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P127 Anti-TNFs patterns of use in clinical practice in inflammatory bowel disease (VERNE study)

G. Bastida*1,2, I. Marín-Jiménez3,4, A. Forés5, E. García-Planella6, F. Argüelles-Arias7, P. Sarasa8, I. Tagarro8, A. Fernández-Nistal8, C. Montoto8, M. Aguas1,2, J. Santos-Fernández9, M. Boscá10, R. Ferreiro-Iglesias11, O. Merino12, X. Aldeguer13, X. Cortés14,15, B. Sicilia16, F. Mesonero17, M. Barreiro-de Acosta11

1Hospital La Fe, Valencia, Spain, 2Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBEREHD), Valencia, Spain, 3Hospital Gregorio Marañón, Department of Gastroenterology, Madrid, Spain, 4Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain, 5Hospital General Universitario de Castellón, Castellón, Spain, 6Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, 7Hospital Universitario Virgen Macarena, Sevilla, Spain, 8Takeda Farmacéutica España SA, Madrid, Spain, 9Hospital Universitario Río Hortega, Department of Gastroenterology, Valladolid, Spain, 10University Clinic Hospital of Valencia, IBD Unit, Gastroenterology Department, Valencia, Spain, 11Hospital Clínico Universitario de Santiago, Department of Gastroenterology, Santiago de Compostela, Spain, 12Hospital Universitario Cruces, Department of Gastroenterology, Bilbao, Spain, 13Hospital Dr. Josep Trueta, Department of Gastroenterology, Girona, Spain, 14Hospital de Sagunto, IBD Unit, Gastroenterology Section, Sagunto, Spain, 15University of Cardenal Herrera-CEU, Castellón, Spain, 16Hospital Universitario de Burgos, Burgos, Spain, 17Hospital Ramón y Cajal, Department of Gastroenterology, Madrid, Spain

Background

Anti-TNFs represent one of the main treatment strategies for the management of IBD. One of the aims of this study was to learn about the patterns of the use of anti-TNFs therapies in Spain when used in biologic-naïve patients for the treatment of IBD.

Methods

VERNE was a retrospective, non-interventional study, conducted in 24 hospitals in Spain. 310 adult patients who started first treatment with anti-TNFs between June 2011 and June 2013 (194 with CD and 116 with UC) were consecutive recruited. Data about patient characteristics (including comorbidities and extraintestinal manifestations) and anti-TNF management were collected. Studied variables were analysed descriptively. Kaplan–Meier analyses were used to evaluate time to treatment intensification and time to discontinuation.

Results

Median time from diagnosis to first anti-TNF use was 45.5 months (IQR 25–75: 11.1–150.2) (45.5 months in CD and 43.8 months in UC), and median follow-up time after administration of the anti-TNFs was 59.8 months (IQR 25–75: 53.3–65.6) (59.8 months in both CD and UC). Comparable fractions of patients used infliximab and adalimumab in CD (43.8% vs. 56.2%). However, in UC infliximab was preferred to adalimumab use (87.1% vs. 12.9%).

Treatment intensification was needed for 31.9% of patients (28.9% in CD and 37.1% in UC). The most common treatment intensification approach was the combination of dose escalation and interval shortening; it was reported in 43.4% of intensified patients (41.1% in CD and 46.5% in UC). The median time to intensification was 9.2 months (IQR 25–75: 3.5–23.3) (14.3 months in CD and 5.3 months in UC). Treatment intensification rates were similar for infliximab and adalimumab, and median time to intensification was longer for adalimumab than for infliximab (10.6 vs. 8.2 months).

Treatment discontinuation occurred in 50.6% of patients (47.4% in CD and 56.0% in UC). The most common cause for discontinuation was loss of response, reported in 29.9% of patients (30.4% in CD and 29.2% in UC). Adverse events accounted for 20.4% of discontinuations (21.7% in CD and 18.5% in UC). Median time to discontinuation was 20.9 months (IQR 25–75: 7.2-37-3) (24.7% in CD and 17.4% in UC).

Conclusion

Around one third of bio-naïve patients who started anti-TNF treatment required intensification, and one in every two discontinued therapy, with loss of response as the most common cause for discontinuation. Further investigations are needed to optimise anti-TNF management and to identify patients’ groups which can benefit from alternative biologic therapies.