Shire reports results of Lialda and 5-ASA persistency analyses

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)

Results of a patient experience survey showed that patients reported that their adherence to Lialda was 88 percent. Of the 319 patients initiating Lialda therapy who were invited to participate in the survey, 110 patients completed the baseline and 60-day surveys. Patient self-assessment revealed that both symptom severity and interference with daily activities were reduced following treatment with Lialda.

Patients were surveyed using a secure Web site or automated telephone system, where they completed a questionnaire on perceived symptom severity, self-assessed disruption to daily activities, prior UC medication and treatment satisfaction, at baseline and at approximately 30 and 60 days post-baseline. Patients were also questioned about their understanding of UC and management of the disease.

The Impact of Oral 5-ASA Adherence on All-Cause Health Care Costs among Ulcerative Colitis Patients

Poster Presentation: October 27, 2009, San Diego Convention Center (#1105)

Results of a database analysis showed that adherence with 5-ASAs for UC patients reduces total all-cause health care utilization and associated costs. Adherent patients had significantly lower mean all-cause total costs compared to non-adherent patients ($11,331 vs. $15,177, P<.05). Although mean pharmacy costs for adherent patients were almost twice as much as those of non-adherent patients ($4,450 vs. $2,794, P<.05), costs were offset by significant reductions in all other costs sectors. Adherent patients had fewer inpatient hospitalizations on average (0.32 vs. 0.46, P<.05), shorter length of stay (8.4 vs. 12.1 days, P<.05), and significantly lower mean inpatient costs ($2,793 vs. $7,019, P<.05). The mean costs associated with Emergency Department visits ($76 vs. $134, P<.05) and other outpatient ancillary services ($3,092 vs. $4,231, P<.05) also were significantly lower.

Insurance claims from the PharMetrics Integrated Outcomes Database were analyzed. Patients who were 18 or older with greater than or equal to 1 claims for a UC diagnosis (ICD-9 556.xx) between June 1997 and August 2005, with greater than or equal to 30 days of oral 5-ASA treatment and greater than or equal to 1 corticosteroid prescription (proxy for active disease) within 12 months following 5-ASA initiation>

Cumulative exposure to oral 5-ASAs over a 12-month period was calculated using the Medication Possession Ratio (MPR), defined as total 5-ASA days supplied during the period divided by 365 days. Patients with an MPR of at least 0.80 were classified as adherent. All-cause resource utilization and costs were computed over the 12-month follow-up period and compared between adherent and non-adherent patients.