Novel adsorptive type apheresis device Immunopure for ulcerative colitis from clinical perspectives based on clinical trials: Japan and Europe

Abstract

Several adsorptive type devices for ulcerative colitis are used for the induction of remission in patients with active severe disease worldwide. In 2020, the novel apheresis device Immunopure for ulcerative colitis was launched in Japan. Immunopure, like the polyethylene terephthalate column, uses polyarylate, a type of polyester resin, as the adsorbent. Similar to the cellulose acetate column, Immunopure is filled with adsorbent beads and expected to provide ease of use, with minimal risk of column clogging. Immunopure adsorbs leukocytes and platelets, especially activated platelets and platelet‐leukocyte aggregates. In this article, the capability of Immunopure is evaluated from clinical perspective based on a clinical trial in Japan/Europe. As a result, Immunopure is comparable to other products in clinical effectiveness and indicated for the treatment of patients with refractory moderate ulcerative colitis, making it highly useful in clinical practice.

Adsorptive cytapheresis for ulcerative colitis with focus on removing platelets and platelet‐aggregates

“…Eighty-three percent of patients benefited from apheresis (five out of six patients) and 67% even went into remission (four out of six patients). This work complements and reinforces the positive experience gained so far and is in line with previous study results with 33 patients in total by Ramlow et al [6] (10 patients-80% remission), Kruis et al [7] (12 patients-75% treatment response and 25% remission) and Endo et al 5 (effectively 11 patients-64% remission).…”

“…Furthermore, an increase in platelets is also accompanied by increased formation of MPs, other inflammatory cells which are activated via the CD40/CD40L pathway [18] and cell adhesion molecules such as sP-selectins [11] along with an increased inflammatory response. In this work, the apheresis module Immunopure known for a strong platelet adsorbing capacity [5][6][7] was investigated in a recirculation model in vitro using down-scaled minimodules and in vivo in a prospective study including six UC patients.…”

“…Since the early 2000 s after the multicenter studies by Shimoyama [3] and Sawada [4], apheresis devices filled with cellulose acetate beads and with non-woven polyester fabric have been used for the treatment of UC in Japan. In 2020, the Immunopure device (Nikkiso Co., Ltd, Tokyo, Japan) has been launched in Japan for moderate UC 5 . This was based on a pilot clinical trial conducted by Ramlow et al [6] and a prospective multicenter controlled study by Kruis et al [7] A clinical trial in Japan was prematurely discontinued due to insufficient patient recruitment [5].…”

“…In 2020, the Immunopure device (Nikkiso Co., Ltd, Tokyo, Japan) has been launched in Japan for moderate UC 5 . This was based on a pilot clinical trial conducted by Ramlow et al [6] and a prospective multicenter controlled study by Kruis et al [7] A clinical trial in Japan was prematurely discontinued due to insufficient patient recruitment [5].…”