To determine if immunization with alloantigenic blood mononuclear cells (MNC) in active rheumatoid arthritis (RA) can result in objective and subjective improvement in RA.
Eleven patients meeting American College of Rheumatology criteria for RA were treated in an open label trial by immunization with allogeneic MNC obtained from donors screened for infectious agents according to American Association of Blood Banks guidelines. MNC (30-250 x 10(6) cells) were given at 6 week intervals. Half the MNC (vol 2 ml) were injected intravenously and half in 4 divided doses subcutaneously (sq, 0.5 ml each). Disease activity assessments were done before entry and at immunotherapy visits thereafter. These included physician global assessment of disease activity, patient global assessment of pain, arthritis impact measurement scales (AIMS), swollen joint count, erythrocyte sedimentation rate (ESR), and/or C-reactive protein (CRP).
Statistically significant improvement was noted in all clinical variables measured when pretreatment data were compared to those obtained at the time of injection number 3. MNC dose related improvement was found when the total number of cells given in the first 2 injections were compared to percentage improvement in patient assessment of pain (r = 0.71, p < 0.02), AIMS (r = 0.60, p = 0.05), and improvement in the means of all variables measured (r = 0.70, p < 0.03). When all variables were averaged, 6 of 11 patients experienced > 20% and 3 of 11 experienced > or = 40% improvement. The only side effects noted were transient local pain and swelling at the sq injection sites.
MNC immunization may represent a suitable and safe alternative to drug treatment for selected patients with RA. Statistically significant improvement was found in all variables and several of these were cell dose related. A placebo controlled randomized trial immunizing with a standardized number of cells will address efficacy of this biological treatment approach.