Skip to main content

Advertisement

Log in

Experience with similar biologic rituximab in 77 patients of granulomatosis with polyangiitis—a real-life experience

  • Original Article
  • Published:
Clinical Rheumatology Aims and scope Submit manuscript

Abstract

Objectives

To present single centre experience on the efficacy and safety of similar biologic of rituximab in patients with granulomatosis with polyangiitis (GPA).

Methods

This was a retrospective study of GPA patients who received similar biologic of rituximab as either remission induction or maintenance agent. Demographic parameters, Birmingham Vasculitis Activity Score (BVAS-v3), vasculitis damage index, relapse and adverse events were retrieved from patient records. Outcomes noted were remission at 6 months in remission induction group and rates of relapses, adverse events, serious infections and mortality in both remission induction and maintenance groups.

Results

Seventy-seven GPA patients were enrolled. Sixty received rituximab for induction and 57 for maintenance; 69% were anti PR-3 positive. In the induction group, median BVAS-v3 reduced from 12 (IQR 6–21.5) to 0 (0–1) at 6 months. At 6 months, 60% patients attained remission, 40% in primary induction group and 74% in re-induction group (p = 0.016%). In the maintenance group, seven (12%) patients had relapses with median time to relapse of 12 (6–22) months. Median relapse free survival was 21 (6–22) months on rituximab maintenance. There were 12 deaths (15.6%) and 18 serious infections.

Conclusion

Similar biologic of rituximab was an effective agent for remission induction and remission maintenance in patients with GPA. Head to head trials with innovator molecule are needed to confirm these results.

Key Points:

• Remission was achieved in 60% of GPA patients who received similar biologic of rituximab as remission induction therapy.

• Relapse rate during maintenance phase was 12% with similar biologic of rituximab. Serious infections and mortality with similar biologic of rituximab were comparable with that reported previously in AAV trials.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Fauci AS, Wolff SM (1973) Wegener’s granulomatosis: studies in eighteen patients and a review of the literature. Medicine (Baltimore) 52(6):535–561

    Article  CAS  Google Scholar 

  2. Flossmann O, Berden A, de Groot K, Hagen C, Harper L, Heijl C, Höglund P, Jayne D, Luqmani R, Mahr A, Mukhtyar C, Pusey C, Rasmussen N, Stegeman C, Walsh M, Westman K, for the European Vasculitis Study Group (2011) Long-term patient survival in ANCA-associated vasculitis. Ann Rheum Dis 70(3):488–494

    Article  Google Scholar 

  3. Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS (1992) Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med 116(6):488–498

    Article  CAS  Google Scholar 

  4. Jones RB, Cohen Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA et al (2010) Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med 363(3):211–220

    Article  CAS  Google Scholar 

  5. Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CGM, St. Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U (2010) Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med 363(3):221–232

    Article  CAS  Google Scholar 

  6. Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaître O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quémeneur T, Blanchard-Delaunay C, Godmer P, Puéchal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L, French Vasculitis Study Group (2014) Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med 371(19):1771–1780

    Article  Google Scholar 

  7. Smith R, Jayne D, Merkel P (2019) A randomized, controlled trial of rituximab versus azathioprine after induction of remission with rituximab for patients with ANCA-associated vasculitis and relapsing disease [abstract]. Arthritis Rheumatol 71(suppl 10)

  8. Dörner T, Kay J (2015) Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol 11(12):713–724

    Article  Google Scholar 

  9. Kumar R, Singh J (2014) Biosimilar drugs: current status. Int J Appl Basic Med Res 4(2):63–66

    Article  Google Scholar 

  10. Roshique KK, Ravindran V (2015) Efficacy and safety of a biosimilar rituximab in biologic naïve patients with active rheumatoid arthritis. Clin Rheumatol 34(7):1289–1292

    Article  Google Scholar 

  11. Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CGM, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DGI, Specks U, Stone JH, Takahashi K, Watts RA (2013) 2012 revised international Chapel Hill Consensus conference nomenclature of vasculitides. Arthritis Rheum 65(1):1–11

