Granulocyte/monocyte apheresis effective in refractory ulcerative colitis

Last Updated: 2016-02-12

By Will Boggs MD

NEW YORK (Reuters Health) - Granulocyte/monocyte apheresis (GMA) using the Adacolumn provides steroid-free remission in some patients with steroid-dependent ulcerative colitis (UC) refractory to other treatments, according to interim results from the ART trial.

The efficacy of GMA has been demonstrated in several earlier studies, and registry data support its effectiveness in providing long-term steroid-free clinical remission in up to one-third of steroid-dependent UC patients.

Dr. Axel Dignass from Markus-Krankenhaus in Frankfurt am Main, Germany, and colleagues in the U.K., France, and Germany are evaluating the effectiveness and safety of Adacolumn GMA in a 96-week, single-arm, open-label study of patients with moderate-to-severe UC who had an inadequate response to, lost response to, or were intolerant to immunosuppressants and/or a biologic therapy.

Their report, online January 27 in the Journal of Crohn's and Colitis, includes interim results from 72 patients (of the original 86 enrolled) who completed week 12.

After treatment, 39.3% of the intent-to-treat (ITT) population and 37.5% of the per-protocol (PP) population achieved remission at week 12 (the primary endpoint), including 40.3% of patients who previously failed on immunosuppressants, 27.8% of patients who failed on anti-TNF treatment, and 30.0% of patients who failed on both immunosuppressants and anti-TNF treatment.

More than half of the patients achieved some measure of clinical response, with median times of 43 days to remission and 24 days to clinical response.

Nearly a quarter of patients (22.6%) in the ITT population achieved steroid-free remission, and all four measures of quality of life improved.

There were no deaths and none of the serious adverse events were attributed to study treatment.

Dr. Satoru Kakizaki from Gunma University's Graduate School of Medicine in Gunma, Japan, who was involved in a different study of UC patients who had GMA, told Reuters Health by email, "It is difficult to conduct a randomized trial for active, steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment. Although this study is single arm, this study is a large-scale, multi-center, and world-wide trial. This study showed that Adacolumn provided significant clinical benefit in a large cohort, with a favorable safety profile."

"Active, steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment are good (candidates) for Adacolumn," he concluded.

Otsuka Pharmaceuticals Ltd. funded the study and had various relationships with seven of the 12 authors of the report. The company also paid for preparation of the manuscript.

Dr. Dignass did not respond to a request for comments.

SOURCE: bit.ly/1oa8YLQ

J Crohns Colitis 2016.