Session Type: Abstract Submissions (ACR)
Background/Purpose: RA patients (pts) with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi) may achieve greater benefit by switching to rituximab (RTX) than to an alternative TNFi.1 Seropositive pts achieve greater clinical responses to RTX than seronegative pts.2,3 SWITCH-RA, a global, multicenter, prospective, observational, clinical practice study, evaluated the relative effectiveness of RTX vs an alternative TNFi in pts with an IR to a single previous TNFi. The objective of this subanalysis was to compare the relative effectiveness of RTX vs an alternative TNFi according to serotype.
Methods: This was a prospective, observational cohort study, designed to evaluate in routine practice the relative clinical outcomes of RTX or a second TNFi to which pts were switched following a single TNFi failure. Primary endpoint was 6-month change from baseline in DAS28 based on DAS28(3)-ESR. Analysis of covariance adjusting for unbalanced baseline characteristics was used for treatment cohort comparisons, with missing DAS28(3)-ESR values imputed with nearest-timepoint values.
Results: Overall, 728 pts were included (RF+ and/or anti-CCP+ [seropositive], n=559; seronegative, n=169). Of seropositive pts, 331 and 228 received RTX or an alternative TNFi; corresponding numbers for seronegative pts were 74 and 95, respectively. In both seropositive and seronegative pts, at time of switch, baseline DAS28(3)-ESR (SD) scores were higher in the RTX than in the alternative TNFi group (5.2 [1.2] vs 4.8 [1.3] p<0.0001, and 5.3 [1.1] vs 4.7 [1.3] p=0.0019, respectively). After adjusting for baseline differences, in seropositive pts receiving RTX, DAS28(3)-ESR improved significantly at 6 months vs pts switching to an alternative TNFi (table). The relative benefit of RTX varied in seropositive pts according to the reason for interrupting the previous TNFi (inefficacy/intolerance). In seronegative pts, improvements in DAS28(3)-ESR at 6 months were not significantly different between RTX and alternative TNFi pts. At 6 months, greater decreases in ESR (LS mean [SE]) were observed in seropositive pts receiving RTX than in those receiving an alternative TNFi (-14.4 [4.5] vs -7.3 [4.8] p=0.006); corresponding results in seronegative pts did not reach statistical significance (-13.4 [8.3] vs -10.4 [9.0] p=0.582).
|Seropositive patients (n=559)||Seronegative patients (n=169)|
|LS mean (SE)||RTX||TNFi||p-value||RTX||TNFi||p-value|
|All patients||-1.6 (0.3)||-1.2 (0.3)||0.011||-1.3 (0.4)||-1.1 (0.4)||0.449|
|Inefficacy||-1.9 (0.3)||-1.5 (0.4)||0.021||-0.5 (0.6)||-0.2 (0.7)||0.472|
|Intolerance||-0.5 (0.5)||-0.5 (0.5)||0.997||-2.1 (1.2)||-1.9 (1.3)||0.815|
Patient numbers (all/inefficacy/intolerance): seropositive RTX=331/253/74; TNFi=228/171/51; seronegative RTX=74/58/15; TNFi=95/65/28
Conclusion: Following discontinuation of a first TNFi, seropositive pts switching to RTX achieved significantly improved effectiveness over 6 months, in particular those interrupting therapy due to inefficacy, compared with pts switching to an alternative TNFi. These differences were not evident in seronegative pts.
1. Finckh, et al. Ann Rheum Dis 2010;69:387.
2. Chatzidionysiou, et al. Ann Rheum Dis 2011;70:1575.
3. Emery & Dörner. Ann Rheum Dis 2011;70:2063.
Roche, Chugai, Abbott, Pfizer, UCB, MSD,
Roche, UCB, Chugai. MSD,
Roche, UCB, Chugai, MSD,
Roche, Pfizer, BMS,
Roche, Pfizer, BMS,
Roche, Pfizer, UCB, Abbott,
J. E. Gottenberg,
Roche, Pfizer, MSD, Abbott,
V. Martínez Taboada,
Schering-Plough, Wyeth-Pharma, Roche,
UCB-Pharma, Bristol Myers Squibb, Roche, Cellerix, Pfizer,
Genentech, Inc (full time),
F Hoffmann-La Roche Ltd,
Pfizer, Merck, Abbott, BMS, Roche, UCB,
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