Effectiveness and Safety of Golimumab in Treating Outpatient Ulcerative Colitis: A Real-Life Prospective, Multicentre, Observational Study in Primary Inflammatory Bowel Diseases Centers

被引：22

作者：

Tursi, Antonio ^{[1
]}

Allegretta, Leonardo ^{[2
]}

Buccianti, Nello ^{[3
]}

Della Valle, Nicola ^{[4
]}

Elisei, Walter ^{[5
]}

Forti, Giacomo ^{[6
]}

Faggiani, Roberto ^{[7
]}

Gallina, Sara ^{[7
]}

Hadad, Yusef ^{[8
]}

Larussa, Tiziana ^{[9
]}

Lauria', Angelo ^{[10
]}

Luzza, Francesco ^{[9
]}

Lorenzetti, Roberto ^{[11
]}

Mocci, Giammarco ^{[12
]}

Penna, Antonio ^{[13
]}

Polimeni, Natale ^{[10
]}

Pranzo, Giuseppe ^{[14
]}

Ricciardelli, Cristina ^{[15
]}

Zampalette, Costantino ^{[7
]}

Picchio, Marcello ^{[16
]}

机构：

[1] ASL BAT, Gastroenterol Serv, Andria, Italy

[2] Santa Caterina Novella Hosp, Div Gastroenterol, Galatina, LE, Italy

[3] Madonna Grazie Hosp, Div Internal Med, Matera, Italy

[4] AO Osped Riuniti, Div Gastroenterol, Foggia, Italy

[5] ASL Roma 6, Div Gastroenterol, Rome, Italy

[6] S Maria Goretti Hosp, Div Digest Endoscopy, Latina, Italy

[7] Belcolle Hosp, Div Gastroenterol, Viterbo, Italy

[8] Card Panico Hosp, Div Internal Med, Tricase, LE, Italy

[9] Univ Catanzaro, Dept Hlth Sci, Catanzaro, Italy

[10] AO Bianchi Melacrino Morelli, Div Gastroenterol, Reggio Di Calabria, Italy

[11] PTP Nuovo Regina Margherita, Div Gastroenterol, Rome, Italy

[12] Brotzu Hosp, Div Gastroenterol, Cagliari, Italy

[13] S Paolo Hosp, Div Gastroenterol, Bari, Italy

[14] Valle DItria Hosp, Ambulatory IBD Treatment, Martina Franca, TA, Italy

[15] Div Veris Delli Ponti Hosp, Scorrano, LE, Italy

[16] ASL Roma 6, P Colombo Hosp, Div Gen Surg, Rome, Italy

来源：

JOURNAL OF GASTROINTESTINAL AND LIVER DISEASES | 2017年 / 26卷 / 03期

关键词：

induction; golimumab; remission; treatment; ulcerative colitis; ACTIVE RHEUMATOID-ARTHRITIS; NECROSIS-FACTOR-ALPHA; PRIMARY GASTROENTEROLOGY CENTERS; EVIDENCE-BASED CONSENSUS; EVERY; WEEKS; ANTI-TNF; CLINICAL-RESPONSE; MONOCLONAL-ANTIBODY; INDUCTION THERAPY; PHASE-III;

D O I：

10.15403/jgld.2014.1121.263.trs

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background & Aims: Golimumab (GOL) has been recently approved in Italy for the treatment of ulcerative colitis (UC) unresponsive to standard treatments. Our aims were to assess the real-life efficacy and safety of GOL in managing UC outpatients in Italian primary Inflammatory Bowel Diseases (IBD) centres. Methods: Consecutive UC outpatients with at least 3-months follow-up were enrolled. Primary end-point was the induction and maintenance of remission in UC, defined as Mayo score at 6-month follow-up. Results: Ninety-three patients were enrolled. At 6-month follow-up, remission was obtained in 34 (36.5%) patients. Shorter duration of disease was the only significant predictive factor of remission. Clinical response was achieved in 60 (64.5%) patients, while mucosal healing (MH) was obtained in 18 (19.3%) patients. Sixteen (47.0%) patients under remission were still under therapy with steroids. C-reactive protein and fecal calprotectin significantly dropped during the follow-up (p<0.001 for both proteins). Adverse events occurred in 4 (4.3%) patients and 3 of them stopped treatment. Colectomy was performed in only one patient (1.1%). Conclusions: Golimumab seems to be safe and effective in inducing and maintaining remission in real life UC outpatients.

引用

页码：239 / 244

页数：6

共 30 条

[1] Real-life outcome of anti-tumor necrosis factor α in the ambulatory treatment of ulcerative colitis [J].

Baki, Enayatullah ;

Zwickel, Philipp ;

Zawierucha, Anna ;

Ehehalt, Robert ;

Gotthardt, Daniel ;

Stremmel, Wolfgang ;

Gauss, Annika .

