Update on the management of ulcerative colitis: treatment and maintenance approaches focused on MMX^® mesalamine

Figures & data

Table 1 Mean (±SD) pK parameters for mesalamine following single dose and steady state administration of MMX mesalamine under fasting or postprandial status

Dosage	N	Cmax (ng/mL)	Median Tmax (hours)	AUC0–∞ (ng h mL)	t½ (hours)
2.4 g^Citation40,a	48	1595 (±1484)	12 (4–31)	21,084 (±13185)	7.05 (±5.54)
4.8 g^Citation40,a	48	2154 (±1140)	12 (4–34)	44775 (±30,302)	7.25 (±8.32)
2.4 g^Citation42,b	37	1553c (857–2812)		13,556c (7616–24,128)	10.2c (5.8–19.9)

Notes:

a single dose administration (fasting);

b steady state administration (postprandial);

c square geometric means (95% confidence intervals).

Abbreviations: SD, standard deviation; AUC, area under the plasma concentrationtime curve; C_max, maximum plasma concentration; t_½, elimination half-life; T_max, time to C_max.

Table 2 Clinical efficacy of MMX mesalamine (MES) in induction (8 weeks) of remission in patients with mild to moderate ulcerative colitis

Study	N	Doses	Clinical and endoscopic remission (%) (OR, 95% CI)	Failure rates (%)
Kamm et al^Citation39	84	MMX mesalamine 2.4 g daily	40.5** (2.40; 1.23–4.69)	21.4***
	85	MMX mesalamine 4.8 g daily	41.2** (2.47; 1.15–5.30)	20.0***
	86	Asacola 800 mg three times daily	32.6 (1.70; 0.86–3.36)	27.9**
	86	Placebo	22.1	47.7
Lichtenstein et al^Citation56	88	MMX mesalamine 1.2 g twice daily	34.1*** (3.48; 1.44–8.41)	28.4***
	85	MES 4.8 g daily	29.2** (2.78; 1.27–6.06)	24.7***
	89	Placebo	12.9	54.1
Kamm et al^Citation58,b	197	MMX mesalamine 2.4 g twice daily (No response to MMX mesalamine previously)	59.5	_
	107	MMX mesalamine 2.4 g twice daily (Placebo previously)	57	_

Notes:

* P < 0.05;

** P < 0.01;

*** P < 0.001 vs placebo.

a Included as an internal reference arm; no comparative statistical analyses with the mesalamine treatment arms were reported;

b patients who did not achieve the primary endpoint of clinical and endoscopic remission in the 8-week Phase III trials^35,51 were eligible for enrolment in the noncomparative extension study (4.8 g MMX mesalamine for 8 weeks).⁵⁴

Abbreviation: OR, odds ratio.

Table 3 Clinical efficacy of MMX mesalamine in maintenance of remission (12 months) in patients with mild to moderate ulcerative colitis

Study	N	Doses	Clinical and endoscopic remission (%)	Relapse rates at 12 months (%)
Kamm et al^Citation59	232	MMX mesalamine 1.2 g twice daily	68.5	6.8
	219	MMX mesalamine 2.4 g twice daily	64.4	11.1
Prantera et al^Citation25	162	MMX mesalamine 2.4 g once daily	60.9a	15.0
	156	Asacol 2.4 g once daily	61.7a	29.9
Kane et al^Citation26	167	MMX mesalamine 2.4 g once daily	_	35.6a

Note:

a Primary endpoint.

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