What question did this study set out to answer?

To assess the effectiveness of adding pentoxifylline to mesalamine therapy in patients with ulcerative colitis.

April 1, 2026Open Access

Adjunctive Pentoxifylline Enhances Clinical Remission and Reduces Inflammatory Biomarkers in Mild-to-Moderate Ulcerative Colitis: A Randomized Double-Blind Placebo-Controlled Pilot Trial

Key Points

To assess the effectiveness of adding pentoxifylline to mesalamine therapy in patients with ulcerative colitis.
Randomized, double-blind, placebo-controlled pilot trial.
Sixty patients with mild-to-moderate ulcerative colitis received either mesalamine plus placebo or pentoxifylline.
Primary outcome measured was the partial Mayo score after 24 weeks.
Quality of life was assessed using the Inflammatory Bowel Disease Questionnaire.
Statistical analyses included intention-to-treat and per-protocol approaches.
Pentoxifylline significantly improved the partial Mayo score compared to placebo in both analysis methods.
Higher rates of clinical response and remission were observed with pentoxifylline.
Quality of life scores increased notably in the pentoxifylline group.
Levels of TNF-α, calprotectin, and ESR decreased significantly more with pentoxifylline.
Positive effects were consistent across different patient subgroups.

Abstract

Background: Despite mesalamine’s efficacy in mild-to-moderate ulcerative colitis (UC), many patients fail to achieve complete clinical or biochemical remission. Pentoxifylline (PTX) may act as an adjunct therapy by modulating cytokine production and oxidative stress. Aim: To evaluate the therapeutic effect of adding PTX in patients with UC. Methods: In this randomized, double-blind, placebo-controlled pilot study, 60 patients with UC were assigned to mesalamine plus placebo (Group 1) or mesalamine plus PTX 400 mg BID (Group 2) for 24 weeks. The primary outcome was changes in the partial Mayo score (PMS). Clinical remission was defined as PMS ≤ 2 with no subscore > 1; clinical response as a reduction in PMS ≥ 2 points. Quality of life (QoL) was measured using the Inflammatory Bowel Disease Questionnaire (IBDQ-32). Serum TNF-α, fecal calprotectin, and erythrocyte sedimentation rate (ESR) were assessed. Analyses were performed using intention-to-treat (ITT) and per-protocol (PP) approaches. Subgroup analyses stratified by prior mesalamine exposure, and multivariable regression adjusted for age, sex, disease duration, smoking, and disease extent. Results: PTX significantly improved PMS compared to placebo in both ITT and PP analyses. Clinical response and remission rates were higher with PTX. IBDQ-32 scores increased, and TNF-α, calprotectin, and ESR decreased significantly more with PTX. Improvements were consistent across mesalamine-naïve and experienced patients. Multivariable regression confirmed that these effects were independent of demographic or disease-related confounders. Conclusions: Adjunctive PTX significantly enhanced clinical outcomes, reduced inflammation, and improved QoL in UC patients, supporting its potential as an effective add-on therapy to mesalamine.

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