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LT-02 safely, effectively treated mesalazine-refractory UC patients
Researchers found modified release phosphatidylcholine LT-02 to be “very safe” and significantly more effective in improving disease activity in ulcerative colitis patients compared with placebo in a recent multicenter trial.
In a double blind, placebo-controlled superiority study, 156 patients with mesalazine-refractory ulcerative colitis (UC) were treated at 24 ambulatory centers in Germany, Lithuania and Romania. Patients were randomly assigned LT-02 (phosphatidylcholine, Lipid Therapeutics) at 0.8 g (n=40), 1.6 g (n=41) or 3.2 g LT-02 (n=35), and were compared with placebo (n=40). All patients maintained steroid therapy during the 1-year study.
Disease activity was assessed using the Simple Clinical Colitis Activity Index (SCCAI), which measured stool frequency, defecation urgency, blood in stool, well-being, abdominal pain and extraintestinal manifestations. Remission was gauged using SCCAI and Histologic Riley Index (HI), and mucosal healing was assessed using the endoscopic Mayo Score.
Greater absolute reductions in SCCAI scores were observed in all LT-02 groups compared with placebo. Only the 3.2-g group, however, attained statistical significance, falling by 51.7% compared with 33% in the placebo group (P=.03). Remission rate in the highest dose group was 31.4% compared with 15% under placebo (P=.09). Mucosal healing rate was 47.4% collectively in all LT-02 groups compared with 32.5% in placebo patients (P=.098), and HI scores were 35.3% in the LT-02 groups vs. 20% (P=.016). The LT-02 groups’ symptoms resolved an estimated 2 weeks sooner than those assigned placebo, and nearly twice as often (P=.02). In 8-week follow-ups without medication, LT-02 patients avoided relapse over a longer period and in higher numbers (P=.02).
The data also indicated an excellent safety profile; treatment-emergent adverse events occurred equally among placebo (55%) and highest-dose LT-02 groups (48.6%).
“There is a pressing need for treatment alternatives in refractory UC,” the researchers concluded. “Although the improvement of the disease activity in the lower doses was not statistically significant compared with placebo, the highest dose was effective and intended for the planned pivotal studies.
“Our findings could possibly further the treatment and understanding of ulcerative colitis.”
Disclosure: See the study for a full list of relevant financial disclosures.