Exploratory Examination of Real-World Treatment Patterns of Mesalamine Products in Patients With Ulcerative Colitis 631

• Published in: The American journal of gastroenterology Vol. 113; no. Supplement; p. S359
• Main Authors: Paudel, Misti, Tong, Junliang, Hass, Steven, Nag, Arpita, Halpern, Rachel
• Format: Journal Article
• Language: English
• Published: New York Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.10.2018
• Subjects: Comorbidity; Gastroenterology; Inflammatory bowel disease
• ISSN: 0002-9270; 1572-0241
• DOI: 10.14309/00000434-201810001-00631

Introduction: Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) primarily affecting the rectum and colon. This analysis evaluated real-world treatment patterns of mesalamine products in patients with UC. Methods: This retrospective study of claims data from a large US health insurer included patients aged 18-63 y with UC. Medical and pharmacy claims (Jan 2011-Apr 2015) for 5-aminosalicylates (5-ASAs), corticosteroids (CS), immunosuppressants (IM), or biologics (BI) were used to identify unique treatment regimens. Index date was the date of first treatment regimen. Patients had 12 months of pre-index and post-index continuous plan enrollment, and no 12-month pre-index Crohn's disease diagnosis or colectomy/colostomy procedures. Analyses included descriptive means and counts. Results: 7,535 patients were identified and underwent <15 different regimen changes during the 12-month follow up. The most commonly observed first-regimen therapies at index were: monotherapy with oral 5-ASA (35.9%), CS (26.6%) or rectal 5-ASA (12.4%); and oral 5-ASA combined with CS (10.2%). The most prevalent oral mesalamines at index were: Shire multimatrix mesalamine (SMM) 2.4g (9.9%) and SMM 4.8g (10.2%); Allergan delayed-release tablets (ADRT) 2.4g (4.8%); and Valeant extended-release capsules (VERC) 1.5g (6.1%). Among mesalamine users, monotherapy use at index was: SMM 2.4g (67%); SMM 4.8g (58%); ADRT 2.4g (68%); and VERC 1.5g (58%). Among all oral mesalamine users at index, Pentasa 4,000 mg users had the highest mean Charlson comorbidity score (0.89; all others <0.42) and age (48.9 y; all others <45.5 y). Progression to BI or IM therapy was infrequent for patients using oral mesalamines at index. Progression to BI was: SMM 2.4g (5.9%); SMM 4.8g (10.0%); ADRT 2.4g (2.2%); and VERC 1.5g (8.3%). Progression to IM was: SMM 2.4g (9.8%); SMM 4.8g (13.6%); ADRT 2.4g (7.0%); and VERC 1.5g (12.6%). Conclusion: In real-world settings, changes in UC regimens are common; the most frequently used are oral 5-ASA, CS or rectal 5-ASA monotherapy, and oral 5-ASA with CS. The most common oral mesalamines were SMM 4.8g, SMM 2.4g, VERC 1.5g, and ADRT 2.4g; 60-70% of patients were monotherapy users. Differences in age and comorbidity burden were observed across mesalamine therapies, and progression to BI or IM in the following year was infrequent across all oral mesalamine doses. Future research should evaluate comparative effectiveness of second line therapies for the delayed progression to BI.