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| |  Adalimumab Effective, Well Tolerated in Infliximab Refractory or Intolerant Ulcerative Colitis: Presented at GASTRO 2009 (UEGW/WCOG) By Sara Freeman LONDON -- December 1, 2009 -- Patients with ulcerative colitis who are refractory or intolerant to infliximab (IFX) and standard immunomodulatory therapies could be given adalimumab as an alternative anti-tumour necrosis factor (TNF) therapy, data from a multicentre, an observational study suggests. A clinical response can be achieved in 67% of patients and clinical remission in 26% after 12 weeks of treatment with adalimumab, Carlos Taxonera, IBD Unit Gastroenterology, Hospital Clínico, Madrid, Spain, reported here on November 25 at GASTRO 2009. Importantly, the need for surgical resection of the bowel was avoided in 78% of patients. “In patients with ulcerative colitis refractory to standard treatment and with prior primary nonresponse, loss of response, or intolerance to infliximab, adalimumab was well tolerated and effective,” Dr. Taxonera said. Although proven effective in the induction and maintenance of remission in Crohn’s disease, adalimumab is not yet approved by the FDA for use in the management of patients with ulcerative colitis. Dr. Taxonera commented, however, that the anti-TNF agent had been show to induce and maintain remission in moderate to severe ulcerative colitis, and preliminary findings were in support of its use in patients who were nonresponsive or intolerant to IFX. To investigate further, data on a total of 27 patients who had been treated with adalimumab on a compassionate basis were examined. The mean age of patients was 40 years, around half (52%) were male, the majority (70.4%) had extensive disease, and the mean disease duration was 7.6 years. All patients had prior experience of using IFX: 15 (55.6%) exhibited a lack of response over time, 10 (37.0%) became intolerance to the drug, and 2 (7.4%) had failed to show any response to IFX from the outset. Immunomodulatory therapies had been used by 24 (89%) patients, with cyclosporine used in 5 (18.5%) of patients. Except for 1 patient who was given a dosing regimen of 80/40 mg of adalimumab for induction, the majority of patients were given adalimumab 160/80 mg. This was followed by a 40 mg maintenance dose every other week, with 6 patients receiving 40 mg/week. A clinical response to induction therapy was defined as a 3-point decrease in the Partial Mayo Score (PMS) and was observed in 15 (55.6%) patients after 4 weeks and in 18 (66.6%) patients after 12 weeks of adalimumab therapy. The overall (weeks 4 and 12) clinical response rate was 48.1%. Clinical remission (PMS <=1) with maintenance therapy was seen in 4 (14.8%) patients at 4 weeks and 7 (26.0%) patients at 12 weeks, with an overall clinical remission rate of 14.8%. “The safety profile of adalimumab was consistent with previous experience with the drug,” Dr. Taxonera said. Six (22.2%) patients experienced adverse events (arthralgia, fever, dermatoid ovarian cyst, urticaria, and asthenia) that were probably due to treatment, of which 2 were serious (intractable cough and psoriasis flare) and required the anti-TNF therapy to be stopped. In total, 13 patients stopped treatment with adalimumab over the course of a mean 41 weeks of follow-up, with a mean time to discontinuation of 25.4 weeks. The main reasons for discontinuation were loss of response (n = 7), intolerance (n = 2), and primary nonresponse (n = 4). Dose intensification was required in 10 (37%) patients at a mean of 16.8 weeks. Dr. Taxonera also reported that only 6 (22.2%) patients underwent colectomy during a mean follow-up of 47.7 weeks, with a mean time to resection of 23.2 weeks. GASTRO 2009 is jointly organised by the United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED), and the British Society of Gastroenterology (BSG). [Presentation title: Initial Response and Long-Term Outcome of Adalimumab for Ulcerative Colitis Previously Treated With Infliximab. Abstract OP324]
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