title: A multicenter study of leukocytapheresis in rheumatoid arthritis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of leukocytapheresis (LCAP) in patients with rheumatoid arthritis (RA) that is refractory to disease modifying antirheumatic drugs (DMARDs), we conducted a prospective, multicenter, open-label clinical trial.
  
  
  METHODS
  We enrolled 38 active RA patients, including 32 patients who showed an inadequate response to > or = 2 DMARDs and 6 patients with rapidly progressive RA. All patients continued drug therapy and were treated with 5 LCAP sessions conducted at 1-week intervals. The clinical response was evaluated at baseline before starting LCAP and at 4 weeks after the completion of all the LCAP sessions using the American College of Rheumatology (ACR) criteria and the 28-joint disease activity score (DAS28) of the European League Against Rheumatism (EULAR).
  
  
  RESULTS
  Of the 35 patients who fulfilled the study's eligibility criteria, 24 (69%), 10 (29%), and 23 (66%) patients achieved 20% (ACR20), 50% (ACR50), and DAS28-C-reactive protein (CRP) EULAR improvement, respectively. The mean DAS28-CRP score of the 35 patients decreased significantly from 5.99 +/- 0.92 at baseline to 4.54 +/- 1.39 after treatment. Comparison analysis of the ACR20 responders and non-responders to LCAP revealed that 22 of 24 responders (92%) concomitantly received methotrexate, whereas significantly fewer, that is, 6 of 11 non-responders (55%) received methotrexate. Less frequent and transient mild-to-moderate adverse events, including nausea and headache, were seen in 12 of 189 LCAP sessions (6.3%).
  
  
  CONCLUSIONS
  These results demonstrate the usefulness of LCAP in combination with DMARDs, particularly methotrexate, as an effective and safe treatment for refractory RA.
authors.affiliation: Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital, The University of Tokyo, Sasebo, Japan. u-yuki@hakujyujikai@or.jp
authors.forename: Y
authors.initials: Y
authors.lastname: Ueki
authors.forename: A
authors.initials: A
authors.lastname: Sagawa
authors.forename: K
authors.initials: K
authors.lastname: Tanimura
authors.forename: A
authors.initials: A
authors.lastname: Yamada
authors.forename: K
authors.initials: K
authors.lastname: Yamamoto
authors.forename: H
authors.initials: H
authors.lastname: Tsuda
authors.forename: S
authors.initials: S
authors.lastname: Tohma
authors.forename: K
authors.initials: K
authors.lastname: Suzuki
authors.forename: M
authors.initials: M
authors.lastname: Tominaga
authors.forename: Y
authors.initials: Y
authors.lastname: Kawabe
authors.forename: M
authors.initials: M
authors.lastname: Mine
authors.forename: S
authors.initials: S
authors.lastname: Honda
authors.forename: M
authors.initials: M
authors.lastname: Tsukano
authors.forename: T
authors.initials: T
authors.lastname: Nakamura
authors.forename: T
authors.initials: T
authors.lastname: Hidaka
authors.forename: K
authors.initials: K
authors.lastname: Eguchi
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000628:therapy*; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007937:Leukapheresis / Q000379:methods; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D008727:Methotrexate