Efficacy and Tolerability of Oral Budesonide in Crohn’s Disease Patients with Attenuated Response to Anti TNF-α Antibody Drug- a Single Institutional Study

Background: Budesonide is a glucocorticoid approved as an oral medication for mild to moderate active Crohn's disease (CD) in 2016.The objective of this study was to clarify the efficacy, side effects, and other details regarding use of budesonide in CD patients with attenuated response to anti-tumor necrosis factor (TNF)-α antibody.Methods: Our clinical records of six patients with CD who had been administered budesonide were retrospectively examined.Anti-TNF-α antibody drugs in double volumes had been administered to all cases; mesalazine had also been administered to all cases.Budesonide was administered at 3 capsules (total, 9 mg) per day for the first 8 weeks and 2 capsules (6 mg) for the subsequent week.The subjective symptoms and objective findings, especially the frequency of bowel movements, C-reactive protein [CRP] and Crohn's Disease Activity Index (CDAI) before, during and after the budesonide administration period were examined.Results: In five cases (83%) budesonide was administered for the full 63 days; in 1 case (17%) it was stopped at 45 days because of Grade 1 edema.Improvement of subjective symptoms was seen in all cases.The frequency of bowel movements tended to decrease after the beginning of budesonide administration.The average values of CDAI tended to decrease and were kept under 150 during and after budesonide administration.CRP values tended to decrease during the administration period but were elevated after the completion of 9-week budesonide.Overall there were no statistically significant data, but some cases showed evident decreases.Conclusion: Oral budesonide was effective in subjective symptom improvement, and well tolerated in CD patients with attenuated response to anti TNF-α antibody drug.