WORLD JOURNAL OF GASTROENTEROLOGY, 2015, 21 (11) :3282-3290

[2]

Berends S, 2016, J CROHNS COLITIS, V10, pS424

[3] Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study [J].

Braun, Juergen ;

Deodhar, Atul ;

Inman, Robert D. ;

van der Heijde, Desiree ;

Mack, Michael ;

Xu, Stephen ;

Hsu, Benjamin .

ANNALS OF THE RHEUMATIC DISEASES, 2012, 71 (05) :661-667

[4] Variability in Golimumab Exposure: A 'Real-Life' Observational Study in Active Ulcerative Colitis [J].

Detrez, Iris ;

Dreesen, Erwin ;

Van Stappen, Thomas ;

de Vries, Annick ;

Brouwers, Els ;

Van Assche, Gert ;

Vermeire, Severine ;

Ferrante, Marc ;

Gils, Ann .

JOURNAL OF CROHNS & COLITIS, 2016, 10 (05) :575-581

[5] Second European evidence-based consensus on the diagnosis and management of ulcerative colitis Part 1: Definitions and diagnosis [J].

Dignass, Axel ;

Eliakim, Rami ;

Magro, Fernando ;

Maaser, Christian ;

Chowers, Yehuda ;

Geboes, Karel ;

Mantzaris, Gerassimos ;

Reinisch, Walter ;

Colombel, Jean-Frederic ;

Vermeire, Severine ;

Travis, Simon ;

Lindsay, James O. ;

Van Assche, Gert .

JOURNAL OF CROHNS & COLITIS, 2012, 6 (10) :965-990

[6] Second European evidence-based consensus on the diagnosis and management of ulcerative colitis Part 2: Current management (Publication with Expression of Concern) [J].

Dignass, Axel ;

Lindsay, James O. ;

Sturm, Andreas ;

Windsor, Alastair ;

Colombel, Jean-Frederic ;

Allez, Mathieu ;

D'Haens, Gert ;

D'Hoore, Andre ;

Mantzaris, Gerassimos ;

Novacek, Gottfried ;

Oeresland, Tom ;

Reinisch, Walter ;

Sans, Miquel ;

Stange, Eduard ;

Vermeire, Severine ;

Travis, Simon ;

Van Assche, Gert .

JOURNAL OF CROHNS & COLITIS, 2012, 6 (10) :991-1030

[7] Golimumab, a Human Anti-Tumor Necrosis Factor α Monoclonal Antibody, Injected Subcutaneously Every Four Weeks in Methotrexate-Naive Patients With Active Rheumatoid Arthritis Twenty-Four-Week Results of a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Golimumab Before Methotrexate as First-Line Therapy for Early-Onset Rheumatoid Arthritis [J].

Emery, Paul ;

Fleischmann, Roy M. ;

Moreland, Larry W. ;

Hsia, Elizabeth C. ;

Strusberg, Ingrid ;

Durez, Patrick ;

Nash, Peter ;

Amante, Eric Jason B. ;

Churchill, Melvin ;

Park, Won ;

Antonio Pons-Estel, Bernardo ;

Doyle, Mittie K. ;

Visvanathan, Sudha ;

Xu, Weichun ;

Rahman, Mahboob U. .

ARTHRITIS AND RHEUMATISM, 2009, 60 (08) :2272-2283

[8] Systematic review with meta-analysis: the efficacy of a second anti-TNF in patients with inflammatory bowel disease whose previous anti-TNF treatment has failed [J].

Gisbert, J. P. ;

Marin, A. C. ;

McNicholl, A. G. ;

Chaparro, M. .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2015, 41 (07) :613-623

[9] Golimumab in psoriatic arthritis: One-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial [J].

Kavanaugh, Arthur ;

van der Heijde, Desiree ;

McInnes, Iain B. ;

Mease, Philip ;

Krueger, Gerald G. ;

Gladman, Dafna D. ;

Gomez-Reino, Juan ;

Papp, Kim ;

Baratelle, Anna ;

Xu, Weichun ;

Mudivarthy, Surekha ;

Mack, Michael ;

Rahman, Mahboob U. ;

Xu, Zhenhua ;

Zrubek, Julie ;

Beutler, Anna .

ARTHRITIS AND RHEUMATISM, 2012, 64 (08) :2504-2517

[10] Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate [J].

Kay, Jonathan ;

Matteson, Eric L. ;

Dasgupta, Bhaskar ;

Nash, Peter ;

Durez, Patrick ;

Hall, Stephen ;

Hsia, Elizabeth C. ;

Han, John ;

Wagner, Carrie ;

Xu, Zhenhua ;

Visvanathan, Sudha ;

Rahman, Mahboob U. .

ARTHRITIS AND RHEUMATISM, 2008, 58 (04) :964-975

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