ongoing, open, prospective pilot trial in systemic sclerosis using anti

< Index
35. Kongress der DGRh und 21. Jahrestagung der ARO
Hamburg, 19. - 22. September 2007
T03.27
ONGOING, OPEN, PROSPECTIVE PILOT TRIAL IN SYSTEMIC
SCLEROSIS USING ANTI-CD25 MONOCLONAL ANTIBODY
BASILIXIMAB TARGETING ACTIVATED T CELLS
Brückner CS. 1, Hanitsch LG. 2, Schmidt K. 1, Burmester GR. 1, Riemekasten G. 1
(1) Med. Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie, Charité Universitätsmedizin Berlin, (2) Med. Klinik mit Schwerpunkt Pulmonologie und
Infektologie, Charité - Universitätsmedizin Berlin
Background: Systemic sclerosis (SSc) is a systemic autoimmunopathy leading to progressive tissue fibrosis due to an
activating humoral and cellular immune response. Serum levels of soluble interleukin (IL) 2 receptors correlate with skin
involvement, disease progression and mortality. This suggests an important role of activated and possibly disregulated T
cells in the pathogenesis of SSc. Basiliximab is a chimeric monoclonal antibody targeting the α chain (CD25) of IL2
receptors.
Objectives: The aim of this ongoing pilot trial is to investigate the effect of basiliximab on disease activity and progression.
Methods: The protocol prescribes 20 mg basiliximab infusions in monthly intervals for six month while continuing a stable
cyclophosphamid iv treatment. Clinical (PFT, HRCT/chest X-ray, ECG, etc.) and laboratory parameters have been
assessed before treatment and after 24 weeks. Skin thickness assessed by the modified Rodnan skin score (MRSS), and
additionally with dermal ultrasound, was measured at week 0, 12, 24 and 44.
9 SSc patients with disease duration of maximal four years have been included. One had to be excluded due to
hypersensitivity against basiliximab, four have already finished the trial, and four are still in the treatment / observation
period.
Results: Within 44 weeks, the mean FVC increased about 8,02% predicted (73,83% vs. 81,83%), the mean DLCOc about
2,6 % predicted (55,78% vs 58,38%). Regarding the skin thickness assessed by the MRSS there was seen an
improvement of about 4 points (mean 25,25 vs. 21,0). One patient who has already finished the treatment but not the
observation period, showed a decrease in MRSS from 20 to 4 within 24 weeks.
Conclusion: There have been presented different beneficial effects of targeting activated T cells by the monoclonal
antibody basiliximab in skin and lung involvement in SSc. In literature, improvement of skin involvement has rarely been
assessed. Therefore further investigations regarding new therapies targeting activated T cells, e.g. basiliximab, are
needed.