Pilot feasibility studies of leukocytapheresis with the Adacolumn Apheresis System in patients with active ulcerative colitis or Crohn disease.
OBJECTIVE
Two uncontrolled, multicenter feasibility studies evaluated safety and pilot efficacy of selective granulocyte and monocyte adsorption apheresis (GMA) with the Adacolumn Apheresis System for treatment of moderate-to-severe ulcerative colitis (UC) and Crohn disease (CD) patients refractory/intolerant to conventional pharmacologic therapy.


BACKGROUND
Patients with UC and CD, characterized by elevations in peripheral blood granulocytes, monocytes/macrophages, and proinflammatory mediators, may benefit from reductions in activated granulocytes and monocytes by selective apheresis.


METHODS
Patients underwent weekly Adacolumn sessions for 5 weeks. Pilot efficacy assessments used disease activity index (DAI) for UC (0-12) or CD activity index (CDAI; 0-600) for CD.


RESULTS
Eleven of 15 UC patients completed all 5 treatments. Mean DAI scores fell from 8.4+/-1.3 (baseline) to 5.2+/-2.9 (week 7). Five patients had DAI reductions of > or = 3 points at week 7. Fourteen of 15 CD patients completed all 5 treatments. Mean CDAI scores fell from 308.0+/-76.5 (baseline) to 200.6+/-117.4 (week 7). Nine CD patients responded (CDAI reductions > or = 70 points) at week 7. Remission (CDAI score < or = 150 at week 7) was observed in 6 patients. There were no device-related serious adverse effects.


CONCLUSIONS
Treatment with Adacolumn may be feasible and effective in patients with moderate-to-severe refractory inflammatory bowel disease. Larger sham-controlled studies are ongoing.
Sands
Bruce E
BE
Gastrointestinal Unit and MGH Crohn's and Colitis Center, Massachusetts General Hospital, Boston, MA 02114, USA. bsands@partners.org
Sandborn
William J
WJ
Wolf
Douglas C
DC
Katz
Seymour
S
Safdi
Michael
M
Schwartz
David A
DA
Hanauer
Stephen B
SB
D000293:Adolescent; D000327:Adsorption; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000494:pharmacology; D003093:Colitis, Ulcerative / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D003424:Crohn Disease / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D004351:Drug Resistance / Q000187:drug effects; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D007937:Leukapheresis / Q000295:instrumentation* / Q000379:methods; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents