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Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar(CT-P13)in patients with inflammatory bowel disease

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World Journal of Gastroenterology 2018年第46期24卷 5288-5296页

作者： María Fernanda Guerra Veloz Federico Argüelles-Arias Luisa Castro Laria Belén Maldonado Pérez antonio benítez roldan Raúl Perea Amarillo Vicente Merino Bohórquez Miguel Angel Calleja Angel Caunedo Alvarez Angel Vilches Arenas Department of Gastroenterology University Hospital Virgen MacarenaSeville 41007Spain Pharmacy Unit University Hospital Virgen MacarenaSeville 41007Spain Preventive Medicine and Public Health University Hospital Virgen MacarenaSeville 41007Spain

BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases(IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with *** An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar(CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the ***98 patients(CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar(P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar(P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar(CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

关键词： Crohn’s disease Ulcerative colitis CT-P13 Inflammatory bowel disease Biosimilar agent Infliximab original Efficacy

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Rethinking de novo immune hepatitis,an old concept for liver allograft rejection:relevance of glutathione S-transferase T1 mismatch

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World Journal of Gastroenterology 2018年第29期24卷 3239-3249页

作者： Isabel Aguilera Elena Aguado-Dominguez Jose Manuel Sousa antonio Nunez-roldan Department of Immunology Instituto de Biomedicina de Sevilla(IBIS)Hospital Universitario Virgen del RocíoSevilla 41013Spain Digestive and Liver Diseases Service Hospital Universitario Virgen del RocíoSevilla 41013Spain

Antibody-mediated rejection(AMR) in liver transplantation has long been underestimated. The concept of the liver as an organ susceptible to AMR has emerged in recent years, not only in the context of the major histocompatibility complex with the presence of HLA donor-specific antibodies, but also with antigens regarded as "minor", whose role in AMR has been demonstrated. Among them, antibodies against glutathione S-transferase T1 have been found in 100% of patients with de novo autoimmune hepatitis(dn AIH) when studied. In its latest update, the Banff Working Group for liver allograft pathology proposed replacing the term dn AIH with plasma cell(PC)-rich rejection. Antibodies to glutathione S-transferase T1(GSTT1) in null recipients of GSTT1 positive donors have been included as a contributory but nonessential feature of the diagnosis of PC-rich rejection. Also in this update, non-organ-specific anti-nuclear or smooth muscle autoantibodies are no longer included as diagnostic criteria. Although initially found in a proportion of patients with PC-rich rejection, the presence of autoantibodies is misleading since they are not diseasespecific and appear in many different contexts as bystanders. The cellular types and proportions of the inflammatory infiltrates in diagnostic biopsies have been studied in detail very recently. PC-rich rejection biopsies present a characteristic cellular profile with a predominance of T lymphocytes and a high proportion of PCs, close to 30%, of which 16.48% are Ig G4+. New data on the relevance of GSTT1-specific T lymphocytes to PC-rich rejection will be discussed in this review.

关键词： glutathione S-transferase T1 mismatch liver allograft rejection plasma cell-rich rejection de novo autoimmune hepatitis donor-specific antibodies newCAST cell quantification IgG4+plasma cell T lymphocytes

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