Shares in US drug major Abbott Laboratories were given a boost on news that Humira (adalimumab) hit its primary target in a late-stage trial assessing its efficacy in patients with ulcerative colitis.
Data from the study, presented at the Digestive Disease Week conference in Chicago, showed that Humira met its goal of inducing clinical remission in significantly more patients with moderate-to-severe forms of the disease than placebo.
In the trial 494 adults with ulcerative colitis who had failed to respond to standard therapy were randomised to receive either Humira or a dummy drug. Of those taking Abbott’s drug,16.5% achieved clinical remission after eight weeks’ therapy versus 9.3% of the control group, while the figures were 17.3% and 8.5%, respectively, after 52 weeks.
The results are important as people with ulcerative colitis – of which there are around 700,000 in the US – have limited options for managing their illness.
“Unmanaged disease lends itself to painful symptom flares that can negatively impact patients, so the potential for new treatments is important for people managing this condition,” said lead study investigator William Sandborn, division chief of Gastroenterology at the University of California, stressing that there is still very much an unmet need in this area.
Humira is a TNF blocker approved for use in reducing the signs and symptoms of rheumatoid arthritis and Crohn’s disease, but the drug has not yet been given a regulatory green light for ulcerative colitis.
Abbott has, however, recently filed applications for approval in moderate-to-severe forms of the disease with both the US Food and Drug Administration and the European Medicines Agency, and will no doubt be hoping that this latest batch of clinical evidence will help persuade regulators of the drug’s use in this setting.
