Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort

被引：140

作者：

Gecse, Krisztina B. ^{[1
]}

Lovasz, Barbara D. ^{[1
]}

Farkas, Klaudia ^{[2
]}

Banai, Janos ^{[3
]}

Bene, Laszlo ^{[4
]}

Gasztonyi, Beata ^{[5
]}

Golovics, Petra Anna ^{[1
]}

Kristof, Tuende ^{[6
]}

Lakatos, Laszlo ^{[7
]}

Csontos, Agnes Anna ^{[8
]}

Juhasz, Mark ^{[8
]}

Nagy, Ferenc ^{[2
]}

Palatka, Karoly ^{[9
]}

Papp, Maria ^{[9
]}

Patai, Arpad ^{[10
]}

Lakner, Lilla ^{[10
]}

Salamon, Agnes ^{[11
]}

Szamosi, Tamas ^{[3
]}

Szepes, Zoltan ^{[2
]}

Toth, Gabor T. ^{[12
]}

Vincze, Aron ^{[13
]}

Szalay, Balazs ^{[14
]}

Molnar, Tamas ^{[2
]}

Lakatosa, Peter L. ^{[1
]}

机构：

[1] Semmelweis Univ, Dept Internal Med 1, H-1085 Budapest, Hungary

[2] Univ Szeged, Dept Internal Med 1, Szeged, Hungary

[3] Hungarian Def Forces, Med Ctr, Budapest, Hungary

[4] Peterfy Hosp, Dept Internal Med 1, Budapest, Hungary

[5] Zala Cty Hosp, Dept Med 2, Zalaegerszeg, Hungary

[6] BAZ Cty & Univ Teaching Hosp, Dept Med 2, Miskolc, Hungary

[7] Csolnoky Ferenc Reg Hosp, Dept Internal Med, Veszprem, Hungary

[8] Semmelweis Univ, Dept Internal Med 2, H-1085 Budapest, Hungary

[9] Univ Debrecen, Fac Med, Dept Internal Med, Div Gastroenterol, Debrecen, Hungary

[10] Markusovszky Hosp, Dept Med & Gastroenterol, Szombathely, Hungary

[11] Tolna Cty Teaching Hosp, Dept Gastroenterol, Szekszard, Hungary

[12] Janos Hosp, Dept Gastroenterol, Budapest, Hungary

[13] Univ Pecs, Dept Med 1, Pecs, Hungary

[14] Semmelweis Univ, Dept Lab Med, H-1085 Budapest, Hungary

来源：

JOURNAL OF CROHNS & COLITIS | 2016年 / 10卷 / 02期

关键词：

Biosimilar; CT-P13; Crohn's disease; efficacy; immunogenicity; inflammatory bowel diseases; infliximab; safety; ulcerative colitis; CROHNS-DISEASE; DOUBLE-BLIND; INNOVATOR INFLIXIMAB; MAINTENANCE THERAPY; POSITION STATEMENT; ULCERATIVE-COLITIS; INDUCTION THERAPY; PARALLEL-GROUP; PHARMACOKINETICS; ANTIBODIES;

D O I：

10.1093/ecco-jcc/jjv220

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background and Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. Methods: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. Results: In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naive, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. Conclusions: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.

引用

页码：133 / 140

页数：8

共 30 条

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