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P563. Clinical response and quality of life in patients with Crohn's disease treated with adalimumab in routine clinical practice

D. Ceballos1, F. Muñoz2, C. Saro3, C. De la Coba3, M.D. Aguilar4, P. Lazaro4, 1Dr. Negrín Hospital, Spain, 2Hospital de León, León, Spain, 3Cabueñes Hospital, 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). It would be interesting to know to what extent these results are reproduced in routine clinical practice. The aim of the study was to determine the effectiveness, measured as clinical response using disease activity and quality of life indices, of ADA in CD patients.

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)] were collected. Such data were again recorded at 1 (V1), 3 (V2), 6 (V3), 9 (V4) and 12 months (V5) later. 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) from 33 centres were included. The CDAI decreased (p < 0.05) at each subsequent visit from V0 to V3, from which the changes were not statistically significant; V0=194 (21–269) vs. V5=48 (10–122) (p < 0.001). The PDAI decreased from 4.0 (0.0–4.0) in V0 to 2.0 (0.0–4.0) in V1 (p < 0.001), from which the changes were not statistically significant. The quality of life measured by the EQ-5D improved from 0.735 (0.633–0.790) in V0 to 0.790 (0.684–1.000) in V1 (p < 0.001), from which the changes were not statistically significant. The IBDQ-9 score increased (p < 0.001) from 56.7 (51.6–61.5) in V0 to 64.7 (59.4–72.1) in V1, continuing the significant improvement in V2 (67.5, 60.6–72.1), remaining at similar levels in V5 (66.5, 60.1–73.6).

Conclusion

In clinical practice, ADA has proven to be effective with a statistically significant improvement in clinical and quality of life variables. This improvement was observed from the first month of starting treatment, and generally continues improving to 3–6 months, keeping stable until 12 months.