126 - Relative Effectiveness of Rituximab and An Alternative TNF Inhibitor in Patients with Rheumatoid Arthritis and An Inadequate Response to a Single Previous TNF Inhibitor: Interim Results From Switch-RA a Global Comparative-Effectiveness Observational Study

Sunday, November 6, 2011: 9:00 AM-6:00 PM
Hall F2 - Poster Hall (McCormick Place West)
Paul Emery1, Piercarlo Sarzi-Puttini2, Robert J. Moots3, Alexandros A. Andrianakos4, Thomas P. Sheeran5, Denis Choquette6, Axel Finckh7, Marie-Laetitia Desjuzeur8, Eric Gemmen9, Chiedzo Mpofu8 and Jacques-Eric Gottenberg10, 1Chapel Allerton Hospital, Leeds, United Kingdom, 2L Sacco University Hospital, Milano, Italy, 3University of Liverpool, Liverpool, United Kingdom, 4Hellenic Foundation for Rheumatological Research, Athens, Greece, 5Cannock Chase Hospital, Cannock, United Kingdom, 6University of Montreal, Notre-dame Hospital, Montreal, QC, 7University Hospital of Geneva, Geneva, Switzerland, 8F. Hoffman-La Roche Ltd, Basel, Switzerland, 9Quintiles Inc, Rockville, MD, 10CHU Strasbourg, Strasbourg, France
Presentation Number: 126

Background/Purpose: A recent longitudinal cohort study suggested that after an inadequate response to a tumor necrosis factor inhibitor (TNFi), switching to rituximab (RTX) may be more effective than switching to an alternative TNFi.1 The current study prospectively evaluated the relative effectiveness of RTX vs an alternative TNFi in rheumatoid arthritis (RA) patients with an insufficient response or intolerance to a single previous TNFi in routine clinical practice.

Method: This is an interim analysis on an ongoing global, multicenter, prospective, observational study in patients with RA who were prescribed RTX or an alternative TNFi following the first TNFi failure. Propensity scores were generated for each patient to reflect the conditional probability of receiving treatment with RTX vs an alternative TNFi. 6-month changes in clinical variables (DAS28-ESR and ESR) following the initiation of the new therapy were compared in the two treatment groups using analysis of covariance; these analyses controlled for baseline value, propensity score, and other covariates found to be statistically different between the two groups at baseline.

Result: Data are presented for 1082 patients enrolled and 660 patients completing 6 months as of Feb 2011 in 9 countries. The 592 RTX and the 490 alternative TNFi patients had a mean (SD) age of 56.4 (12.46) and 54.4 (13.70) yrs, respectively; mean (SD) disease duration 8.9 (7.87) and 7.8 (6.60) yrs; female 77.4% and 80.6%; mean (SD) duration of all previous TNFi therapy 25.2 (25.4) and 25.4 (26.7) months. At the start of the new therapy, mean (SD) DAS28-ESR was significantly higher (p<0.0001) in the RTX group (5.57 [1.33]; n=385) vs the alternative TNFi group (4.97 [1.38]; n=272). At 6 months, there was a significantly greater decrease in DAS28-ESR in RTX patients (n=277) than in alternative TNFi patients (n=203): mean improvement at 6 months -1.6 vs -1.2; p=0.047. In addition, there was a significantly greater decrease in ESR (-15.4 vs -9.7; p=0.0219) in the RTX group vs the alternative TNFi group and numerically better results for the other DAS28 components (joint counts, global disease activity assessment).

Conclusion: Following discontinuation of a first TNFi, patients starting treatment with RTX achieved significantly better efficacy at 6 months as measured by DAS28-ESR compared with patients switching to an alternative TNFi.

Reference: 1Finckh A, et al. Ann Rheum Dis 2010;69:387–393.

Keywords: B cells

Disclosure: P. Emery, Pfizer, Merck, Abbott, BMS, Roche, 5 ; P. Sarzi-Puttini, Roche, Pfizer, UCB, Abbott, 2 ; R. J. Moots, Roche Pharmaceuticals, 2 ; A. A. Andrianakos, None; T. P. Sheeran, None; D. Choquette, None; A. Finckh, Pfizer, Abbott, 2, Roche Pharmaceuticals, 5, Roche Pharmaceuticals, 8 ; M. L. Desjuzeur, F Hoffman-La Roche Ltd, 3 ; E. Gemmen, Quintiles, 3 ; C. Mpofu, F Hoffman-La Roche Ltd, 3 ; J. E. Gottenberg, Abbott, BMS, Pfizer, Roche, Schering-Plough, 5 .