Analysis Of Ulcerative Colitis Remission Rates From Long-Term Safety Study Of Lialda

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Nearly nine out of ten patients taking once-daily LIALDA remained relapse free at the end of 12 months.

Secondary endpoints of study 303 were presented as post-hoc analyses at Digestive Disease Week (DDW).

Approved by the FDA on January 16, 2007, for the induction of remission in patients with active, mild to moderate UC, LIALDA is the first and only oral once-daily mesalamine on the market. Safety and effectiveness have been established for up to eight weeks. LIALDA is being evaluated for longer term use.

A post-hoc analysis of study 303 evaluated maintenance of remission and relapse rates over 12 months. Remission was defined using stringent clinical and endoscopic criteria: modified UC Disease Activity Index (UC-DAI) score of less than or equal to 1, with scores of 0 for rectal bleeding and stool frequency, a combined Physician's Global Assessment and sigmoidoscopy score of less than or equal to 1, with a sigmoidoscopy score reduction of greater than or equal to 1 point from baseline and no mucosal friability. Relapse was defined as withdrawing from the study due to a need for alternative therapy for UC.

Overall, a total of 459 patients entered the maintenance phase of study 303. Of these patients, 362 patients met the stringent remission criteria (clinical and endoscopic as defined above) at baseline (in parent studies 301 and 302 -- LIALDA's eight-week, phase III, placebo-controlled trials that demonstrated efficacy for the induction of remission in active, mild to moderate UC) and received LIALDA once daily (2.4g/day; n=171) or twice daily (2.4g/day; n=191) for 12 months as part of study 303.

The analysis found that 67.8 percent of the 171 patients on once-daily LIALDA remained in remission and 88.7 percent of these patients remained relapse free at the end of 12 months.

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"Earlier studies showed that LIALDA is effective at inducing remission in patients with active, mild to moderate UC. We were encouraged when we did this secondary analysis and found that more than two-thirds of patients in the maintenance phase of study 303 remained in remission and nearly 90 percent of patients did not relapse," says Asher Kornbluth, M.D., Associate Clinical Professor of Medicine at The Mount Sinai Medical Center.

Another post-hoc analysis of the 303 extension study investigated those patients on a 5-ASA who achieved remission or were deemed to be sufficiently controlled by the physician in study 301 (patients received LIALDA) and study 302 [patients received LIALDA or Asacol(R) (mesalamine)] to determine if they had remained in remission when staying on or changing to LIALDA for 12 months.

A total of 198 patients who received LIALDA or Asacol in the parent studies entered the maintenance phase of study 303 directly. Of these patients, 151 were in clinical and endoscopic remission, while 47 were considered well enough by their physician to receive maintenance treatment.

Study findings show approximately 75 percent (n=148/198) of patients remained in remission on LIALDA after 12 months, regardless of whether they were previously on LIALDA or Asacol: 73.4 percent (58/79) for patients previously on LIALDA once or twice daily (2.4g/day); 74.7 percent (62/83) for patients previously on LIALDA once daily (4.8g/day); and 77.8 percent (28/36) for patients previously on Asacol three times daily (2.4g/day).

Another post-hoc analysis assessed long-term remission and relapse rates (secondary endpoints) of study 303. The analysis evaluated data from patients taking Lialda from all three studies: 301, 302, and 303. Patients in the parent studies (301 and 302) who did not achieve remission after eight weeks on Lialda were eligible for enrollment in the acute phase of study 303. In this acute phase, they were given a higher dose of Lialda (4.8g/day, once daily) for an additional eight weeks to induce remission. In total, 63.6 percent of patients (n=220/346) treated with Lialda for up to 16 weeks achieved remission.

Those patients, who achieved remission either in the parent studies (n=125), or the acute phase of study 303 (n=95), were allowed to enter the 12-month maintenance phase of study 303. Of the 220 patients who were in remission, 218 patients actually entered the maintenance phase.

A combined analysis of both long-term remission rates and relapse rates showed that of the patients who started on Lialda therapy, 56.6 percent achieved remission and remained relapse free for at least one year.

LIALDA is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for UC. LIALDA is indicated for the induction of remission in patients with active, mild to moderate UC. The safety and efficacy of LIALDA have been established for up to eight weeks.

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