Tu1252 Effect of Budesonide MMx 6 mg on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Patients With Ulcerative Colitis: Results From a Phase III, 12 Month Safety and Extended use Study

Lichtenstein, Gary R.; Danese, Silvio; Ballard, Elizabeth D.; Moro, Luigi; Jones, Richard J.; Bagin, Robert; Gautille, Therese; Huang, Michael; Yeung, Philip; Harris-Collazo, Raul; Travis, Simon

doi:10.1016/s0016-5085(12)63046-7

Cited by 9 publications

(8 citation statements)

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“…Reductions in morning plasma cortisol levels occurred at a higher frequency in both budesonide MMX groups and the Entocort EC group, which is an expected consequence of any oral steroid treatment. However, mean morning plasma cortisol levels remained within the normal range at all times, and a subsequent extended maintenance treatment study with budesonide MMX 6 mg over 12 months showed no further decline 28 29. There were also no notable increases in glucocorticosteroid-related side effects with budesonide MMX compared with placebo.…”

Section: Discussionmentioning

confidence: 86%

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Travis

Danese²,

Kupčinskas

et al. 2013

Gut

Self Cite

232

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ObjectiveBudesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC).DesignPatients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score ≤1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a ≥1-point reduction in endoscopic index score from baseline.Results410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4%, 8.3%, 12.6% and 4.5%, respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95% CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2% vs 33.7%) and endoscopic improvement (42.2% vs 31.5%) versus placebo. The rate of histological healing (16.5% vs 6.7%; p=0.0361) and proportion of patients with symptom resolution (23.9% vs 11.2%; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups.ConclusionBudesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.

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Section: Discussionmentioning

confidence: 86%

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Travis

Danese²,

Kupčinskas

et al. 2013

Gut

Self Cite

232

196

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“…An open‐label 12‐month extension study of CORE I and II was performed to explore the efficacy and safety of budesonide‐MMX for maintenance of UC remission . It is important to note that a 6‐mg budesonide‐MMX formulation was used for this maintenance study and currently only 9 mg capsules are commercially available.…”

Section: Budesonide‐mmx Is Efficacious and Safe In Mild‐to‐moderate Ucmentioning

confidence: 99%

Review article: integrating budesonide‐MMX into treatment algorithms for mild‐to‐moderate ulcerative colitis

Danese

Siegel

Peyrin–Biroulet

2014

Aliment Pharmacol Ther

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SUMMARYBackground 5-Aminosalicylates (5-ASA) are first-line treatment for mild-moderately active ulcerative colitis (UC). When 5-ASAs fail, systemic corticosteroids have been the standard next step. Due to the significant side effect profile of systemic corticosteroids, alternative options in the treatment algorithm after 5-ASA failures are needed. Budesonide-Multi-Matrix System (MMX) is a novel oral formulation of budesonide that uses colonic release MMX technology to extend release of the drug to the colon. Now that budesonide-MMX has been approved for use in some countries, and pending in others we need to understand its position in the treatment algorithm for UC.

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“…There was no increased incidence in adverse events, steroid-related adverse events, or bone loss in the budesonide 6 mg daily group compared with placebo. There was a probability of relapse at 12 months of 40.9 % in the budesonide-MMX group compared to 59.7 % in the placebo group (p=0.0224) [16,17]. While one can infer from the above abstracts that budesonide-MMX 6 mg is effective at maintaining remission, there are no fully published trials to date that demonstrate budesonide-MMX at a dose of 6 mg to be an effective therapy for induction or maintenance of UC.…”

Section: Introductionmentioning

confidence: 98%

Positioning Therapy for Ulcerative Colitis

Grinspan

Kornbluth

2015

Curr Gastroenterol Rep

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Ulcerative colitis (UC) is a chronic inflammatory condition of the colon, characterized by diffuse mucosal inflammation, bloody diarrhea, and urgency. The mainstay of treatment has been mesalamine agents, steroids, thiopurines, and anti-tumor necrosis factor alpha (TNF-α) antibodies. Over the past several years, new therapies have emerged which have provided clinicians new treatment options as well as new challenges in deciding which treatment is best for their patient at given points in their disease course. These agents include budesonide-Multi-Matrix System (MMX), adalimumab, golimumab, and vedolizumab. In addition, randomized controlled trials have investigated a combination therapy of infliximab and azathioprine and a controlled trial of infliximab versus cyclosporine for intravenous steroid refractory UC. This review will focus on where these agents may be optimally positioned in treatment algorithms for UC.

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Tu1252 Effect of Budesonide MMx 6 mg on the Hypothalamic-Pituitary-Adrenal (HPA) Axis in Patients With Ulcerative Colitis: Results From a Phase III, 12 Month Safety and Extended use Study

Cited by 9 publications

References 0 publications

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study

Review article: integrating budesonide‐MMX into treatment algorithms for mild‐to‐moderate ulcerative colitis

Positioning Therapy for Ulcerative Colitis

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