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"This published data demonstrates that Lialda is generally well toleratedand has a strong safety profile," said Gary R. Lichtenstein, MD, co-author ofstudy 303 and director of the Center for Inflammatory Bowel Diseases at theHospital of the University of Pennsylvania. "Not only does this datademonstrate Lialda's safety and tolerability, but secondary endpoints from themaintenance phase of the 303 study show that a majority of patients on Lialdacontinued to remain in remission through 12 months."
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Specifically, the primary endpoints of the Phase III, open-label, 12-monthextension study were to evaluate the safety and tolerability of Lialda dosedonce (2.4g/day) or twice daily (1.2g twice daily) over 12 months, includingadverse events (AEs), treatment exposure, and time to withdrawal. AEs referto any untoward medical occurrence that happens in a clinical trial patient.AEs can be "treatment-related" (TRAEs) and occur as a result of the study drugor they can be considered unrelated to the study drug. In study 303, all AEswere classified in one of three categories according to severity: mild,moderate, or severe.
Results of the study showed Lialda demonstrated a good safety profile,with 37.9 percent of patients (safety population n=459) experiencing AEs, themajority of which were mild or moderate in intensity. Treatment-related AEswere experienced by a total of 10.2 percent of patients [11.1 percent ofpatients (n=225) in the once-daily group and 9.4 percent of patients (n=234)in the twice-daily group]. A total of 3.9 percent of patients experiencedserious AEs [4 percent of patients (n=225) in the once-daily group and3.8 percent of patients (n=234) in the twice-daily group], most of which weregastrointestinal disorders, and only one serious AE was considered to berelated to study treatment.
The secondary endpoints of the study evaluated maintenance of remissionand relapse rates over 12 months. In the efficacy population at entry(month 0), 78.1 percent of patients (n=219) in the once-daily group and82.3 percent of patients (n=232) in the twice-daily group were in clinical andendoscopic remission. At month 12, 64.4 percent of patients in the once-dailyand 68.5 percent of patients in the twice-daily group were in strictly definedclinical and endoscopic remission (P=0.351). Thus, there was no significantdifference between the once-daily and twice-daily groups with respect tostrictly defined clinical and endoscopic remission at month 12. Further,88.9 percent and 93.2 percent of patients in each group, respectively, hadmaintained clinical remission and were considered "relapse-free".
Study Background
A total of 459 patients were enrolled and randomized in the 303 long-termsafety study (246 directly from the parent studies 301 and 302 -- Lialda'seight-week, Phase III, placebo-controlled trials that demonstrated efficacyfor the induction of remission in active, mild to moderate UC -- and 213patients who received an additional 8 weeks of treatment with Lialda 4.8 g/dayto induce remission). Remission was defined using stringent clinical andendoscopic measures: modified UC Disease Activity Index (UC-DAI) score of .1,with scores of 0 for rectal bleeding and stool frequency, and a combinedPhysician's Global Assessment and sigmoidoscopy score of
