CHICAGO (EGMN) –Oral budesonide is at least as beneficial as mesalazine for the treatment of active ulcerative colitis, achieving a clinical remission rate of 72% in a randomized, controlled phase III trial.

The study, sponsored by a German pharmaceutical company, also found that budesonide is just as effective at a once-daily 9 mg dose as it is at a thrice-daily 3 mg dose, Dr. Andreas Tromm said at the annual Digestive Disease Week.

The study involved 307 patients with active ulcerative colitis, who were randomized to 4.5 grams/day of mesalazine or to one of the two budesonide doses, said Dr. Tromm of the Evangelisches Krankenhaus, Hattingen, Germany.

At baseline, the patients’ mean age was 37 years. Their mean score on the Crohn’s Disease Activity Index (CDAI) was 265; more than 20% had a CDAI of more than 300. Their mean duration of disease was 6 years.

At the end of the 8-week study, clinical remission occurred in 72% of the budesonide group and 69% of the mesalazine group, not a significant difference. Both groups experienced similar 100-point improvements in the CDAI index within the first 4 weeks. The absolute decrease in CDAI at 8 weeks was 150 points in the budesonide groups and 130 points in the mesalazine group. Both budesonide groups were equally effective, Dr. Tromm said.

The median time to remission was 14 days in the budesonide groups and 16 days in the mesalazine group, also not a statistically significant difference.

There was a nonsignificant trend toward a better response in patients with a baseline CDAI score of more than 300. Among these patients, the clinical remission rate was 66% in the budesonide groups and 49% in the mesalazine group.

“All 3 treatment regimens were safe and no unexpected drug-related serious adverse events were observed,” according to Dr. Tromm.

Dr. Tromm mentioned that the trial was initially designed as a superiority study. However, after enrolling about half the patients, the investigators switched to a noninferiority design. “We did this because of the unexpectedly high remission rate in both groups,” Dr. Tromm said, noting that the trial had been powered to detect a 10% efficacy difference between the groups.

Dr. Tromm disclosed that he has received remuneration from the Falk Foundation for speaking and teaching, and that he is on the review and advisory panels of Dr. Falk Pharma GmbH of Freiberg, Germany, the study’s sponsor.

 

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芝加哥(EGMN)－一项随机对照的III期临床试验显示，口服布地奈德(budesonide)治疗活动性溃疡性结肠炎的效果至少与美沙拉嗪(mesalazine)相当，临床缓解率达到72%。

这项由德国制药公司发起的研究中同时发现，布地奈德9 mg每日用药1次与每日3次、每次3 mg的用法同样有效，德国Hattingen福音新教医院的Andreas Tromm医生在消化疾病周年会上报告。

研究中共纳入307例活动性溃疡性结肠炎患者，这些患者随机接受美沙拉嗪每日4.5g或上述2种布地奈德用法之一治疗， Tromm医生说。

基线时，患者平均年龄为37岁，其平均克罗恩病活动指数(CDAI)为265，20%以上的患者CDAI超过300，平均病程为6年。

在为期8周的研究结束时，布地奈德组和美沙拉嗪组的临床缓解率分别为72%和69%，无统计学差异。在最初的4周内两组患者的CDAI指数均得到100分的改善。第8周时，布地奈德组和美沙拉嗪组的CDAI绝对降低分别为150分和130分。布地奈德两种用法治疗组的疗效相同，Tromm医生说。

布地奈德和美沙拉嗪组的中位至缓解时间分别为14天和16天，也无统计学差异。

基线CDAI评分在300分以上者具有反应更佳的趋势，但无统计学意义。在这些患者中，布地奈德和美沙拉嗪组的临床缓解率分别为66%和49%。

据Tromm医生报告，“所有3种治疗方案均安全性良好，未观察到任何预期以外的药物相关严重不良事件。”

Tromm医生提到，该研究最初为优效性设计，但在入选约一半的患者后，研究者将其改为非劣效性设计。“我们这样做的原因是两种药物治疗组的缓解率都出乎意料的高，”Tromm医生说，他指出该试验的统计学效能允许检出治疗组间10%的疗效差异。

Tromm医生披露他接受了福克基金会的演讲和教学酬金，并且他是德国福克大药厂的审查和顾问小组成员，该药厂是本项研究的发起者。