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J Gastroenterol. 2017 Jul;52(7):788-799. doi: 10.1007/s00535-016-1274-1. Epub 2016 Oct 8.

Effectiveness of adalimumab for the treatment of ulcerative colitis in clinical practice: comparison between anti-tumour necrosis factor-naïve and non-naïve patients.

Author information

1
Gastroenterology Department and CIBEREHD, Hospital Universitari i Politecnic La Fe, Avinguda de Fernando Abril Martorell, no 106, 46026, Valencia, Spain. marisaiborra@hotmail.com.
2
Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
3
Gastroenterology Department, Hospital Clínic Universitari de Valencia and INCLIVA Health Research Institute, Valencia, Spain.
4
Departamento de Gastroenterología, Hospital Clinic i Provincial, C/Villarroel 170, 08036, Barcelona, Spain.
5
Hospital Reina Sofía, IMIBIC, Universidad de Córdoba, Córdoba, Spain.
6
Gastroenterology Department, Hospital Ramón y Cajal, Madrid, Spain.
7
Servicio de Medicina Digestivo, Hospital de Manises, Valencia, Spain.
8
Metgessa adjunta. Servei de Digestiu, Parc de Salut Mar, Barcelona, Spain.
9
Departamento de Gastroenterología, Hospital Universitario Miguel Servet, Saragossa, Spain.
10
Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
11
Hospital Universitari Mútua Terrassa, Plaça Doctor Robert, 08221, Terrassa, Barcelona, Spain.
12
Servei d'Aparell Digestiu, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
13
Digestive Diseases Department, Hospital Universitari de Bellvitge-IDIBELL, Barcelona, Spain.
14
Hospital San Jorge Huesca, Avenida Martínez de Velasco 36, 22004, Huesca, Spain.
15
Médico adjunto, Servicio de Aparato Digestivo, Hospital Clínico Universitario "Lozano Blesa", IIS Aragón., CIBEREHD, Saragossa, Spain.
16
Department of Gastroenterology, Hospital Donostia/Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Universidad del País Vasco (UPV/EHU), San Sebastián, Guipúzcoa, Spain.
17
Gastroenterology Department, Hospital Universitari i Politecnic La Fe, CIBEREHD, Valencia, Spain.
18
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.
19
Servicio de Gastroenterología, Hospital Universitario Río Hortega, C/Dulzaina, no 2, 47012, Valladolid, Spain.
20
Hospital de Galdakao, Galdakao, Bilbao, Spain.
21
Hospital Universitario Marqués de Valdecilla, Santander, Spain.
22
Gastroenterology Department, Hospital Clínico Virgen de la Victoria, Málaga, Spain.
23
Hospital Universitario de Torrejón, C/Mateo Inurria, s/n, 28850, Torrejón de Ardoz, Madrid, Spain.
24
Servei de Malalties Digestives, Hospital Parc Tauli de Sabadell, Departament de Medicina, Universitat Autònoma de Barcelona, CIBEREHD-Instituto de Salud Carlos III, Barcelona, Spain.
25
Hospital Nuestra Señora de la Candelaria, Tenerife, Islas Canarias, Spain.
26
Unidad Bioestadística, Instituto de Investigación Sanitaria La Fe, Valencia, Spain.
27
Gastroenterology Department, CIBEREHD, Hospital Universitari i Politecnic La Fe, Valencia, Spain.

Abstract

BACKGROUND:

Ulcerative colitis (UC) treatment is focused to achieve mucosal healing, avoiding disease progression. The study aimed to evaluate the real-world effectiveness of adalimumab (ADA) in UC and to identify predictors of remission to ADA.

METHODS:

This cohort study used data from the ENEIDA registry. Clinical response, clinical remission, endoscopic remission, adverse events (AE), colectomy, and hospitalisations were evaluated; baseline characteristics and biological parameters were compared to determine predictors of response.

RESULTS:

We included 263 patients (87 naïve and 176 previously exposed to anti-tumour necrosis factor alpha, TNF). After 12 weeks, clinical response, clinical remission, and endoscopic remission rates were 51, 26, and 14 %, respectively. The naïve group demonstrated better response to treatment than the anti-TNF-exposed group at short-term. Clinical and endoscopic remission within 1 year of treatment was better in the naïve group (65 vs. 49 and 50 vs. 35 %, respectively). The rates of AE, dose-escalation, hospitalisations, and colectomy during the first year were higher in anti-TNF-exposed patients (40, 43, and 27 % vs. 26, 21, and 11 %, respectively). Patients with primary failure and intolerance to the first anti-TNF and severe disease were associated with worse clinical response. Primary non-response to prior anti-TNF treatment and severe disease were predictive of poorer clinical remission. Low levels of C-reactive protein (CRP) and faecal calprotectin (FC) at baseline were predictors of clinical remission.

CONCLUSIONS:

In clinical practice, ADA was effective in UC, especially in anti-TNF naïve patients. FC and CRP could be predictors of treatment effectiveness.

KEYWORDS:

Adalimumab; Treatment; Ulcerative colitis

PMID:
27722996
DOI:
10.1007/s00535-016-1274-1
[Indexed for MEDLINE]

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