Search in the Abstract Database

Search Abstracts 2013

* = Presenting author

P564. Clinical response, quality of life and work activity in patients with Crohn's disease treated with adalimumab in routine clinical practice

C. Saro1, D. Ceballos2, F. Muñoz3, C. De la Coba1, M.D. Aguilar4, P. Lazaro4, 1Cabueñes Hospital, Spain, 2Dr. Negrín Hospital, Spain, 3Hospital de León, León, Spain, 4TAISS, Madrid, Spain

Background

Several clinical trials have demonstrated the efficacy of adalimumab (ADA) for inducing and maintaining clinical response in patients with Crohn's disease (CD). The aim of the study was to determine the effectiveness, measured as clinical response, quality of life (QoL) and work activity, of ADA in CD patients in routine clinical practice.

Methods

Multicentre prospective observational cohort study with follow up of 12 months. Inclusion criteria: Patients with CD naïve to biologics, in which the doctor prescribes ADA according to routine clinical practice. In the medical visit at the beginning of the biologic treatment (V0), sociodemographic variables, Crohn's Disease Activity Index (CDAI), Perianal Disease Activity Index (PDAI), quality of life (QoL) indices [Inflammatory Bowel Disease Questionnaire (IBDQ-9) and EuroQol five dimensions (EQ-5D)] and Work Productivity Activity Index (WPAI) were collected. Such data were again recorded 12 months later (V12). When the data distribution was normal, the mean (±SD) were used as statistics. When the data distribution was not normal, the median (Percentil25–percentil75) were used. For hypothesis testing, parametric or nonparametric tests were used according to the data distribution. Differences were considered significant at p < 0.05.

Results

126 patients (50.8% men; age 39.1±13.8 years; 60.3% active workers) from 33 centres were included. The proportion of patients in remission (CDAI <150) increased from 34.1% in V0 to 83.0% in V12. The CDAI decreased from 194 (21–269) to 48 (10–122) (p < 0.001). The PDAI decreased from 4.0 (0.0–4.0) to 0.0 (0.0–4.0) (p < 0.001). The quality of life measured by the EQ-5D improved from 0.735 (0.633–0.790) to 0.797 (0.726–1.000) (p < 0.001). The IBDQ-9 score increased (p < 0.001) from 56.7 (51.6–61.5) to 66.5 (60.1–73.6) (p < 0.001). The work hours lost by the EC in the previous week decreased from 2.0 (0.0–27.0) at V0 to 0.0 (0.0–1.0) at V12 (p = 0.004) and the work productivity (0–10 scale) decreased from 3.0 (0.3–5.8) to 1.0 (0.0 to 2.0) (p = 0.006).

Conclusion

In clinical practice, ADA has proven to be effective with a statistically significant improvement in clinical variables, quality of life, and work productivity.