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Granulocyte/monocyte apheresis may not effectively treat Crohn's disease
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Patients with Crohn’s disease did not benefit from treatment with granulocyte/monocyte apheresis compared with sham apheresis in a recent study.
In a double blind trial conducted at 32 medical facilities throughout the United States and Canada, researchers randomly assigned 235 patients (aged 18 to 75 years) with moderate-to-severe Crohn’s disease (CD) to receive either granulocyte/monocyte apheresis (GMA) (n=157) or a sham control (n=78) for 10 sessions administered during 9 weeks. Treatment efficacy was evaluated after 12 weeks and compared against the sham procedure, and a follow-up period of 12 additional weeks also was conducted. Therapy was discontinued before week 12 by 30 patients in the treated group and 17 in the sham group, including 10 who stopped because of disease flare. Full follow-up was conducted for 51 patients in the treated group and 26 in the sham group.
Clinical remission occurred in 17.8% of patients receiving GMA compared with 19.2% in the sham group (P=.858 for difference). Clinical response occurred in 28.0% of the GMA group and 26.9% of the sham group (P=1.00). Change in CDAI from baseline was comparable between the two groups (309.6 at baseline to 240.6 at week 12 in the treated group vs. 314.7 to 246.4 in the sham group, P=.813), as was change in quality of life and in disease severity according to endoscopic evaluation (P=.65 for difference).
Most patients (93.0% of treated and 93.6% of sham patients) experienced adverse events, including 17 in the treated group and nine in the sham group who stopped treatment because of severe events. Common events included decreased blood pressure, hypotension, nausea and abdominal pain, with no significant difference in incidence rates found between the two groups. Only one severe event, a moderately severe viral infection requiring hospitalization, was associated with the Adacolumn Apheresis System.
“In a rigorous, double blinded, sham-controlled trial, we were unable to demonstrate efficacy for a granulocyte/monocyte apheresis system,” researcher Bruce E. Sands, MD, MS, told Healio.com. “Studies of medical devices are rarely done with the rigor of a sham control and blinding, which adds weight to the findings.”
Disclosure: See the study for a full list of relevant disclosures.
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