Biosimilars for vasculitis: promise requires validation by quality studies
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LETTER TO THE EDITOR
Biosimilars for vasculitis: promise requires validation by quality studies Durga Prasanna Misra 1
&
Pallavi Patro 2
&
Vikas Agarwal 1
Received: 14 July 2020 / Revised: 14 July 2020 / Accepted: 21 July 2020 # International League of Associations for Rheumatology (ILAR) 2020
Abbreviations AAV ANCA-associated vasculitis ANCA Anti-neutrophil cytoplasmic antibody BD Behcet’s disease GPA Granulomatosis with polyangiitis IFX Infliximab PET-CT Positron emission tomography computerized tomography RTX Rituximab TAK Takayasu arteritis
We read with great interest the recent description of the effectiveness of rituximab biosimilar for induction and maintenance of remission in granulomatosis with polyangiitis (GPA) [1]. The exploration of biosimilars in the management of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) [2] and other vasculitides addresses an important knowledge gap, due to potential cost-savings and wider accessibility for biosimilars in low- and middleincome countries for the treatment of these chronic diseases. Real-world evidence often provides valuable information in this regard, complementary to higher quality evidence from randomized controlled trials [3]. * Durga Prasanna Misra [email protected]; [email protected] Pallavi Patro [email protected] Vikas Agarwal [email protected]; [email protected] 1
Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow 226014, India
2
School of Telemedicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow 226014, India
Therefore, we reviewed the published literature on biosimilar use in vasculitis by conducting searches on Medline, PubMed Central and Scopus on 14 July 2020 with the search terms “biosimilar” and “vasculitis”. We could retrieve six observational studies (including the aforementioned article on rituximab in AAV) [1, 4–8], summarized in Table 1. The use of infliximab biosimilar in Behcet’s disease (BD) has been reported in small numbers of patients from Turkey and Italy. The first such available report described 3 patients with BD who all relapsed after switching from innovator infliximab to biosimilar infliximab [4]. However, later reports from Turkey of 6 patients reported continued remission in twothirds [5], and of 13 patients from Italy reported persistent remission of disease activity in a similar proportion at one year follow-up [6]. The use of infliximab biosimilar has also been reported in 11 patients with Takayasu arteritis (TAK) from South Korea. This study used a composite of clinical assessment, inflammatory markers as well as positron emission tomography computerized tomography (PET-CT) for assessing TAK disease activity in the cohort. Nine of the eleven patients were able to attain some degree of control of disease activity by 30 weeks of follow-up [7]. A prospective cohort of 51 patients with mixed cryoglobulinemic vasculitis from multiple centres in Italy treated with bios
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