Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Early Versus Delayed Retreatment with Rituximab (RTX) in Relation to Long Term Clinical ResponseData From the CERERRA Collaboration.
Lie1, Elisabeth, Chatzidionysiou2, Katerina, Nasonov3, Evgeny L., Lukina3, Galina, Pavelka4, Karel, Nordstrom5, Dan C., Tomsic6, Matija
Diakonhjemmet Hospital, Oslo, Norway
Hospital Clinico Universitario, Santiago, Spain
Lisbon Academic Medical Center, on behalf of Rheumatic Diseases Portuguese Register (Reuma.pt), Lisbon, Portugal
Copenhagen University Hospital at Glostrup, on behalf of DANBIO, Copenhagen, Denmark
Aarhus University Hospital, Aarhus, Denmark
Karolinska Institute, Stockholm, Sweden
Institute of Rheumatology, Moscow, Russia
1Institute of Rheumatology, Department of Experimental Rheumatology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic
ROB-FIN, Helsinki University Central Hospital, Helsinki, Finland
University Medical Centre Ljubjana, Ljubljana, Slovenia
Geneva University Hospitals, for the SCQM registry, Geneva, Switzerland
Cantacuzino Hospital, Bucharest, Romania
Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
Open-label extensions of RCTs have shown sustained clinical response with repeated courses of RTX in rheumatoid arthritis (RA). However, there has been a lack of data on retreatment and long term effectiveness in patients (pts) treated with RTX in clinical practice. Our objective was to characterize pts receiving early vs. delayed retreatment with RTX during the 1st year and compare long-term responses.
10 European biologics registries provided anonymized data sets of pts treated with RTX in clinical practice for analysis of pooled data. Pts were grouped as having received early (up to approx. 7 months after baseline) or delayed (after approx. 813 months) retreatment; pts not retreated the 1st year were excluded. Baseline (BL) characteristics, and year 1 and year 2 DAS28 states and changes were compared. Due to heterogeneity in timing of follow-up visits, overall mean DAS28 was calculated for the period 312 months and for year 2. Two-samples T, Mann-Whitney U and Chi2 tests were applied as appropriate. The main effectiveness outcome was mean DAS28 during year 2. Associations between retreatment group and longitudinal DAS28 values and low disease activity (DAS28 <=3.2; LDA) were examined by generalized estimating equations (GEE).
932 pts were retreated the 1st year (496 pts with 'early' and 436 pts with 'delayed' retreatment). 83.9%/83.5% were female, 79%/81% RF pos (p=0.39), and 83%/78% received concomitant DMARDs at baseline (BL) (p=0.07). Pts had used mean 2.7 vs. 2.6 (p=0.38) prior synthetic and 0.86 vs. 0.97 (p=0.50) prior biologic DMARDs, and 40% vs. 44% were biologics naïve (p=0.24). Pts in the early group were significantly younger (50.1 vs. 53.7 years, p<0.001). Mean DAS28 was similar for months 312 overall, but higher in the early group at 6 months and higher in the delayed group at 9 and 12 months (Table). 27% of pts in the early group also received a third course of RTX within month 13. 82% in the early vs. 90% in the delayed group had >18 months follow-up time, and mean(SD) total number of RTX courses from baseline through year 2 was 2.75(0.95) vs. 2.52(0.72) (p=0.001). Overall year 2 mean DAS28 and DDAS28 BL to year 2 were very similar (Table). Proportions of EULAR good response, LDA and remission were also similar between groups across year 2 visits. The GEE analyses showed no significant associations between timing of retreatment (early vs. delayed) and DAS28 value or LDA state neither during months 312 (p=0.38 for DAS28/p=0.34 for LDA), year 2 (p=0.41/p=0.93), or the two periods combined (p=0.61/p=0.27).
|Early retreatment n=496||Delayed retreatment n=436||p-value|
|DAS28 months 3/6/9/12||4.42/4.51/4.11/4.21||4.26/4.05/4.95/4.51||0.07/<0.001/<0.001/0.01|
|DAS28 month 312||4.36||4.42||0.44|
|DDAS28 BL to month 312||-1.86||-1.66||0.01|
|DAS28 year 2||4.16||4.10||0.58|
|DDAS28 BL to year 2||-2.06||-2.03||0.77|
|DDAS28 month 312 to year 2||-0.22||-0.32||0.30|
Younger pts who with higher disease activity and greater functional impairment at BL were more likely to have earlier relapses leading to retreatment. Perhaps owing to more frequent retreatment, their results over 2 years were similar to pts retreated at longer intervals. These results suggest that certain subsets of pts for whom earlier retreatment should be considered, may be identified.
To cite this abstract, please use the following information:
Lie, Elisabeth, Chatzidionysiou, Katerina, Nasonov, Evgeny L., Lukina, Galina, Pavelka, Karel, Nordstrom, Dan C., et al; Early Versus Delayed Retreatment with Rituximab (RTX) in Relation to Long Term Clinical ResponseData From the CERERRA Collaboration. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :444