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P397. Quality of life of Crohn's disease patients under immunosuppressive therapy in Germany – preliminary results of the DaLi study

M. Reinshagen1, B. Bokemeyer2, T. Krummenerl3, M.R. Mross4, P. Nurwakagari5, M. Schwarz5, B.M. Wittig5, 1Klinikum Braunschweig, Dep. of Medicine I, Braunschweig, Germany, 2Gastroenterology Practice, Minden, Germany, 3Gastroenterology Center at Germania Campus, Muenster, Germany, 4Gastroenterology Practice, Berlin, Germany, 5Abbott GmbH & Co. KG, Medical Department, Wiesbaden, Germany

Background

The improvement of health-related quality of life (HRQoL) is one of the treatment goals of a patient-centred medical therapy. HRQoL in patients with Crohn's disease (CD) can be measured by the EQ-5D questionnaire (EQ-5D). It comprises a descriptive system (EQ-5D d.s.) covering health-related impairment in five dimensions and a visual analogue scale (EQ-VAS). The aim of the study was to investigate HRQoL in CD patients treated with different immunosuppressive therapies during 9 months of follow-up in clinical routine.

Methods

In this ongoing prospective observational study patients with moderate to severe CD receiving conventional immunosuppressive therapy (i.e. systemic corticosteroids [CS] and/or immunosuppressants [IMM]) in clinical routine, but naïve to anti-TNF therapy are followed for 9 months. HRQoL status using the EQ-5D, disease severity according to investigator, and current medical treatment is recorded at baseline, month 3, 6, and 9. During the study patients are permitted to switch to anti-TNF or other immunosuppressive therapy. The mean change of EQ-5D scores from baseline to month 9 of the study were compared between different immunosuppressive treatments using the Mann–Whitney U test.

Results

In total, 161 IBD centres across Germany participate in the study. As of February 2012, complete documentation was available for 350 patients for preliminary analysis. At baseline 64.9% of patients received CS of any dose (mono or combination therapy with IMM), and 35.1% an IMM monotherapy, respectively. At baseline EQ-5D d.s. and EQ-VAS scores were higher in patients on IMM monotherapy compared with patients on CS mono or combination therapy (e.g. mean EQ-VAS: 76.3 vs 70.5, p < 0.005). 38% of patients with CS use at baseline discontinued CS treatment during the study, while an anti-TNF therapy was started in 19% of all patients and in 24% of patients with baseline CS use. Significant EQ-5D d.s. and EQ-VAS improvements were seen in anti-TNF patients compared with patients under non-biological therapy at month 9 (e.g. mean EQ-VAS change at month 9 from baseline: 12.51 vs 2.42; p < 0.001). Patients on combined IMM with anti-TNF agents showed significant improvements in EQ-5D d.s. and EQ-VAS scores compared with patients on IMM alone within 9 months.

Conclusion

Anti-TNF therapy (alone or in combination with IMM) was associated with significantly HRQoL improvements in German CD patients compared with patients treated with IMM monotherapy.