Dr Miner and colleagues compared the effects of alicaforsen enema to standard of care mesalazine enema in active left-sided ulcerative colitis.
The investigative team conducted a randomized, double-blind, active-controlled multicenter clinical trial.
The team randomized 55 subjects to a nightly enema of 120 mg alicaforsen, 50 subjects to 240 mg alicaforsen, and a further 54 to 4 g mesalazine for 6 weeks.
The subjects were followed by a 24-week monitoring period.
The primary end point was Disease Activity Index at week 6.
The team's secondary endpoints included clinical improvement, remission and relapse.
|Complete mucosal healing occurred in 24% with alicaforsen vs 17% in the mesalazine group|
|Alimentary Pharmacology & Therapeutics|
The investigators observed no significant difference between treatment arms in the primary end point.
However, the median duration of response to alicaforsen enema treatment was 2 to 3-fold longer in comparison with mesalazine.
The investigators found that complete mucosal healing occurred in 24% of the 240 mg alicaforsen group, when compared with 17% in the mesalazine.
Dr Miner's team concluded, “Alicaforsen enema demonstrated an acute response and safety profile similar to mesalazine enema, but was differentiated by a more durable response.”
“The extended length of remission suggests that alicaforsen enema treatment may have a disease modifying effect.”