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P608 Crohn’s disease patients with high baseline symptoms achieve clinical remission more rapidly with Budesonide than with Mesalazine

I. Kunz*1, R. Hofmann1

1Tillotts Pharma AG, Rheinfelden, Switzerland


Budesonide (Entocort®) showed non-inferiority compared with Mesalazine (Pentasa®) in Japanese patients with mild-to-moderate active Crohn’s disease (CD) after 8 weeks of treatment.1 The aim of this analysis was to compare 2, 4, and 8 weeks remission rates based on Patient-reported Outcome (PRO) in patients treated with Budesonide (BUD) or Mesalazine (MZ) grouped according to high or low level of symptoms at baseline (week 0).


In a post-hoc sub-group analysis, patients with mild-to-moderate CD on BUD 9 mg/day (n = 54) or MZ 3 g/day (n = 53) were analysed. A two item weighted PRO based on stool frequency and abdominal pain (PRO2) was calculated. The daily values were accumulated for the whole week. Patients with a baseline PRO2 above or below the median of the study population (103) were compared. Calculations for difference between BUD and MZ were done for five different outcomes which were defined as: (1) PRO2<53 (clinical remission), and clinical improvements: (2) PRO2<53 or reduction of at least 57, (3) PRO2<53 or reduction of at least 38, (4) PRO2 change from BSL of at least 57 and (5) PRO2 change from BSL of at least 38.


Clinical remission [def 1] was achieved in significantly more patients starting with high BSL (>103) and treated with BUD compared with MZ after 2 weeks (n = 5 (19.2%) vs. n = 0 (0%) p = 0.05) and 4 weeks (n = 6 (22.2%) vs. n = 0 (0%) p = 0.03) of treatment. Also clinical improvements [def 2–5] were more expressed in patients starting with high BSL (data not shown). This significant difference in clinical remission between BUD and MZ was not achieved in patients starting with low BSL PRO2<103 (Week 2: (n = 4 (14.8%) vs. n = 7 (24.1%) p = 0.51); Week 4: (n = 4 (14.3%) vs. n = 8 (28.6%) p = 0.33)). There was no relevant difference between patients starting with high or low BSL after 8 weeks treatment.


This post-hoc sub-group analysis reveals that PRO2 is a suitable instrument to detect early improvement of symptoms. Budesonide (Entocort®) showed a more rapid onset of effect compared with Mesalazine (Pentasa®) in patients starting with high baseline symptoms.


1. Yokoyama T, et al. Inflamm Intest Dis 2017.