Novel oral-targeted therapies for mucosal healing in ulcerative colitis

Table 2 Summary of treatment results with sphingosine-1-phosphate receptor modulators, AJM300, and phospholipids in ulcerative colitis patients

Study	Drug	Study population	Treatment arm	Endoscopy endpoint	Time of observation, wk	Rate of mucosal healing
Sandborn et al[41]	Ozanimod	Moderate to severe UC patients (n = 197)	Dose of 0.5 mg or 1 mg or placebo, once daily	Mcosal healing (endoscopy subscore ≤ 1)	At 8 wk; at 32 wk	Placebo 12%
						Ozanimod 0.5 mg = 28%, (P = 0.03)
						Ozanimod 1 mg = 34%, (P = 0.002)
						At week 8
						Placebo 12%
						Ozanimod 0.5 mg = 32%, (P = 0.006)
						Ozanimod 1 mg = 33%, (P = 0.005)
						At week 32
Yoshimura et al[46]	AJM300	Moderate to severe UC patients (n = 102)	Dose of 960 mg or placebo, 3 times daily	Mucosal healing, (endoscopic subscore of 0 or 1)	At 8 wk	Placebo 29.4%
						AJM300 960 mg = 58.8% (P = 0.0014)
Stremmel et al[50]	Phosphatidylcholine-rich phospholipids	Chronic active, ulcerative colitis, with a clinical activity index (CAI) of > 4 (n = 60)	Dose of PC rich phospholipids (1.5 g /dose) or placebo, four times daily	Mucosal healing, was not formally assessed 48 patients were examined using the standard endoscopic activity index (EAI); Secondary end point analysis DEAI (> 50%)	At three mo	None of 29 placebo patients DEAI (> 50%) in 11 of 29 evaluated of PC patients P = 0.00016
Karner et al[51]	LT-02	Ulcerative colitis patients with an inadequate response to mesalazine, a disease activity score (Simple Clinical Colitis Activity Index (SCCAI)) of ≥ 5, and bloody diarrhea (n = 156)	Dose of LT-2 (0.8, 1.6 or 3.2 g) or placebo	Mucosal healing (endoscopic Mayo Score ≤ 1)	At 12 wk	Placebo 40.0%
						LT-2 0.8 g = 57.5%, (P = 0.097)
						LT-2 1.6 g = 56.1%, (P = 0.097)
						LT-2 3.2 g = 51.4%, (P = 0.097)
						Pooled LT-02 groups 55.2 (P = 0.098)

UC: Ulcerative colitis; OCTAVE: Oral Clinical Trials for tofAcitinib in ulceratiVE colitis.