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FRI0200 Relative effectiveness of rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis and an inadequate response to a single previous TNF inhibitor: Results from switch-RA, a global, comparative-effectiveness, observational study
  1. P. Emery1,
  2. J.-E. Gottenberg2,
  3. P. Sarzi-Puttini3,
  4. R.J. Moots4,
  5. D. Choquette5,
  6. A. Finckh6,
  7. A. Östör7,
  8. A. Andrianakos8,
  9. L. Barile-Fabris9,
  10. M.-L. Desjuzeur10,
  11. L. Hinsch-Gylvin10,
  12. C. Chung11,
  13. C. Mpofu10
  1. 1Leeds General Infirmary, Leeds, United Kingdom
  2. 2CHU Strasbourg, Strasbourg, France
  3. 3L Sacco University Hospital, Milan, Italy
  4. 4University of Liverpool, Liverpool, United Kingdom
  5. 5University of Montreal, Montreal, Canada
  6. 6University Hospital of Geneva, Geneva, Switzerland
  7. 7Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom
  8. 8Hellenic Foundation for Rheumatological Research, Athens, Greece
  9. 9Hospital de Especialidades Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, México City, Mexico
  10. 10F. Hoffmann-La Roche Ltd, Basel, Switzerland
  11. 11Genentech Inc, South San Francisco, United States

Abstract

Background Recent studies indicate that RA patients (pts) with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi) may achieve greater clinical benefit from switching to rituximab (RTX) than to an alternative TNFi.1 SWITCH-RA, a global, multicentre, 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.

Methods The primary endpoint was 6-month change from baseline in DAS28 based on DAS28(3)-ESR, whichexcludes patient’s global health component. Analysis of covariance adjusting for unbalanced baseline characteristics was used for treatment cohort comparisons, with missing DAS28(3)-ESR valuesimputed with investigator-reported and nearest-timepoint values. “As observed” analysis was performedto validate the results’robustness.

Results Of 1107 eligible pts (mean age 55.5 yrs; 79.0% women), 602 switched to RTX and 505 to an alternative TNFi. The RTX pts (vs alternative TNFi pts) had a mean RA disease duration of 8.9 yrs (vs 7.6, p=0.056) and a mean initial TNFi duration of 25.4 months (vs 25.2, p=0.227). At time of switch, RTX pts had greater mean baseline DAS28(3)-ESRfor the study overall (5.5 vs 5.0, p<0.001), for the sub-cohort (n=824) who discontinued initial TNFi due to inefficacy (5.3 vs 4.7, p<0.001)and for the sub-cohort (n=264) who discontinued due to intolerance (5.0 vs 4.5, p=0.019). The study had a high incidence of missing data (similar between treatment cohorts). Data for 530 (observed) and 703 (imputed) pts were available for the primary endpoint analysis. At 6 months, there were greater decreases in DAS28(3)-ESR (least squares means) in RTX than in alternative TNFi pts for overall (-1.5 vs -1.1, p=0.008) and the “inefficacy” sub-cohort (-1.5 vs -1.0, p=0.007), but not the “intolerance” sub-cohort (-1.0 vs -0.9, p=0.877). “As observed” analysis showed similar results. A greater decrease in ESR was also noted in the RTX vs the alternative TNFi group, both overall (-15.2 vs -9.2; p=0.009) and the “inefficacy” sub-cohort (-12.8 vs -6.8; p=0.035). Rates of AEs and serious AEs were similar between the treatment cohorts.

Conclusions These data from SWITCH-RA indicate that, following discontinuation of a first TNFi, pts starting treatment with RTX achieved improved effectiveness as demonstrated by significantly greater decreases in DAS28-ESR, in particular those switched for inefficacy, over 6 months compared with pts switching to an alternative TNFi.

  1. Finckh, et al. Ann Rheum Dis 2010;69:387.

Disclosure of Interest P. Emery Consultant for: Pfizer, Merck, Abbott, BMS, Roche, Novartis, J.-E. Gottenberg Consultant for: Abbott, BMS, Pfizer, Roche, Schering-Plough, P. Sarzi-Puttini Grant/Research support from: Roche, Pfizer, UCB, Abbott, R. Moots Grant/Research support from: Roche, UCB, MSD, D. Choquette Consultant for: Roche, Speakers Bureau: Roche, A. Finckh Grant/Research support from: Pfizer, Abbott, Roche, Consultant for: Roche, Pfizer, BMS, Speakers Bureau: Roche, A. Östör Consultant for: Roche, Chugai, Schering-Plough/MSD, Abbott, Wyeth/Pfizer, BMS, GSK, MerckSorono, UCB, A. Andrianakos Speakers Bureau: Roche, L. Barile-Fabris Consultant for: Roche, Pfizer, MSD, BMS, M.-L. Desjuzeur Employee of: F. Hoffmann-La Roche Ltd, L. Hinsch-Gylvin Employee of: F. Hoffmann-La Roche Ltd, C. Chung Employee of: Genentech, Inc, C. Mpofu Employee of: F. Hoffmann-La Roche Ltd

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