Anita Bálint1, Klaudia Farkas1, Károly Palatka2, Lilla Lakner3, Pál Miheller4, István Rácz5, Gábor Hegede6, Áron Vincze7, Gábor Horváth8, Andrea Szabó5, Ferenc Nagy1, Zoltán Szepes1, Zoltán Gábor8, Ferenc Zsigmond9, Ágnes Zsóri10, Márk Juhász4, Ágnes Csontos4, Mónika Szűcs11, Renáta Bor1, Ágnes Milassin1, Mariann Rutka1, Tamás Molnár12. 1. 1st Department of Medicine, University of Szeged, Szeged, Hungary. 2. 2nd Department of Medicine, University of Debrecen, Debrecen, Hungary. 3. Markusovszky University Hospital, Szombathely, Hungary. 4. 2nd Department of Medicine, Semmelweis University, Budapest, Hungary. 5. Petz Aladár Country Hospital, Győr, Hungary. 6. Péterfy Sándor Street Hospital-Clinic and Emergency Center, Budapest, Hungary. 7. 1st Department of Internal Medicine, University of Pécs, Pécs, Hungary. 8. Semmelweis Hospital and University Hospital [MISEK], Miskolc, Hungary. 9. Military Hospital, Budapest, Hungary. 10. Kazincbarcika Hospital, Kazincbarcika, Hungary. 11. Department of Medical Physics and Informatics, University of Szeged, Szeged, Hungary. 12. 1st Department of Medicine, University of Szeged, Szeged, Hungary molnar.tamas@med.u-szeged.hu.
Abstract
BACKGROUND AND AIM: Adalimumab [ADA] was approved for the treatment of ulcerative colitis [UC] refractory to conventional therapy in 2012 in Europe. Due to the observed discrepancies between clinical trials and practice, data on the outcome of ADA therapy are really needed from the real life. The aim of this study was to estimate the short- and long-term efficacy and safety of ADA in UC patients from each Hungarian biological centre. PATIENTS AND METHODS: This prospective study consisted of UC patients treated with ADA in 10 Hungarian inflammatory bowel disease centres. The primary endpoints of the study were rates of continuous clinical response, remission, non-response and loss of response at Weeks 12, 30, and 52.The secondary endpoints included mucosal healing at Week 52 and the comparison of the efficacy of ADA between biological naive and infliximab [IFX]-treated groups. Colonoscopy was performed before starting the therapy and at Week 52. RESULTS: In all, 73 active UC patients were enrolled in the study: 67.1% of the patients received previous IFX therapy; 75.3% of the patients showed short-term clinical response at Week 12. The probability of maintaining ADA was 48.6% at Week 52 with a continuous clinical response in 92% of these remaining patients. Mucosal healing was achieved in 48.1% of the patients at Week 52. Escalation of ADA was performed in 17.6%, and minor side effects developed in 4% of the patients; 5.4% of the patients underwent colectomy during the 1-year treatment period. CONCLUSION: UC is a progressive disease that may need early aggressive therapy to prevent structural and functional complications. The results of our study demonstrated the favourable efficacy of short- and long-term ADA treatment for patients with UC.
BACKGROUND AND AIM: Adalimumab [ADA] was approved for the treatment of ulcerative colitis [UC] refractory to conventional therapy in 2012 in Europe. Due to the observed discrepancies between clinical trials and practice, data on the outcome of ADA therapy are really needed from the real life. The aim of this study was to estimate the short- and long-term efficacy and safety of ADA in UC patients from each Hungarian biological centre. PATIENTS AND METHODS: This prospective study consisted of UC patients treated with ADA in 10 Hungarian inflammatory bowel disease centres. The primary endpoints of the study were rates of continuous clinical response, remission, non-response and loss of response at Weeks 12, 30, and 52.The secondary endpoints included mucosal healing at Week 52 and the comparison of the efficacy of ADA between biological naive and infliximab [IFX]-treated groups. Colonoscopy was performed before starting the therapy and at Week 52. RESULTS: In all, 73 active UC patients were enrolled in the study: 67.1% of the patients received previous IFX therapy; 75.3% of the patients showed short-term clinical response at Week 12. The probability of maintaining ADA was 48.6% at Week 52 with a continuous clinical response in 92% of these remaining patients. Mucosal healing was achieved in 48.1% of the patients at Week 52. Escalation of ADA was performed in 17.6%, and minor side effects developed in 4% of the patients; 5.4% of the patients underwent colectomy during the 1-year treatment period. CONCLUSION: UC is a progressive disease that may need early aggressive therapy to prevent structural and functional complications. The results of our study demonstrated the favourable efficacy of short- and long-term ADA treatment for patients with UC.
Authors: Carlos Taxonera; Eva Iglesias; Fernando Muñoz; Marta Calvo; Manuel Barreiro-de Acosta; David Busquets; Xavier Calvet; Antonio Rodríguez; Ramón Pajares; Javier P Gisbert; Pilar López-Serrano; José Luís Pérez-Calle; Ángel Ponferrada; Cristóbal De la Coba; Fernando Bermejo; María Chaparro; David Olivares; Cristina Alba; Ignacio Fernández-Blanco Journal: Dig Dis Sci Date: 2016-12-19 Impact factor: 3.199
Authors: Marisa Iborra; Javier Pérez-Gisbert; Marta Maia Bosca-Watts; Alicia López-García; Valle García-Sánchez; Antonio López-Sanromán; Esther Hinojosa; Lucía Márquez; Santiago García-López; María Chaparro; Montserrat Aceituno; Margalida Calafat; Jordi Guardiola; Blanca Belloc; Yolanda Ber; Luis Bujanda; Belén Beltrán; Cristina Rodríguez-Gutiérrez; Jesús Barrio; José Luis Cabriada; Montserrat Rivero; Raquel Camargo; Manuel van Domselaar; Albert Villoria; Hugo Salata Schuterman; David Hervás; Pilar Nos Journal: J Gastroenterol Date: 2016-10-08 Impact factor: 7.527
Authors: Sara Rundquist; Michael C Sachs; Carl Eriksson; Ola Olén; Scott Montgomery; Jonas Halfvarson Journal: Aliment Pharmacol Ther Date: 2020-12-19 Impact factor: 8.171
Authors: Simon Travis; Brian G Feagan; Laurent Peyrin-Biroulet; Remo Panaccione; Silvio Danese; Andreas Lazar; Anne M Robinson; Joel Petersson; Brandee L Pappalardo; Mareike Bereswill; Naijun Chen; Song Wang; Martha Skup; Roopal B Thakkar; Jingdong Chao Journal: J Crohns Colitis Date: 2017-10-27 Impact factor: 9.071
Authors: Samba Siva Reddy Pulusu; Ashish Srinivasan; Krupa Krishnaprasad; Daniel Cheng; Jakob Begun; Charlotte Keung; Daniel Van Langenberg; Lena Thin; Tamara Mogilevski; Peter De Cruz; Graham Radford-Smith; Emma Flanagan; Sally Bell; Soleiman Kashkooli; Miles Sparrow; Simon Ghaly; Peter Bampton; Elise Sawyer; Susan Connor; Quart-Ul-Ain Rizvi; Jane M Andrews; Gillian Mahy; Paola Chivers; Simon Travis; Ian Craig Lawrance Journal: World J Gastroenterol Date: 2020-08-14 Impact factor: 5.742