Efficacy of Combined Therapy With 5-Aminosalicylic Acids in Patients With Ulcerative Colitis With Isolated Biochemical Activity: A Real-Life Study
Background:
Ulcerative colitis (UC) is a chronic inflammatory bowel disease primarily affecting the colon and rectum, characterized by persistent mucosal inflammation. Common symptoms include rectal bleeding, abdominal pain, and urgency to defecate. The main therapeutic goals in UC are to induce and maintain clinical and biochemical remission, as well as to achieve mucosal healing. 5-Aminosalicylic acids (5-ASA), such as mesalazine and sulfasalazine, are first-line treatments for mild to moderate UC. Combining oral and topical 5-ASA therapies may provide additional benefits in inducing remission. This study aims to evaluate the efficacy of combined oral and topical 5-ASA therapy in inducing remission in UC patients with isolated biochemical activity.
Methods:
A cross-sectional, analytical study was conducted, including 26 UC patients treated at the Inflammatory Bowel Disease Clinic of the General Hospital of Mexico “Dr. Eduardo Liceaga.” All patients were clinically inactive according to the Truelove and Witts criteria. Laboratory parameters, including leukocyte count, albumin, C-reactive protein, serum potassium, and erythrocyte sedimentation rate, were within normal ranges. However, fecal calprotectin (FCP) levels exceeded 150 µg/g, indicating isolated biochemical activity. Patients received combined 5-ASA therapy (4.5 grams of oral mesalazine or 3 grams of sulfasalazine, plus a 4-gram rectal enema for extensive disease, or a 1-gram rectal suppository for rectal-limited disease) for 8 weeks. Post-treatment fecal calprotectin levels were reassessed. Statistical analysis was performed using SPSS version 29, with Wilcoxon tests used to compare changes in FCP. A <italic>P-</italic>value of < 0.05 was considered statistically significant.
Results:
All patients completed the study. The median baseline FCP was 800 µg/g (interquartile range: 528.5–1997.5), which decreased to 242.5 µg/g (interquartile range: 98.5–759.5) after 8 weeks of treatment, yielding a median difference (Δ) of 557.5 µg/g (95% CI: -430 to -1238; <italic>P<</italic> 0.001). The combined therapy reduced FCP levels by a factor of 3.61 compared to baseline.
Conclusions:
Combined oral and topical 5-ASA therapy is effective in reducing fecal calprotectin levels in UC patients with isolated biochemical activity. FCP levels significantly decreased after 8 weeks of treatment. These findings suggest that the combination of oral mesalazine and rectal enema/suppository is a promising approach for inducing remission in this patient population.
