Mildly to Moderately Active Ulcerative Proctitis Not Responsive to Rectal 5-ASA

This protocol addresses the next clinical step for patients with mildly to moderately active ulcerative proctitis who have not achieved remission following first-line rectal 5-ASA therapy within the expected assessment window.

Clinical scenario

Mildly to moderately active ulcerative proctitis — inflammation limited to the rectum, in the mild-to-moderate activity range.

Previous treatment — remission not achieved

Prior therapy: Rectal 5-ASA therapy
Goals not met at 8 weeks: Absence of rectal bleeding, no bowel urgency, normalized stool frequency, and a Mayo endoscopic score of 0 or 1.

Remission targets for this step

Induction of remission is defined as absence of rectal bleeding, no bowel urgency, normalized stool frequency, and a Mayo endoscopic score of 0 or 1.

Treatment approach — partial overview

When rectal 5-ASA has not produced remission, the structured protocol turns to alternative topical agents. The complete selection criteria, sequencing, and dosing are available in the full protocol below.

Instant Access to Structured Evidence-Based Regimens

References

DOI: 10.14309/ajg.0000000000003463

In patients with mildly to moderately active ulcerative proctitis, we recommend rectal 5-aminosalicylate acid (5-ASA) therapies at a dose of 1 g/daily for induction of remission.

For patients with mildly to moderately active proctitis not responsive to topical 5-ASA, we suggest tacrolimus suppository or beclomethasone suppository over no treatment.

For patients with mildly to moderately active proctitis or left-sided colitis, we suggest use of topical corticosteroids (suppository, foam, enema), over no treatment.

In a double-blind RCT conducted in 85 patients with refractory ulcerative proctitis, treatment with once daily 2 mg tacrolimus suppositories or 3 mg daily beclomethasone suppositories was associated with similar rates of clinical response at 4 weeks (63% and 59%, respectively, P 5 0.812).

In clinical trials, the definition of clinical remission has been a MES of 0 or 1, stool frequency of ≤1, and absence of rectal bleeding.

View source ↗