Shire announces Lialda trial results

At the annual meeting of Digestive Disease Week, Shire presented positive post-hoc analyses of phase III clinical results of the company’s ulcerative colitis (UC) treatment Lialda (mesalamine).

Lialda is an orally-administered once-daily aminosalicylate – a drug containing 5-aminosalicyclic acid – and is indicated for the induction of remission in patients with UC.

The post-hoc analyses showed that of the 171 patients treated with Lialda, 67.8 remained in remission, while 88.7 per cent of those patients still being relapse-free after 12 months.

In this study, relapse was defined as the patient being forced to leave the trial in order to seek a different therapy for their condition.

Asher Kornbluth, associate clinical professor of medicine at the Mount Sinai Medical Centre, said: “Earlier studies showed that Lialda is effective at inducing remission in patients with active, mild to moderate UC.”

He added that the company was encouraged by the results of this secondary analysis, noting that two thirds of patients in the maintenance phase of the trial remained in remission with almost 90 per cent not relapsing.

Shire announced the availability of Lialda in March 2007, with the firm reporting that patient compliance may be improved with the drug’s “convenient” once-daily dosing regimen.