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Meta-Analysis
. 2023 Oct;58(8):740-762.
doi: 10.1111/apt.17666. Epub 2023 Aug 17.

Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis

Achuthan Aruljothy  1 , Siddharth Singh  2 , Neeraj Narula  3 , Gordon W Moran  4 , Sudheer K Vuyyuru  1   5 , Malcolm Hogan  5 , Alexa Zayadi  5 , John K MacDonald  5 , Benedicte Caron  6   7 , Silvio Danese  8 , Laurent Peyrin Biroulet  6   7 , Christopher Ma  5   9   10 , Vipul Jairath  1   5   11   12
Affiliations
Meta-Analysis

Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis

Achuthan Aruljothy et al. Aliment Pharmacol Ther. 2023 Oct.

Abstract

Background: Ulcerative proctitis (UP) is a common highly symptomatic form of ulcerative colitis that can be difficult to treat.

Aim: To assess the efficacy of medical treatments for UP.

Methods: We searched MEDLINE, EMBASE, and CENTRAL on 23 November 2022 for randomised controlled trials (RCTs) of medical therapy for adults with UP. Primary outcomes included induction and maintenance of clinical remission. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for each outcome.

Results: We included 53 RCTs (n = 4096) including 46 induction studies (n = 3731) and seven maintenance studies (n = 365). First-line therapies included topical 5-aminosalicylic acid (5-ASA), conventional corticosteroids, budesonide, and oral 5-ASA. Therapy for refractory UP included topical tacrolimus and small molecules. Topical 5-ASA was superior to placebo for induction (RR 2.72, 95% CI 1.94-3.82) and maintenance of remission (RR 2.09, 95% CI 1.26-3.46). Topical corticosteroids were superior to placebo for induction of remission (RR 2.83, 95% CI 1.62-4.92). Topical budesonide was superior to placebo for induction of remission (RR 2.34, 95% CI 1.44-3.81). Combination therapy with topical 5-ASA and topical corticosteroids was superior to topical monotherapy with either agent. Topical tacrolimus was superior to placebo. Etrasimod was superior to placebo for induction (RR 4.71, 95% CI 1.2-18.49) and maintenance of remission (RR 2.08, 95% CI 1.31-3.32).

Conclusions: Topical 5-ASA and corticosteroids are effective for active UP. Topical 5-ASA may be effective for maintenance of remission. Tacrolimus may be effective for induction of remission. Etrasimod may be effective for induction and for maintenance of remission. Trials should include UP to expand the evidence base for this under-represented population.

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Conflict of interest statement

Declaration of funding interests: None.

Figures

FIGURE 1
FIGURE 1
The pooled risk ratio comparing clinical remission between patients receiving topical corticosteroids and placebo.
FIGURE 2
FIGURE 2
The pooled risk ratio comparing clinical remission between patients receiving topical 5-aminosalicylic acid and placebo.
FIGURE 3
FIGURE 3
The pooled risk ratio comparing clinical response between patients receiving topical 5-aminosalicylic acid and placebo.
FIGURE 4
FIGURE 4
The pooled risk ratio comparing endoscopic remission between patients receiving topical 5-aminosalicylic acid and placebo.
FIGURE 5
FIGURE 5
The pooled risk ratio comparing endoscopic response between patients receiving topical 5-aminosalicylic acid and placebo.
FIGURE 6
FIGURE 6
The pooled risk ratio comparing maintenance of clinical remission between topical 5-aminosalicylic acid and placebo.
FIGURE 7
FIGURE 7
The pooled risk ratio comparing clinical response between patients receiving topical corticosteroids and topical 5-aminosalicylic acid.
FIGURE 8
FIGURE 8
The pooled risk ratio comparing histologic response between patients receiving topical corticosteroids and topical 5-aminosalicylic acid.
FIGURE 9
FIGURE 9
The pooled risk ratio comparing clinical remission between patients receiving once daily and conventionally dosed (two or three times per day) topical 5-aminosalicylic acid.
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