63% of surveyed gastroenterologists in the USA say they are prescribing Abbott/Eisai’s blockbuster arthritis treatment Humira (adalimumab) off-label for the treatment of ulcerative colitis, according to a new report.



The surveyed gastroenterologists add that they most often prescribe Humira for the disease in patients who have experienced loss of response, intolerance or no response to Centocor Ortho Biotech’s Remicade (infliximab), says the study, which is published by Decision Resources.

Analysis of patient-level claims data reveals that Humira is also being prescribed in a minority of instances as a first- or second-line ulcerative colitis therapy, and estimates by the surveyed gastroenterologists of their use of the top-selling anti-inflammatory by line of therapy reinforce the early-line use of Humira which is observed in these patient-level claims, as the clinicians estimate that more than one-third of their Humira prescriptions in ulcerative colitis are in the first or second line, the study adds.

Moreover, it reports that Warner Chilcott’s Asacol (mesalamine) and Shire’s Lialda (mesazalamine) are the leading oral aminosalicylate drugs being used to treat US patients who are newly-diagnosed with ulcerative colitis. Oral aminosalicylates account for over half of first-line therapy patient share in these patients, with Asacol making up 60% of the prescriptions for this class in first-line therapy. Lialda is second to Asacol in first- and second-line patient share in newly-diagnosed patients, maintaining half of Asacol’s patient share in the second line.__

“Surveyed gastroenterologists have a more favorable view of Lialda’s efficacy in inducing remission, targeted delivery and dosing frequency compared with Asacol; however, they are more familiar with Asacol given its much earlier entry to the market,” comments Madhuri Borde, therapeutic area director at Decision Resources.

Asacol was launched in the USA back in 1992, while Lialda has been available there since March 2007.

“Lialda and Salix Pharmaceuticals’ Apriso (mesalamine - which launched in 2009) will likely see greater momentum in stealing share from Asacol as gastroenterologists become convinced of their efficacy in maintaining and inducing remission, as an agent’s dosing frequency or lower tablet burden is less important to surveyed gastroenterologists than these key attributes,” Dr Borde forecasts.

- In July, Abbott reported that total sales of Humira, which is approved for rheumatoid arthritis, Crohn’s disease and psoriasis, rose 2.15% in second-quarter 2010 to reach $1.59 billion. And a recent study by EvaluatePharma forecasts that by 2016 it will be the world’s top-selling drug, with sales growing 9% a year to total $10.1 billion in that year.