22 December 2019 : Clinical Research
Budesonide Foam for Ulcerative Colitis Patients Experiencing Inadequate Response to Biological TherapyTomoyoshi Shibuya1ABCDEF*, Kei Nomura1BCE, Koki Okahara1BC, Keiichi Haga1BC, Osamu Nomura1BC, Takashi Murakami1BC, Shino Uchida1BC, Tomohiro Kodani1BC, Dai Ishikawa1BC, Naoto Sakamoto1BC, Tatsuo Ogihara1BC, Taro Osada1CD, Akihito Nagahara1ADE
Med Sci Monit 2019; 25:9855-9863
BACKGROUND: In recent years, a plethora of therapeutic agents for ulcerative colitis (UC), especially novel biologics (Bio), have become available. Although it is now possible to use biological drugs, there should be no need for frequently changing medications. To avoid first-pass metabolism in the liver, thus reducing systemic bioavailability, budesonide foam has been applied as a topical steroid. We therefore evaluated whether budesonide foam has therapeutic value in UC patients who responded inadequately to Bio or to tacrolimus.
MATERIAL AND METHODS: We enrolled 10 patients who were experiencing an inadequate response to Bio (n=7) or to tacrolimus (n=3) at Juntendo University. We used Lichtiger’s index to assess UC activity and clinical response.
RESULTS: Of the study patients, 4 were receiving adalimumab, 3 golimumab, and 3 tacrolimus. The average Lichtiger’s index before budesonide administration was 7.1 (range 13–3), which improved to 3.4 (range 7–0) after budesonide therapy (p=0.01). Notably, 4 of the 6 cases with a Lichtiger’s index >4 before budesonide administration achieved improvement of ≥3 points or remission.
CONCLUSIONS: Although the number of patients was small, budesonide foam had significant efficacy when added to the treatment of patients having an inadequate response to Bio or to tacrolimus. These results suggest that in cases responding poorly to Bio, adding budesonide foam as combination therapy can achieve a clinical remission.
Keywords: Biological Therapy, Budesonide, Colitis, Ulcerative, adalimumab, Antibodies, Monoclonal, Drug Therapy, Combination, Glucocorticoids, Middle Aged, Remission Induction, Retrospective Studies, Severity of Illness Index, Tacrolimus, Treatment Outcome
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