OBJECTIVE: To report the findings of a 10-year followup of patients enrolled in a randomized trial of total lymphoid irradiation (TLI) versus chemotherapy for rheumatoid arthritis (RA). METHODS: A retrospective analysis of the charts of 19 patients who had been included in a randomized trial comparingTLI and chemotherapy for the treatment of RA. RESULTS: Ten years after the start of the trial, a higher number of TLI-treated patients had died (7 of 10), compared with patients who had received chemotherapy (2 of 9). In addition, 3 of the TLI-treated patients developed B cell-related malignancies, whereas no such malignancies developed in the control group. CONCLUSION:TLI was associated with a less-favorable long-term outcome than chemotherapy. These data stress the importance of careful long-term followup in experimental trials of immunosuppressive agents.
RCT Entities:
OBJECTIVE: To report the findings of a 10-year followup of patients enrolled in a randomized trial of total lymphoid irradiation (TLI) versus chemotherapy for rheumatoid arthritis (RA). METHODS: A retrospective analysis of the charts of 19 patients who had been included in a randomized trial comparing TLI and chemotherapy for the treatment of RA. RESULTS: Ten years after the start of the trial, a higher number of TLI-treated patients had died (7 of 10), compared with patients who had received chemotherapy (2 of 9). In addition, 3 of the TLI-treated patients developed B cell-related malignancies, whereas no such malignancies developed in the control group. CONCLUSION: TLI was associated with a less-favorable long-term outcome than chemotherapy. These data stress the importance of careful long-term followup in experimental trials of immunosuppressive agents.
Authors: Alexandra Alexopoulou; Spyros P Dourakis; Alexandra Apostolopoulou; Anna Kandyli; Helen Pandelidaki; Athanasios J Archimandritis Journal: Clin Rheumatol Date: 2005-04-23 Impact factor: 2.980