Advertisement

Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study

  • Author Footnotes
    1 Both authors equally contributed.
    Emanuel Della-Torre
    Correspondence
    Corresponding author. Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS-San Raffaele Scientific Institute, via Olgettina 60, 20132, Milan.
    Footnotes
    1 Both authors equally contributed.
    Affiliations
    Università Vita-Salute San Raffaele, All at IRCCS San Raffaele Scientific Institute, Milan, Italy

    Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Author Footnotes
    1 Both authors equally contributed.
    Marco Lanzillotta
    Footnotes
    1 Both authors equally contributed.
    Affiliations
    Università Vita-Salute San Raffaele, All at IRCCS San Raffaele Scientific Institute, Milan, Italy

    Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Corrado Campochiaro
    Affiliations
    Università Vita-Salute San Raffaele, All at IRCCS San Raffaele Scientific Institute, Milan, Italy

    Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Giulia Di-Colo
    Affiliations
    Università Vita-Salute San Raffaele, All at IRCCS San Raffaele Scientific Institute, Milan, Italy

    Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Gaia Mancuso
    Affiliations
    Università Vita-Salute San Raffaele, All at IRCCS San Raffaele Scientific Institute, Milan, Italy

    Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Gabriele Capurso
    Affiliations
    Pancreato-Biliary Endoscopy and Endosonography Division, All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Massimo Falconi
    Affiliations
    Università Vita-Salute San Raffaele, All at IRCCS San Raffaele Scientific Institute, Milan, Italy

    Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Lorenzo Dagna
    Affiliations
    Università Vita-Salute San Raffaele, All at IRCCS San Raffaele Scientific Institute, Milan, Italy

    Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), All at IRCCS San Raffaele Scientific Institute, Milan, Italy
    Search for articles by this author
  • Author Footnotes
    1 Both authors equally contributed.
Published:December 29, 2020DOI:https://doi.org/10.1016/j.ejim.2020.12.006

      Highlights

      • High costs limit rituximab wide off-label administration in IgG4-related disease
      • Biosimilars are used in alternative to originators in many autoimmune disorders
      • Rituximab biosimilar CT-P10 is safe and effective in IgG4-related disease
      • This study first reports on a rituximab biosimilar in IgG4-related disease

      Abstract

      Objective

      Rituximab is increasingly used in IgG4-related disease (IgG4-RD) but high costs limit its wide off-label administration. European and US regulatory agencies have recently approved rituximab biosimilars for the treatment of different rheumatologic and hematological conditions. No data are available, yet, on the efficacy and safety of rituximab biosimilars for the treatment of IgG4-RD. Scope of the present work is to evaluate the efficacy and safety of the rituximab biosimilar CT-P10 (RTX-B) in patients with IgG4-RD.

      Methods

      Patients with active IgG4-RD, naïve to rituximab or switched from the originator (RTX-O) to the biosimilar were treated with RTX-B and prospectively followed-up for 18 months. Safety and efficacy were assessed at six months. Relapse rate was assessed at 18 months. Disease activity was assessed by means of the IgG4-RD Responder Index (IgG4-RD RI).

      Results

      Thirty-eight patients were included in this study. Thirty-three patients (87%) were naïve to RTX. Five patients (13%) relapsed after RTX-O and were switched to RTX-B. After six months, 21 patients (60%) achieved disease remission. The median serum IgG4 concentration decreased from 1344 to 575 mg/L (p < 0.01), and the median IgG4-RD RI decreased from 7.5 to 0 (p < 0.01). B-cell depletion was observed in all patients. Eight patients (36%) relapsed within 18 months. Side effects related to RTX-B administration were observed in 14 patients (37%). These results are in line with our previous experience with RTX-O.

