Oral budesonide for induction of remission in ulcerative colitis

Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis

“…Although relatively few patients in the budesonide groups presented decreased cortisol levels, we observed no clinical sequelae, and their cortisol levels remained within normal limits, thus verifying budesonide's excellent safety profile as reported in numerous studies in conjunction with oral and rectal preparations with AE rates similar to those of placebo. 19,[25][26][27][28] In conclusion, our study shows similar efficacy and safety as well as excellent acceptance of novel budesonide suppositories and the gold standard 1 g MES suppositories in patients with active ulcerative proctitis. Our findings show a novel treatment alternative for patients intolerant of mesalamine or nonadherent to rectal foam or enemas.…”

Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis

“…Although relatively few patients in the budesonide groups presented decreased cortisol levels, we observed no clinical sequelae, and their cortisol levels remained within normal limits, thus verifying budesonide's excellent safety profile as reported in numerous studies in conjunction with oral and rectal preparations with AE rates similar to those of placebo. 19,[25][26][27][28] In conclusion, our study shows similar efficacy and safety as well as excellent acceptance of novel budesonide suppositories and the gold standard 1 g MES suppositories in patients with active ulcerative proctitis. Our findings show a novel treatment alternative for patients intolerant of mesalamine or nonadherent to rectal foam or enemas.…”

Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis

“…The ability to achieve and maintain remission using optimised 5-ASA therapy and locally acting steroids has several key clinical benefits. First, these treatments are able to achieve remission rapidly and are generally well tolerated 3 4 12 13 25. It is well documented that systemic steroids and advanced therapies, such as anti-TNFs, have the potential for serious AEs,5–8 31–34 which this study shows could be avoided in those achieving remission using an optimised approach.…”

Medical Treatment of Ulcerative Colitis: Does Traditional Therapy Still Have a Role?

“…Oral BUDE 9 mg MMX formulation for 8 weeks was tested in two controlled clinical trials for mild active left-sided and extensive UC. BUDE was significantly superior to a placebo in both studies but not superior to mesalamine 2.4 g/day and non-MMX BUDE 9 mg/day [43,44]. When BUDE was used as add-on therapy in patients not adequately controlled by mesalamine 2.4 g/day, it was significantly more effective than a placebo [45].…”

Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis

“…Although relatively few patients in the budesonide groups presented decreased cortisol levels, we observed no clinical sequelae, and their cortisol levels remained within normal limits, thus verifying budesonide's excellent safety profile as reported in numerous studies in conjunction with oral and rectal preparations with AE rates similar to those of placebo. 19,[25][26][27][28] In conclusion, our study shows similar efficacy and safety as well as excellent acceptance of novel budesonide suppositories and the gold standard 1 g MES suppositories in patients with active ulcerative proctitis. Our findings show a novel treatment alternative for patients intolerant of mesalamine or nonadherent to rectal foam or enemas.…”

Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis

“…The ability to achieve and maintain remission using optimised 5-ASA therapy and locally acting steroids has several key clinical benefits. First, these treatments are able to achieve remission rapidly and are generally well tolerated 3 4 12 13 25. It is well documented that systemic steroids and advanced therapies, such as anti-TNFs, have the potential for serious AEs,5–8 31–34 which this study shows could be avoided in those achieving remission using an optimised approach.…”

Medical Treatment of Ulcerative Colitis: Does Traditional Therapy Still Have a Role?

“…Oral BUDE 9 mg MMX formulation for 8 weeks was tested in two controlled clinical trials for mild active left-sided and extensive UC. BUDE was significantly superior to a placebo in both studies but not superior to mesalamine 2.4 g/day and non-MMX BUDE 9 mg/day [43,44]. When BUDE was used as add-on therapy in patients not adequately controlled by mesalamine 2.4 g/day, it was significantly more effective than a placebo [45].…”

Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis

“…Although relatively few patients in the budesonide groups presented decreased cortisol levels, we observed no clinical sequelae, and their cortisol levels remained within normal limits, thus verifying budesonide's excellent safety profile as reported in numerous studies in conjunction with oral and rectal preparations with AE rates similar to those of placebo. 19,[25][26][27][28] In conclusion, our study shows similar efficacy and safety as well as excellent acceptance of novel budesonide suppositories and the gold standard 1 g MES suppositories in patients with active ulcerative proctitis. Our findings show a novel treatment alternative for patients intolerant of mesalamine or nonadherent to rectal foam or enemas.…”

Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-moderate ulcerative colitis

“…The ability to achieve and maintain remission using optimised 5-ASA therapy and locally acting steroids has several key clinical benefits. First, these treatments are able to achieve remission rapidly and are generally well tolerated 3 4 12 13 25. It is well documented that systemic steroids and advanced therapies, such as anti-TNFs, have the potential for serious AEs,5–8 31–34 which this study shows could be avoided in those achieving remission using an optimised approach.…”

Medical Treatment of Ulcerative Colitis: Does Traditional Therapy Still Have a Role?

“…Oral BUDE 9 mg MMX formulation for 8 weeks was tested in two controlled clinical trials for mild active left-sided and extensive UC. BUDE was significantly superior to a placebo in both studies but not superior to mesalamine 2.4 g/day and non-MMX BUDE 9 mg/day [43,44]. When BUDE was used as add-on therapy in patients not adequately controlled by mesalamine 2.4 g/day, it was significantly more effective than a placebo [45].…”