Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, presented the results of three 5-aminosalicylic acid (5-ASA) persistency analyses at ACG 2009 Annual Scientific Meeting, evaluating persistency of Lialda® (mesalamine), Asacol® (mesalamine), Pentasa® (mesalamine) (250mg and 500mg), balsalazide [combined results from generic balsalazide disodium and Colazal® (balsalazide disodium)], and Dipentum® (olsalazine sodium) (500mg). Additionally, on October 27, 2009, Shire will present results of a Lialda patient experience survey as well as the results of a study that evaluated the impact of oral 5-ASAs on all-cause health care utilization and costs among ulcerative colitis (UC) patients with active disease.
"Persistency plays a significant role in the management of UC, and this data shows us just how challenging adherence can be for UC patients," said Roger Adsett, senior vice president of Shire's GI business unit. "The results of the Lialda and 5-ASA persistency analyses will provide insights as to how UC patients manage their mesalamine prescription refills."
Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.
Factors Affecting Persistence with Mesalamine Therapy: Results from a Large Pharmacy Database
Poster Presentation: October 25, 2009, San Diego Convention Center (#293)
Results of a long-term persistency analysis showed that after 18 months of treatment, 13 percent of Lialda patients>
The database analysis evaluated the persistency of UC patients who filled a prescription for the aforementioned 5-ASAs between March and September 2007. Persistency is defined as the proportion of patients who remained on their prescribed therapy over an extended period of time. Continuing patients were defined as those who refilled their prescription within a period of up to twice the duration of the prescription that preceded the refill. This database analysis was neither designed nor intended to compare the safety and efficacy of the 5-ASA products and no such conclusions can be drawn from its results.
Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.
Persistence with Mesalamine Therapy: Long-term Results in Patients Persistent with Therapy at Outset
Poster Presentation: October 25, 2009, San Diego Convention Center (#290)
Results of a long-term persistency analysis showed that among continuing and restart patients who were persistent (continuing) after three months of therapy, the persistency rates at 12 and 18 months were as follows: Lialda patients>
Persistent (continuing) patients were defined as those who refilled their prescription within a period of up to twice the duration of the prescription that preceded the refill. Restart patients were defined as those who refilled their prescription after the grace period of twice the duration of their prescription had elapsed. Refill records for patients who were considered persistent (continuing) over the initial 3 months of treatment were analyzed at 12 and 18 months. This database analysis was neither designed nor intended to compare the safety and efficacy of the 5-ASA products and no such conclusions can be drawn from its results.
Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.
Continuing Persistence with Mesalamine Therapy: Results from Patients Persistent with Long-term Therapy
Poster Presentation: October 25, 2009, San Diego Convention Center (#292)
A long-term persistency analysis evaluated patients who were persistent (continuing) at month 12 and followed them for an additional six months. At month 18, results showed 66 percent were persistent (continuing) with Lialda>
Persistent (continuing) patients were defined as those who refilled their prescription within a period of up to twice the duration of the prescription that preceded the refill. In total, 4,776 patients were identified as being persistent (continuing) with mesalamine therapy over 12 months and were included in this analysis. This database analysis was neither designed nor intended to compare the safety and efficacy of the 5-ASA products and no such conclusions can be drawn from its results.
Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate UC. The safety and effectiveness of Lialda beyond eight weeks have not been established.
Preliminary Outcomes from a Patient Experience Program on Ulcerative Colitis Treatment with Lialda® (mesalamine)
Poster Presentation: October 27, 2009, San Diego Convention Center (#1123)