    Article  CAS  Google Scholar 

  12. Watts R, Lane S, Hanslik T, Hauser T, Hellmich B, Koldingsnes W, Mahr A, Segelmark M, Cohen-Tervaert JW, Scott D (2007) Development and validation of a consensus methodology for the classification of the ANCA-associated vasculitides and polyarteritis nodosa for epidemiological studies. Ann Rheum Dis 66(2):222–227

    Article  Google Scholar 

  13. Hellmich B, Flossmann O, Gross WL, Bacon P, Cohen-Tervaert JW, Guillevin L et al (2007) EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis. Ann Rheum Dis 66(5):605–617

    Article  CAS  Google Scholar 

  14. Specks U, Fervenza FC, McDonald TJ, Hogan MC (2001) Response of Wegener’s granulomatosis to anti-CD20 chimeric monoclonal antibody therapy. Arthritis Rheum 44(12):2836–2840

    Article  CAS  Google Scholar 

  15. Keogh KA, Wylam ME, Stone JH, Specks U (2005) Induction of remission by B lymphocyte depletion in eleven patients with refractory antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum 52(1):262–268

    Article  Google Scholar 

  16. Keogh KA, Ytterberg SR, Fervenza FC, Carlson KA, Schroeder DR, Specks U (2006) Rituximab for refractory Wegener’s granulomatosis: report of a prospective, open-label pilot trial. Am J Respir Crit Care Med 173(2):180–187

    Article  CAS  Google Scholar 

  17. Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CGM, St. Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH (2013) Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med 369(5):417–427

    Article  CAS  Google Scholar 

  18. Thery-Casari C, Euvrard R, Mainbourg S, Durupt S, Reynaud Q, Durieu I, Belot A, Lobbes H, Cabrera N, Lega JC (2020) Severe infections in patients with anti-neutrophil cytoplasmic antibody-associated vasculitides receiving rituximab: a meta-analysis. Autoimmun Rev 19(5):102505

    Article  CAS  Google Scholar 

  19. Charles P, Guillevin L (2013) S3. Rituximab for ANCA-associated vasculitides: the French experience. 16th Int Vasc ANCA Workshop. 42(4, Part 2):534–6

  20. Charles P, Terrier B, Perrodeau É, Cohen P, Faguer S, Huart A, Hamidou M, Agard C, Bonnotte B, Samson M, Karras A, Jourde-Chiche N, Lifermann F, Gobert P, Hanrotel-Saliou C, Godmer P, Martin-Silva N, Pugnet G, Matignon M, Aumaitre O, Viallard JF, Maurier F, Meaux-Ruault N, Rivière S, Sibilia J, Puéchal X, Ravaud P, Mouthon L, Guillevin L, French Vasculitis Study Group (2018) Comparison of individually tailored versus fixed-schedule rituximab regimen to maintain ANCA-associated vasculitis remission: results of a multicentre, randomised controlled, phase III trial (MAINRITSAN2). Ann Rheum Dis 77(8):1143–1149

    Article  Google Scholar 

  21. Alberici F, Smith RM, Jones RB, Roberts DM, Willcocks LC, Chaudhry A, Smith KGC, Jayne DRW (2015) Long-term follow-up of patients who received repeat-dose rituximab as maintenance therapy for ANCA-associated vasculitis. Rheumatol Oxf Engl 54(7):1153–1160

    Article  CAS  Google Scholar 

  22. Little MA, Nightingale P, Verburgh CA, Hauser T, De Groot K, Savage C et al (2010) Early mortality in systemic vasculitis: relative contribution of adverse events and active vasculitis. Ann Rheum Dis 69(6):1036–1043

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Aman Sharma.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

ESM 1

(DOCX 19 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mittal, S., Naidu, G.S.R.S.N.K., Jha, S. et al. Experience with similar biologic rituximab in 77 patients of granulomatosis with polyangiitis—a real-life experience. Clin Rheumatol 40, 645–651 (2021). https://doi.org/10.1007/s10067-020-05261-7

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10067-020-05261-7

Keywords

Navigation