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SAT0127 Long-Term Safety and Efficacy Following the Administration of Multiple Rituximab Cycles in Rheumatoid Arthritis (RA) Patients: The Multicenter, Prospective Launch Study
  1. L. Settas1,
  2. A. Andrianakos2,
  3. S. Aslanidis3,
  4. P. Boura4,
  5. M. Katsounaros5,
  6. D. Vassilopoulos6,
  7. P. Athanassiou7,
  8. K. Tempos8,
  9. G. Skarantavos9,
  10. C. Antoniadis10,
  11. L. Sakkas11,
  12. A. P. Andonopoulos12,
  13. V. Galanopoulou13,
  14. F. Solioti14,
  15. K. Boki15,
  16. E. Vritzali16,
  17. P. P. Sfikakis17
  1. 1Rheumatology Unit, AHEPA Hosp., Unv of Thess/niki, Thessaloniki
  2. 2Hellenic Foundation of Rheumatology, Athens
  3. 32nd Internal Medicine Dpt., Hippokratio Hosp.
  4. 42nd Internal Medicine Dpt, Unv of Thess/niki
  5. 52nd Internal Medicine Dpt, Papanikolaou Hosp., Thessaloniki
  6. 62nd Internal Medicine Dpt, Hippokratio Hosp., Athens Unv Medical School, Athens
  7. 7Rheumatology Division, St. Paul Hosp., Thessaloniki
  8. 8Rheumatology Division, KAT Hosp.
  9. 9Rheumatology and Bone Metabolic Diseases Clinic, Attikon Hosp.
  10. 10Rheumatology Division, Asclepieion Hosp., Athens
  11. 11Rheumatology Division, Unv Hosp. of Thessaly, Larissa
  12. 12Rheumatology Dpt, Patras Unv, Patras
  13. 131st Internal Medicine Dpt, Papageorgiou Hosp., Thessaloniki
  14. 14Rheumatology Clinic, Euroclinic Hosp.
  15. 15Rheumatology Clinic, Sismanoglio Hosp., Athens
  16. 16Medical Affairs, Roche Hellas SA, Maroussi
  17. 17Dpt of Prop. & Internal Medicine, Laikon Hosp., Athens Unv Medical School, Athens, Greece

Abstract

Background About one third of RA patients do not initially respond to treatment with an anti-TNF agent whereas a similar rate demonstrates lack of efficacy over time. Rituximab/Mabthera administration (temporary B-lymphocyte depletion) is one of the therapeutic options for them.

Objectives The LAUNCH prospective study aimed at the evaluation of long-term efficacy and safety data following rituximab administration in standard clinical practice

Methods 17 Rheumatology sites in Greece enrolled 234 adult patients (63.0±12.4 years, 79.5% women) with severe RA and an inadequate response or non-tolerance to anti-TNF treatment. Rituximab (1gr) was administered IV on days 1 and 14 of each cycle, repeated every 6-12 months, for up to 7 cycles. Of these patients 41.2% and 56.2% had received one, or more, anti-TNF agent(s), respectively. Adverse events, DAS28, and the quality of life evaluation indices (Euroqol) were collected every 2 to 6 months for 5 years according to each site’s standard clinical practice

Results During 496 patient/years, 28 adverse events /100 pt-yrs (including9.9 serious adverse events and 7.7 serious infectious per 100pt-yrs, respectively) were observed. Of the total number of adverse events a 46.7% was not related to rituximab. The mean number of adverse events per patient remained stable during repeated treatment cycles. Disease activity at baseline (mean±SD DAS28 of 5.36±1.40) was significantly reduced in cycles 1,2, 3, 4, 5, and 6 by 1.34, 2.12, 2.25, 2,56, 2.42 and 2.79, respectively (p<0.01). Compared to baseline, significant improvement in quality of life was also observed in all cycles (p<0.01)

Conclusions Rituximab administration in clinical practice for up to 5 years demonstrated an acceptable safety profile which was maintained over time. Likewise, maintenance and/or improvement of efficacy with repeated treatment cycles in patients with severe RA not responding to anti-TNF were evident

Disclosure of Interest L. Settas: None Declared, A. Andrianakos: None Declared, S. Aslanidis: None Declared, P. Boura: None Declared, M. Katsounaros: None Declared, D. Vassilopoulos: None Declared, P. Athanassiou: None Declared, K. Tempos: None Declared, G. Skarantavos: None Declared, C. Antoniadis : None Declared, L. Sakkas: None Declared, A. Andonopoulos: None Declared, V. Galanopoulou: None Declared, F. Solioti: None Declared, K. Boki: None Declared, E. Vritzali Employee of: Roche Hellas SA, P. Sfikakis: None Declared

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