      Conclusions

      The (TruximaTM) rituximab biosimilar CT-P10 represents a safe and effective alternative to rituximab originator for the treatment of IgG4-RD.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to European Journal of Internal Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Lanzillotta M
        • Mancuso G
        • Della-Torre E.
        Advances in the diagnosis and management of IgG4 related disease.
        BMJ. 2020; 369: m1067https://doi.org/10.1136/bmj.m1067
        • Bledsoe JR
        • Della-Torre E
        • Rovati L
        • Deshpande V.
        IgG4-related disease: review of the histopathologic features, differential diagnosis, and therapeutic approach.
        APMIS. 2018; 126: 459-476
        • Della-Torre E
        • Stone JH.
        How I manage" IgG4-Related Disease.
        J Clin Immunol. 2016; 36: 754-763
        • Della-Torre E
        • Mattoo H
        • Mahajan VS
        • et al.
        IgG4-related midline destructive lesion.
        Ann Rheum Dis. 2014; 73: 1434-1436
        • Lanzillotta M
        • Campochiaro C
        • Mancuso G
        • et al.
        Clinical phenotypes of IgG4-related disease reflect different prognostic outcomes. Rheumatology (Oxford).
        2020https://doi.org/10.1093/rheumatology/keaa221
        • Deshpande V
        • Zen Y
        • Chan JK
        • et al.
        Consensus statement on the pathology of IgG4-related disease.
        Mod Pathol. 2012; 25: 1181-1192
        • Khosroshahi A
        • Wallace ZS
        • Crowe JL
        • et al.
        International Consensus Guidance Statement on the Management and Treatment of IgG4-Related Disease.
        Arthritis Rheumatol. 2015; 67: 1688-1699
        • Wallace ZS
        • Naden RP
        • Chari S
        • et al.
        The 2019 American College of Rheumatology/European League Against Rheumatism Classification Criteria for IgG4-Related Disease.
        Arthritis Rheumatol. 2019; https://doi.org/10.1002/art.41120
        • Della-Torre E
        • Bozzalla-Cassione E
        • Sciorati C
        • et al.
        A CD8α- Subset of CD4+SLAMF7+ Cytotoxic T Cells Is Expanded in Patients With IgG4-Related Disease and Decreases Following Glucocorticoid Treatment.
        Arthritis Rheumatol. 2018; 70: 1133-1143
        • Della-Torre E
        • Rigamonti E
        • Perugino C
        • et al.
        B lymphocytes directly contribute to tissue fibrosis in patients with IgG4-related disease.
        J Allergy Clin Immunol. 2020; 145: 968-981
        • Lanzillotta M
        • Della-Torre E
        • Milani R
        • et al.
        Effects of glucocorticoids on B-cell subpopulations in patients with IgG4-related disease.
        Clin Exp Rheumatol. 2019; 37: 159-166
        • Della-Torre E
        • Feeney E
        • Deshpande V
        • et al.
        B-cell depletion attenuates serological biomarkers of fibrosis and myofibroblast activation in IgG4-related disease.
        Ann Rheum Dis. 2015; 74: 2236-2243
        • Berti A
        • Della-Torre E
        • Gallivanone F
        • et al.
        Quantitative measurement of 18F-FDG PET/CT uptake reflects the expansion of circulating plasmablasts in IgG4-related disease.
        Rheumatology (Oxford). 2017; 56: 2084-2092
        • Ebbo M
        • Grados A
        • Samson M
        • et al.
        Long-term efficacy and safety of rituximab in IgG4-related disease: Data from a French nationwide study of thirty-three patients.
        PLoS One. 2017; 12e0183844
        • Carruthers MN
        • Topazian MD
        • Khosroshahi A
        • et al.
        Rituximab for IgG4-related disease: a prospective, open-label trial.
        Ann Rheum Dis. 2015; 74: 1171-1177
        • Campochiaro C
        • Della-Torre E
        • Lanzillotta M
        • et al.
        Long-term efficacy of maintenance therapy with Rituximab for IgG4-related disease.
        Eur J Intern Med. 2020; 74: 92-98
        • Sarzi-Puttini P
        • Marotto D
        • Caporali R
        • et al.
        Biosimilars vs originators: Are they the same?.
        Autoimmun Revev. 2019; 18102404
        • Vacchi C
        • Visentini M
        • Gragnani L
        • et al.
        Safety and effectiveness of biosimilar of Rituximab CT-P10 in the treatment of cryoglobulinemic vasculitis: the MARBLe study (Mixed cryoglobulinemiA Rituximab BiosimiLar).
        Intern Emerg Med. 2020; https://doi.org/10.1007/s11739-020-02386-0
        • Lee K
        • Ha JY
        • Jung AR
        • et al.
        The clinical outcomes of rituximab biosimilar CT-P10 (Truxima(®)) with CHOP as first-line treatment for patients with diffuse large B-cell lymphoma: real-world experience.
        Leuk Lymphoma. 2020; https://doi.org/10.1080/10428194.2020.1742906
        • Wallace ZS
        • Khosroshahi A
        • Carruthers MD
        • et al.
        An International Multispecialty Validation Study of the IgG4-Related Disease Responder Index.
        Arthritis Care Res (Hoboken). 2018; 70: 1671-1678
        • Wallace ZS
        • Zhang Y
        • Perugino CA
        • et al.
        Clinical phenotypes of IgG4-related disease: an analysis of two international cross-sectional cohorts.
        Ann Rheum Dis. 2019; 78: 406-412
        • Benucci M
        • Iannazzo S
        • Zaniolo O
        • Sabadini L.
        Rituximab in the treatment of rheumatoid arthritis patients in Italy: a budget impact analysis.
        Clin exp Rheumatol. 2010; 28: 722-727