Rheumatology Advance Access originally published online on May 31, 2005
Rheumatology 2005 44(9):1140-1144; doi:10.1093/rheumatology/keh701
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Adsorptive granulocyte/monocyte apheresis for the treatment of refractory rheumatoid arthritis: an open pilot multicentre trial
1 Hospital Clínic, IDIBAPS, Rheumatology, 2 Hospital General i Universitari Vall d'Hebrón, Rheumatology, 3 Hospital Universitari de Bellvitge, Rheumatology, L'Hospitalet de Llobregat, 4 Corporació Parc Taulí, Rheumatology, Sabadell, 5 Otsuka Pharmaceutical SA, Barcelona, Spain and 6 Otsuka Frankfurt Research Institute GmbH, Frankfurt, Germany.
Correspondence to: R. Sanmartí. E-mail: sanmarti{at}clinic.ub.es
Objective. To assess the efficacy and safety of adsorptive granulocyte and monocyte apheresis (GCAP) in patients with refractory rheumatoid arthritis (RA).
Methods. Patients with active and refractory RA were treated with weekly GCAP sessions using a column filled with acetate beads (Adacolumn®) over five consecutive weeks. Clinical assessments and response to therapy were analysed at weeks 5, 7, 12 and 20 in an open multicentre trial. The primary outcome measure of clinical response was 20% improvement in the American College of Rheumatology criteria (ACR20) at week 20. EULAR (European League Against Rheumatism) response criteria, based on the disease activity score for 28 joints (DAS28) and disability using the Health Assessment Questionnaire (HAQ), were also assessed.
Results. Of 27 patients, 81.5% were women with mean disease duration of 14.4 yr. The mean number of previous disease-modifying antirheumatic drugs (DMARDs) was 3.7, and 48.1% of patients had previously failed on biologicals. On an intention-to-treat basis, 40.7% of patients achieved an ACR20 and 44.4% a therapeutic EULAR response at week 20. These percentages were 50 and 54.5% in 22 patients who completed the trial. In the 10 completers who had previously failed on biologicals, an ACR response was achieved in four patients (ACR20, two; ACR50, one; ACR70, one). A significant decrease was recorded in different ACR response components, including the tender joint and swollen joint counts, pain score and patient and physician global disease assessments, as well as the DAS28 index; most of them improved after week 5. ESR and CRP, but not the HAQ score, had decreased significantly at week 20. The treatment was well tolerated and only one serious adverse event related to the study procedure was documented (sepsis due to a catheter infection).
Conclusions. GCAP treatment led to significant clinical improvement in a subset of patients with RA who had failed to respond to DMARDs or biologicals. Further large, placebo-controlled studies are warranted to fully assess the therapeutic value of GCAP for refractory RA.
KEY WORDS: Rheumatoid arthritis, Apheresis