Publikationsrepositorium - Helmholtz-Zentrum Dresden-Rossendorf

T‐cell‐located CD4 antigen represents one of the therapeutic targets in rheumatoid arthritis (RA). However, up to now it has not been possible to visualize this target in vivo. The aim of our study was to assess the safety and tolerability of a Technetium 99 labelled anti‐CD4 antibody fragment (Tc‐99m‐anti‐CD4) in patients with active synovitis due to rheumatoid arthritis and to evaluate its potential as a marker of disease activity. Methods: In the present phase I proof of principle study 5 patients (3 female, 2 male, 58 to 71 years) with RA were examined. Planar whole body scans as well as separate hand and feet scintigraphies were taken 30 minutes, 1, 2, 4, 8 and 24 hours after application of 585 +/‐ 115 MBq Tc‐99m‐anti‐CD4. The obtained scintigramms were analysed visually and compared with clinical data in 68 joints per patient. Active inflammation was clinically defined by swelling and tenderness in at least one joint (gold standard). Patients were clinically re‐evaluated 7 days p.i. Results: Neither infusion related adverse events nor adverse events during follow up were observed. No increase in HAMA titres was seen. All 5 patients had positive scans in 25 of 37 clinically affected joints. Positive scans were also found in 19 out of 227 joints without evidence of swelling or tenderness yielding a 7% rate of false positive joints and a 32% rate of false negative joints. Conclusion: Scintigraphy with Tc‐99m‐anti‐CD4 is a new promising technique for evaluation of inflammatory activity in patients with RA. Tracer uptake in clinically inconspicuous joints strongly indicates diagnostic potential of 99Tc anti CD4. Based on the few patients investigated, it seems that inflammation is detected with apparently higher specificity than sensitivity. Whether this technique is eligible for prognostic disease evaluation needs to be analysed in further studies as well as the pathophysiological background of clinically affected joints lacking tracer uptake.