Outcomes of a drug shortage requiring switching in patients with ulcerative colitis

Table 1 Characteristics of the patient cohort (n = 31) who were switched from balsalazide (due to shortage) to an alternative aminosalicylate formulation

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)

¹Median 3 mo after baseline–overall cohort data reported here (i.e., either on alternative aminosalicylate or had resumed balsalazide).

²Marketed as Mezavant^® (Shire Pty Ltd) and Pentasa^® (Ferring Pty Ltd) in Australia respectively.

³Based on Balsalazide Product Information[7].

Table 2 Long term cumulative outcomes including rates of treatment escalation, colectomy and mortality in those who continued on alternative aminosalicylate therapy (n = 19) vs those who switched but then returned to balsalazide as soon as supply returned (n = 12), n (%)

Outcome (cumulative)	Post-switch review (baseline), n (%)		As of 3y follow-up1, n (%)		As of 5y follow-up1, n = (%)
	Alternative 5-ASA2	Resumed alsalazide	Alternative 5-ASA2	Resumed balsalazide	Alternative 5-ASA2	Resumed balsalazide
Escalated to immunomodulator	14 (73.7)	5 (41.7)	16 (84.2)	5 (41.7)	16 (84.2)	5 (41.7)
Escalated to biologic	0 (0)	0 (0)	3 (15.8)	0 (0)	6 (31.6)	2 (16.7)
Hospitalised for flare3	0 (0)	0 (0)	3 (15.8)	0 (0)	7 (36.8)a	0 (0)a
Colectomy	0 (0)	0 (0)	1 (5.3)	0 (0)	1 (5.3)	0 (0)
All-cause mortality4	0 (0)	0 (0)	2 (10.5)	0 (0)	2 (10.5)	0 (0)

¹Outcome occurring prior to or at timepoint.

²5-ASA: Aminosalicylae.

³First hospitalization counted for UC flare only.

⁴Both deaths in cohort were unrelated to ulcerative colitis (one due to sarcoma and one acute myocardial infarction).

^aP < 0.05.