Table 1.
Variable | Pre-switch (baseline) | Post-switch (at subsequent review)1 |
Age (yr) (median, range) | 54 (20-79) | |
Male sex (%) | 16 (51.6) | |
Disease duration (yr) (median, range) | 10 (3-48) | |
Montreal Classification, n (%) | ||
Disease extent | ||
Proctitis (E1) | 4 (12.9) | |
Left sided colitis (E2) | 21 (67.7) | |
Extensive colitis (E3) | 6 (19.4) | |
Disease severity | ||
Clinical remission (S0) | 14 (45.2) | 10 (32.2) |
Mild (S1) | 16 (51.6) | 15 (48.4) |
Moderate (S2) | 1 (3.2) | 6 (19.4) |
Severe (S3) | 0 (0.0) | 0 (0.0) |
Endoscopic (Mayo) subscore, n (%) | ||
Mayo 0 | 6 (19.4) | 13 (41.9) |
Mayo 1 | 9 (29.0) | 9 (29.0) |
Mayo 2 | 13 (41.9) | 5 (16.1) |
Mayo 3 | 3 (9.7) | 3 (9.7) |
Endoscopic remission (Mayo 0/1) | 15 (48.4) | 22 (71.0) |
Alternative 5-ASA formulation switched to | ||
MMX mesalazine | 28 (90.3) | |
Time-dependent, ethylcellulose coated2 | 2 (6.5) | |
Sulfasalazine | 1 (3.2) | |
Median balsalazide dose (g, range) | 5.3 (3.0-9.0) | - |
Median equivalent mesalazine dose (g, range)3 | 2.1 (1.1-3.2) | 3.6 (2.0-4.8) |
Concurrent Medical therapy, n (%) | ||
Nil other | 7 (22.6) | |
Topical aminosalicylate | 10 (32.2) | |
Oral corticosteroid | 1 (3.2) | |
Azathioprine/mercaptopurine | 14 (45.2) | |
Methotrexate | 3 (9.7) | |
Anti-TNF biologic | 0 (0.0) | |
Other biologic | 0 (0.0) |
Median 3 mo after baseline–overall cohort data reported here (i.e., either on alternative aminosalicylate or had resumed balsalazide).
Marketed as Mezavant® (Shire Pty Ltd) and Pentasa® (Ferring Pty Ltd) in Australia respectively.
Based on Balsalazide Product Information[7].