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OP0228 Rituximab Monotherapy of Severe Hcv-Related Cryoglobulinemic Vasculitis for More than 2 Years: Follow-Up of A Randomized Controlled Multicentre Study
  1. L. Quartuccio1,
  2. F. Zuliani2,
  3. L. Corazza2,
  4. P. Scaini3,
  5. R. Zani3,
  6. M. Lenzi4,
  7. A. Tavoni5,
  8. M. Sebastiani6,
  9. S. Baldovino7,
  10. T. Urraro8,
  11. F. Saccardo9,
  12. C. Sbreglia10,
  13. C. Mazzaro11,
  14. P. Pioltelli12,
  15. P. Fraticelli13,
  16. D. Filippini14,
  17. A. Gabrielli13,
  18. O. Perrella10,
  19. S. Scarpato15,
  20. D. Roccatello7,
  21. A.L. Zignego8,
  22. C. Ferri6,
  23. S. Bombardieri5,
  24. M. Pietrogrande16,
  25. M. Galli17,
  26. G. Monti9,
  27. S. De Vita1
  1. 1DSMB
  2. 2Rheumatology Clinic, University of Udine, Udine
  3. 3Nephrology, Spedali Civili di Brescia, Brescia
  4. 4Università di Bologna, Bologna
  5. 5Rheumatology Unit, University of Pisa, Pisa
  6. 6Rheumatology Clinic, University of Modena and Reggio Emilia, Modena
  7. 7Centro Multidisciplinare di Immunopatologia e Documentazione su Malattie Rare (CMID) - Ospedale S. Giovanni Bosco, Torino
  8. 8Center for Systemic Manifestations of Hepatitis Viruses (MASVE), Department of Experimental and Clinical Medicine, University of Florence, Florence
  9. 9Internal Medicine, Ospedale di Saronno, AO Busto Arsizio, Saronno (VA)
  10. 10Rheumatology Unit, AO Cotugno, Naples
  11. 11Internal Medicine, AO Pordenone, Pordenone
  12. 12Hematology, AO San Gerardo, Università di Milano-Bicocca, Milano
  13. 13Clinica Medica Generale, Ematologia e Immunologia Clinica, Università di Ancona, Ancona
  14. 14Rheumatology Unit, Ospedale Niguarda Ca' Granda, Milano
  15. 15UO Reumatologia, Scafati
  16. 16Internal Medicine, Policlinico di Zingonia, Bergamo
  17. 17Infectious Diseases, L.Sacco Hospital, Milano, Italy

Abstract

Background Two independent controlled randomized trials demonstrated the efficacy and safety of rituximab (RTX) monotherapy in severe cryoglobulinemic vasculitis (CV) (1, 2), with one reporting a prolonged follow-up (1).

Objectives To report the very long term efficacy and safety of RTX monotherapy in severe CV since a regimen of RTX monotherapy was maintained after the end of the abovementioned trial (1).

Methods Long term follow up data of a trial of RTX in severe CV (1) were analysed. During this follow-up, only RTX monotherapy was used. Disease activity at the last follow-up visit, adverse events and survival were registered. Clinical response was evaluated at the last follow-up visit, and was scored as follows: i) complete remission (no activity), partial remission (response >50% of at least one manifestation among glomerulonephritis, severe neuropathy or skin ulcers) (1), and active disease.

Results After the end of the 2-year controlled trial (1), follow-up data were available in 36 patients undergoing RTX, all HCV positive. The mean follow up after the beginning of RTX therapy (1) was 70.22±20.41 months, including 29 patients followed for more than 4 years (78.4±12.6 months) and 7 patients followed for 2.4-4 years (36.4±6 months). Of them, 3 patients were lost from follow-up shortly after the end of the trial, and 9 patients died. Of the remaining 24 patients, 14/24 (58.3%) showed complete clinical remission at the last follow-up, 6/24 (25%) a partial remission, while 4/24 (16.7%) had an active disease. A first repeated RTX course (1 g two weeks apart) was required in 50% of the patients (12/24), while 25% of the patients (6/24) needed more than one course, for a total of 19 retreatments. Patients were retreated for nephritis (7/19), neuropathy (6/19), skin ulcers (7/19) or diffuse purpura (6/19). Three patients underwent a maintenance RTX regimen, all with 1 g × 2 every 6 months, with a complete and partial remission at the last follow-up noticed in 2/3 and 1/3, respectively. Recurrent infections occurred only in three patients (8%; urinary and upper respiratory), and they were related to persistent hypogammaglobulinemia in 2/3. Death occurred in 9 patients, all showing persistent active disease.

Conclusions A long-term RTX therapy lasting several years is effective and safe in about two thirds of the patients with severe CV. The advantage of retreatment at relapse regimen instead of a maintenance therapy, and whether this may occur in a further subset of patients, needs further investigation.

References

  1. De Vita S, et al. Arthritis Rheumatol. 2012;64(3):843-53.

  2. Sneller MC, et al. Arthritis Rheumatol. 2012;64(3):835-42.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.3872

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