin increased, liver function test increased, blood alkaline phosphatase increased.1
MS=multiple sclerosis; OLE=open-label extension; UC=ulcerative colitis.
ALT=alanine aminotransferase; LFT=liver function test; ULN=upper limit of normal.
In controlled clinical trials with ZEPOSIA, mean lymphocyte counts decreased to approximately 45% of baseline at 3 months (approximate mean blood lymphocyte counts 0.8 x 109/L), and low lymphocyte counts were maintained during treatment with ZEPOSIA.1
†Patients may be included in both placebo and ZEPOSIA treatment groups. The total count in the placebo group includes 227 patients who were treated with ZEPOSIA in the induction period and were re-randomized to placebo in the maintenance period of TRUE NORTH.6
ALC=absolute lymphocyte count.
UC Study 1—Induction: 6.5% for ZEPOSIA | 11.1% for Placebo
UC Study 2—Maintenance: 20.0% for ZEPOSIA | 45.4% for Placebo
vs 3.2%for placebo
vs 2.6%for placebo
One case of macular edema was reported during the maintenance phase in 1 person with preexisting risk factors at baseline; it resolved after discontinuation of treatment1,7
Overall, the discontinuation rate because of elevations in hepatic enzymes was 0.4% in patients treated with ZEPOSIA 0.92 mg and none in patients who received placebo in the controlled UC studies1
TEAEs=treatment-emergent adverse events.
IR=incidence rate; PT=preferred term; PY=patient years; S1P=sphingosine 1-phosphate; SOC=system organ class.
This safety analysis includes patients (N=823) with UC from the TRUE NORTH parent study who entered the TRUE NORTH OLE
Data cutoff: September 30, 2020.
EAIR=exposure-adjusted incidence rate; NR=not reported; SAE=serious adverse event; TEAE=treatment-emergent adverse event; UC=ulcerative colitis; ULN=upper limit of normal.
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